2252: Bimekizumab Maintained Efficacy Responses Through 52 Weeks in Patients with Psoriatic Arthritis and Inadequate Response or Intolerance to TNF-α Inhibitors Who Were Responders at Week 16: Results from a Phase 3, Randomized Study

William R Tillett¹, Joseph Merola², Yoshiya Tanaka³, Ennio G Favalli⁴, Dennis McGonagle⁵, Diamant Thaçi⁶, Jessica A Walsh⁷, Barbara Ink⁸, Rajan Bajracharya⁸, Jason Coarse⁹ and Christopher T Ritchlin¹⁰, ¹Department of Rheumatology, Royal National Hospital for Rheumatic Diseases, Bath, United Kingdom, ²Harvard Medical School, Brigham and Women's Hospital, Newton, MA, ³University of Occupational and Environmental Health, Kitakyushu, Japan, ⁴ASST Gaetano Pini-CTO, University of Milan, Department of Rheumatology, Milan, Italy, ⁵Leeds Biomedical Research Centre, University of Leeds, Leeds, United Kingdom, ⁶Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany, ⁷Salt Lake City Veterans Affairs Health and University of Utah Health, Division of Rheumatology, Salt Lake City, UT, ⁸UCB Pharma, Slough, United Kingdom, ⁹UCB Pharma, Morrisville, NC, ¹⁰University of Rochester Medical School, Rochester, NY

Background/Purpose: PsA is a chronic disease affecting multiple domains; however, patients (pts) can experience loss of response with long-term therapy.¹ Therefore, maintaining long-term treatment responses is important. Bimekizumab (BKZ), a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A, demonstrated rapid and clinically meaningful improvements in joint and skin efficacy outcomes to Week (Wk) 16, vs placebo (PBO), that were sustained to Wk 52.^2–4 The objective of this analysis was to report maintenance of response in joint, skin, and composite efficacy outcomes to 52 wks in BKZ-treated pts with PsA who were Wk 16 responders.

Methods: BE COMPLETE (NCT03896581), a 16-wk double-blind phase 3 study, included pts with active PsA who had inadequate response or intolerance to 1–2 TNF-α inhibitors (TNFi‑IR). Pts were randomized 2:1 to subcutaneous BKZ 160 mg every 4 wks (Q4W) or PBO. Pts completing Wk 16 were eligible to enter an open-label extension, BE VITAL (NCT04009499). Maintenance of response is reported as the percentage of BKZ-treated pts who achieved a response at Wk 16 and maintained response at Wk 52. ACR20/50/70, Psoriasis Area and Severity Index (PASI)75/90/100, minimal/very low disease activity (MDA/VLDA), and Disease Activity Index for PsA (DAPSA) remission/low disease activity (REM+LDA; ≤14) and remission (REM; ≤4) responses are presented. Data are reported as observed case (OC) and using non‑responder imputation (NRI) or multiple imputation (MI). Treatment-emergent adverse events (TEAEs) to Wk 52 are reported for pts who received ≥1 dose of BKZ, including those who entered BE VITAL (PBO/BKZ).

Results: Overall, 267 pts were randomized to BKZ 160 mg Q4W; 263 (98.5%) and 236 (88.4%) completed Wks 16 and 52, respectively. Of BKZ-treated pts who were Wk 16 responders, ≥80% maintained response across all joint and skin outcomes, as well as MDA and DAPSA REM+LDA. At Wk 16, 179 (67.0%), 116 (43.4%), and 71 (26.6%) pts achieved ACR20/50/70, respectively. Over 80% of those responders maintained an ACR20/50/70 response at Wk 52: 81.6%, 80.2%, 83.1% (NRI); 89.6%, 86.1%, 85.5% (OC) (Figure). Of 176 pts with psoriasis affecting ≥3% body surface area (BSA) at baseline, 145 (82.4%), 121 (68.8%), and 103 (58.5%) achieved PASI75/90/100 at Wk 16. Of those responders, 88.3%, 88.4%, 84.5% (NRI); 97.0%, 96.4%, 91.6% (OC) maintained a PASI 75/90/100 response at Wk 52 (Figure). Similar results were observed for composite measures; 118 (44.2%) pts achieved MDA at Wk 16 and, of those, 81.4%/87.3% (NRI/OC) maintained their response at Wk 52. A high proportion of Wk 16 responders also maintained their VLDA, DAPSA REM+LDA, and DAPSA REM response at Wk 52 (Figure). To Wk 52, 243/388 (62.6%) BKZ‑treated pts reported ≥1 TEAE and 23 (5.9%) reported serious TEAEs.

