Article

1 Iconography
Access to the text (HTML) Access to the text (HTML)
PDF Access to the PDF text
Advertising


Access to the full text of this article requires a subscription.
  • If you are a subscriber, please sign in 'My Account' at the top right of the screen.

  • If you want to subscribe to this journal, see our rates



@@#116300@@

Journal of the American Academy of Dermatology
Sous presse. Epreuves corrigées par l'auteur. Disponible en ligne depuis le jeudi 31 octobre 2019
Doi : 10.1016/j.jaad.2019.05.075
accepted : 16 May 2019
Measuring psoriatic arthritis symptoms: A core domain in psoriasis clinical trials
 

Lourdes Maria Perez-Chada, MD, MMSc a, Alice Bendix Gottlieb, MD, PhD b, Jeffrey Cohen, MD c, Philip Mease, MD d, e, f, Kristina Callis Duffin, MD, MS g, Amit Garg, MD h, John Latella, BS i, April Wang Armstrong, MD, MPH j, Alexis Ogdie, MD, MSE k, l, Joseph Frank Merola, MD, MMSc m, n,
a Department of Dermatology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 
b Department of Dermatology, Icahn School of Medicine at Mt. Sinai, New York, New York 
c The Ronald O. Perelman Department of Dermatology, New York University School of Medicine, New York, New York 
d Division of Rheumatology Research, Swedish Medical Center, Seattle, Washington 
e Providence St. Joseph Health, Seattle, Washington 
f University of Washington School of Medicine, Seattle, Washington 
g Department of Dermatology, University of Utah, Salt Lake City, Utah 
h Department of Dermatology, Hofstra Northwell School of Medicine, New Hyde Park, New York 
i International Dermatology Outcome Measures, Windsor, Connecticut 
j Department of Dermatology, University of Southern California Keck School of Medicine, Los Angeles, California 
k Division of Rheumatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania 
l Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania 
m Department of Dermatology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 
n Department of Medicine, Division of Rheumatology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 

Correspondence to: Joseph Frank Merola MD, MMSc, Department of Dermatology and Department of Medicine, Division of Rheumatology, Brigham and Women's Hospital, 221 Longwood Ave, Boston, MA 02115.Department of Dermatology and Department of MedicineDivision of RheumatologyBrigham and Women's Hospital221 Longwood AveBostonMA02115
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).

The full text of this article is available in PDF format.

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



 Dr Ogdie and Dr Merola contributed equally to this work.
 Funding sources: Supported by International Dermatology Outcome Measures.
 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.
 Reprints not available from the authors.



© 2019  Published by Elsevier Masson SAS.
EM-CONSULTE.COM is registrered at the CNIL, déclaration n° 1286925.
As per the Law relating to information storage and personal integrity, you have the right to oppose (art 26 of that law), access (art 34 of that law) and rectify (art 36 of that law) your personal data. You may thus request that your data, should it be inaccurate, incomplete, unclear, outdated, not be used or stored, be corrected, clarified, updated or deleted.
Personal information regarding our website's visitors, including their identity, is confidential.
The owners of this website hereby guarantee to respect the legal confidentiality conditions, applicable in France, and not to disclose this data to third parties.
Close
Article Outline