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JANUARY 2015
VOL 11
NUMBER 1
Advancing Knowledge | Enhancing Care
PSORIASIS REVIEW
Included in this Issue
1
2
Top 5 Clinical Papers Review
• Long-lived memory T cells present
challenges in treating psoriasis
relapse
• Epidermal defects may lead
to heightened inflammatory
responses and initiation/
exacerbation of psoriasis
• Brodalumab study shows
targeting IL-17 results in improved
response in treating psoriatic
arthritis
• Consequences of antibody
formation against adalimumab in
patients with psoriasis
• Variations in the promoter
region of the IL-22 gene may
be associated with early-onset
psoriasis and in production of IL22 in patients with psoriasis
A Letter from the President
8Focus on Psoriasis: A Report
from the 23rd European
Academy of Dermatology
& Venereology Congress,
Amsterdam, Netherlands
17IPC’s Crossfire Symposium:
The Advent of Biosimilars
1910TH ANNIVERSARY SECTION
27 IPC News
• Access to care
• Patient care
• Research
• Education and Outreach
• New IPC councilor
International Psoriasis Council
1034 S. Brentwood Blvd., Suite 600
St. Louis, MO 63117
Tel 972.861.0503
Fax 214.242.3391
www.psoriasiscouncil.org
IPC’S SEMI-ANNUAL REVIEW OF THE TOP
FIVE PAPERS: JANUARY-JUNE 2014
Every six months, IPC’s board and councilors suggest and vote on articles that
make the greatest impact on psoriasis research. The 5 papers that received the
most votes are reviewed here with commentary. Summaries and commentaries
were written by co-editors Drs. Robert Bissonnette and Johann Gudjonsson.
1. Persistence of long-lived memory T cells presents
major challenge in treating psoriasis in previously
inflamed sites
Epidermal Th22 and Tc17 cells form a localized disease memory in clinically
healed psoriasis. Cheuk S, Wikén M, Blomqvist L, Nylén S, Talme T, Ståhle M, et al. J
Immunol. 2014 Apr 1;192(7):3111-20. doi: 10.4049/jimmunol.1302313. Epub 2014 Mar 7.
Summary
A remarkable characteristic of
psoriasis is that on withdrawal of
successful treatments, the disease
recurs in previously inflamed sites.
This suggests that a site-specific
disease memory is formed during
active disease and that such disease
memory is maintained within the
skin during remission. Acting on
this observation, Dr. Cheuk et al
performed detailed analyses of
T-cell function within the epidermis
and dermis after successful biologic
(anti-TNF and anti-IL-12/IL-23) and
narrow-band (nb) UVB treatments.
In their study, the authors confirm
previous observations that there is
a major infiltration of CD8+ T cells
into psoriatic epidermis in active
lesions, and demonstrate that a large
proportion of these cells belong to a
subset of T cells called tissue-resident
memory (TRM) cells. Importantly, the
authors demonstrate that these cells
maintain their inflammatory capacity
in resolved lesions as long as 6 years
after the initiation of treatment.
On reactivation, these cells readily
produce IL-22 and IL-17, and are likely
to be the main cause of recurrent
psoriasis in previously affected skin.
Cont., Page 3
PSORIASIS REVIEW
JANUARY 2015
VOL 11, NUMBER 1
A LETTER FROM THE PRESIDENT
Dear colleagues,
I am pleased to welcome you to this
issue of the IPC Psoriasis Review
Newsletter, which celebrates
IPC’s 10th anniversary as a global
organization working to advance
our understanding of psoriasis
through research and education,
and to enhance patient care. Thanks
to the participation and support of key opinion leaders in
psoriasis, IPC has, over the past 10 years, grown in influence
worldwide through educational exchanges and ambitious
initiatives that bring together leaders in psoriasis research,
education and clinical management.
Looking ahead to the next 10 years, we will expand our
programmes and projects at an international level and
continue to serve as a think tank for promoting new ideas.
The past decade has been an exciting time to be involved in
research and education; the next 10 years hold promise for
continued collaboration among psoriasis leaders that will
lead to the best care for their patients.
You can read about IPC’s first decade, its growth and
accomplishments in a special tenth-anniversary section
that begins on page 19. It includes a look at how IPC began,
a timeline highlighting major milestones, and observations
from our board members.
Also in this issue:
•O
ur regular “Top 5” feature – reviews of the top five
clinical and research articles nominated and chosen
earlier this year by IPC councilors. For this issue, the
articles had to be published between January and June
2014.
•A
report by contributing writer Mahir Patel, MD, from the
23rd Congress of the European Academy of Dermatology
& Venereology (EADV), which took place in Amsterdam,
The Netherlands, in October. The report summarizes the
conference’s most significant discussions about psoriasis
research.
•M
ahir Patel also attended the IPC-sponsored “Crossfire
Symposium: the Advent of Biosimilars,” held during
2
Advancing Knowle dge | Enhancing C are
the EADV congress. He reports on highlights of the
symposium’s discussions and debates about the science,
safety and future clinical use of these “follow-on”
biologics.
• I PC CEO Steve O’Dell made two appearances recently to
advocate for access to treatment and care for patients
with psoriasis. Read about his testimony at a Food
and Drug Administration advisory committee meeting
about the importance of developing additional psoriasis
therapies and his speech to pharmaceutical industry
leaders about the need for a better understanding of the
worldwide prevalence of psoriasis.
• I PC’s Board of Directors responded to proposed changes
by the U.S. insurance carrier United Healthcare that
could have limited access to certain biologics that treat
psoriatic diseases.
• I PC welcomed Christine Bundy, PhD, from Manchester,
United Kingdom, as our newest councilor.
As I write this message, I am eagerly anticipating the IPC
Think Tank and the Psoriasis: From Gene to Clinic Congress
in London in December. A report of these two important
events for IPC will appear in the next issue of the Psoriasis
Review.
I want to acknowledge the co-editors of this issue, Dr.
Johann Gudjonsson of the University of Michigan, Ann
Arbor, and Dr. Robert Bissonnette of Innovaderm Research
Inc., Montreal, Canada, for their significant contributions to
this issue.
I hope you find this newsletter interesting and informative.
I wish to thank all of our board members and councilors
for your support of and enthusiasm for IPC over the past
10 years.
With best wishes,
Professor Chris Griffiths, MD, FRCP, FMedSci
President, International Psoriasis Council
Manchester, United Kingdom
PSORIASIS REVIEW
JANUARY 2015
VOL 11, NUMBER 1
IPC’S SEMI-ANNUAL REVIEW OF THE TOP FIVE PAPERS
JANUARY-JUNE 2014
Cont. from Page 1
COMMENTARY Persistence of long-lived memory T
cells in tissues has been well known for a long time, and
these cells have a key role in protecting against resolved
local viral infections, such as those mediated by herpes
simplex viruses. These cells are also known to have a
major role in mediating the recurrent lesions that are
seen with fixed drug eruptions. The majority of the T
cells mediating these reactions belong to a subset of
tissue-resident memory (TRM) T cells, which in contrast
to effector memory (TEM) and central memory T cells
(TCM), do not circulate and reside in tissues for prolonged
periods of time. The enrichment of this subset in psoriatic
skin as well as resolved psoriatic lesions is perhaps not
unexpected; however, the persistence of these cells over
such a long period of time is striking. These findings are
of critical importance as a major challenge in treating
psoriasis relapse when treatment is withdrawn. These
findings indicate that TRM cells are the major culprits
for the local relapse of psoriasis. A major focus now
should be to identify the factors that help maintain this
population in resolved psoriatic lesions, thereby leading
to eventual therapeutic targeting of this T-cell population,
and, with it, new ways of inducing and maintaining
permanent remission in psoriasis.
For additional copies of IPC’s Psoriasis Review Newsletter or to learn more about IPC, please visit www.psoriasiscouncil.org.
IPC BOARD OF DIRECTORS
IPC COUNCILORS
Officers
Christopher EM Griffiths,
President, United Kingdom
Alexa B. Kimball, Vice
President & PresidentElect, United States
Hervé Bachelez, Secretary,
France
Craig L. Leonardi, Treasurer,
United States
Steve O’Dell, Chief Executive
Officer, United States
Africa
Members
Jonathan Barker, United
Kingdom
Robert Holland III, United
States
Alan Menter, Founding
President, United States
Wolfram Sterry, Germany
Bruce Strober, United States
Peter Van De Kerkhof,
Immediate Past President,
Netherlands
South Africa
Gail Todd
Asia
India
Murlidhar Rajagopalan
Israel
Arnon D. Cohen
Japan
Hidemi Nakagawa
Philippines
Vermén Verallo-Rowell
Singapore
Wai-Kwong Cheong
Colin Theng
Australia
Peter Foley
Europe
Austria
Georg Stingl
Robert Strohal
Denmark
Lars Iversen
Knud Kragballe
Lone Skov
Claus Zachariae
Netherlands
Menno Alexander de Rie
Elke MGJ de Jong
Errol Prens
Marieke B. Seyger
France
J.P. Ortonne
Carle Paul
Spain
Esteban Dauden
Carlos Ferrándiz
Lluís Puig Sanz
Germany
Matthias Augustin
Ulrich Mrowietz
Alexander Nast
Jörge Prinz
Kristian Reich
Robert Sabat
Diamant Thaçi
Ireland
Brian Kirby
Italy
Sergio Chimenti
Alberto Giannetti
Giampiero Girolomoni
Paolo Gisondi
Luigi Naldi
Carlo Pincelli
Sweden
Mona Ståhle
Switzerland
Wolf-Henning Boehncke
Michel Gilliet
Jean-H. Saurat
United Kingdom
Ian Bruce
Christine Bundy
Arthur David Burden
Robert Chalmers
Andrew Finlay
Elise Kleyn
Ruth Murphy
Frank O. Nestle
Tony Ormerod
Nick Reynolds
Catherine Smith
Richard Warren
Helen Young
North America
Canada
Robert Bissonnette
Marc Bourcier
Wayne Gulliver
Charles W. Lynde
Richard Langley
Kim Papp
Yves Poulin
Ronald Vender
United States
April Armstrong
Andrew Blauvelt
Kevin Cooper
Charles Ellis
Joel Gelfand
Kenneth Gordon
Alice Gottlieb
Johann Gudjonsson
Francisco Kerdel
Gerald Krueger
James Krueger
Mark Lebwohl
Nehal Mehta
Amy Paller
David Pariser
Mark Pittelkow
Linda Stein Gold
Jashin Wu
South America
Argentina
Edgardo Chouela
Cristina Echeverría
Fernando Stengel
Brazil
Gladys Aires-Martins
André Vicente Esteves de
Carvalho
Ricardo Romiti
Chile
Claudia de la Cruz
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JANUARY-JUNE 2014
2. Epidermal defects may lead to heightened inflammatory responses and eventual
initiation or exacerbation of psoriasis
Abnormal Epidermal Barrier Recovery in Uninvolved Skin Supports the Notion of an Epidermal Pathogenesis of Psoriasis.
Ye L, Lv C, Man G, Song S, Elias PM, Man MQ. J Invest Dermatol. 2014 Apr 29. doi: 10.1038/jid.2014.205. [Epub ahead of print]
Summary
In this short communication, Dr. Ye et al demonstrate that
involved and uninvolved skin of patients with psoriasis
display altered epidermal function and homeostasis.
In this study, 44 patients with chronic plaque psoriasis
and 68 normal controls were enrolled, and epidermal
functions were evaluated both in psoriatic lesions,
uninvolved skin, and comparable sites in normal controls.
