International Patient and Physician Consensus on Psoriatic Arthritis Outcomes for Clinical Trials

Ana-Maria Orbai¹, Maarten de Wit², Philip J Mease³, Judy A. Shea⁴, Laure Gossec⁵, Ying Ying Leung⁶, William Tillett⁷, Musaab Elmamoun⁸, Kristina Callis Duffin⁹, Willemina Campbell¹⁰, Robin Christensen¹¹, Laura C. Coates¹², Emma Dures¹³, Lihi Eder¹⁴, Oliver FitzGerald¹⁵, Dafna D. Gladman¹⁶, Niti Goel¹⁷, Suzanne Grieb¹⁸, Sarah Hewlett¹⁹, Pil Hoejgaard²⁰, Umut Kalyoncu^21,22, Christine Lindsay²³, Neil J. McHugh²⁴, Bev Shea²⁵, Ingrid Steinkoenig²⁶, Vibeke Strand²⁷ and Alexis Ogdie²⁸, ¹Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, ²Medical Humanities, VU Medical Centre, Amsterdam, Netherlands, ³Rheumatology Research, Swedish Medical Center, Seattle, WA, ⁴Division of General Internal Medicine, University of Pennsylvania, Philadelphia, PA, ⁵Rheumatology, Paris 06 University, Paris, France, ⁶North District Hospital, Hong Kong, China, ⁷Rheumatology, Royal National Hospital for Rheumatic Diseases, Bath, United Kingdom, ⁸Rheumatology, St. Vincent's University Hospital, Dublin 4, Ireland, ⁹Department of Dermatology, University of Utah, Salt Lake City, UT, ¹⁰Toronto Western Hospital, Toronto, ON, Canada, ¹¹Musculoskeletal Statistics Unit, The Parker Institute, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Copenhagen, Denmark, ¹²University of Leeds, Leeds, United Kingdom, ¹³Academic Rheumatology, Bristol, University of the West of England, Bristol, Bristol, United Kingdom, ¹⁴Women's College Research Institute, University of Toronto, Toronto, ON, Canada, ¹⁵Department of Rheumatology, St Vincent’s University Hospital and Conway Institute, University College, Dublin, Ireland, ¹⁶Rheumatology, Centre for Prognosis Studies in the Rheumatic Diseases, Toronto Western Hospital and University of Toronto, Toronto, ON, Canada, ¹⁷Quintiles; Duke University School of Medicine, Durham, NC, ¹⁸Johns Hopkins Bayview Medical Center, Center for Child and Community Health Research, Baltimore, MD, ¹⁹Academic Rheumatology, University of West of England, Bristol, United Kingdom, ²⁰The Parker Institute, Bispebjerg and Frederiksberg Hospital, The Capital Region of Denmark, Denmark, ²¹Rheumatology, Johns Hopkins University, Baltimore, MD, ²²Rheumatology, Hacettepe University Faculty of Medicine, Ankara, Turkey, ²³Medical Affairs, Amgen Inc, Thousand Oaks, CA, ²⁴Rheumatology, Royal National Hospital for Rheumatic Diseases, Upper Borough Walls, United Kingdom, ²⁵University of Ottawa, Ottawa, ON, Canada, ²⁶Patient Research Partner,, Cleveland, OH, ²⁷School of Medicine, Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, ²⁸University of Pennsylvania, Philadelphia, PA

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: outcomes, patient engagement and psoriatic arthritis

Session Information

Date: Sunday, November 13, 2016

Title: Spondylarthropathies and Psoriatic Arthritis – Clinical Aspects and Treatment I: Psoriatic Arthritis – Treatment

Session Type: ACR Concurrent Abstract Session

Session Time: 2:30PM-4:00PM

Background/Purpose: A psoriatic arthritis (PsA) core domain set to be measured in randomized controlled trials (RCT) was developed by Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and endorsed by Outcome Measures in Rheumatology (OMERACT) in 2006. Over the past 2 years, the GRAPPA-OMERACT PsA working group conducted research projects with the objective to update the PsA core domains set to reflect patients’ and physicians’ priorities and evolving PsA research.

Methods: We conducted: 1) a systematic literature review (SLR) of domains assessed in PsA RCTs and longitudinal observational studies (LOS); 2) international qualitative focus groups on five continents to identify domains important to patients with PsA; 3) international surveys with patients with PsA and physicians to prioritize domains; and 4) an international face-to-face consensus meeting among patient research partners (PRPs) and physicians using the nominal group technique (NGT) method to draft a PsA core domain set. Patient research partners (PRPs) were involved in each phase and one co-chaired the working group.

