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Recategorization of psoriasis severity: Delphi consensus from the International Psoriasis Council
Journal Pre-proof Re-Categorization of Psoriasis Severity: Delphi Consensus from the International Psoriasis Council Bruce Strober, MD, PhD, Caitriona Ryan, MD, Peter van de Kerkhof, MD, PhD, Joelle van der Walt, PhD, Alexa B. Kimball, MD, MPH, Jonathan Barker, MD, FRCP, FRCPath, Andrew Blauvelt, MD, MBA PII:
S0190-9622(19)32573-3
DOI:
https://doi.org/10.1016/j.jaad.2019.08.026
Reference:
YMJD 13746
To appear in:
Journal of the American Academy of Dermatology
Received Date: 23 April 2019 Revised Date:
2 August 2019
Accepted Date: 7 August 2019
Please cite this article as: Strober B, Ryan C, van de Kerkhof P, van der Walt J, Kimball AB, Barker J, Blauvelt A, Re-Categorization of Psoriasis Severity: Delphi Consensus from the International Psoriasis Council, Journal of the American Academy of Dermatology (2019), doi: https://doi.org/10.1016/ j.jaad.2019.08.026. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2019 Published by Elsevier on behalf of the American Academy of Dermatology, Inc.
1 1
Article type: Original article
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Title: Re-Categorization of Psoriasis Severity: Delphi Consensus from the International Psoriasis
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Council
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Bruce Strober, MD, PhD 1, Caitriona Ryan, MD2, Peter van de Kerkhof, MD, PhD3, Joelle van der Walt, PhD3, Alexa B. Kimball, MD, MPH4, Jonathan Barker, MD, FRCP, FRCPath5, Andrew Blauvelt, MD, MBA6 1 Yale University School of Medicine, New Haven, CT, USA and Central Connecticut Dermatology, Cromwell, CT USA
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3
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On behalf of: International Psoriasis Council Board members and councilors
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Corresponding author: Bruce E. Strober, MD, PhD Central Connecticut Dermatology
2
Blackrock Clinic Dublin and Charles Institute, University College Dublin, Dublin, Ireland International Psoriasis Council, St. Louis, MO, USA
4
Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, MA, USA
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St John's Institute of Dermatology, King's College London, UK
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Oregon Medical Research Center, Portland, OR, USA
1 Willowbrook Road, Suite #2, Cromwell, CT 06416. Phone: (860) 322-2222
Email: [email protected] Reprint requests: Joelle van der Walt, PhD [email protected] Funding sources: None Conflicts of Interest:
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Dr. Bruce Strober has acted as Consultant and received honoraria from AbbVie, Almirall,
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Amgen, Arena, Boehringer Ingelheim, Bristol-Myers-Squibb, Celgene, Dermavant, Dermira,
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Janssen, Leo, Eli Lilly, Medac, Meiji Seika Pharma, Sebela Pharmaceuticals, Menlo Therapeutics,
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Novartis, Pfizer, GlaxoSmithKline, UCB Pharma, Sirtris, Sun Pharma, Ortho
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Dermatologics/Valeant, Regeneron, Sanofi-Genzyme. Dr. Strober has served as investigator (no
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direct payments made to Bruce Strober, MD, PhD) for AbbVie, Celgene, Eli Lilly, Janssen, Merck,
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Boehringer Ingelheim, GlaxoSmithKline, Pfizer, Galderma, and Sienna. Dr. Strober has received
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consulting fee as Scientific Director for the CORRONA Psoriasis Registry and grant support to
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the University of Connecticut for Fellowship Program (payments to the University of
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Connecticut, not Bruce Strober, MD, PhD) from AbbVie, Janssen, and the National Psoriasis
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Foundation. Dr. Caitriona Ryan has received compensation as a speaker, consultant or advisor
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for AbbVie, Boehringer Ingelheim Dermira, Dr Reddys, Janssen, Leo, Lilly, Novartis, Regeneron-
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Sanofi, and UCB. Dr. Peter van de Kerkhof received fees for consultancy service or
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lectureships from Celgene, Allmirall, AbbVie, Eli Lilly, Novartis, Jansen Pharmaceutica , Leo
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Pharma, Bristol Mayer Squib and Dermavant.
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Dr. Joelle van der Walt has no conflicts of interest to declare. Dr. Alexa Kimball has received
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compensation as a consultant and an investigator for Novartis, AbbVie, UCB, Lilly, and Janssen
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and has received fellowship funding from Janssen and AbbVie.
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Dr. Jonathan Barker has served as an advisory board member and received honoraria from
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AbbVie, Almirall, Boehringer Ingelheim, Bristol-Meyers Squibb, Celgene, Eli Lilly, Janssen,
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Novartis, Leo, Samsung, Sienna Bio, Sun Pharma, UCB. Dr. Barker has also received research
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grant funding from Pfizer.
