BIMEKIZUMAB TREATMENT RESULTED IN CLINICALLY MEANINGFUL IMPROVEMENTS IN THE PSORIATIC ARTHRITIS IMPACT OF DISEASE-12 (PSAID-12) SCORES USING POOLED RESULTS FROM TWO PHASE 3 TRIALS IN PATIENTS WITH PSORIATIC ARTHRITIS

L. Gossec, L. Coates, A. M. Orbai, M. De Wit, J. Lambert, B. Ink, V. Taieb, D. D. GladmanSorbonne Université, N/A, Paris, France AP-HP, Pitié-Salpêtrière Hospital, N/A, Paris, France Oxford University Hospitals NHS Trust, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Diseases, University of Oxford and Oxford Biomedical Research Centre, Oxford, United Kingdom Johns Hopkins University School of Medicine, Division of Rheumatology, Baltimore, United States of America Stichting Tools, Patient Research Partner, Amsterdam, Netherlands UCB Pharma, N/A, Colombes, France UCB Pharma, N/A, Slough, United Kingdom University of Toronto, Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, University Health Network, Ontario, United States of America  Background The Psoriatic Arthritis (PsA) Impact of Disease‑12 (PsAID‑12) questionnaire assesses PsA impact from the patient (pt) perspective . Bimekizumab (BKZ), a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17A and IL‑17F, has shown superior efficacy vs placebo (PBO) and tolerability to 16 weeks (wks) in pts with PsA . Objectives To assess the efficacy of BKZ from the pt perspective, over 16 wks of treatment, using data from two phase 3 trials. Methods Analysis of pts with PsA randomised to subcutaneous BKZ 160 mg every 4 wks vs PBO in BE OPTIMAL (NCT03895203, N=712, biologic DMARD-naïve pts) and BE COMPLETE (NCT03896581, N=400, tumour necrosis factor alpha inhibitor-inadequate responders). PsAID‑12 total and single-item domain scores range from 0 to 10; higher scores indicate worse status. Change from baseline (CfB) data and clinically meaningful within pt improvement response (threshold: decrease of ≥3 from baseline [BL] when respective PsAID‑12 score ≥3 at BL) for total and single‑item domain scores were calculated. Missing data imputed using multiple imputation (continuous) and non-responder imputation (binary). Results Of 1,112 pts randomised to BKZ or PBO, 96.5% completed Wk 16. BL characteristics were generally similar between treatment groups within trials; mean age: 49.3 years, BMI: 29.5 kg/m, years since diagnosis: 7.2; 46.6% male. At BL, mean (SD) PsAID-12 total score: 4.1 (2.0) BKZ, 4.2 (2.0) PBO. Mean (SE) Wk 16 PsAID‑12 total CfB: −2.0 (0.1) BKZ, −0.5 (0.1) PBO (Table 1). Clinically meaningful response rate for Wk 16 PsAID‑12 total score: 41.9% BKZ, 8.4% PBO with results similar in both pt populations (Figure 1). Similar differences between BKZ and PBO results were found for single‑item domain responders, for example Wk 16 PsAID‑12 pain score response rate: 46.5% BKZ, 18.7% PBO; skin problem score response rate: 68.5% BKZ, 21.4% PBO (Table 1). Conclusion By Wk 16, over half of BKZ‑treated pts reported clinically meaningful improvements in most PsAID-12 single-item domain scores assessing PsA‑specific symptoms and impact. Results may support shared treatment decisions. References Gossec L. Ann Rheum Dis 2014;73:1012–9. McInnes IB. Lancet 2022; DOI: 10.1016/S0140-6736(22)02302-9. Merola JF. Lancet 2022; DOI: 10.1016/S0140-6736(22)02303-0. Image/graph: Table 1. Pooled BL scores, Wk 16 CfB and clinically meaningful response rate for PsAID‑12 total and single‑item domain scores Pooled Analysis (bDMARD‑naïve + TNFi‑IR) PBO (N=414) BKZ 160 mg Q4W (N=698) BL