The authors show that trans-epidermal water loss (TEWL)
and surface pH are increased in psoriatic lesions, whereas
stratum corneum hydration and barrier recovery were
markedly decreased in psoriatic skin. Interestingly,
surface pH and barrier recovery were also abnormal
in uninvolved skin in a subset of patients with more
active/progressive disease (defined as recent or ongoing
development of new lesions and prominent inflammation,
often accompanied by pruritus). This was interpreted as
supporting an “outside-to-inside” scenario similar to what
exists in atopic dermatitis, with the epidermal defects
leading to heightened inflammatory responses and
eventual initiation or exacerbation of psoriasis.
4
COMMENTARY The argument whether psoriasis is
driven by a primary defect in epidermal function or an
immunologically-initiated disorder is an old one. In the
60s and late 70s, the dominant view was that psoriasis
was primarily a keratinocyte-driven disease. However,
with the advent of cyclosporine in the mid-to-late 80s,
the immune system was implicated in its pathogenesis
and the focus shifted toward the adaptive, and later the
innate, arms of the immune system as having key roles,
with the role of epidermal function in psoriasis largely
falling to the side. Recently, the focus has shifted back
to the epidermis, as several of the risk loci identified
through genome-wide association studies include genes
that have important roles in epidermal biology and
homeostasis. The importance of the findings presented in
this commentary is that they demonstrate a mechanism
by which elevated surface pH can lead to changes in
the epidermal barrier homeostasis and inflammatory
responses, which in turn may initiate or exacerbate
psoriasis. Although these findings are highly intriguing,
they do not rule out other potential scenarios. A key one
is to determine what comes first. Is it the spillover or
systemic inflammation resulting from an active disease
that leads to the abnormal barrier defect, or is it the
defective barrier that is turning on the inflammation? This
remains unanswered, but, judged from recent genetic
findings, both immune- and epidermal-specific genes
are implicated in the genetic susceptibility of psoriasis.
Therefore, the answer to this question is likely not going
to be one-sided, but more likely that the epidermis and
inflammatory responses are intrinsically linked, and both
are critically involved in the initiation and/or exacerbation
of psoriasis.
PSORIASIS REVIEW
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3. Study of the biologic brodalumab confirms that targeting IL-17 results in
significant clinical response when treating psoriatic arthritis
Brodalumab, an Anti-IL17RA Monoclonal Antibody, in Psoriatic Arthritis. Mease PJ, Genovese MC, Greenwald MW,
Christopher T. Ritchlin, et al. N Engl J Med 2014; 370:2295-2306 June 12, 2014 DOI: 10.1056/NEJMoa1315231.
Summary
In this paper, Mease et al present the results of a
multi-center, phase II, placebo-controlled clinical trial on
the use of brodalumab in psoriatic arthritis. Patients were
randomly split into three groups: placebo, 140-mg, and
280-mg groups for 12 weeks, at which time all patients
were eligible to participate in an open-label extension
phase receiving 280 mg of brodalumab every 2 weeks
for an additional 40 weeks. At week 12, 37% and 29% of
patients in the 140-mg and 280-mg groups, respectively,
achieved significant clinical response as measured by the
ACR20 criteria (20% improvement in American College of
Rheumatology response criteria), in contrast to 18% of
patients receiving placebo. At week 24, rates of ACR20
response in the 140-mg and 280-mg groups were 51% and
64% respectively, as compared with 44% in patients who
switched from placebo to 280 mg brodalumab in the
extension phase. These responses continued to improve
during the remainder of the study. Overall, the drug was
well tolerated, with the main adverse event being upper
respiratory tract infection. Importantly, clinical responses
were similar among patients who had received previous
biologic therapy and those who had not received such
therapy.
COMMENTARY IL-17A has recently been implicated
as having a role in both psoriatic arthritis and other
seronegative spondylarthropathies. Brodalumab is one
of three new drugs that target IL-17 and are currently in
clinical trials or have just completed phase III trials for the
treatment of psoriasis. In contrast to the other two—
secukinumab and ixekizumab, which only target IL-17A—
brodalumab targets and blocks the IL-17 receptor A, which
mediates signaling for IL-17A and the signaling for several
other members of the IL-17 family: IL-17F, IL-17C, and IL-17E.
Whether this translates to higher efficacy still is not clear.
Although no data yet exists on the effect of ixekizumab in
psoriatic arthritis, secukinumab has been shown to give
similar response, although this did not reach statistical
significance given the small study cohort (n=42 patients,
28 drug vs. 14 placebo) and the short study period (24
weeks). In summary, this study confirms that targeting
IL-17 in psoriatic arthritis is beneficial and leads to clinical
improvement. Importantly, these data also indicate
that a full clinical response may take longer than the 12
weeks of observation used in most clinical trials. This is
one of the lead agents in a new and very promising class
of biologics that will markedly improve our options in
treating both psoriasis and, as has now been suggested,
psoriatic arthritis as well.
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4. The presence of anti-drug antibodies is associated with lower drug levels and
lower clinical response in patients with psoriasis receiving the biologic adalimumab
Extent and consequences of antibody formation against adalimumab in patients with psoriasis: one-year follow-up.
Menting SP, van Lümig PP, de Vries AC, et al. JAMA Dermatol. 2014 Feb;150(2):130-6. doi: 10.1001/jamadermatol.2013.8347.
Summary
Clinical relevance of anti-drug antibodies (ADA) in psoriatic
patients treated with a biologic remains a controversial
issue. In this publication, Menting et al extend previously
reported findings from the same group on the relationship
between ADA, drug levels, and clinical response in
patients with psoriasis. They show that the presence of
ADA is associated with lower drug levels and lower clinical
response in patients with psoriasis receiving adalimumab.
They followed 80 patients treated with adalimumab for up
to a year. Clinical efficacy was assessed using the Psoriasis
Area Severity Index (PASI) at baseline, week 12, week 24,
and week 52. Serum through levels of adalimumab and ADA
were also evaluated at the same time points. Anti-drug
antibodies were detected in 49% of patients, and these
ADA were already present by week 24 in 90% of patients. At
week 52 or at the early termination visit, adalimumab drug
levels were undetectable (median value of 0) in patients
who had high levels of ADA, and all of these patients were
nonresponders. Fewer patients receiving adalimumab in
combination with methotrexate had ADA as compared to
patients receiving adalimumab alone.
6
COMMENTARY There are several different techniques
available to measure anti-drug antibodies, and results
may vary according to the technique used. The
adalimumab phase III (REVEAL) study reported that
8.8% of patients had detectable levels of ADA at least
once within the first 52 weeks. More recent publications,
using different techniques, showed higher levels of
ADA. The presence or absence of ADA is usually relevant
if it is associated with lower drug levels and lower
clinical responses. The study by Menting et al is one of
the most extensive in which ADA and drug levels were
measured and correlated with clinical efficacy in patients
with psoriasis. This study confirms previous findings
in patients suffering from psoriasis and rheumatoid
arthritis on the close relationship between the presence
of high titers of ADA, low adalimumab drug levels and
low clinical response. The lower frequency of ADA in
patients on methotrexate is interesting; however, it is
difficult to draw conclusions because of the small number
of patients. This certainly deserves to be investigated
in larger studies. Interestingly, 90% of patients who
developed ADA had detectable levels within 24 weeks
of starting adalimumab treatment. This suggests
that patients losing response after 6 or 12 months of
treatment initiation may be less likely to do so because
of ADA. This is an important question that should also be
investigated in trials of longer duration as it may influence
treatment optimization strategies.
PSORIASIS REVIEW
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5. Variations in the promoter region of the IL-22 gene may play a significant role in
early-onset psoriasis and in increased production of IL-22 in patients with psoriasis
Genetic variants of the IL-22 promoter associate to onset of psoriasis before puberty and increased IL-22 production in T
cells. Nikamo P, Cheuk S, Lysell J, et al. J Invest Dermatol. 2014 Jun;134(6):1535-41. doi: 10.1038/jid.2014.5. Epub 2013 Jan 3.
Summary
This study by Nikamo et al provides interesting new
information on the importance of interleukin-22 (IL-22) in
psoriasis. The authors sequenced the promoter region of
the IL-22 gene and identified 13 previously reported small
nucleotide polymorphisms (SNPs). Mutations were mostly
found in areas that are putative binding sites for the Aryl
Hydrocarbon Receptor (AhR), an important transcription
factor for IL-22. The authors further analyzed the presence
of 4 of these genetic variations in the promoter region
of the IL-22 gene in 1,069 patients with psoriasis and
1,529 controls without psoriasis. They found a significant
association between the presence of these variations and
an early onset of psoriasis (before 10 years of age). The
authors further compared IL-22 plasma levels and IL-22
production in vitro by peripheral blood mononuclear cells
(PBMCs) from psoriasis patients with and without those
variants. They found no difference in plasma levels of IL-22,
but found that the proportion of CD4+ cells expressing IL-22
was higher in patients with variants in the promoter region
of the IL-22 gene. They also found that the production of
IL-22 and IL-17 was higher after in vitro stimulation of PBMCs
of patients with the variants as compared to patients
without the gene variants.
COMMENTARY IL-22 can be viewed as a cytokine in search
of a role in the pathogenesis of psoriasis. IL-22 mRNA
and protein levels have been shown to be increased in
psoriatic skin. Serum levels of IL-22 are also increased in
patients with psoriasis and some studies have shown
a correlation between disease severity and IL-22 serum
levels. Despite these findings, the exact role of IL-22 in
the pathogenesis of psoriasis remains elusive. Studies
using anti-IL-22 monoclonal antibodies for the treatment
of psoriasis have been conducted, but have not yet
been published. At least one study was terminated early
when an interim analysis showed it would not achieve its
primary endpoint (clinicaltrial.gov identifier NCT01010542).
The study by Nikamo et al suggests that IL-22 may have
a more important role in early-onset psoriasis. The fact
that mutations were mostly found in areas that are
putative binding sites for AhR is very interesting, as
tobacco combustion generates several AhR agonists. The
prevalence of smoking has been reported to be increased
in patients who have psoriasis. It would be interesting to
study the impact of smoking on psoriasis severity in this
patient population. ■
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PSORIASIS REVIEW
JANUARY 2015
VOL 11, NUMBER 1
A REPORT FROM THE 23RD CONGRESS OF THE EUROPEAN
ACADEMY OF DERMATOLOGY & VENEREOLOGY
Pustular psoriasis, methotrexate use, biomarkers among conference topics
By Mahir Patel, MD
Contributing writer Dr. Mahir Patel has
completed a two-year clinical research
fellowship focusing on psoriasis under
the supervision of Dr. Alan Menter at
Baylor University Medical Center-Dallas,
where he is now in his second year
of dermatology residency training.
He has a Bachelor of Arts degree in
biochemistry from Austin College in Sherman, Texas, and
received his doctor of medicine degree from University of
Texas Southwestern Medical Center in Dallas.
Psoriasis management and treatment were significant
topics of discussion during the 23rd European Academy of
Dermatology and Venereology Congress in Amsterdam,
Netherlands in October 2014. Updates in patient care were
presented by renowned international speakers. Following
are summaries of the most significant discussions.
Palmoplantar pustular psoriasis
Palmoplantar pustular psoriasis (PPPP) is a phenotype
of psoriasis that is particularly challenging to treat and
has special management considerations. Randomized
controlled trials have shown that cyclosporine has the best
evidence-based efficacy for PPPP. It is the most suitable
therapy for induction therapy, but, due to adverse events
with continuous use, it is not appropriate for long-term
treatment.1 Acitretin is also used as a first-line therapy,
although it needs to be further evaluated using randomized
controlled trials as monotherapy. Anti-TNF therapy has
been reported in case series as having predominant
efficacy. Research is limited, however, so anti-TNF
therapy is considered a second-line treatment for PPPP.