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Dr. Blauvelt has served as a scientific adviser and/or clinical study investigator for AbbVie,
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Aclaris, Akros, Allergan, Almirall, Amgen, Arena, Athenex, Boehringer Ingelheim, Bristol-Myers
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Squibb, Celgene, Dermavant, Dermira, Inc., Eli Lilly and Company, FLX Bio, Galderma,
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Genentech/Roche, GlaxoSmithKline, Janssen, Leo, Meiji, Merck Sharp & Dohme, Novartis,
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Pfizer, Purdue Pharma, Regeneron, Revance, Sandoz, Sanofi Genzyme, Sienna Pharmaceuticals,
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Sun Pharma, UCB Pharma, Valeant, and Vidac, and as a paid speaker for AbbVie, Regeneron,
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and Sanofi Genzyme.
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Manuscript word count: 1579 words Abstract word count: 200 Capsule summary word count: 46 References: 18 Figures: 1 Tables: 1 Supplementary tables: 2
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Supplementary materials: 1 (available at https://data.mendeley.com/datasets/4svjdh4yrd/1)
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Keywords: psoriasis, severity, BSA, topicals, systemics
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Running title: Psoriasis severity classification
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4 70 71
ABSTRACT
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Background: Psoriasis severity categories have been important tools for clinicians to use in
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treatment decisions as well as to determine eligibility criteria for clinical studies. However, due
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to the heterogeneity of severity classifications and their lack of consideration for the impact of
75
psoriasis involvement of special areas or past treatment history, patients may be mis-
76
categorized, which can lead to under-treatment of psoriasis.
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Objective: To develop a consensus statement on the classification of psoriasis severity.
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Methods: A modified Delphi approach was developed by the International Psoriasis Council to
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define psoriasis severity.
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Results: After completion of the exercise, seven severity definitions were preferentially ranked.
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This most preferred statement rejects the mild, moderate and severe categories in favor of a
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dichotomous definition: Psoriasis patients should be classified as either candidates for topical
83
therapy or candidates for systemic therapy; the latter are patients who meet at least one of the
84
following criteria: 1) BSA > 10%, 2) Disease involving special areas, 3) Failure of topical therapy.
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Limitations: This effort might have suffered from a lack of representation by all relevant
86
stakeholders, including patients.
87
Conclusion: The consensus statement describes two categories of psoriasis severity, while
88
accounting for special circumstances where patients may require systemic therapy.
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5 90 91
Capsule summary: •
there is no international consensus.
92 93
Psoriasis severity classifications are often defined by objective measures; however,
•
An international Delphi exercise was used to categorize psoriasis severity. The
94
consensus statement should prove useful for guiding therapeutic decisions in clinical
95
practice and changing enrollment criteria in psoriasis clinical research.
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6 97
INTRODUCTION
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In both clinical practice and clinical trials, psoriasis severity is often categorized as mild,
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moderate, and severe, which is guided by measurements such as body surface area (BSA),
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Physician’s Global Assessment (PGA), and the Psoriasis Area and Severity Index (PASI).[1] These
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objective measures may underestimate disease severity, however, if lower degrees of skin
102
involvement (e.g., BSA <10%) are recorded while ignoring disease involvement of “special
103
areas” (e.g., face, palms, soles, genitalia, scalp), prior treatment history, and/or the impact of
104
psoriasis on quality of life. Therefore, it is often emphasized that dermatologists should
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consider the location of lesions[2, 3] and quality of life (e.g., utilizing the Dermatology Life
106
Quality Index (DLQI))[4] to more fully and accurately assess psoriasis severity.
107 108
Many different guidelines and consensus definitions of psoriasis severity exist and include a
109
combination of assessor- and patient-reported measures for disease classification.[5, 6, 3, 7-9]
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For example, the Rule of Tens describes “Current Severe Psoriasis” = if BSA involved > 10% or
111
PASI > 10 or DLQI > 10.[10] Other proposed systems similarly employ combined ranges of PASI
112
and DLQI to compartmentalize patients into severity categories.[11]
113
Commonly, patient reported severity is misaligned with physician reported severity.[12, 13]
114
Severity measures used in routine practice often under-classify psoriasis severity, resulting in
115
undertreatment. Furthermore, there is no consensus regarding the definition for patients
116
affected by lower levels of BSA involvement who, nonetheless, have disease characteristics that
117
may severely impact quality of life and disability.[14] Typically, only patients with a minimum of
118
10% BSA are permitted entry to clinical trials of newer targeted agents, so evidence is lacking as
7 119
to the efficacy of these agents in patients with lower BSA involvement or disease involving
120
special sites. This also impacts the approval of agents for patients with lower degrees of skin
121
involvement, with some national health systems and third-party payers declining
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reimbursements for patients who do not have at least 10% BSA involvement.
123 124
To define psoriasis disease severity in a practical manner that is useful in both clinical and
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research settings, the International Psoriasis Council (IPC) used the collective experience of
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global psoriasis experts in a Delphi exercise.
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8 128
METHODS
129
Study Management
130
The study was designed and led by the Steering Committee (AB, CR, PvdK, JvdW) under the
131
leadership of BS, the Project Chair. The database was managed through Question Mark Media,
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LLC, which provided web development services to configure and maintain the hosting
133
environment (IPCDelphi.com). The web-based interface was used for the anonymous collection
134
and rating of content submitted by participants.
