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Achieving international consensus on the assessment of psoriatic arthritis in psoriasis clinical trials: an International Dermatology Outcome Measures (IDEOM) initiative

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Abstract

Psoriatic arthritis (PsA) is rarely assessed in psoriasis randomized controlled trials (RCT); thus, the effect of psoriasis therapy on PsA is unknown. The International Dermatology Outcome Measures (IDEOM) has included “PsA Symptoms” as part of the core domains to be measured in psoriasis RCT. This study aimed to achieve consensus about screening for PsA and how to measure for “PsA Symptoms” in psoriasis RCT. At the IDEOM 2017 Annual Meeting, stakeholders voted on the role of PsA screening in psoriasis RCT. To select measures for “PsA Symptoms”, we adapted the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) guidelines. Three potential measures were selected. At the meeting, stakeholders voted on the validity, feasibility, and responsiveness of these measures. Of the 47 stakeholders, 93% voted that all psoriasis trial participants should be screened for PsA. “PsA Symptoms” measures included Patient Global (PG)-arthritis, Routine Assessment Patient Index Data (RAPID)-3, and Psoriatic Arthritis Impact of Disease (PsAID)-9. During the voting, more than 50% of the voters agreed that RAPID3 and PsAID9 were good measures for PsA Symptoms, able to capture all its essential elements. PsAID9 was considered the most feasible instrument, followed by RAPID3 and PG-arthritis, respectively. Finally, most participants agreed that RAPID3 and PsAID9 were responsive measures. Most study participants voted that all subjects in a psoriasis clinical trial should be screened for PsA. RAPID3 and PsAID9 outperformed PG-arthritis in measuring PsA Symptoms. This will be followed by a Delphi survey involving a larger stakeholder group.

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Acknowledgements

We thank Dr. Philip Mease for his collaboration in the design of the Delphi Survey during the 2018 GRAPPA adjacent to the AAD Meeting in San Diego, CA, USA.

Funding

This study was funded by the International Dermatology Outcome Measures group.

Author information

Author notes

  1. Lourdes M. Perez-Chada and Jeffrey M. Cohen are co-first authors.

  2. Alexis Ogdie and Joseph F. Merola are co-senior authors.

Authors and Affiliations

  1. Department of Dermatology, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA

    Lourdes Maria Perez-Chada & Joseph Frank Merola

  2. The Ronald O. Perelman Department of Dermatology, New York University School of Medicine, New York, NY, USA

    Jeffrey M. Cohen

  3. Department of Dermatology, New York Medical College at Metropolitan Hospital, New York, NY, USA

    Alice Bendix Gottlieb

  4. Department of Dermatology, University of Utah, Salt Lake City, UT, USA

    Kristina Callis Duffin

  5. Department of Dermatology, Hofstra Northwell School of Medicine, New Hyde Park, NY, USA

    Amit Garg

  6. International Dermatology Outcome Measures (IDEOM), Windsor, CT, USA

    John Latella

  7. Department of Dermatology, University of Southern California Keck School of Medicine, Los Angeles, CA, USA

    April Wang Armstrong

  8. Division of Rheumatology and Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA

    Alexis Ogdie

  9. Division of Rheumatology, Department of Medicine, Brigham and Women’s Hospital, Boston, MA, USA

    Joseph Frank Merola

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  1. Lourdes Maria Perez-Chada
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Corresponding author

Correspondence to Joseph Frank Merola.

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Conflict of interest

Dr. Gottlieb is an advisor/consultant for Janssen Inc.; Celgene Corp., Bristol Myers Squibb Co., Beiersdorf, Inc., Abbvie, UCB, Novartis, Incyte, Pfizer, Lilly, Xenoport, Development Crescendo Bioscience, Aclaris, Amicus, Reddy Labs, Valeant, Dermira, Allergan, CSL Behring, Merck, Sun Pharmaceutical Industries. Also, she received research/educational grants from Janssen, Incyte. Dr. Duffin has been a consultant and/or investigator for Amgen, Janssen, Lilly, Novartis, Celgene, Pfizer; Bristol-Myers Squibb Co. Dr. Garg served on the advisory board of Abbvie, Janssen, and Pfizer receiving honoraria. Also, he received research/educational grants from AbbVie and Merck. Dr. Armstrong has served as investigator, advisor and/or consultant to AbbVie, Janssen, Novartis, Lilly, Regeneron, Sanofi, Science 37, Modernizing Medicine, and Valeant. Dr. Merola has served as an advisor/consultant for Biogen IDEC, AbbVie, Amgen, Eli Lilly, Novartis, Pfizer, Janssen, UCB, Kiniksa, Momenta and Mallinckrodt. He has been a speaker for AbbVie and Eli Lilly, and an investigator for Biogen IDEC, Amgen, Pfizer and Boehringer Ingelheim. Dr. Ogdie served as a consultant for Bristol-Myers Squibb, Lilly, Novartis, Pfizer, and Takeda and has received grant funding to the University of Pennsylvania from Pfizer (co-investigator) and Novartis. John Latella has served as Patient Consultant for Boehringer Ingelheim, and Patient Advocate for GfK. Dr. Perez-Chada has received research funding from “RADLA Scholarship 2010”. The other authors have no disclosures.

Research involving human participants and/or animals

Evaluation by an ethical board was deemed exempt given the nature of a consensus meeting. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Informed consent

Process to obtain informed consent was deemed exempt given the nature of a consensus meeting.

Electronic supplementary material

Below is the link to the electronic supplementary material.

Online Resource 1: Table comparing the characteristics of different screening tools (PDF 98 KB)

Online Resource 2: Table presenting the eligibility criteria to select “PsA Symptoms” measures (PDF 85 KB)

403_2018_1855_MOESM3_ESM.pdf

Online Resource 3: Pubmed search strategy to identify articles reporting the psychometric properties of the PG-arthritis VAS, PG-arthritis NRS, RAPID3, PsAID9 and PsAID12 (PDF 99 KB)

Table presenting the definition of psychometric terms (PDF 89 KB)

403_2018_1855_MOESM5_ESM.pdf

Overview and summary of the psychometric properties of the PG-arthritis VAS, PG-arthritis NRS, RAPID3, PsAID9 and PsAID12 (PDF 242 KB)

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Perez-Chada, L.M., Cohen, J.M., Gottlieb, A.B. et al. Achieving international consensus on the assessment of psoriatic arthritis in psoriasis clinical trials: an International Dermatology Outcome Measures (IDEOM) initiative. Arch Dermatol Res 310, 701–710 (2018). https://doi.org/10.1007/s00403-018-1855-3

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