A recent study by Morales et al evaluated ustekinumab
for refractory palmoplantar pustulosis in five patients
and demonstrated complete resolution in all patients at
week 20.2 In contrast, a recent randomized control trial
comparing treatment efficacy of ustekinumab to placebo in
patients with PPPP suggest limited efficacy of ustekinumab
45 mg dosage. Therefore, the role of ustekinumab for
treatment in PPPP is presently unclear and needs to be
evaluated further.3 Treatment of PPPP with anakinra, an IL-1
8
inhibitor, demonstrated partial improvement in an isolated
case study.4
Generalized pustular psoriasis
A discussion of generalized pustular psoriasis (GPP) focused
on National Psoriasis Foundation treatment guidelines.
First-line therapies include acitretin, cyclosporine,
methotrexate, and etanercept, while second-line
considerations are adalimumab and infliximab.5 Clinical
trials are underway to test secukinumab, an IL-17A
antagonist and ustekinumab for treating GPP.
(Generalized pustular) psoriasis
does not appear to respond
in the same manner to traditional
therapies as psoriasis vulgaris
and can paradoxically occur
in patients on anti-TNF-∝ treatments.
Also discussed were mutations in the interleukin-36
receptor antagonist (IL-36RN) gene and their association
with pustular forms of psoriasis, but not typical psoriasis
vulgaris, which appears to be genetically distinct. IL36RN
is a part of the extended IL-1 family of cytokine/cytokine
receptors, and mutations of this gene have been found
in palmoplantar pustular psoriasis, generalized pustular
psoriasis, and acrodermatitis continua of Hallopeau, an
uncommon variant of pustular psoriasis.6 Successful
treatment with anakinra was reported in a patient with
generalized pustular psoriasis carrying mutations in the
IL36RN gene.7 This type of psoriasis does not appear to
respond in the same manner to traditional therapies as
psoriasis vulgaris and can paradoxically occur in patients
on anti-TNF-∝ treatments, providing further evidence of
its distinct immunopathogenetic basis.8 Thus, this form
of psoriasis may require reclassification and a different
therapeutic approach, compared with standard psoriasis.
PSORIASIS REVIEW
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A REPORT FROM 23RD CONGRESS OF THE EUROPEAN ACADEMY
OF DERMATOLOGY & VENEREOLOGY
Methotrexate and liver screening
This discussion session addressed screening patients on
long-term methotrexate for liver fibrosis. Methotrexate
remains a first-line systemic agent for chronic plaque
psoriasis due to its long-term efficacy, safety, availability,
and cost. Thus, screening for liver fibrosis from long-term
use continues to be an important topic for dermatologists.
Increasingly, data show that as long as patients on
methotrexate are appropriately screened and monitored,
they can continue to use it safely and effectively for the
long term. A systematic review of 23 published studies
explored treatment modalities, incidence, risk factors,
and monitoring of liver toxicity.9 The review suggests the
drug may not be as hepatotoxic as previously believed.
Noninvasive markers for liver fibrosis were also reviewed,
including serum measurements of type III procollagen
(PIIINP) and Fibrotest, which is commonly used in France,
as well as the imaging modality transient elastography,
which measures liver stiffness as a surrogate for fibrosis.
The review suggested that Fibrotest and elastography can
improve the ability to detect liver fibrosis noninvasively
and ideally should be used in combination with PIIINP to
minimize the need for liver biopsies.
Polyglutamation occurs when methotrexate is actively
transported into cells, at which point they can affect
multiple pathways related to inflammation. The process
of polyglutamation takes time and reaches steady states
at 4-5 months, which can be concluded to be the exact
time of maximal efficacy. Due to the long-term nature of
this process, red blood cell polyglutamation is believed
to be a potential surrogate marker for compliance and
can be measured through high-performance liquid
chromatography. In addition, the test can help guide
dose adjustments, as increasing dosage after adequate
polyglutmation may not yield any increase in efficacy.10
Biologics and long-term efficacy
Management planning for psoriasis patients includes five
significant factors: guidelines, patient considerations,
clinician preference for treatment, financial considerations,
and clinical service infrastructure. Revised guidelines from
the British Association of Dermatologists will be published
in 2015. Also discussed was an important UK-based website,
www.nice.org.uk/cg153, which outlines National Institute
for Health and Care Excellence (NICE) clinical guidelines
for the assessment and management of psoriasis. These
guidelines considered multiple systematic reviews, 23,000
abstracts, 16,000 full manuscripts, and 298 studies to create
algorithms for guiding psoriasis management.
Investigation into the pathogenesis of psoriasis over the
course of the last decade has resulted in many novel and
effective biologics for treating moderate to severe disease.
Little is known, however, regarding variability in treatment
response. For example, a significant proportion of patients
on biologic therapy responds inadequately to biologics –
defined by failing to respond initially or secondary failure
– with diminishing response over time. Thus, the ability to
target treatment to a particular molecular profile would be
advantageous moving forward.
Loss of efficacy with biologic therapy is a frequent problem.
Approaches to consider in this scenario include adjusting
the dosage of the biologic, monitoring anti-drug antibodies
(ADAs), adding another therapy (eg, methotrexate,
phototherapy, acitretin), changing to another drug, or
reintroduction of a biologic after some time. Increasing
the dosage of a medication in patients with anti-drug
antibodies is unlikely to offer additional response.
The benefit of measuring anti-drug
antibodies or biologic serum levels in
clinical practice is unclear. Additional
studies are needed.
Drug levels have been shown to correlate negatively with
anti-drug antibodies (ADAs), as higher levels of neutralizing
ADAs were associated with lower serum levels, suggesting
there is no need to measure both levels.11 In one study of
221 patients with adalimumab for rheumatoid arthritis,
adalimumab response at 4 weeks could be extrapolated
to predict efficacy at 6 months, as no further efficacy was
achieved after 5-8 μg/mL adalimumab concentration.
Adalimumab concentration appeared to increase with
concomitant methotrexate use.12 Currently, adalimumab
and ustekinumab drug levels can be measured through
pathology services. The benefit of measuring anti-drug
antibodies or biologic serum levels in clinical practice,
however, is unclear. Limitations with monitoring ADAs
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include problems with the reliability of assays in detecting
functional ADAs, lack of availability, and cost. Additional
studies are needed to further investigate the utility of
these tests.
Speakers emphasized the need
for greater collaboration between
dermatologists and rheumatologists
to decide on management plans
(in treating patients with psoriatic
arthritis).
Molecular biomarkers
Predicting responses to biologics through pharmacologic
biomarkers is another area of investigation. Such markers
can be used to assess whether a patient is more likely to
respond to a given biologic, as well as help elucidate why a
patient does not respond at all.
One area of study is determining whether patients are
genetically predisposed to respond in a certain way
to an individual biologic. A study from Italy evaluated
the association of LCE3B, HLA-Cw6 and TNFAIP3
polymorphisms and treatment response to ustekinumab.
The researchers found that a higher proportion of
HLA-Cw6-positive patients responded more quickly to
ustekinumab, and TNFAIP3 was associated with better
response to TNF inhibition.13
Interpreting data on the long-term efficacy of biologic
treatments can vary, depending on the statistical strategy
chosen for a study, particularly when accounting for missing
data or “discontinued” patients. Methods accounting for
missing data include (from most conservative approach
to least) “intent to treat with nonresponder imputation
(ITT-NRI),” “last observation carried forward (LOCF),”
and “as observed.” “Intent to treat” considers patients
dropping out for any reason as nonresponders. “Last
observation carried forward” includes the last data
point obtained from a subject and carries it forward for
the remainder of the study. “As observed” includes only
patients who have completed the study. Less conservative
measures can result in artificially high efficacy results. Thus,
10
it is important for clinicians to be aware of the methods
used to interpret efficacy data presented for clinical trials.
Psoriatic arthritis
Psoriatic arthritis and the need to intervene with early
and aggressive treatment was a major topic of discussion.
Psoriatic arthritis is a common disorder that can affect
up to 30% of psoriasis patients and can yield permanent
structural damage in as many as 50% of patients. Data
from the PRESTA study (Psoriasis Randomized Etanercept
STudy in Subjects with Psoriatic Arthritis), have shown
that early intervention results in better outcomes.15
Because 75% of patients develop psoriatic arthritis after
their skin psoriasis, it is important for dermatologists to
recognize the signs and symptoms of psoriatic arthritis,
such as chronic inflammation of joints and entheses, and
initiate treatment.16
The role of questionnaires to aid dermatologists in early
diagnosis of psoriatic arthritis was also discussed. A
review of the Toronto Psoriatic Arthritis Screen (ToPAS),
Psoriasis Epidemiology Screening Tool (PEST), and Psoriatic
Arthritis Screening and Evaluation (PASE) questionnaires
showed sensitivities of 41%, 24%, and 24%, respectively,
demonstrating a need for new questionnaires with
increased sensitivity for early detection of psoriatic
arthritis.17 In the interim, dermatologists may still use
these existing questionnaires, inquire/examine for tender
and/or swollen joints, and have heightened vigilance
for psoriatic arthritis in patients with scalp, nail, and
intertriginous psoriasis, as there is an increased incidence
of psoriatic arthritis in patients with these phenotypes.
Diagnostic delay of more than 6 months contributes
to poor radiographic and functional outcomes, further
underscoring the need for early recognition and initiation
of treatment.18
Current treatment regimes for psoriatic arthritis were
also reviewed. Speakers emphasized the need for
greater collaboration between dermatologists and
rheumatologists to decide on management plans. None
of the traditional disease-modifying anti-rheumatic
drugs (DMARDs) demonstrated efficacy in preventing
radiographic progression. Although these drugs are
commonly used, limited data are currently available on the
efficacy of methotrexate for psoriatic arthritis.19 Anti-TNF
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therapies show similar ACR 20 (American College of
Rheumatology measurement in which patients achieve a 20
percent improvement in tender or swollen joint counts as
well as 20 percent improvement in other criteria) responses
to each other and are believed to arrest the progression of
psoriatic arthritis.20
initiation of therapy are necessary, as a lack of treatment
could potentially result in cardiovascular disease. This can
usually be achieved by referral to the patient’s primary care
physician. While Mehta advocated also treating a patient’s
psoriasis, there are currently not enough data to show that
this will improve cardiovascular health.
The discussion also addressed the concept of treating to
achieve a goal of minimal disease activity. MDA is defined
by alleviation of parameters, which include tender joints,
swollen joints, PASI/BSA, patient pain, and tender entheseal
points. The Infliximab Multinational Psoriatic Arthritis
Controlled Trial (IMPACT) demonstrated that a higher
proportion of patients treated to minimal disease activity
had no progression in their radiologic score compared with
standard-of-care therapy.21
Patients with psoriasis have an increased risk of insulin
resistance, which correlates with increased disease
severity.22 A recent large study also indicated an increased
risk for diabetes in psoriasis patients, particularly in those
with more severe disease after 10 years of follow-up. In
addition, there is also an increased risk of diabetes mellitus
in relation to other metabolic issues, such as dyslipidemia
and hypertension.22
A recent large study indicated an
increased risk for diabetes in psoriasis
patients, particularly in those with
more severe disease after 10 years of
follow-up.
Comorbidities and psoriasis
Cardio-metabolic comorbitidies
Current studies are showing that psoriasis is an emerging
risk factor for cardiovascular disease, with important
implications for the management of psoriasis patients. IPC
councilor Dr. Nehal Mehta of the National Heart, Lung, and
Blood Institute (NHLBI) in Bethedsa, Md., recommended
a practical approach in assessing psoriasis patients
for cardiovascular disease risk. He offered screening
recommendations, which, he emphasized, are not yet
guidelines but have been endorsed by the European Society
of Cardiology. Screenings can be done by any provider
and should first be conducted at age 18 and every 5 years
thereafter. He recommended that screening should
target a seated blood pressure of <140/90mmHg, body
mass index (BMI) of 25-27, fasting glucose of <100 pg/mL,
and LDL goal depending on cardiovascular risk factors.