135 136
Participants
137
The IPC is a dermatology-led, voluntary, non-profit organization that represents psoriasis
138
experts from 32 countries. Participants have established expertise in psoriasis clinical practice,
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basic psoriasis research, and/or psoriasis clinical trials. The Delphi process consisted of a
140
brainstorming stage, two rounds of voting, and a consensus meeting. See Figure 1 and
141
supplementary material for details. All IPC Board members and councilors were invited to
142
participate in all steps of the Delphi exercise. In addition, one representative from each IPC
143
corporate sponsor was invited to participate in only the brainstorming stage.
144 145 146
RESULTS
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In total, 78 anonymous statements were collected (68 from IPC Board and Councilors and 10
148
from corporate sponsors). The statements from IPC participants reflected views on psoriasis
149
severity across geographic regions, including Europe (Denmark, France, Germany, Ireland, Italy,
9 150
the Netherlands, Portugal, Spain, United Kingdom; 24 statements), North America (Canada,
151
United States; 25 statements), and other regions (Argentina, Australia, Brazil, Chile, China,
152
Colombia, Egypt, Iran, Israel, Japan, Kuwait, Malaysia, Singapore; 19 statements)
153
(Supplementary Table 1).
154 155
A total of 74 voters participated (62% of the IPC Board and Councilor membership) in Round 1.
156
Mean scores were calculated for each statement. Subsequently, results were displayed for a
157
discussion session whereby participants anonymously could comment online on the ranking of
158
Round 1 statements. A total of 39 comments were submitted.
159 160
Seventy-two voters participated in Round 2 voting. The mean scores of Rounds 1 and 2 were
161
recorded and differences in mean scores were calculated (Supplementary Table 2).
162 163
From the 30 statements, seven statements receiving the highest scores after Round 2 were
164
chosen for voting in Round 3 at the in-person consensus meeting. After all seven statements
165
were presented and discussed, the participants voted anonymously via smart phone or tablet
166
to arrive at a final ranking of the statements. Table 1 lists the final ranking derived from the
167
Round 3 voting.
168 169
Statement ID 6 achieved the highest score, however, the group decided that the statement
170
could be optimized for wording and clarity. Therefore, two amended versions of the statement
10 171
were written and then uploaded for online voting to the entire group of participants (all IPC
172
board and councilors and IPC corporate sponsor representatives).
173 174 175
The final consensus statement is as follows : Psoriasis patients should be classified as
176
either candidates for topical therapy or candidates for systemic therapy; the latter are patients
177
who meet at least one of the following criteria:
178
1. BSA > 10%
179
2. Disease involving special areas
180
3. Failure of topical therapy
181
Systemic therapies for psoriasis were understood to include both biologic and non-biologic
182
treatments, such as phototherapy and older systemic agents. For clarity and brevity, the term
183
“special areas” was used in the severity statement to refer to psoriasis affecting more impactful
184
sites such as the face, palms, soles, genitalia, scalp, or nails.
185 186
11 187
DISCUSSION
188
The iterative, interactive and anonymous approach of the Delphi method was selected as the
189
best method to collect and prioritize statements that reflect global expert opinion on the
190
classification of psoriasis severity. This method allowed the identification of a most favored
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final consensus statement.
192 193
The multistep process of this exercise encouraged ample interspersed discussion. The merits
194
and weaknesses of many statements were debated after the first round of voting and during
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the in-person consensus meeting. The participants highlighted a concern regarding high
196
variability across countries and regions on use of different severity measures. For example, the
197
PASI is a complex measure that is frequently used by dermatologists in Europe to assess
198
severity and monitor disease response to treatment and is often needed for reimbursement
199
decisions[15]. However, PASI is infrequently used in the US in routine clinical practice where the
200
BSA is the preferred measure for therapeutic decision making and reimbursement.[2, 16]
201
Importantly, neither severity scoring tool can measure patient symptoms or quality of life, and
202
neither consider how psoriasis can affect special areas or past failure of topical therapy.
203
Therefore, participants agreed that any system of severity classification must go beyond strict
204
assessor-driven cutoffs, which in many instances incorrectly downgrade disease severity and
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thus restrict access to therapies appropriate for more severely affected patients. Ultimately,
206
the group agreed that severity definitions in part require objective numerical thresholds.
207
However, such parameters need to be coupled with other measures and concepts that are
208
relevant to the patient’s experience. In this vein, in addition to the extent and intensity
12 209
(erythema, scaling, and induration) of skin involvement, the participants highlighted the
210
importance of lesion locations (i.e., special areas) that impact quality of life and function.
211 212
As objective measures do not account for either psychologic burden or indirect costs and
213
consequences to the patient, the classification of severity, in part, should be patient-centered.
214
While the group agreed that the patient-reported outcome (PRO) metrics are relevant, they are
215
often disregarded by payers, and might explain why the top vote-winner in this exercise omits
216
the use of a PRO.