mean (SD) [OC] Wk 16 CfB mean (SE) [MI] Response rate% (n/N) [NRI] BL mean (SD) [OC] Wk 16 CfB mean (SE)[MI] Response rate% (n/N) [NRI] Total Score 4.2 (2.0) –0.5 (0.1) 8.4 (25/299) 4.1 (2.0) –2.0 (0.1) 41.9 (207/494) Pain 5.6 (2.3) –0.6 (0.1) 18.7 (69/369) 5.5 (2.3) –2.3 (0.1) 46.5 (282/606) Fatigue 4.8 (2.5) –0.6 (0.1) 20.7 (68/328) 4.8 (2.6) –1.8 (0.1) 44.7 (241/539) Skin Problems 4.7 (2.8) –0.4 (0.1) 21.4 (65/304) 4.7 (2.8) –2.9 (0.1) 68.5 (348/508) Work and/or Leisure Activities 4.6 (2.6) –0.6 (0.1) 25.2 (79/314) 4.5 (2.6) –2.2 (0.1) 53.6 (281/524) Functional Capacity 4.8 (2.5) –0.6 (0.1) 23.2 (76/328) 4.8 (2.5) –2.3 (0.1) 53.0 (289/545) Discomfort 4.5 (2.7) –0.6 (0.1) 25.4 (75/295) 4.5 (2.6) –2.3 (0.1) 58.1 (297/511) Sleep Disturbance 3.8 (3.0) –0.5 (0.1) 28.5 (70/246) 3.7 (2.8) –1.6 (0.1) 54.7 (222/406) Coping 4.0 (2.4) –0.6 (0.1) 24.4 (70/287) 3.8 (2.4) –1.7 (0.1) 53.6 (245/457) Anxiety, Fear and Uncertainty 2.3 (2.5) –0.2 (0.1) 33.3 (50/150) 2.2 (2.4) –0.9 (0.1) 57.5 (134/233) Embarrassment and/or Shame 2.6 (2.7) –0.2 (0.1) 35.9 (60/167) 2.5 (2.7) –1.6 (0.1) 70.6 (187/265) Social Participation 2.9 (2.7) –0.4 (0.1) 36.3 (70/193) 2.7 (2.6) –1.5 (0.1) 61.0 (191/313) Depression 1.4 (2.2) 0.0 (0.1) 28.7 (25/87) 1.3 (2.1) –0.6 (0.1) 68.6 (96/140) Randomised set. PsAID‑12 scores range from 0–10; higher scores indicate a worse status. Clinically meaningful response rate: decrease in score from BL ≥3 in patients with score ≥3 at BL. N=697. Acknowledgements This study was funded by UCB Pharma. Medical writing support was provided by Costello Medical, funded by UCB Pharma. Disclosure of Interests Laure Gossec Consultant of: AbbVie, Amgen, BMS, Celltrion, Galapagos, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Sandoz, UCB Pharma, Grant/research support from: Sandoz, UCB Pharma, Laura Coates Speakers bureau: AbbVie, Amgen, Biogen, Celgene, Eli Lilly, Galapagos, Gilead, GSK, Janssen, medac, Novartis, Pfizer and UCB Pharma, Consultant of: AbbVie, Amgen, BMS, Boehringer Ingelheim, Celgene, Domain, Eli Lilly, Gilead, Galapagos, Janssen, Moonlake, Novartis, Pfizer and UCB Pharma, Grant/research support from: AbbVie, Amgen, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer and UCB Pharma, Ana-Maria Orbai Consultant of: BMS, Janssen, Sanofi and UCB Pharma, Grant/research support from: Research grants to Johns Hopkins University from AbbVie, Amgen and Janssen, Maarten de Wit Speakers bureau: Over the last five years Stichting Tools has received fees for lectures or consultancy provided by Maarten de Wit from Celgene, Eli Lilly, Janssen-Cilag, Novartis, Pfizer and UCB Pharma, Consultant of: Over the last five years Stichting Tools has received fees for lectures or consultancy provided by Maarten de Wit from Celgene, Eli Lilly, Janssen-Cilag, Novartis, Pfizer and UCB Pharma, Jérémy Lambert Shareholder of: UCB Pharma, Employee of: UCB Pharma, Barbara Ink Shareholder of: UCB Pharma, AbbVie and GSK, Employee of: UCB Pharma, Vanessa Taieb Employee of: Employee of UCB Pharma, Dafna D Gladman Consultant of: Abbvie, Amgen, BMS, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, and UCB Pharma, Grant/research support from: Abbvie, Amgen, BMS, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, and UCB Pharma. Keywords: Psoriatic arthritis, Patient reported outcomes, Clinical trials DOI: 10.1136/annrheumdis-2023-eular.1305Citation: , volume 82, supplement 1, year 2023, page 1130Session: Psoriatic arthritis - treatment (Poster View)