These evaluations can be simplified as the “3 Bs”: blood
pressure, BMI and blood glucose. If an abnormality in any
of the measurements is found, patient education and
It is known that there is an increased prevalence of obesity
in the psoriatic population, but whether obesity precedes
or follows the disease is still unclear. An association
between BMI and incident psoriasis has been demonstrated
in some studies,23 while others suggest obesity follows the
development of psoriasis.24
Gastrointestinal comorbidities
The Rotterdam Study, a cross-sectional, population-based
investigation, included approximately 2,300 patients,
118 (5.1%) of whom had psoriasis. The prevalence of
non-alcoholic fatty liver disease (NAFLD) was significantly
higher in psoriasis patients, independent of common
hepatic risk factors (46.2% compared to 33.3% in the
nonpsoriatic population). Results of this study should lead
to heightened awareness among dermatologists about the
possible presence of NAFLD before starting therapies with
potentially hepatotoxic drugs such as methotrexate.25
Psoriasis is also associated with an increased frequency
of celiac disease markers, including anti-tissue
transglutaminase, endomysial, and anti-gliadin antibodies.
Patients with psoriasis should be questioned about
symptoms pertaining to celiac disease. Patients who test
positive may benefit from a gluten-free diet.26
Investigative therapies in psoriasis
One discussion session examined the results of several
pivotal studies of investigational drugs in the final stages of
clinical development. Results from an open-label extension
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of a phase 2 study of brodalumab, an IL-17R antagonist
illustrated long-term maintenance of response in 181
patients with chronic plaque psoriasis. During the extension
phase of the study, patients received 210 mg every 2 weeks,
unless the patient’s weight was <100 kg. Those patients
received 140 mg every 2 weeks, with the possibility of dose
escalation to 210 mg if there was an inadequate response.
A PASI 100 response was reported in 62.9% patients in week
12, 61.8% patients at week 48, and in 51.4% patients at week
144. A PASI 75 response was observed in 85.4% of patients,
PASI 90 in 73.6% of patients, and PASI 100 in 51.4% at week
144, compared with 95.4%, 85.1% and 62.9% at week 12,
respectively.27
One discussion session examined
the results of several pivotal studies
of investigational drugs in the final
stages of clinical development.
Also discussed were results from two studies, ESTEEM
1 and ESTEEM 2, of the efficacy and safety of the oral
phosphodiesterase 4 inhibitor, apremilast. The ESTEEM 1
and 2 (Study to Evaluate Safety and Effectiveness of Oral
Apremilast [CC-10004] in Patients with Moderate to Severe
Plaque Psoriasis) trials randomized patients to apremilast
30 mg twice a day or placebo in 2:1 ratio in the first part of
the study. The maintenance phase occurred at week 16, in
which placebo patients were switched to the treatment
medication and a randomized withdrawal phase occurred
for responders at weeks 32-52.
At week 16 of ESTEEM 1, a PASI 75 response was observed
in 33.1% of patients receiving 30 mg of apremilast twice
daily, compared with 5.3% in the placebo arm. In ESTEEM 2,
28.8% of patients receiving 30 mg of apremilast twice daily
reached PASI 75, compared with 5.8% patients on placebo.
No serious adverse events were reported. The most
common were diarrhea and nausea, particularly during the
first few weeks of treatment. These side effects typically
subsided in the following month. No markedly abnormal
labs were noted.28
12
Also discussed was the relationship of ixekizumab
treatment response and treatment emergent (TEAEs) and
serious adverse events (SAEs) from pooled safety data in
phase II clinical trials. While higher treatment response
is associated with greater satisfaction with therapy, it is
unclear whether increased response is associated with
increased rate of adverse events. In phase II clinical trials,
142 were analyzed in the following subgroups: PASI 100,
PASI 90-99, PASI 75-89, and < PASI 75. No SAEs were
reported from Part A of the study and TEAEs were 37% for
placebo and 37.4% for ixekizumab-treated patients. During
the open-label extension, a total of 80 TEAEs and 10 SAEs
were reported, with no statistically significant increase in
TEAEs or SAEs with increased response to treatment. Thus,
through exploratory analysis of phase II data, there was no
evidence to suggest higher TEAE and SAE rates in PASI 100
or PASI 90 responders.29
Oral curcumin used in combination with topical steroids
was more effective than topical steroids alone. Treatment
response was shown to correlate with decreased IL-22
serum levels. Therefore, oral curcumin can be used as a safe
and effective adjuvant therapy.30
Certolizumab pegol, pegylated fragmented anti-TNF
agent, was investigated for long-term safety and efficacy
in patients with psoriatic arthritis during the ongoing
RAPID-psoriatic arthritis phase III clinical trial with primary
endpoint of ACR20. Patients were randomized to one of
three arms: placebo; subcutaneous certolizumab 400 mg
at weeks 0, 2 and 4, followed by 200 mg every 2 weeks;
or 400 mg every 4 weeks. ACR 20 response at week 12 for
200 mg biweekly, 400 mg monthly, and placebo cohorts
were 58.0%, 51.9% and 24.3% of patients, respectively. Similar
ACR20 responses were seen in patients previously treated
with anti-TNF agents as well as patients naïve to anti-TNF
therapy. In addition, ACR response rates were maintained
to week 96. Safety profile was consistent with what has
been seen with other TNF-α inhibitors and similar across all
treatment arms.31
Also presented were results of the 12-week, phase III,
noninferiority Oral treatment Psoriasis Trial (OPT) Compare
study, which compared the safety and efficacy of tofacitinib
versus etanercept. The study demonstrated that use
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of tofacitinib twice daily was noninferior to high-dose
etanercept (50 mg twice weekly), whereas 5 mg of
tofacitinib twice daily was less efficacious than etanercept.
PASI 75 response at week 12 for tofacitinib 10 mg twice
daily, etanercept 50 mg twice weekly, and tofacitinib 5 mg
twice daily were 63.6, 58.8 and 39.5%, respectively. Rates of
adverse events were similar to phase II clinical trials.32
Data on safety and efficacy of BI655066, a selective
monoclonal antibody to the p19 subunit of IL-23, were
reported. Thirty-nine patients with chronic plaque psoriasis
were enrolled, and the trial was divided into two parts.
Part I involved intravenous administration of the study
drug to establish the safety and tolerability of increasing
the dosage of the antibody. Part II involved subcutaneous
administration of 0.25 mg/kg or 1.0 mg/kg. Patients with
>PASI 50 response had the option of long-term follow-up
lasting 66 weeks. PASI assessments achieved at week 12
were 87% with PASI 75 response and 58% with a PASI 90
response. Six of nine PASI 100 responders remained clear
after 44-66 weeks of treatment during the extension
period. Overall, the drug was well tolerated, and the only
serious adverse event reported, possibly attributable to the
treatment drug, was a 5-minute transient ischemic attack.
Immunohistochemical analysis of psoriatic lesions from
BI655066-treated patients demonstrated normalization of
histological and gene expression parameters accompanying
clinical response. In this initial phase II trial, BI655066
appears to offer safe and efficacious results with the
potential for long-term results. Currently, a phase IIb trial is
underway.33
Paradoxical psoriasis
This term refers to psoriasis that can occur (paradoxically)
as an adverse event in patients on anti-TNF treatment.
Its pathogenesis is poorly understood and occurs in
2-5% of patients receiving anti-TNF treatment. Dr. Curdin
Conrad of Lausanne, Switzerland, presented results of
a retrospective study of patients treated in Switzerland
evaluating characteristics of patients with paradoxical
psoriasis induced by anti-TNF therapy. This phenomenon
appeared to be a class effect and not linked to any
particular anti-TNF agent. Furthermore, it appears to
be independent of the underlying disease. In case of
discontinuing anti-TNF medication, patients did not develop
any relapses, indicating that paradoxical psoriasis does not
represent newly developed psoriasis but a drug side effect.
Molecular analysis demonstrated uniform upregulation
of Type I interferons (IFN). The data presented indicated
that anti-TNF agents induce acute psoriasis such as skin
inflammation through unabated Type I IFN.
Treatment considerations relating to paradoxical psoriasis
were also addressed. Because of the class effect, patients
should not be switched to another anti-TNF medication.
However, anti-TNF treatment can be continued and treated
topically when reactions are mild. For moderate to severe
disease, patients can continue treatment, and either
acitretin (particularly for pustular forms) or methotrexate
can be added. In case of positive clinical response, anti-TNF
therapy can be continued, though relapses of paradoxical
psoriasis occur in a marked percentage of these patients.
Alternatively, if anti-TNF treatment is not mandatory or if
no response is seen after 8-12 weeks of therapy, anti-TNF
therapy should be discontinued. Phototherapy or more
aggressive systemic treatments such as cyclosporine
A should be introduced. If feasible, a class switch of
the biologic therapy – eg, from anti-TNF to anti-IL-12/23
or anti-IL-17 in case of psoriasis – should be considered
depending on the underlying disease.
Nail psoriasis
Nail Assessment in Psoriasis and Psoriatic Arthritis
(NAPPA) is a tool developed to comprehensively measure
various outcomes associated with nail psoriasis. It is
believed to offer an increased ease of use compared
with the current gold standard, the Nail Psoriasis
Severity Index (NAPSI) scoring instrument, which is
not routinely used in clinical practice. The NAPPA tool
consists of three components to assess quality of life
(NAPPA-QoL), relevant treatment benefits (the Patient
Benefit Index, NAPPA-PBI) and a Clinical Assessment of
Severity (NAPPA-CLIN). Thorough evaluation of the tool
demonstrated feasibility, validity, reliability, sensitivity
to change, and internal consistency. As a result, authors
of one study propose its use in routine clinical practice,
outcomes-related research, and clinical trials.34
Pediatric psoriasis
The algorithm for care of pediatric patients with psoriasis
was a topic of discussion. This should be guided by a
patient’s severity of disease and the patient’s and parents’
13
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preferences. Studies show that early onset of psoriasis is
associated with more severe disease. However, in addition
to disease severity, impact on quality of life should also
be considered. Treatment algorithms were discussed
and it was advised to begin with topical corticosteroids/
vitamin D derivatives, and to consider calcineurin inhibitors
for facial/flexural psoriasis.35 Dithranol is also a safe and
effective treatment that can be considered. Phototherapy
is reserved for moderate to severe disease. Narrow-band
ultraviolet light B (UVB) is the preferred phototherapy,
as it is more efficacious than broad-band, does not cause
ocular damage, and does not appear to have the long-term
skin cancer risk associated with PUVA therapy (ultraviolet
light A with the light-sensitizing medication psoralen). For
moderate to severe psoriasis or disease resistant to topical
and phototherapy, methotrexate is the next treatment
consideration. Methotrexate is the most commonly
prescribed systemic medication for pediatric psoriasis,
although it is not currently approved for that purpose.
Cyclosporine can be administered in 3-4-month intervals,
although there is little literature regarding its use in the
pediatric population. Retinoids are considered first-line
therapy for pustular or erythrodermic variants, but must
be avoided in teenage girls and young women, in view
of the need to wait three years to be off the drug before
getting pregnant. In patients who have not responded
to phototherapy or methotrexate, etanercept is the
first biologic to consider, as its use is supported with the
most evidence and has been reported in literature in 117
patients.36 It is the only biologic licensed for use for severe
disease in patients over 8 years of age in Europe, but it has
not yet been licensed for this purpose by the U.S. Food and
Drug Administration. There is currently little evidence for
treatment efficacy of other biologics such as adalimumab or
ustekinumab, although a clinical trials studying adalimumab
and ustekinumab are currently underway.