217 218
The IPC consensus statement determined here is similar to the severity definition proposed in
219
2007 by the National Psoriasis Foundation where two tiers of severity stratified by the response
220
to topical therapy were endorsed.[6] In addition, the Spanish Psoriasis Group and the European
221
Consensus Group also recognize that response to topical treatment is an important
222
consideration of psoriasis severity.[9, 5] The European Consensus Group recognized that the
223
presence of clinical manifestations (involvement of scalp, genitals, palms, soles or nails;
224
involvement of visible areas; recalcitrant plaques) may warrant systemic treatment in a
225
patient diagnosed as mild based on symptom severity and body surface area.[5] The British
226
Association of Dermatologists guidelines also include areas of involvement and functional or
227
psychosocial impact as criteria for severity classification and treatment decisions.[17] The
228
Canadian guidelines also define severity categories of psoriasis based in part on lack of control
229
of symptoms with topical therapy and the impact of patient’s quality of life.[18] The top vote-
230
receiving statement includes BSA > 10% as severity criterion, since it is easily performed and a
13 231
well-established standard of psoriasis severity. Importantly, the statement also includes
232
involvement of special areas and failure of topic therapy as criteria for more severe disease.
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Thus, this definition is more complex than “BSA > 10%” alone, accounting for important
234
exceptions to this standard that are practical and patient-centered.
235 236
The results of Delphi exercises are limited by those who choose to participate. While this effort
237
was large and international, it may have suffered from a lack of representation by all relevant
238
stakeholders, particularly community dermatologists who are not involved in academic
239
research and, importantly, psoriasis patients.
240
14 241
CONCLUSION
242
This Delphi exercise resulted in an international consensus for the classification of psoriasis
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severity. The statement that received the highest score endorses a simple, practical approach
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to classifying psoriasis disease severity. The terms mild, moderate, and severe were rejected in
245
favor of considerations of 1) a basic standard objective criteria (BSA); 2) involvement of special
246
areas of the body; and 3) the patient’s response to topical therapy. Hopefully, this new
247
consensus statement will extend to the realm of clinical research and allow expanded access of
248
psoriasis patients into clinical trials.
249
15 250
Acknowledgments:
251
The co-authors would like to thank for following IPC Board Members and Councilors for their
252
thoughtful participation in the Delphi process: Marc Bourcier, Andre Carvalho, Arnon Cohen,
253
Peter Foley, Colby Evans, Paolo Gisondi, Chris Griffiths, Mahira Hamdy El-Sayed, Cristina
254
Eschevarria, Andrew Finlay, Robert Kalb, Craig Leonardi, Chuck Lynde, Ruth Murphy, Masamoto
255
Murakami, Yukari Okubo, Errol Prens, Lluís Puig, Marieke Seyger, Lone Skov, Tadashi Terui,
256
Fernando Valenzuela, Nicole Ward, Jashin Wu, and Min Zheng. We are grateful to David Stark
257
from Question Mark Media for database development and support of this project.
258
16 259
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19 320 321
Figure 1. Psoriasis severity classification Delphi process
20
Table 1. Psoriasis severity classification statements ranking from Round 3 RANK
STATEMENT TEXT [Statement ID: 6]
1
ROUND 3 MEAN (STD) 4.2778 (1.193)
ROUND 2 MEAN (STD) 3.6667 (1.093)
0.6111
ROUND 3 VOTES 18
DIFFERENCE
There are "candidates for topical therapy," and then there are "candidates for systemic therapy " who are patients who meet at least 1 of the following criteria : 1. BSA> 10% 2. Disease involving special areas 3. Failure of topical therapy [Statement ID: 7]
2.8889 (0.994)
3.5634 (1.11)
-0.6745
18
2.6111 (1.112)
3.9718 (1.048)
-1.3607
18
Two degrees of severity: 1. That which can be adequately controlled with topical therapy alone (mild or mild-to-moderate) 2
3
2. That which requires phototherapy or systemic therapy (including biologics) (moderate-to-severe or severe, respectively). Adequate control may be determined by both objective (e.g. PASI, BSA, PGA) and subjective (e.g. DLQI, POI, PSS, SF36, EQ-5D) means/measurements/instruments. [Statement ID: 2]
21
Moderate to severe: the dermatologist perceives the need of a systemic treatment after a careful consideration of several factors (e.g., PASI, QoL impairment, comorbidities , and others)
Mild: the dermatologist perceives that only topical treatment needs to be prescribed [Statement ID: 15]
2.5 (1.258)
2.875 (1.117)
-0.375
18
2.3889 (1.061)
2.7746 (1.064)
-0.3857
18
2.1111 (0.875)
2.9306 (0.962)
-0.8195
18
Mild: BSA 0 - 5% with special areas not affected and with OLQI < 5 4
Moderate: BSA 5-10% or special areas affected; or BSA 1-5% and DLQI 5-10
Severe : > 10% BSA or special areas affected or BSA 5-10% and DLQI >10 [Statement ID: 29]
5
Mild: < 3% BSA and not affecting special areas Moderate: BSA 3-10% BSA or less than 3% BSA and involvement of special areas that cannot be managed with topical therapy alone. Severe: BSA> 10% or < 10% BSA and involvement of t wo special areas that cannot be managed with topical therapy alone. [Statement ID: 24]
6
Mild: managed by topical treatment alone
22 Moderate to severe: requires systemic treatment or phototherapy [Statement ID: 3] Mild: does not interfere with the patient's daily life and requires no treatment or only infrequent topical treatment.
