AB0766 ACCURACY OF PATIENT REPORTED OUTCOME REPORTING IN RANDOMIZED CONTROLLED TRIALS IN PSORIATIC ARTHRITIS
Authors: B. Frade-Sosa, A. Kerschbaumer, P. Studenic, E. Chwala, J. S. Smolen, D. Aletaha
Journal: Annals of the Rheumatic Diseases (2020)

Background: Patient-reported outcomes (PROs) allow incorporating the patient’s perspective and health related quality of life (HRQoL) into shared decision making when choosing the optimal treatment strategy in patients suffering from psoriatic arthritis (PsA). PsA is a chronic inflammatory disease with heterogeneous manifestations with a range of symptoms, co-morbidities and reduced quality of life. International working groups (1) emphasized to integrate these outcomes as endpoints in clinical trials and as part of the core set of measures. Objectives: To evaluate the quality of PRO reporting in randomized clinical trials in PsA. Methods: We conducted a systematic literature review (PROSPERO ID 160930) searching PUBMED, MEDLINE and the Cochrane Library for publications (in English language) on randomized controlled trials investigating biological or targeted synthetic disease modifying drugs in adult PsA patients that included some PROs to evaluate the response to treatment. Two of the authors (BFS, AK) screened, selected and extracted the data of the trials that fulfilled inclusion criteria. Statistics were descriptive. Results: Of 1392 articles in total 880 were screened (512 duplicates); 92 were selected for detailed analysis with 48 finally analysed. 87% were primary publications were some patient-outcome measure were reported. The Health Assessment Questionnaire Disability Index (HAQ-DI) was reported in all RCTs (100%), while 70% of trials reported on the Short Form (36) Health Survey (SF36). Fatigue (FACIT-F) was reported in 29% of trials with different rates of articles published before and after the OMERACT working group recommendations (27% vs 50%) (1). Data on burden of psoriasis through the Dermatology Life Quality Index in 45%. Other PRO measurements to assess potentially affected health domains such as sleep disturbance, psychological disorders or well-being at work were reported only rarely. Conclusion: Our SLR shows that all trials report data on HAQ-DI. However, important domains as also emphasized by the OMERACT working group (1) are not routinely reported. Especially fatigue, included in 2016 as part of the OMERACT “Inner core” of the PsA Core Domain Set is only reported in about one quarter of studies, although 50% of studies published after 2016 report on fatigue. Data on emotional well-being, psychological status, productivity losses, and sleep disturbance remain rarely reported in PsA randomized controlled trials. References: [1]Orbai A, de Wit M, Mease P, et al International patient and physician consensus on a psoriatic arthritis core outcome set for clinical trials. Annals of the Rheumatic Diseases 2017;76:673-680. Acknowledgments: Acknowledgements: The author BFS had received an economic grant from the Spanish Society of Rheumatology (FER KERN-PHARMA Scholarships for Short stays: Plan for the promotion of research) and the Catalan Society of Rheumatology (BequesNovartis de formació per estades a l’estranger) for the research stay in Vienna (Austria). Disclosure of Interests: Beatriz Frade-Sosa Grant/research support from: FER KERN-PHARMA Scholarships for Short stays: Plan for the promotion of research. BequesNovartis de formació per estades a l’estranger, Andreas Kerschbaumer Paid instructor for: Celgene, Speakers bureau: Andreas Kerschbaumer has received lecture fees from Bristol-Myers Squibb, Gilead, Merck Sharp and Dohme and Pfizer., Paul Studenic Grant/research support from: Abbvie, Eva Chwala: None declared, Josef S. Smolen Grant/research support from: AbbVie, Eli Lilly, Janssen, Merck Sharp &amp; Dohme, Pfizer, Roche – grant/research support, Consultant of: AbbVie, Amgen Inc., AstraZeneca, Astro, Celgene Corporation, Celtrion, Eli Lilly, Glaxo, ILTOO, Janssen, Medimmune, Merck Sharp &amp; Dohme, Novartis, Pfizer, Roche, Samsung, Sanofi, UCB – consultant, Speakers bureau: AbbVie, Amgen Inc., AstraZeneca, Astro, Celgene Corporation, Celtrion, Eli Lilly, Glaxo, ILTOO, Janssen, Medimmune, Merck Sharp &amp; Dohme, Novartis, Pfizer, Roche, Samsung, Sanofi, UCB – speaker, Daniel Aletaha Grant/research support from: AbbVie, Novartis, Roche, Consultant of: AbbVie, Amgen, Celgene, Lilly, Medac, Merck, Novartis, Pfizer, Roche, Sandoz, Sanofi Genzyme, Speakers bureau: AbbVie, Celgene, Lilly, Merck, Novartis, Pfizer, Sanofi Genzyme, UCB