A thorough understanding of the safety and efficacy of these
medications is required for use in children with psoriasis.
There are multiple studies that demonstrate a link
between psoriasis in childhood and an increased risk
of obesity, as well as other components of metabolic
syndrome. Risk factors for obesity in current studies
include severity of psoriasis, obesity in one parent, and
female gender.37 There is some degree of variability
14
Multiple studies demonstrate a link
between psoriasis in childhood and an
increased risk of obesity…Risk factors
include severity of psoriasis, obesity in
one parent, and female gender.
in the definition of obesity in studies, as well as
differing measurements of psoriasis severity. Currently,
implications of comorbidities in pediatric psoriasis on
treatment options need to be further explored.
Summary
Research presented at the EADV conference highlighted
the significant progress investigators have made in the
genetics, pathogenesis, therapeutics and comorbidities of
psoriasis, and in psoriatic arthritis, increasing the potential
for more effective treatment and care and treatment for
people living with these diseases.
Contributing writer Mahir Patel acknowledges Drs. Alan
Menter and Caitriona Ryan and the International Psoriasis
Council team for their assistance with this article. He
also thanks the following for allowing him access to data
and materials they presented at the EADV sessions: Drs./
Professors Emiliano Antiga, Hervé Bachelez, Jonathan Barker,
Christine Blome, Wolf-Henning Boehncke, Curdis Conrad,
Antonio Costanzo, Owen Davies, Christopher Griffiths, James
Krueger, Emmanuel Laffitte, Nehal Mehta, Ruth Murphy, Kim
Papp, Carl Paul, Kristian Reich, Marieke Seygar, Bruce Strober,
Francisco Valenzuela, and Peter van de Kerkhof. ■
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VOL 11, NUMBER 1
31. Mease PJ, Fleischmann R, Deodhar AA, et al. Effect of
certolizumab pegol on signs and symptoms in patients with psoriatic
arthritis: 24-week results of a Phase 3 double-blind randomised
placebo-controlled study (RAPID-PsA). Ann Rheum Dis. 2014
Jan;73(1):48-55. doi: 10.1136/annrheumdis-2013-203696. Epub 2013
Aug 13.
34. Augustin M, Blome C, Costanzo A, Dauden E, Ferrandiz C,
Girolomoni G, Gniadecki R, Iversen L, Menter A, Michaelis-Wittern
K, Morita A, Nakagawa H, Reich K. Nail Assessment in Psoriasis
and Psoriatic Aarthritis (NAPPA): development and validation of a
tool for assessment of nail psoriasis outcomes. Br J Dermatol. 2014
Mar;170(3):591-8. doi: 10.1111/bjd.12664.
32. http://www.pfizer.com/news/press-release/press-release-detail/
pfizer_announces_detailed_results_of_opt_compare_phase_3_
study_of_tofacitinib_5_mg_and_10_mg_twice_daily_compared_
to_high_dose_enbrel_in_adults_with_moderate_to_severe_
chronic_plaque_psoriasis.
35. de Jager ME, de Jong EM, van de Kerkhof PC, Seyger MM. Efficacy
and safety of treatments for childhood psoriasis: a systematic
literature review. J Am Acad Dermatol. 2010 Jun;62(6):1013-30. doi:
10.1016/j.jaad.2009.06.048. Epub 2009 Nov 8. Review.
33. http://www.skinandallergynews.com/home/article/
novel-psoriasis-biologic-wows-with-jaw-dropping-results/
e5f325dd1d4c13b538f3d6cc559904b6.html.
36. Hadj-Rabia S. What’s new in pediatric dermatology in 2011? Ann
Dermatol Venereol. 2011 Dec;138 Suppl 4:S245-52. doi: 10.1016/S01519638(11)70098-9. Review. French.
37. Paller AS, Mercy K, Kwasny MJ, Choon SE, et al. Association
of pediatric psoriasis severity with excess and central adiposity:
an international cross-sectional study. JAMA Dermatol. 2013
Feb;149(2):166-76.
Crossfire Symposium:
PRESENTS
The Advent of Biosimilars
On-Demand Webcasts
Point Counter-Point Debates
Degree of Similarity
Joerg Windisch, PhD & Jaap Venema, PhD
Pharmacovigilance
Sergio Chimenti, MD & Claus Zachariae, MD
Biosimilars in Dermatology Practice
Errol Prens, MD, PhD & Lluís Puig, MD, PhD
Moderated by Andy Blauvelt, MD, MBA
Get the information
you need to make
important decisions
for your patients
and your practice
Webcast supported in part by
Learn more at: www.psoriasiscouncil.org/biosimilars.htm
16
PSORIASIS REVIEW
JANUARY 2015
VOL 11, NUMBER 1
Safety, use of biosimilars debated at IPC’s Biosimilars Crossfire Symposium
As part of the European Academy of Dermatology
Congress, IPC hosted “Crossfire Symposium: The
Advent of Biosimilars,” a discussion forum sponsored
by the pharmaceutical companies AbbVie and Sandoz.
Contributing writer Mahir Patel, MD, attended the
symposium. His report, below, summarizes the meeting’s
discussions.
The symposium, moderated by IPC Councilor Dr. Andrew
Blauvelt, U.S., featured key opinion leaders. These panelists
presented contrasting positions on topics that included
the science, manufacturing, and clinical development
of biosimilars; tracking their safety; and their use in
dermatology practice.
Biosimilars, also called “follow-on biologics,” are drugs
that are highly similar to an already approved biologic
drug. Though there are minor differences between
biosimilars and the drugs they are intended to replace,
they are expected to produce similar clinical results as the
original drugs, also referred to as “reference products”
or “originators,” according to the U.S. Food and Drug
Administration.
The symposium’s first speaker, Dr. Marie-Christine Bielsky
of the United Kingdom, an EMA official, explained the
term “biosimilarity” and the challenges of the regulatory
process. Because biologic drugs have complex structures,
they are difficult to replicate exactly; hence, the concept
of “biosimilarity.” A stringent regulatory process is
required, she said, to ensure that these follow-on drugs are
interchangeable with the original biologics.
Speakers addressed controversial issues surrounding
biosimilars. Joerg Windisch, PhD, chief science officer for
Sandoz, a biosimilars industry leader, said manufacturers
use highly sensitive analytics and biological assays to
confirm that these drugs show no meaningful structural or
functional differences from their originators. Then, clinical
programs are designed to detect potential differences; they
do not repeat the same studies conducted by the makers of
the originator drugs.
Jaap Venema, PhD, global medical affairs and
biotherapeutics at AbbVie, which makes the psoriasis drug
adalimumab (Humira), argued for rigorous standards in
the development of biosimilars, as many uncertainties and
difficulties remain, such as maintaining tight controls of
biochemical composition and manufacturing processes.
The European Union, through its regulatory arm, the
European Medicines Agency
(EMA), has approved several
biosimilars. They include
Remsima, made by the South
Korean biopharmaceutical
manufacturer Celltrion,
and Inflectra, made by U.S.
manufacturer Hospira, for
treating psoriasis. Both are
biosimilar versions of the
psoriasis drug infliximab
(Remicade). So far, the
FDA has not approved any
biosimilars for psoriasis, but
has established an approval
pathway for them. Celltrion
has filed for FDA approval of
Remsima and a decision could IPC councilors, from left, Lluís Puig (Spain), Errol Prens (Netherlands), Sergio Chimenti (Italy), and
Claus Zachariae (Denmark) enjoy a lively discussion following their presentations during IPC’s
come sometime in 2015.
Crossfire Symposium.
17
PSORIASIS REVIEW
JANUARY 2015
VOL 11, NUMBER 1
The range of variability between an original drug and its
biosimilar counterpart is narrow and must be maintained
through consistent and careful oversight to ensure safety
and efficacy.
Speakers also addressed biosimilars from a clinician’s
perspective. These drugs have the potential to broaden
the accessibility and reduce the cost of expensive therapies
that patients cannot now afford. However, several issues
need to be resolved before healthcare providers begin
prescribing them. For example, if a patient is being
successfully treated with a biologic, should physicians
switch that patient to a biosimilar because it is less
expensive?
Biosimilars have the potential
to broaden the accessibility
and reduce the cost of expensive
therapies that patients cannot afford.
But several issues must be resolved
before healthcare providers begin
prescribing them.
Speaker Errol Prens, MD, PhD, of the Netherlands, argued
that a patient shouldn’t switch if doing well because the
follow-on drug may not replicate the same clinical and
safety profile as the parent biologic. If patients were
switched from an original to a biosimilar drug, he said,
there would be a need for “traceability” so a provider
could know which medication caused an adverse event.
Prens argued that biosimilars should be prescribed only
18
for patients who have not been treated with the original
drug. Prens also suggested that long-term safety data be
collected in the form of registries.
Another concern for those who advocate a conservative
approach is the potential that biosimilars could be
substituted for a biologic without the authorization of
the provider or the patient. Lluís Puig, MD, PhD, of Spain,
argued that biosimilars would be similar enough to the
original drugs – and safe enough – to prescribe for both
patients new to treatment and for those already taking the
originator biologic. Doing so, he said, would reduce costs
and enhance patient care. Also, biosimilar proponents
noted, efficacy and safety data on Remsima and Inflectra,
the Remicade follow-ons, are promising thus far.
The concept of “indication extrapolation” was another
topic of lively discussion. It refers to biosimilars that are
studied for one indication, eg, rheumatoid arthritis, then
approved for other indications, such as psoriasis, whether
or not they have been clinically tested to treat these
other conditions. The debate is between those who are
comfortable with the idea of extrapolation and those
who are wary of using biosimilars for indications that have
not been tested. Of note, the two infliximab biosimilars
Remsima and Inflectra gained approval for psoriasis by
the EMA, even though clinical studies tested them for
rheumatoid arthritis and ankylosing spondylitis.
As leaders in regulatory, pharmaceutical, and clinical arenas
continue to debate biosimilars, research and development
continue worldwide. In the U.S., FDA approval of the
first biosimilar could come sometime this year. For more
discussion of biosimilars, the webcast of this program can
be viewed at www.psoriasiscouncil.org/biosimilars.htm. ■
SPECIAL 10 YEAR ANNIVERSARY SECTION
Founded in 2004, the International Psoriasis
Council (IPC) is a dermatology-led, voluntary,
global nonprofit organization dedicated to
innovation across the full spectrum of
psoriasis through research, education and
patient care.
Happy Anniversary − Celebrating 10 Years with the IPC
It all started in the summer of 2004
when Dr. Alan Menter suggested
a meeting with Dr. Craig Leonardi
and Professor Chris Griffiths, along
with
biotechnology
consultant
Malia Tee Lewin, at a dermatology
conference in New York City to
discuss the possibility of forming an
international organization to advance
the understanding of psoriasis
research and education. Alan Menter
had spent a year working with a
patient, Scott Ginsburg in Dallas,
Texas, who donated $100,000 to the
cause, as well as helping recruit Malia
Tee Lewin after hosting a meeting
with pharmaceutical officials and
members of the National Psoriasis
Foundation.
A portion of initial funding
came from a patient who
donated $100,000
At the time, biologic therapies were
just coming onto the scene (the
first biologics for treating psoriasis
were approved in 2003), fueling a
heightened awareness of psoriasis
and research into the disease.
"We felt that we needed a group of
international psoriasis experts to
make treatment recommendations
and to educate others about these
new developments," says Menter,
who first had the idea and broached a
Alan Menter, MD
colleague in the rheumatology
world in Europe to review how
rheumatologists had formed a
similar organization.