7
Moderate: sometimes interferes with the patient's life due to social or occupational challenges or psoriasis-related pain. Requires regular treatment with topical medications, phototherapy, oral medications or biologic therapy. Severe: psoriasis or PsA interferes daily or frequently with the patient's life and prevents them from achieving their social or occupational goals.
1.7778 (0.916)
2.9722 (1.013)
-1.1944
18
S0190-9622(19)32573-3
DOI:
https://doi.org/10.1016/j.jaad.2019.08.026
Reference:
YMJD 13746
To appear in:
Journal of the American Academy of Dermatology
Received Date: 23 April 2019 Revised Date:
2 August 2019
Accepted Date: 7 August 2019
Please cite this article as: Strober B, Ryan C, van de Kerkhof P, van der Walt J, Kimball AB, Barker J, Blauvelt A, Re-Categorization of Psoriasis Severity: Delphi Consensus from the International Psoriasis Council, Journal of the American Academy of Dermatology (2019), doi: https://doi.org/10.1016/ j.jaad.2019.08.026. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2019 Published by Elsevier on behalf of the American Academy of Dermatology, Inc.
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Article type: Original article
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Title: Re-Categorization of Psoriasis Severity: Delphi Consensus from the International Psoriasis
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Council
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Bruce Strober, MD, PhD 1, Caitriona Ryan, MD2, Peter van de Kerkhof, MD, PhD3, Joelle van der Walt, PhD3, Alexa B. Kimball, MD, MPH4, Jonathan Barker, MD, FRCP, FRCPath5, Andrew Blauvelt, MD, MBA6 1 Yale University School of Medicine, New Haven, CT, USA and Central Connecticut Dermatology, Cromwell, CT USA
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On behalf of: International Psoriasis Council Board members and councilors
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Corresponding author: Bruce E. Strober, MD, PhD Central Connecticut Dermatology
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Blackrock Clinic Dublin and Charles Institute, University College Dublin, Dublin, Ireland International Psoriasis Council, St. Louis, MO, USA
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Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, MA, USA
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St John's Institute of Dermatology, King's College London, UK
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Oregon Medical Research Center, Portland, OR, USA
1 Willowbrook Road, Suite #2, Cromwell, CT 06416. Phone: (860) 322-2222
Email: [email protected] Reprint requests: Joelle van der Walt, PhD [email protected] Funding sources: None Conflicts of Interest:
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Dr. Bruce Strober has acted as Consultant and received honoraria from AbbVie, Almirall,
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Amgen, Arena, Boehringer Ingelheim, Bristol-Myers-Squibb, Celgene, Dermavant, Dermira,
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Janssen, Leo, Eli Lilly, Medac, Meiji Seika Pharma, Sebela Pharmaceuticals, Menlo Therapeutics,
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Novartis, Pfizer, GlaxoSmithKline, UCB Pharma, Sirtris, Sun Pharma, Ortho
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Dermatologics/Valeant, Regeneron, Sanofi-Genzyme. Dr. Strober has served as investigator (no
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direct payments made to Bruce Strober, MD, PhD) for AbbVie, Celgene, Eli Lilly, Janssen, Merck,
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Boehringer Ingelheim, GlaxoSmithKline, Pfizer, Galderma, and Sienna. Dr. Strober has received
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consulting fee as Scientific Director for the CORRONA Psoriasis Registry and grant support to
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the University of Connecticut for Fellowship Program (payments to the University of
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Connecticut, not Bruce Strober, MD, PhD) from AbbVie, Janssen, and the National Psoriasis
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Foundation. Dr. Caitriona Ryan has received compensation as a speaker, consultant or advisor
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for AbbVie, Boehringer Ingelheim Dermira, Dr Reddys, Janssen, Leo, Lilly, Novartis, Regeneron-
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Sanofi, and UCB. Dr. Peter van de Kerkhof received fees for consultancy service or
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lectureships from Celgene, Allmirall, AbbVie, Eli Lilly, Novartis, Jansen Pharmaceutica , Leo
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Pharma, Bristol Mayer Squib and Dermavant.
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Dr. Joelle van der Walt has no conflicts of interest to declare. Dr. Alexa Kimball has received
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compensation as a consultant and an investigator for Novartis, AbbVie, UCB, Lilly, and Janssen
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and has received fellowship funding from Janssen and AbbVie.
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Dr. Jonathan Barker has served as an advisory board member and received honoraria from
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AbbVie, Almirall, Boehringer Ingelheim, Bristol-Meyers Squibb, Celgene, Eli Lilly, Janssen,
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Novartis, Leo, Samsung, Sienna Bio, Sun Pharma, UCB. Dr. Barker has also received research
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grant funding from Pfizer.
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Dr. Blauvelt has served as a scientific adviser and/or clinical study investigator for AbbVie,
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Aclaris, Akros, Allergan, Almirall, Amgen, Arena, Athenex, Boehringer Ingelheim, Bristol-Myers
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Squibb, Celgene, Dermavant, Dermira, Inc., Eli Lilly and Company, FLX Bio, Galderma,
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Genentech/Roche, GlaxoSmithKline, Janssen, Leo, Meiji, Merck Sharp & Dohme, Novartis,
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Pfizer, Purdue Pharma, Regeneron, Revance, Sandoz, Sanofi Genzyme, Sienna Pharmaceuticals,
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Sun Pharma, UCB Pharma, Valeant, and Vidac, and as a paid speaker for AbbVie, Regeneron,
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and Sanofi Genzyme.
