Measuring psoriatic arthritis symptoms: A core domain in psoriasis clinical trials - 31/10/19
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Abstract |
Background |
The International Dermatology Outcome Measures established a set of core domains to be measured in all psoriasis trials. This set requires that symptoms of psoriatic arthritis (PsA) be measured in all psoriasis studies.
Objective |
To identify the approach to PsA screening and the most appropriate outcome measure for capturing PsA symptoms.
Methods |
Following guidelines (ie, the COnsensus-based Standards for the selection of health Measurement INstruments, Core Outcome Measures in Effectiveness Trials Initiative, and Outcome Measures in Rheumatology Handbook), we conducted a consensus-building study that included patients, physicians, industry partners, and patient association representatives. The process consisted of a literature review and quality appraisal of measures for PsA symptoms, a pre-Delphi exercise, a Delphi survey, and a consensus meeting.
Results |
Among the 297 expert participants in the Delphi survey, 87.5% agreed that all patients in a psoriasis trial should be screened for PsA with a validated screening tool. Regarding the measurement of PsA symptoms, the preferred instrument was the Psoriatic Arthritis Impact of Disease-9 (PsAID9), with the Routine Assessment Patient Index Data-3 (RAPID3) representing an acceptable alternative.
Limitations |
Only International Dermatology Outcome Measures members participated in the consensus meeting.
Conclusion |
The overwhelming majority of expert stakeholders agreed that all psoriasis trial participants should be screened for PsA, with PsA symptoms measured by using PsAID9 (or alternatively with RAPID3).
Le texte complet de cet article est disponible en PDF.Key words : clinical trials, patient-reported outcome measures, psoriatic arthritis, psychometric, screening
Abbreviations used : COS, COSMIN, GRAPPA, HRQoL, IDEOM, OMERACT, PGA, PPACMAN, PsA, PsAID, RAPID3
Plan
Dr Ogdie and Dr Merola contributed equally to this work. |
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Funding sources: Supported by International Dermatology Outcome Measures. |
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Conflicts of interest: Dr Gottlieb served as an advisor or consultant for Abbvie, Allergan, Beiersdorf, BMS, Celgene, Dermira, Dr Reddy, Incyte Corporation, Janssen Ortho Inc, Lilly ICOS LLC, Novartis, Sun Pharmaceutical Industries, UCB, Valeant Pharmaceutical International, Valeant Pharmaceutical North America LLC, and XBiotech. She received research and educational grants from Janssen Ortho Inc, Incyte Corporation, Novartis and UCB. Dr Gottlieb is also a speaker for Abbvie, Eli Lilly and Co, Janssen Biotech and an investigator for Incyte Corporation, Janssen Ortho Inc, Lilly ICOS LLC, Novartis, and UCB. Dr Mease served as an advisor, consultant, speaker, or investigator for Abbvie, Amgen, BMS, Celgene, Eli Lilly, Galapagos, Genentech, Gilead, Janssen, Leo, Merck, Novartis, Pfizer, SUN Pharma, and UCB. Dr Duffin has served on the advisory board, as a consultant for, or an investigator for Novartis, Amgen, Abbvie, Celgene, Lilly, UCB, Ortho, Sienna, Pfizer, and Bristol-Myers Squibb Janssen. Dr Garg served as a consultant for Abbvie, Pfizer, UCB, and Asana Biosciences. Also, he received research and educational grants from UCB and served as an investigator for Abbvie. Dr Armstrong has served as investigator, advisor, or consultant to Leo Pharma, Novartis, Dermira, UCB Pharma, AbbVie, Janssen, Eli Lilly, Regeneron & Sanofi, Science 37, Modernizing Medicine, Merck, Parexel, Celgene, Ortho Dermatologics, and Pfizer. Dr Ogdie served as a consultant for Abbvie, Amgen, BMS, Celgene, Corrona, Lilly, Novartis, Pfizer, and Takeda. She also received research grants from Novartis and Pfizer. Dr Merola has served as a consultant and investigator for Biogen IDEC, AbbVie, Amgen, Eli Lilly, Novartis, Pfizer, Janssen, UCB, Samumed, Science37, Celgene, Sanofi Regeneron, Merck, and GlaxoSmithKline. Dr Perez-Chada, Dr Cohen, and Mr Latella have no conflicts of interest to disclose. |
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Reprints not available from the authors. |
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