2003 First biologics for
treating psoriasis appear
Recalls Griffiths, "There needed to
be an international organization
that furthered our understanding
of research and education − a
global body, like a think tank, one
that was distinct from patientsupport organizations. (It would be)
composed of professional healthcare
practitioners and researchers and
focused primarily on psoriasis."
Craig Leonardi, MD
Chris Griffiths, MD
"We weren’t exactly sure where we
were going, but we knew that there
was a huge gap in the education
of physicians," says Leonardi. "We
thought we would create a group
that would be structured along
those lines with the highest ethical
standards we could apply to the
process, trying to stay as neutral
as possible in regards to industry,
producing high-quality educational
materials for our members and
dermatologists in general."
After a lively discussion reaching
long into the night, the group decided
to move forward with this new
organization. Dr. Menter approached
an attorney friend in Dallas, who,
Cont., Page 20
"There needed to be an international organization that furthered
our understanding of research and education − a global body...
(It would be) composed of professional healthcare practitioners
and researchers and focused primarily on psoriasis."
SPE CIA L 10 YEA R A NNIV ER S A R Y S ECTIO N
Chris Griffiths, MD
University of Manchester, United Kingdom
19
on a pro bono basis, helped create
a not-for-profit organization and
to research potential names for
the organization, which finally was
structured under the name of the
International Psoriasis Council (IPC).
Menter was elected as the IPC’s first
president.
Pharmaceutical companies provided
additional
financial
support.
Following the meeting in New York,
Tee Lewin served as IPC’s first
CEO/executive director (2004-2008),
establishing a basis for the council
to create educational programs and
materials. She remained on IPC’s
board of directors for a year after
her departure as CEO. In 2008, IPC
welcomed Karen Baxter Rodman
Karen Baxter Rodman, IPC CEO/executive director,
2008-2012.
from Dallas, a patient of Menter’s,
to lead the organization. Rodman, a
nonprofit executive with expertise
in fundraising and capacity building,
served the organization until her
untimely death from cancer in the
fall of 2012. Under her leadership, the
organization expanded its Meet the
Experts (MTE) educational programs,
embarked on an ambitious genetics
project, and developed its first
strategic plan for the years ahead.
Early accomplishments
As the council expanded and took on
new members, it launched projects
and programs aimed at developing
20
a global understanding of psoriasis.
These included the MTE Program,
which brings together clinicians from
around the world to discuss difficultto-treat cases, and the IPC Psoriasis
Review Newsletter, a twice-yearly
publication that features reviews and
commentaries of recently published
psoriasis research papers, and report
from international congresses.
2005 First IPC roundtable
meeting  Held in London
Griffiths
chaired
IPC’s
first
roundtable meeting in London in
2005. That meeting was the genesis
for an early IPC accomplishment: the
2007 publication of a paper titled "A
Classification of Psoriasis Vulgaris
According to Phenotype" in the British
Journal of Dermatology, a paper,
Griffiths says, that still is cited today.
It outlined the first international
consensus for classifying psoriasis
phenotypes that could be used in
clinics and by researchers.
With the success of the meeting in
London, more programs followed.
In 2006, IPC held a multidisciplinary
meeting in Rhodes, Greece, focused
on obesity in psoriasis, and was
the first symposium to highlight
comorbidities
associated
with
psoriasis. From this meeting
came the IPC publication, "Obesity
in psoriasis: the metabolic, clinical
and therapeutic implications. Report
of an interdisciplinary conference
and review" (Sterry et al, 2007). In
addition, a subsequent meeting in
2008 in Dallas featured Nobel Prize
2006 First symposium to
highlight comorbidities
associated with psoriasis
 Presented by IPC
Board and councilors at IPC’s first roundtable meeting,
London, 2005. Back row, left to right, Sergio Chimenti,
Craig Leonardi, Robert Chalmers, Enno Christophers,
Jean-Paul Ortonne, Gerald Krueger, Wai-Kwong Cheong,
Jonathan Barker. Front row, left to right, Lionel Fry,
Chris Griffiths, who served as chairman, Malia Tee Lewin,
Alan Menter.
winner Dr. Michael Brown, who won
the award for his discoveries in
cholesterol metabolism.
Today, more than 700 manuscripts
have been published worldwide on
the connection between psoriasis
and its multiple comorbidities. The
recent publication of the IPC paper
"Accumulating Evidence for the
Association and Shared Pathogenic
Mechanisms between Psoriasis
and
Cardiovascular-Related
Co-morbidities" (Shlyankevich et
al, 2014) in the American Journal
of Medicine shows IPC’s continued
efforts to synthesize the current
understanding of psoriasis with
various cardio-metabolic risk factors.
Today, more than 700
manuscripts have been published
worldwide on the connection
between psoriasis and its
multiple comorbidities
In 2009, IPC launched a study
correlating the severity of pediatric
psoriasis with the risk of obesity,
enrolling
656
patients
from
20 countries. Led by IPC Councilor
Amy Paller, the study showed that
overweight children with severe
psoriasis were more likely to be
obese than children with a mild
SP E CIA L 1 0 YEA R A NNIV ER S A R Y S ECTIO N
BOARD MEMBER
FEEDBACK
HOW IPC CAN STAY RELEVANT
OVER THE NEXT 10 YEARS:
"By contributing to the literature,
and convening meetings to bring
together the best minds to tackle
our problems."
Alexa Kimball
IPC Vice President & President-Elect
Harvard Medical School and
Massachusetts General Hospital
Boston, Massachusetts, USA
IPC’s IMPACT ON DERMATOLOGY:
"Strong international
professional voice representing
balanced multiple viewpoints
from around the globe. Strong
focus on patient needs with
interests extending from science
through education to clinical care."
“
Jonathan Barker
St. John’s Institute of Dermatology
London, United Kingdom
IPC’s GREATEST ACHIEVEMENTS:
"In education: MTE sessions
(interactive, scientifically accurate,
real-life, management-based).
In research: IPC workshops and
genetics project. These achievements and many others legitimate
IPC as a global organization."
HOW IPC CAN STAY RELEVANT
OVER THE NEXT 10 YEARS:
"IPC must focus on academic/scientific
endeavors that advance the cutting-edge
assessment of psoriatic disease. Projects
should address unanswered academic
questions about which we have no
answers currently."
Hervé Bachelez
Bruce Strober
University of Connecticut Health Center
Farmington, Connecticut, USA
Secretary
Saint-Louis University Hospital
Paris, France
IPC’s GREATEST
ACHIEVEMENTS:
"Creating an agenda for
research needs, providing
support for a large genetics
study, providing guidance for
important clinical studies.
In patient care, addressing
important questions, among
them: biosimilars, outcome
measures, definition of clinical
phenotypes of psoriasis."
Peter van de Kerkhof
Immediate Past President
Radboud University Nijmegen
Medical Centre
Nijmegen, The Netherlands
IPC’s IMPACT ON
DERMATOLOGY:
"IPC is the leading body in
dermatology with respect
to all questions related
to psoriasis. It initiates
scientific activities,
releases dermatopolitical
statements and scientific
publications. Moreover,
it is instrumental in
giving advice to various
stakeholders in the field."
“
Wolfram Sterry
University Hospital Charité,
Humboldt University
wBerlin, Germany
2008: IPC hosts
interdisciplinary
conference on psoriasis &
comorbidities in Dallas;
methotrexate consensus
conference in London
2006: Roundtable
2008: 1st
meeting in Rhodes, Greece,
associates psoriasis
and comorbidities
Meet the Experts
Program at EADV
meeting, Istanbul
Meetings also in
Finland, New York;
topics: topical therapies,
outcomes measures
2004: Leaders in
psoriasis research
meet to create
International
Psoriasis Council
2004
2005
2005: First IPC
meeting held in
London; topics:
phenotypes,
patient registries
2008: IPC paper
published
"Psoriasis: consensus
on topical therapies,"
van de Kerkhof et al.
J Eur Acad Dermatol
Venereol. 2008;22(7):859-70
2006: 2nd
Psoriasis Review
Newsletter published
2006
2007
2008
2007: Two papers
2009: IPC launches
resulting from
London & Rhodes
meetings published
in scientific journals
pediatric study
assessing correlation
between juvenile
psoriasis and obesity
5
2007: 1st working
2005: IPC publishes
first Psoriasis Review
Newsletter issue;
includes CME
"A classification of psoriasis vulgaris
according to phenotype," Griffiths et al.
Br J Dermatol. 2007;156(2):258-62,
and "Obesity in psoriasis: the metabolic,
clinical and therapeutic implications.
Report of an interdisciplinary conference
and review," Sterry et al. Br J Dermatol.
2007;157(4):649-55
2009
groups meet in
Vienna; topics:
quality of care,
research profiles
RESEARCH SITES
170
SUBJECTS
ENROLLED
2009: 1st
Psoriasis Review
Newsletter
Spanish, Portuguese
translations
2010: 1st interaction with
European Medicines Agency;
provides info on methotrexate,
clinical research, comorbidities,
biosimilars
2010: Genetics Workshop
in Montreal, Canada, leads
to launch of IPC project,
"Towards Completing the
Genetic Map of Psoriasis:
Rare Protein Altering
Variants in 10,000
Psoriasis Cases and
10,000 Controls"
TOP
10
2014: Data from Delphi
2012: IPC’s
Meet the Experts
Programs take place
on each continent
2010: 1st
Biosimilars
Task Force
meeting,
Gothenburg,
Sweden
2011
2012: IPC publishes
position paper
on biosimilars
"Biopharmaceuticals and
Biosimilars in Psoriasis:
What the Dermatologist
Needs to Know," Strober et al.
JAAD. 2012 Feb;66(2):317-22
2012
2011: IPC poster reporting
results of pediatric study
presented at Society
for Investigative Dermatology
(SID) annual meeting,
Phoenix, Arizona
2010: IPC paper published
"Exploring the association between
cardiovascular and other disease-related
risk factors in the psoriasis population: the
need for increased understanding across
the medical community," Menter et al.
JEADV. 2010;Volume 24, pages 1371-77
2014:
Report from IPC’s 2013
Think Tank published
2010: IPC councilors
select first "Top 10"
psoriasis research papers
2010
and Genetics projects
presented at "Psoriasis:
From Gene to Clinic"
meeting, London
"Accumulating Evidence for the
Association and Shared Pathogenic
Mechanisms Between Psoriasis and
Cardiovascular-related Comorbidities.
Shlyankevich et al. Am J Med.
2014 Dec;127(12):1148-1153
2014:
Set top psoriasis
research priorities
using Delphi process
2013
2014
2013: IPC officially
launches its Genetics Project
in Kiel, Germany;
Ann Arbor, Michigan;
London, UK
2013: IPC
topical therapy and
biosimilars working
groups activated,
meet during EADV
congress, Istanbul
2013: IPC
publishes results
of pediatric study
"Association of pediatric
psoriasis severity with
excess and central
adiposity: an international
cross-sectional study,"
Paller et al. JAMA Dermatol.
2013;Feb;149(2):166-76
J.T. Elder presents on “Genetic Approaches” during the IPC
Symposium, “Stratifying Psoriasis: Methods and Clinical Utility”
at the 2013 IID meeting in Edinburgh, Scotland.
IPC councilors and colleagues gather after a successful Meet the Experts Program in Ecuador at
the 2011 RADLA meeting. From left to right, Matías Maskin, Fernando Stengel, Ricardo Romiti,
Christina Echeverría, Alan Menter, Edgardo Chouela, and Ezequiel Chouela.
Cont. from Page 22
form of the disease. Following the
study, JAMA Dermatology published
the paper, "Association of pediatric
psoriasis severity with excess and
central adiposity: an international
cross-sectional
study"
(Paller
et al, 2013).