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Manuscript word count: 1579 words Abstract word count: 200 Capsule summary word count: 46 References: 18 Figures: 1 Tables: 1 Supplementary tables: 2
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Supplementary materials: 1 (available at https://data.mendeley.com/datasets/4svjdh4yrd/1)
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Keywords: psoriasis, severity, BSA, topicals, systemics
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Running title: Psoriasis severity classification
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4 70 71
ABSTRACT
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Background: Psoriasis severity categories have been important tools for clinicians to use in
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treatment decisions as well as to determine eligibility criteria for clinical studies. However, due
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to the heterogeneity of severity classifications and their lack of consideration for the impact of
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psoriasis involvement of special areas or past treatment history, patients may be mis-
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categorized, which can lead to under-treatment of psoriasis.
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Objective: To develop a consensus statement on the classification of psoriasis severity.
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Methods: A modified Delphi approach was developed by the International Psoriasis Council to
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define psoriasis severity.
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Results: After completion of the exercise, seven severity definitions were preferentially ranked.
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This most preferred statement rejects the mild, moderate and severe categories in favor of a
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dichotomous definition: Psoriasis patients should be classified as either candidates for topical
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therapy or candidates for systemic therapy; the latter are patients who meet at least one of the
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following criteria: 1) BSA > 10%, 2) Disease involving special areas, 3) Failure of topical therapy.
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Limitations: This effort might have suffered from a lack of representation by all relevant
86
stakeholders, including patients.
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Conclusion: The consensus statement describes two categories of psoriasis severity, while
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accounting for special circumstances where patients may require systemic therapy.
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5 90 91
Capsule summary: •
there is no international consensus.
92 93
Psoriasis severity classifications are often defined by objective measures; however,
•
An international Delphi exercise was used to categorize psoriasis severity. The
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consensus statement should prove useful for guiding therapeutic decisions in clinical
95
practice and changing enrollment criteria in psoriasis clinical research.
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6 97
INTRODUCTION
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In both clinical practice and clinical trials, psoriasis severity is often categorized as mild,
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moderate, and severe, which is guided by measurements such as body surface area (BSA),
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Physician’s Global Assessment (PGA), and the Psoriasis Area and Severity Index (PASI).[1] These
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objective measures may underestimate disease severity, however, if lower degrees of skin
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involvement (e.g., BSA <10%) are recorded while ignoring disease involvement of “special
103
areas” (e.g., face, palms, soles, genitalia, scalp), prior treatment history, and/or the impact of
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psoriasis on quality of life. Therefore, it is often emphasized that dermatologists should
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consider the location of lesions[2, 3] and quality of life (e.g., utilizing the Dermatology Life
106
Quality Index (DLQI))[4] to more fully and accurately assess psoriasis severity.
107 108
Many different guidelines and consensus definitions of psoriasis severity exist and include a
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combination of assessor- and patient-reported measures for disease classification.[5, 6, 3, 7-9]
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For example, the Rule of Tens describes “Current Severe Psoriasis” = if BSA involved > 10% or
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PASI > 10 or DLQI > 10.[10] Other proposed systems similarly employ combined ranges of PASI
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and DLQI to compartmentalize patients into severity categories.[11]
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Commonly, patient reported severity is misaligned with physician reported severity.[12, 13]
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Severity measures used in routine practice often under-classify psoriasis severity, resulting in
115
undertreatment. Furthermore, there is no consensus regarding the definition for patients
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affected by lower levels of BSA involvement who, nonetheless, have disease characteristics that
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may severely impact quality of life and disability.[14] Typically, only patients with a minimum of
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10% BSA are permitted entry to clinical trials of newer targeted agents, so evidence is lacking as
7 119
to the efficacy of these agents in patients with lower BSA involvement or disease involving
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special sites. This also impacts the approval of agents for patients with lower degrees of skin
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involvement, with some national health systems and third-party payers declining
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reimbursements for patients who do not have at least 10% BSA involvement.
123 124
To define psoriasis disease severity in a practical manner that is useful in both clinical and
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research settings, the International Psoriasis Council (IPC) used the collective experience of
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global psoriasis experts in a Delphi exercise.
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METHODS
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Study Management
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The study was designed and led by the Steering Committee (AB, CR, PvdK, JvdW) under the
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leadership of BS, the Project Chair. The database was managed through Question Mark Media,
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LLC, which provided web development services to configure and maintain the hosting
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environment (IPCDelphi.com). The web-based interface was used for the anonymous collection
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and rating of content submitted by participants.