Results: Thirty-nine unique PsA domains were identified through the SLR (24 domains) and focus groups (34 domains). Patients (n=50) and physicians (n=75) completed electronic surveys rating the importance of the 39 domains for inclusion in the core set (Figure 1). At the consensus meeting, 12 patients and 12 physicians used these data to agree upon 10 domains for inclusion in PsA clinical trials, one strongly recommended to be measured at least once during the development of a new medication (middle circle) and four domains for the research agenda. These domains were rated in a second international survey with patients (n=49) and physicians (n=71) (Figure 1). The results were presented at the OMERACT conference in May 2016 and voted upon for endorsement. The updated PsA Core Domain set endorsed at OMERACT 2016 with 90% vote includes: musculoskeletal disease activity (peripheral arthritis, enthesitis, dactylitis, and spine symptoms), skin disease activity (skin and nail disease), pain, patient global, physical function, health-related quality of life, fatigue, and systemic inflammation (Figure 2).

Conclusion: The updated PsA Core Domain Set incorporates patients’ and physicians’ priorities and evolving PsA research. Next steps include identifying outcome measurement instruments that adequately assess these domains. Figure 1: Survey results from patients and physicians. Figure 2: 2016 Psoriatic Arthritis Core Domain Set.

Disclosure: A. M. Orbai, Celgene, 2,Janssen Pharmaceutica Product, L.P., 2,Janssen Pharmaceutica Product, L.P., 5; M. de Wit, None; P. J. Mease, abbvie, 2,abbve, 5,Abbvie, 8,Amgen, 2,Amgen, 5,Amgen, 8,Bristol-Myers Squibb, 2,Bristol-Myers Squibb, 5,Bristol-Myers Squibb, 8,Celgene, 2,Celgene, 5,Celgene, 8,crescendo, 5,crescendo, 8,Corrona, 5,demira, 5,Genentech and Biogen IDEC Inc., 8,Janssen Pharmaceutica Product, L.P., 2,Janssen Pharmaceutica Product, L.P., 5,Janssen Pharmaceutica Product, L.P., 8,Lilly, 2,lilly, 5,Lilly, 8,Merck Pharmaceuticals, 5,Novartis Pharmaceutical Corporation, 2,Novartis Pharmaceutical Corporation, 5,Novartis Pharmaceutical Corporation, 8,Pfizer Inc, 2,Pfizer Inc, 5,Pfizer Inc, 8,Sun, 2,Sun, 5,UCB, 2,UCB, 5,UCB, 8,Zynerba, 5; J. A. Shea, None; L. Gossec, None; Y. Y. Leung, None; W. Tillett, AbbVie, Celgene, Pfizer, and UCB, 2,AbbVie, Celgene, Pfizer, and UCB, 5,AbbVie, Celgene, Pfizer, and UCB, 8; M. Elmamoun, None; K. Callis Duffin, None; W. Campbell, None; R. Christensen, R. Christensen Consultant for:, 5; L. C. Coates, Abbvie, 2,Janssen Pharmaceutica Product, L.P., 2,Eli Lilly and Company, 5,Novartis Pharmaceutical Corporation, 5,Abbvie, 5,Pfizer Inc, 5,MSD, 5,Janssen Pharmaceutica Product, L.P., 5,BMS, 5,UCB, 5,Sun Pharma, 5; E. Dures, None; L. Eder, None; O. FitzGerald, Abbvie, 2,Pfizer Inc, 2,BMS, 2,Abbvie, 5,Pfizer Inc, 5,BMS, 5,Celgene, 5,Janssen Pharmaceutica Product, L.P., 5,Novartis Pharmaceutical Corporation, 5,UCB, 5,Lilly, 5; D. D. Gladman, None; N. Goel, Quintiles, Inc., 3; S. Grieb, None; S. Hewlett, None; P. Hoejgaard, None; U. Kalyoncu, None; C. Lindsay, Amgen, Inc., 3,Amgen, Inc., 1; N. J. McHugh, None; B. Shea, None; I. Steinkoenig, None; V. Strand, None; A. Ogdie, None.

To cite this abstract in AMA style:

Orbai AM, de Wit M, Mease PJ, Shea JA, Gossec L, Leung YY, Tillett W, Elmamoun M, Callis Duffin K, Campbell W, Christensen R, Coates LC, Dures E, Eder L, FitzGerald O, Gladman DD, Goel N, Grieb S, Hewlett S, Hoejgaard P, Kalyoncu U, Lindsay C, McHugh NJ, Shea B, Steinkoenig I, Strand V, Ogdie A. International Patient and Physician Consensus on Psoriatic Arthritis Outcomes for Clinical Trials [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/international-patient-and-physician-consensus-on-psoriatic-arthritis-outcomes-for-clinical-trials/. Accessed .

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