2009 IPC study showed
children with severe
psoriasis were more likely to
be obese than children with
a mild form of the disease
IPC today
OVER THE PAST
10 YEARS, IPC HAS:
These days, "anything IPC puts its
name to is considered high quality,
whether it’s publications, symposia,
workshops or roundtables," Griffiths
says. "I think we are established as
an organization."
Held 31 educational
events in 15 countries
Published 17 articles
in international
peer-reviewed journals
IPC’s programs are well known, and
Griffiths, Leonardi and Menter are still
in leadership roles. Griffiths currently
is IPC’s board president, Leonardi
serves as board treasurer, and
Menter is founding board member
who continues to provide advice
and expertise. The organization now
has 87 councilors from 23 different
countries, with intentions to expand in
order to strengthen its international
presence and consensus.
Partnered with
organizations to provide
9 CME programs
In addition to these achievements
over the past 10 years, IPC has held
a total of 31 educational events in
15 countries, published 17 articles
in
international
peer-reviewed
journals, and partnered with other
organizations to offer 9 CME
programs. IPC councilors have been
invited to participate in summits
with the European Medicines
Agency (EMA), which monitors the
safety of medicines throughout the
European Union, and have spoken
before the U.S. Food and Drug
Administration (FDA). The IPC is a
partner along with St John’s Institute
of Dermatology, The University
of Manchester, and the British
Association of Dermatologists in the
triennial premier psoriasis congress,
"Psoriasis: from Gene to Clinic."
These days, anything IPC
puts its name to is considered
high quality, whether it’s
publications, symposia,
workshops or roundtables..."
24
SP E CIA L 1 0 YEA R A NNIV ER S A R Y S ECTIO N
Chris Griffiths, MD
University of Manchester
United Kingdom
In striving to become a global psoriasis
leader, IPC has taken on several
ambitious initiatives. Two of the most
IPC currently has
87 councilors from
23 countries
notable are a research project that
aims to complete a genetic "map" of
psoriasis and the Global Psoriasis
Atlas project, which would document
the prevalence and incidence of
psoriasis worldwide.
The genetics project, titled "Towards
Completing the Genetic Map of
Psoriasis: Rare Protein Altering
Variants
in
10,000
Psoriasis
Cases and 10,000 Controls," involves
sequencing the DNA of 10,000 patients
with psoriasis and 10,000 controls,
Faculty of IPC Board and Councilors following the first Meet the Experts Program in Istanbul, Turkey, in
2008. From left to right, Wolfram Sterry, Jörg Prinz, Chris Griffiths, and Alan Menter.
using the exome chip. Researchers are
working with this data to identify novel
genetic associations and patterns that
correlate with psoriasis. Results from
this work will help lay the groundwork to find innovative approaches to
new treatment strategies.
"IPC’s genetics project will lead
toward much greater understanding
of
psoriasis,"
Menter
says.
"Pharmacogenetics
and
pharmacogenomics
−
analyzing
biomarkers based on genetic profile
− will indicate which drug works best
for each person, hopefully with the
least side effects possible. IPC should
have a leading role in developing and
disseminating this knowledge."
RESEARCH PROJECT:
IPC has taken an initiative
to complete a genetic map"
of psoriasis
The objective of the Global Psoriasis
Atlas Project is to determine the true
global burden of psoriasis, which,
says Griffiths, will demonstrate to
national governments, healthcare
providers, and the World Health
Organization (WHO) that psoriasis is
not an inconsequential condition.
IPC councilors Andrew Finlay, at front, and Edgardo Chouela
(behind Finlay) at IPC’s 2013 Think Tank in Boston,
Massachusetts, which focused on comorbidities.
"Work never stops for IPC," says
Leonardi. "It’s been an amazing
ride in our specialty. When I was
in training, we thought psoriasis
was a skin cell disease. With a new
understanding came a concentration
on
using
immunosuppressant
therapies to control this disease.
It’s one of the hottest areas of
research right now."
GLOBAL PSORIASIS
ATLAS PROJECT
Will document the
prevalence and incidence
of psoriasis worldwide.
The next 10 years
Thanks to solid management,
board stability, and enthusiastic
commitment from its members,
IPC’s future is secure, says Griffiths.
The organization will continue the
programs that have strengthened
its work − educational programs,
published papers, the IPC Psoriasis
Review Newsletter − while also
advancing its work on the genetics
and Global Psoriasis Atlas projects.
Working with physicians from
Central and South America, over
the years, Menter and IPC helped
establish SOLAPSO (Society of Latin
American Psoriasis Organizations).
Through educational events and
symposia, IPC has provided
educational
opportunities
for
doctors who were looking for
information
about
psoriasis
research and treatments. "We’re
filling a huge gap in that regard,"
says Leonardi.
Employing the global expertise and
commitment of its councilors, IPC has
established working groups to develop
consensus, identify research priorities,
and to pave the way for further
educational initiatives. They include
the Topical Therapy Working Group,
led by Lars Iversen of Denmark, and
the Biosimilars Working Group, led by
Andrew Blauvelt of the United States.
A Pediatric Working Group, headed by
Marieke Seyger of the Netherlands
and Amy Paller of the United States,
and a Comorbidities Working Group
are due to start up within the next
year.
Ultimately, say founders Menter,
Griffiths and Leonardi, they want
IPC to be a go-to source for the latest
information about psoriasis research
and treatment.
Cont., Page 26
SPE CIA L 10 YEA R A NNIV ER S A R Y S ECTIO N
25
IPC LEADERSHIP 2004-2014
CURRENT BOARD MEMBERS
Christopher Griffiths, MD
University of Manchester, UK
President
Board President  2014 - 2017
Serving on Board  2004 - Present
Peter van de Kerkhof, MD, PhD
IPC Board’s Craig Leonardi and Alexa Kimball spend time at IPC’s exhibit
booth catching up on the latest Psoriasis Review Newsletter during the
2013 PIN meeting in Paris, France.
Radboud University, the Netherlands
Immediate Past President
Alexa Kimball, MD, MPH
Harvard Medical School and Massachusetts
General Hospital, USA
Vice President, President-Elect
Serving on Board 2005 - Present
Craig Leonardi, MD
St. Louis University School of Medicine, USA
Treasurer
Hervé Bachelez, MD, PhD
Saint-Louis University Hospital, France
Secretary
Steve O’Dell
CEO  2014 - Present
A scene from IPC’s first Think Tank in Barcelona, Spain, in 2010.
"Psoriasis won’t be cured by any means, there
will still be a need for practitioners to best
manage their patients," Griffiths says. "We
want IPC to be a think tank for promoting
new ideas, to be a source for future research."
"The past 10 years have been an incredible
journey for IPC," he continues. "Psoriasis is
now taken more seriously as a disease and
researchers have made significant progress
in worldwide understanding of the disease.
It’s a very exciting time to be involved in
research and public education." ■
Alan Menter, MD
Baylor University Medical Center, US
Jonathan Barker, MD
St. John’s Institute of Dermatology, UK
Robert B. Holland, III
Interim CEO of Max Petroleum, USA
Wolfram Sterry, MD
University Hospital Charité, Humboldt University, Germany
Bruce Strober, MD, PhD
University of Connecticut Health Center, USA
Joined Board in 2014
PAST BOARD MEMBERS
Melodie Young, RN, ANP-C  2004 - 2009
Malia Tee Lewin  2009
CHIEF EXECUTIVE OFFICERS
Malia Tee Lewin  2004 - 2008
Karen Baxter Rodman  2008 - 2012
Christy Langan, interim  2012 - 2013
Steve O’Dell  named in January 2014
SCIENTIFIC DIRECTORS
26
Elizabeth Horn, PhD  2008 - 2009
Paul Tebbey, PhD, MBA  2009 - 2014
PSORIASIS REVIEW
JANUARY 2015
VOL 11, NUMBER 1
IPC NEWS
ACCESS TO CARE
Two appearances by IPC CEO Steve O’ Dell last year – at
a Food and Drug Administration advisory committee
hearing on the psoriasis drug secukinumab and before
a global conference of pharmaceutical manufacturers –
underscored IPC’s commitment to improving access to
patient care.
FDA committee hearing
In October, O’Dell appeared before the FDA’s
Dermatologic and Ophthalmic Drugs Advisory Committee,
which was considering whether to recommend FDA
approval of the drug secukinumab to treat moderate
to severe plaque psoriasis in the US . He presented a
consensus statement from the IPC Board of Directors
describing the incidence, prevalence, and burden of
psoriasis, and emphasized the importance of developing
additional targeted therapies, such as secukinumab, which
clinical trials have shown to be safe and effective. On Oct.
20, the committee unanimously recommended that the
FDA approve the drug for treating moderate to severe
plaque psoriasis. The agency’s final decision is expected in
early 2015. National Psoriasis Foundation representatives
also testified in favor of the drug. Also attending the
hearing were IPC board members Drs. Bruce Strober
and Craig Leonardi. A press release announcing the
committee’s unanimous recommendation are available
at www.psoriasiscouncil.org/fdasecukinumab.htm.
Bringing psoriasis into the light
At the meeting of the International Federation of
Pharmaceutical Manufacturers and Associations
(IFPMA) in Geneva, O’Dell emphasized the need for a
better understanding of the worldwide incidence and
prevalence of psoriasis. He described IPC’s efforts to
fill in these knowledge gaps through its participation
in the Global Psoriasis Atlas Project, a partnership with
the International Federation of Psoriasis Associations
(IFPA) and the International League of Dermatological
Societies (ILDS). Among other objectives, it will encourage
the collection of data and research that might lead to
improvements in psoriasis treatment and care around the
world. O’Dell was one of four speakers at the forum titled
“Bringing Psoriasis into the Light.” The panel discussion
addressed issues such as awareness of the disease,
research, and access to care on a global scale.
IPC advocates for patients
Last July, the International Psoriasis Council learned that
a large U.S. insurance carrier, United Healthcare, was
considering changes to its prescription drug list in the
area of biological immunomodulators. Concerned that
these changes could limit healthcare provider and patient
access to several biologics prescribed for treating plaque
psoriasis and psoriatic arthritis, the IPC Board of Directors
came together to draft an evidence-based opinion letter
to the United Healthcare Pharmacy and Therapeutics
Committee and to its directors. The IPC letter discussed
the importance of provider and patient access to all
FDA-approved biologics prescribed to treat these
diseases, focusing on the scientific evidence of the burden
of disease and the drugs’ patient-specific efficacy and
risk benefits. IPC asked United Healthcare to reconsider
these potential limitations and offered its counseling
services. Noting that the proposed formulary could force
some patients to switch away from effective treatments,
potentially resulting in difficult-to-control flares, the letter
also asked that every patient currently being treated
with a specific biologic be allowed to continue with that
treatment. The letter was signed by IPC President Prof.
Christopher Griffiths and CEO Steve O’Dell.
In less than 24 hours, United Healthcare officials
responded via phone and letter, stating their appreciation
for the IPC statements, and said they were no longer
considering the proposed changes, but would contact
IPC if any changes were made. A letter from United
Healthcare sent to O’Dell and addressed to the IPC
seemed to have taken the scientific evidence provided by
IPC into account. Its recently-announced new formulary,
which took effect Jan. 1, 2015, will not remove any drugs
it currently covers. In addition, patients currently taking a
specific biologic will not be forced to change therapies in
order to continue to receive United Healthcare coverage.