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Participants
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The IPC is a dermatology-led, voluntary, non-profit organization that represents psoriasis
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experts from 32 countries. Participants have established expertise in psoriasis clinical practice,
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basic psoriasis research, and/or psoriasis clinical trials. The Delphi process consisted of a
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brainstorming stage, two rounds of voting, and a consensus meeting. See Figure 1 and
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supplementary material for details. All IPC Board members and councilors were invited to
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participate in all steps of the Delphi exercise. In addition, one representative from each IPC
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corporate sponsor was invited to participate in only the brainstorming stage.
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RESULTS
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In total, 78 anonymous statements were collected (68 from IPC Board and Councilors and 10
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from corporate sponsors). The statements from IPC participants reflected views on psoriasis
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severity across geographic regions, including Europe (Denmark, France, Germany, Ireland, Italy,
9 150
the Netherlands, Portugal, Spain, United Kingdom; 24 statements), North America (Canada,
151
United States; 25 statements), and other regions (Argentina, Australia, Brazil, Chile, China,
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Colombia, Egypt, Iran, Israel, Japan, Kuwait, Malaysia, Singapore; 19 statements)
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(Supplementary Table 1).
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A total of 74 voters participated (62% of the IPC Board and Councilor membership) in Round 1.
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Mean scores were calculated for each statement. Subsequently, results were displayed for a
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discussion session whereby participants anonymously could comment online on the ranking of
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Round 1 statements. A total of 39 comments were submitted.
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Seventy-two voters participated in Round 2 voting. The mean scores of Rounds 1 and 2 were
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recorded and differences in mean scores were calculated (Supplementary Table 2).
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From the 30 statements, seven statements receiving the highest scores after Round 2 were
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chosen for voting in Round 3 at the in-person consensus meeting. After all seven statements
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were presented and discussed, the participants voted anonymously via smart phone or tablet
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to arrive at a final ranking of the statements. Table 1 lists the final ranking derived from the
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Round 3 voting.
168 169
Statement ID 6 achieved the highest score, however, the group decided that the statement
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could be optimized for wording and clarity. Therefore, two amended versions of the statement
10 171
were written and then uploaded for online voting to the entire group of participants (all IPC
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board and councilors and IPC corporate sponsor representatives).
173 174 175
The final consensus statement is as follows : Psoriasis patients should be classified as
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either candidates for topical therapy or candidates for systemic therapy; the latter are patients
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who meet at least one of the following criteria:
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1. BSA > 10%
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2. Disease involving special areas
180
3. Failure of topical therapy
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Systemic therapies for psoriasis were understood to include both biologic and non-biologic
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treatments, such as phototherapy and older systemic agents. For clarity and brevity, the term
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“special areas” was used in the severity statement to refer to psoriasis affecting more impactful
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sites such as the face, palms, soles, genitalia, scalp, or nails.
185 186
11 187
DISCUSSION
188
The iterative, interactive and anonymous approach of the Delphi method was selected as the
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best method to collect and prioritize statements that reflect global expert opinion on the
190
classification of psoriasis severity. This method allowed the identification of a most favored
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final consensus statement.
192 193
The multistep process of this exercise encouraged ample interspersed discussion. The merits
194
and weaknesses of many statements were debated after the first round of voting and during
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the in-person consensus meeting. The participants highlighted a concern regarding high
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variability across countries and regions on use of different severity measures. For example, the
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PASI is a complex measure that is frequently used by dermatologists in Europe to assess
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severity and monitor disease response to treatment and is often needed for reimbursement
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decisions[15]. However, PASI is infrequently used in the US in routine clinical practice where the
200
BSA is the preferred measure for therapeutic decision making and reimbursement.[2, 16]
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Importantly, neither severity scoring tool can measure patient symptoms or quality of life, and
202
neither consider how psoriasis can affect special areas or past failure of topical therapy.
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Therefore, participants agreed that any system of severity classification must go beyond strict
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assessor-driven cutoffs, which in many instances incorrectly downgrade disease severity and
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thus restrict access to therapies appropriate for more severely affected patients. Ultimately,
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the group agreed that severity definitions in part require objective numerical thresholds.
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However, such parameters need to be coupled with other measures and concepts that are
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relevant to the patient’s experience. In this vein, in addition to the extent and intensity
12 209
(erythema, scaling, and induration) of skin involvement, the participants highlighted the
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importance of lesion locations (i.e., special areas) that impact quality of life and function.
211 212
As objective measures do not account for either psychologic burden or indirect costs and
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consequences to the patient, the classification of severity, in part, should be patient-centered.
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While the group agreed that the patient-reported outcome (PRO) metrics are relevant, they are
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often disregarded by payers, and might explain why the top vote-winner in this exercise omits
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the use of a PRO.
217 218
The IPC consensus statement determined here is similar to the severity definition proposed in
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2007 by the National Psoriasis Foundation where two tiers of severity stratified by the response
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to topical therapy were endorsed.[6] In addition, the Spanish Psoriasis Group and the European
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Consensus Group also recognize that response to topical treatment is an important
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consideration of psoriasis severity.[9, 5] The European Consensus Group recognized that the
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presence of clinical manifestations (involvement of scalp, genitals, palms, soles or nails;
224
involvement of visible areas; recalcitrant plaques) may warrant systemic treatment in a
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patient diagnosed as mild based on symptom severity and body surface area.[5] The British
226
Association of Dermatologists guidelines also include areas of involvement and functional or
227
psychosocial impact as criteria for severity classification and treatment decisions.[17] The
228
Canadian guidelines also define severity categories of psoriasis based in part on lack of control
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of symptoms with topical therapy and the impact of patient’s quality of life.[18] The top vote-
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receiving statement includes BSA > 10% as severity criterion, since it is easily performed and a
13 231
well-established standard of psoriasis severity. Importantly, the statement also includes
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involvement of special areas and failure of topic therapy as criteria for more severe disease.
