BIMEKIZUMAB-TREATED PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS SHOWED SUSTAINED ACHIEVEMENT OF MINIMAL DISEASE ACTIVITY AND REMISSION: UP TO 2-YEAR RESULTS FROM TWO PHASE 3 STUDIES

Background: Bimekizumab (BKZ), a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A, has demonstrated clinically meaningful, sustained joint and skin efficacy responses at Week (Wk) 52, in patients (pts) with psoriatic arthritis (PsA). PsA is a clinically heterogenous inflammatory disease characterised by multiple domains, including skin and joint disease. Treatment efficacy can therefore be comprehensively evaluated using composite outcome measures that assess disease activity across the multiple affected domains. Minimal disease activity (MDA) and remission have been recommended as key treatment targets. Objectives: To assess the efficacy of BKZ using composite outcomes, including MDA and remission, in pts with active PsA using data from two phase 3 studies up to 2 years. Methods: The phase 3 BE OPTIMAL (NCT03895203) and BE COMPLETE (NCT03896581) trials, both placebo (PBO)-controlled to Wk 16, assessed BKZ 160 mg every 4 wks (Q4W) in pts with PsA who were biologic disease-modifying antirheumatic drug (bDMARD)-naïve or had inadequate response/intolerance to tumour necrosis factor inhibitors (TNFi-IR), respectively. BE OPTIMAL included a reference arm (adalimumab [ADA] 40 mg every 2 weeks [Q2W]). PBO pts switched to BKZ (PBO/BKZ) at Wk 16. BE OPTIMAL Wk 52 and BE COMPLETE Wk 16 completers were eligible to enter BE VITAL (open-label extension; NCT04009499), in which all pts received BKZ. Pt populations are hereafter referred to by the name of their starting study. Endpoints include minimal and very low disease activity (MDA, VLDA) responses and components, Disease Activity Index for Psoriatic Arthritis (DAPSA) remission or low disease activity (REM ≤4; REM+LDA ≤14) responses and DAPSA change from baseline (CfB). Interim data cut reported. Data reported to Wk 104 for BE OPTIMAL and Wk 88 for BE COMPLETE as some BE COMPLETE pts had not completed Wk 100 at time of data cut. Missing data were imputed using non-responder imputation (binary) or worst-category imputation (categorical; missing data are set to the most severe category). Results: At the time of data cut, 710/852 (83.3%) and 330/400 (82.5%) pts had completed Wk 104/88 of BE OPTIMAL and BE COMPLETE. Outcomes are reported to Wk 88 for BE COMPLETE because 18 (4.5%) had not yet attended their Wk 100 visit. Baseline MDA components were generally comparable between treatment groups within trials ( Table 1 ). In BKZ-randomised pts, achievement of MDA by Wk 52 (bDMARD-naïve 54.8%; TNFi-IR 46.4%) was sustained to Wk 104/88 in both trial populations (bDMARD-naïve 52.4%; TNFi-IR 46.1%; Figure 1A ). In PBO/BKZ pts, MDA achievement was sustained from 53.7% at Wk 52 to 49.8% at Wk 104 in bDMARD-naïve pts, and from 33.1% at Wk 52 to 36.8% at Wk 88 in TNFi-IR pts. In bDMARD-naïve ADA/BKZ pts, MDA achievement was sustained from 52.9% at Wk 52 to 50.7% at Wk 104. Trends were similar at Wk 104/88 for achievement of VLDA and DAPSA REM+LDA ( Table 1 ), and improvements in DAPSA scores to Wk 104/88 ( Figure 1B ). BKZ treatment led to improvements to Wk 104/88 in most MDA components across all treatment arms in both trial populations ( Table 1 ). Substantial improvements were achieved to Wk 104/88, including in objective clinical measures (swollen and tender joint count; skin improvements) and patient-reported components (pain; physical function). Conclusion: BKZ-treated pts with PsA achieved sustained MDA and DAPSA REM+LDA responses up to 2 years, regardless of prior bDMARD use. Improvements were observed across all patient-reported and most clinical components of MDA, with robust improvements observed in joint and skin outcomes. REFERENCES: [1] Ritchlin CT. Ann Rheum Dis 2023;82:1404–14. [2] Coates LC. Ann Rheum Dis 2023;82:346–347. [3] Coates LC. Rheum Dis Clin North Am 2015;41:699–710. [4] Coates LC. Nat Rev Rheumatol 2022;18:465–79. Acknowledgements: Funded by UCB Pharma. Medical writing support provided by Costello Medical and funded by UCB Pharma. Disclosure of Interests: Laura C. Coates Speaking fees from AbbVie, Amgen, Biogen and Celgene, Eli Lilly, Galapagos, Gilead, GSK, Janssen, medac, Novartis, Pfizer, and UCB Pharma, Consultant for AbbVie, Amgen, BMS, Boehringer Ingelheim, Celgene, Domain, Eli Lilly, Galapagos, Gilead, Janssen, Moonlake Immunotherapeutics, Novartis, Pfizer and UCB Pharma, Grants/research support from AbbVie, Amgen, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer and UCB Pharma, Lars Erik Kristensen Speaking and consultancy from AbbVie, Amgen, Biogen, BMS, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer and UCB Pharma, IIT research grants from AbbVie, Eli Lilly, Novartis, and UCB Pharma, Alexis Ogdie Consultant of AbbVie, Amgen, BMS, Celgene, CorEvitas, Eli Lilly, GSK, Gilead, Janssen, Novartis, Pfizer, Takeda and UCB Pharma, Grant/research support from AbbVie, Amgen, Janssen, Novartis and Pfizer, William Tillett Research grants, consulting fees, speaking fees, and/or honoraria from AbbVie, Amgen, Celgene, Eli Lilly, GSK, Janssen, MSD, Novartis, Ono Pharma, Pfizer and UCB Pharma., Research grants, consulting fees, speaking fees, and/or honoraria from AbbVie, Amgen, Celgene, Eli Lilly, GSK, Janssen, MSD, Novartis, Ono Pharma, Pfizer and UCB Pharma., Research grants, consulting fees, speaking fees, and/or honoraria from AbbVie, Amgen, Celgene, Eli Lilly, GSK, Janssen, MSD, Novartis, Ono Pharma, Pfizer and UCB Pharma., Barbara Ink Shareholder of AbbVie, GSK and UCB Pharma, Employee of UCB Pharma, Nadine Goldammer Shareholder of UCB Pharma, Employee of UCB Pharma, Rajan Bajracharya Shareholder of UCB Pharma, Employee of UCB Pharma, Jason Coarse Shareholder of UCB Pharma, Employee of UCB Pharma, Ana-Maria Orbai Consulting fees from BMS, Janssen, Sanofi and UCB Pharma, Research grants to Johns Hopkins University from AbbVie, Amgen and Janssen DOI: 10.1136/annrheumdis-2024-eular.2557 Keywords: Remission, Clinical Trial, Outcome measures Citation: , volume 83, supplement 1, year 2024, page 706Session: Psoriatic arthritis (Poster View)

Remission, Clinical Trial, Outcome measures