The American Academy of Dermatology and the National
Psoriasis Foundation joined IPC in contacting United
Healthcare officials and advocating for patients in the
United States to have greater access to these treatments
and for their dermatologists’ ability to prescribe them. ■
27
PSORIASIS REVIEW
JANUARY 2015
VOL 11, NUMBER 1
IPC NEWS
PATIENT CARE
EDUCATION AND OUTREACH
Topical Therapy Working Group
Meet the Experts Programs
Completing a global survey on the use of topical therapies,
guidelines for using topical therapies, and a manuscript
addressing the knowledge gaps in the use of topical
treatments were discussed at the meeting of IPC’s
Topical Therapy Working Group in October during the
annual meeting of European Academy of Dermatology
and Venereology. Working group chair Lars Iversen,
MD, Denmark, led the meeting. The group was joined by
representatives of Pfizer and Leo Pharma pharmaceutical
companies. ■
Biosimilars Working Group
Also meeting during the EADV congress was IPC’s
Biosimilars Working Group. Topics included the role
biosimilar drugs will play in treating psoriasis patients,
and a variety of IPC biosimilars initiatives. The group also
discussed the possibility of producing and publishing an
updated manuscript on what biosimilars could mean to
dermatologists treating patients with psoriasis. Working
group chair Andrew Blauvelt, MD, MBA, United States,
led the meeting. Also attending the meeting were
representatives from pharmaceutical companies AbbVie,
Amgen and Sandoz Biopharmaceuticals. ■
RESEARCH
IPC article in the AJM
The prestigious American Journal of Medicine published
in its December 2014 issue a manuscript addressing the
potential link between psoriasis and cardio-metabolic
diseases. The manuscript – titled “Accumulating Evidence
for the Association and Shared Pathogenic Mechanisms
between Psoriasis and Cardiometabolic Diseases” –
summarizes the scientific program presented at the
November 2013 IPC Think Tank. At that session, global
dermatology, immunology and cardiovascular experts
discussed the current status of the science that might
link psoriasis and various cardio-metabolic-related
comorbidities. The article is available online at
www.psoriasiscouncil.org/news_comorbid.htm
and in the journal’s December print edition. ■
28
IPC sponsored five international Meet the Experts meetings
in 2014. These meetings feature a panel of experts who
discuss challenging psoriasis cases encountered in their
clinical practices. Here’s an overview:
Santiago, Chile
IPC’s first meeting of the year took place May 1 with Dr. Alan
Menter of the U.S. and Dra. Claudia de la Cruz of Santiago
serving as co-moderators. Panelists were Dr. Ricardo
Romiti of São Paulo, Brazil, and Dra. Nancy Podoswa of
Mexico City, Mexico. Discussions focused on psoriasis
and Hodgkin’s disease, managing palmoplantar psoriasis,
severe and recalcitrant pustular psoriasis, and obesity with
psoriasis and psoriatic arthritis. A webcast of this session
is available in English and Spanish at www.psoriasiscouncil.
org/education/webcasts_date.htm.
Vancouver, Canada
IPC Councilor Jashin Wu, MD, of Los Angeles, California,
chaired this session held Aug. 15 during the 66th Pacific
Dermatologic Association meeting. Topics were TNF
inhibitor therapy and herpes zoster, ustekinumab therapy,
combination biologic and oral/photo therapies, and acute
generalized pustular psoriasis. Panelists were IPC Councilor
Andrew Blauvelt, MD, MBA, of Portland, Oregon, and
dermatology colleagues John Koo, MD, of San Francisco,
California, and Robert Kalb, MD, of Buffalo, New York.
Montevideo, Uruguay
Erythrodermic and von Zumbusch psoriasis were among
the case studies discussed at this meeting held Sept. 27
as part of the 14th meeting of the Uruguayan Congress
of Dermatology. Other topics were psoriasis and systemic
lupus and psoriasis resistant to therapy. Dr. Alan Menter
served as moderator. Panelists were local psoriasis
specialists Drs. Carlos Bazzano and Carlos Carmona, both
of Montevideo. Also presenting a case study was Dra.
Nélida Raimondo of Argentina, president of SOLAPSO
(Sociedad Latinoamericana de Psoriasis/Latin American
Society of Psoriasis).
PSORIASIS REVIEW
JANUARY 2015
VOL 11, NUMBER 1
IPC NEWS
Left to right, Menno Alexander de Rie, MD, PhD, Netherlands;
Giampiero Girolomoni, MD, Italy; Bruce Strober, Md, PhD, US,
served as faculty at the Meet the Experts meeting in Amsterdam.
Amsterdam, Netherlands
IPC Board Member Bruce Strober, MD, PhD, United States,
moderated a lively Meet the Experts session on Friday, Oct.
10, during the 23rd EADV congress. IPC Councilors Menno
Alexander de Rie, MD, PhD, Netherlands, and Giampiero
Girolomoni, MD, Italy, served as faculty. Psoriasis and HCV
infection, a challenging case from the Netherlands, and
history of tumor malignancy were all discussed during the
program.
Cancun, Mexico
As part of IPC’s participation in the 2° Congreso
Latinamericano de Psoriasis de SOLAPSO, IPC sponsored a
Meet the Experts dinner discussion Thursday, Dec. 4. Case
study topics included psoriasis and Hodgkin’s disease, the
role of biologics in lifetime psoriatic erythrodermia, male
child with inverse psoriasis, challenges in the histologic
diagnosis of psoriasis, and psoriasis and hyperprolactinemia.
The faculty consisted of IPC Board member Alan Menter,
MD, United States, IPC Councilors Fernando Stengel, MD,
Argentina, and Claudia de la Cruz, MD, Chile. Clay Cockerell,
MD, United States, and organizer Nancy Podoswa, MD,
Mexico, also presented case studies. ■
New Webcast Available for CME Credit
A webcast titled “The Shifting Paradigm in Psoriasis
Treatment” is available for CME credit at
www.psoriasiscme.tv. The webcast features IPC board
members Drs. Alexa Kimball and Bruce Strober moderating
a discussion on how to integrate the latest data on the
treatment of psoriasis into clinical practice. This webcast is
a recording of one of four meetings that took place in New
York, St. Louis, Dallas, and Boston early in 2014. ■
NEW IPC COUNCILOR
Christine Bundy, PhD, AFBPS,
C Psychol
Manchester, United Kingdom
Dr. Bundy is a chartered
psychologist and senior lecturer in
psychology applied to medicine at
the University of Manchester. For
20 years, she has been involved
with translational research by
developing and evaluating psychological interventions
in long-term health conditions such as diabetes and
psoriasis. She is a co-leader of a research program on
helping primary care staff better manage depression in
diabetes and coronary heart disease as part of the Greater
Manchester Collaboration for Leadership in Applied
Health Research and Care (CLAHRC). She leads training
for healthcare staff that incorporates psychological
support into their clinical management. With colleagues
in Manchester, she developed a web-based Cognitive
Behavioural Therapy (CBT) program for patients with
chronic plaque psoriasis. Dr. Bundy belongs to a group
called SPARK, which is composed of dermatology experts
who are developing educational and training for other
dermatology specialists. She is committed to integrating
psychological care with medical care. As part of a team
called IMPACT, she works to improve services for people
with psoriasis at any stage of their condition. ■
29
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" #" ! $#
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30
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Advancing Knowle dge | Enhancing
C are
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"!#!
PSORIASIS REVIEW
JANUARY 2015
VOL 11, NUMBER 1
IPC NEWS
IPC’s LEADERSHIP
ACKNOWLEDGMENTS
IPC’s Dr. Bruce
Strober receives
leadership award
IPC gratefully acknowledges Co-editors
Dr. Johann Gudjonsson of the University
of Michigan, Ann Arbor, Michigan, United
States, and Dr. Robert Bissonnette of
Innovaderm Research Inc., Montreal,
Canada, for their writing and editing
contributions to the January 2015
IPC Psoriasis Review Newsletter.
Dr. Bruce Strober, at
right, was one of two
physicians honored by
the National Psoriasis
Foundation for their
steadfast efforts to
improve the lives of
people who have
psoriasis and psoriatic
arthritis. Strober, vice
chairman of the University of Connecticut Health Center dermatology
department, and Dr. Jeffrey M. Weinberg of Forest Hills, N.Y., at left
in the photo, both received the foundation’s Excellence in Leadership
Award at an Oct. 29 Commit to Cure gala held New York City. The award
is a reflection of outstanding achievement in healthcare or philanthropy,
according to the foundation. Strober and Weinberg were chosen for
both their ability to communicate effectively with their patients and for
their commitment to share their knowledge with colleagues through
presentations, seminars and publications. Strober, an IPC councilor since
2006, joined the IPC Board of Directors in 2014. ■
r. Gudjonsson has
D
provided research
support, received a
research award and
served as a consultant
for Amgen, Pfizer, and
Novartis.
Dr. Bissonnette has
received honoraria,
participated in advisory
boards and/or received
research grants from
AbbVie, Amgen, Celgene,
Eli- Lilly, Galderma, Incyte,
Janssen, Leo Pharma, Merck, Novartis,
Pfizer, and Tribute.
IPC PSORIASIS REVIEW
Writer
Mahir Patel, MD
Editorial Staff
Mary L. Bellotti, editor
Erika Fey, editor
Rene Choy, graphic designer
Tina Rouhoff, contributing designer
31
PSORIASIS REVIEW
JANUARY 2015
VOL 11, NUMBER 1
RESOURCES
The International Psoriasis Council is pleased to bring you the following educational
opportunities to advance your knowledge of treating patients with psoriasis.
UPCOMING IPC EVENTS
IPC’S ONLINE RESOURCES
March 20 – 24, 2015
The Shifting Paradigm in
Psoriasis Treatment
73rd Annual Meeting of
the American Academy of
Dermatology
San Francisco, California
2014 CORPORATE
MEMBERS
President’s Council
AbbVie
Amgen
Pfizer
Executive’s Council
Eli Lilly and Company
Janssen Biotech Inc.
Director’s Council
Celgene Corporation
Galderma
Leo Pharma
Novartis Pharmaceuticals Corporation
Sandoz Biopharmaceuticals
Corporate Members provide unrestricted funds to support the overall
mission of IPC.
May 1 – 4, 2015
33rd Reunión Anual de
Dermatólogos Latinoamericanos
(RADLA)
Lima, Peru
June 8 – 13, 2015
23rd World Congress of
Dermatology
Vancouver, Canada
July 8 – 12, 2015
4th World Psoriasis & Psoriatic
Arthritis Conference
Stockholm, Sweden
On-demand webcast for CME credit,
www.psoriasiscme.tv/index.cfm
Challenging Cases Webcasts
Recorded over the years at our Meet
the Experts Programs around the
world. These challenging cases now
listed online by topic:
• Psoriasis and pregnancy
• Palmoplantar psoriasis
• Psoriasis and Hodgkin disease
• Juvenile psoriasis
• Many more
www.psoriasiscouncil.org/
education/webcasts_date.htm
Psoriasis Image Library
Access IPC’s psoriasis image library,
made available as a courtesy for
diagnosing and treating psoriasis.
www.psoriasiscouncil.org/
imagelibrary.htm
October 7 - 11, 2015
24th European Academy of
Dermatology & Venereology
Conference
Copenhagen, Denmark
Scan this code with your smartphone
to connect to the IPC Psoriasis Review
online.
No smartphone?
Visit www.
psoriasiscouncil.org/
psoriasisreview.htm
Advancing Knowledge | Enhancing Care
The International Psoriasis Council (IPC) is a dermatology-led, voluntary,
global nonprofit organization dedicated to innovation across the full spectrum
of psoriasis through research, education and patient care. IPC’s mission is to empower
our network of global key opinion leaders to advance the knowledge of psoriasis
and its associated comorbidities, enhancing the care of patients worldwide.

PDF - International Psoriasis Council

Transcription

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