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Thus, this definition is more complex than “BSA > 10%” alone, accounting for important
234
exceptions to this standard that are practical and patient-centered.
235 236
The results of Delphi exercises are limited by those who choose to participate. While this effort
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was large and international, it may have suffered from a lack of representation by all relevant
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stakeholders, particularly community dermatologists who are not involved in academic
239
research and, importantly, psoriasis patients.
240
14 241
CONCLUSION
242
This Delphi exercise resulted in an international consensus for the classification of psoriasis
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severity. The statement that received the highest score endorses a simple, practical approach
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to classifying psoriasis disease severity. The terms mild, moderate, and severe were rejected in
245
favor of considerations of 1) a basic standard objective criteria (BSA); 2) involvement of special
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areas of the body; and 3) the patient’s response to topical therapy. Hopefully, this new
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consensus statement will extend to the realm of clinical research and allow expanded access of
248
psoriasis patients into clinical trials.
249
15 250
Acknowledgments:
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The co-authors would like to thank for following IPC Board Members and Councilors for their
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thoughtful participation in the Delphi process: Marc Bourcier, Andre Carvalho, Arnon Cohen,
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Peter Foley, Colby Evans, Paolo Gisondi, Chris Griffiths, Mahira Hamdy El-Sayed, Cristina
254
Eschevarria, Andrew Finlay, Robert Kalb, Craig Leonardi, Chuck Lynde, Ruth Murphy, Masamoto
255
Murakami, Yukari Okubo, Errol Prens, Lluís Puig, Marieke Seyger, Lone Skov, Tadashi Terui,
256
Fernando Valenzuela, Nicole Ward, Jashin Wu, and Min Zheng. We are grateful to David Stark
257
from Question Mark Media for database development and support of this project.
258
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Figure 1. Psoriasis severity classification Delphi process
20
Table 1. Psoriasis severity classification statements ranking from Round 3 RANK
STATEMENT TEXT [Statement ID: 6]
1
ROUND 3 MEAN (STD) 4.2778 (1.193)
ROUND 2 MEAN (STD) 3.6667 (1.093)
0.6111
ROUND 3 VOTES 18
DIFFERENCE
There are "candidates for topical therapy," and then there are "candidates for systemic therapy " who are patients who meet at least 1 of the following criteria : 1. BSA> 10% 2. Disease involving special areas 3. Failure of topical therapy [Statement ID: 7]
2.8889 (0.994)
3.5634 (1.11)
-0.6745
18
2.6111 (1.112)
3.9718 (1.048)
-1.3607
18
Two degrees of severity: 1. That which can be adequately controlled with topical therapy alone (mild or mild-to-moderate) 2
3
2. That which requires phototherapy or systemic therapy (including biologics) (moderate-to-severe or severe, respectively). Adequate control may be determined by both objective (e.g. PASI, BSA, PGA) and subjective (e.g. DLQI, POI, PSS, SF36, EQ-5D) means/measurements/instruments. [Statement ID: 2]
21
Moderate to severe: the dermatologist perceives the need of a systemic treatment after a careful consideration of several factors (e.g., PASI, QoL impairment, comorbidities , and others)
Mild: the dermatologist perceives that only topical treatment needs to be prescribed [Statement ID: 15]
2.5 (1.258)
2.875 (1.117)
-0.375
18
2.3889 (1.061)
2.7746 (1.064)
-0.3857
18
2.1111 (0.875)
2.9306 (0.962)
-0.8195
18
Mild: BSA 0 - 5% with special areas not affected and with OLQI < 5 4
Moderate: BSA 5-10% or special areas affected; or BSA 1-5% and DLQI 5-10
Severe : > 10% BSA or special areas affected or BSA 5-10% and DLQI >10 [Statement ID: 29]
5
Mild: < 3% BSA and not affecting special areas Moderate: BSA 3-10% BSA or less than 3% BSA and involvement of special areas that cannot be managed with topical therapy alone. Severe: BSA> 10% or < 10% BSA and involvement of t wo special areas that cannot be managed with topical therapy alone. [Statement ID: 24]
6
Mild: managed by topical treatment alone
22 Moderate to severe: requires systemic treatment or phototherapy [Statement ID: 3] Mild: does not interfere with the patient's daily life and requires no treatment or only infrequent topical treatment.
7
Moderate: sometimes interferes with the patient's life due to social or occupational challenges or psoriasis-related pain. Requires regular treatment with topical medications, phototherapy, oral medications or biologic therapy. Severe: psoriasis or PsA interferes daily or frequently with the patient's life and prevents them from achieving their social or occupational goals.
1.7778 (0.916)
2.9722 (1.013)
-1.1944
18