Conclusion: BKZ demonstrated robust maintenance of response at Wk 52 in TNFi-IR pts with PsA who responded to BKZ treatment at Wk 16. The safety profile was consistent with previous reports.^2,3

References: 1. Boehncke WH. Am J Clin Dermatol 2013;14:377–88; 2.McInnes IB. Lancet 2023;401:25–37; 3. Merola JF. Lancet 2023;401:38–48; 4.Coates LC. Ann Rheum Dis 2023;82(suppl 1):346.




W. Tillett: AbbVie, 2, 5, 6, Amgen, 2, 5, 6, Celgene, 2, 5, 6, Eli Lilly, 2, 5, 6, GSK, 2, 5, 6, Janssen, 2, 5, 6, MSD, 2, 5, 6, Novartis, 2, 5, 6, Ovo Pharma, 2, 5, 6, Pfizer, 2, 5, 6, UCB Pharma, 2, 5, 6; J. Merola: Abbvie, 2, 12, Investigator, Amgen, 2, 12, Investigator, Biogen, 2, 12, Investigator, Bristol-Myers Squibb, 2, 12, Investigator, Dermavant, 2, 12, Investigator, Eli Lilly, 2, 6, 12, Investigator, Janssen, 2, 12, Investigator, Leo Pharma, 2, 12, Investigator, Novartis, 2, 12, Investigator, Pfizer, 2, 12, Investigator, Regeneron, 2, 12, Investigator, Sanofi, 2, 12, Investigator, Sun Pharma, 2, 12, Investigator, UCB Pharma, 2, 12, Investigator; Y. Tanaka: AbbVie, 6, AstraZeneca, 6, BMS, 6, Boehringer-Ingelheim, 6, Chugai, 5, 6, Eisai, 5, 6, Eli Lilly, 6, Gilead, 6, GSK, 6, Mitsubishi-Tanabe, 5, Pfizer, 6, Taiho, 6, Taisho, 5, 6; E. Favalli: AbbVie, 2, 6, Bristol-Myers Squibb (BMS), 2, 6, Celltrion, 2, 6, Eli Lilly, 2, 6, Galapagos, 2, 6, Janssen, 2, 6, MSD, 2, 6, Novartis, 2, 6, Pfizer, 2, 6, UCB Pharma, 2, 6; D. McGonagle: AbbVie, 2, 5, 6, Celgene, 2, 5, 6, Janssen, 2, 5, 6, Merck, 2, 5, 6, Novartis, 2, 5, 6, Pfizer, 2, 5, 6, UCB, 2, 5, 6; D. Thaçi: AbbVie, 1, 2, 5, 12, Investigator, Almirall, 1, 2, 12, Investigator, Amgen, 1, 2, 12, Investigator, Boehringer-Ingelheim, 1, 2, 12, Investigator, Bristol-Myers Squibb(BMS), 1, 2, 12, Investigator, Celltrion, 1, 2, 12, Investigator, Eli Lilly, 1, 2, 12, Investigator, Galapagos, 1, 2, 12, Investigator, Galderma, 1, 2, 5, 12, Investigator, Janssen-Cilag, 1, 2, 12, Investigator, LEO Pharma, 1, 2, 5, 12, Investigator, Novartis, 1, 2, 5, 12, Investigator, Pfizer, 1, 2, 12, Investigator, Regeneron, 1, 2, 12, Investigator, Samsung, 1, 2, 12, Investigator, Sandoz, 1, 2, 12, Investigator, Sanofi, 1, 2, 12, Investigator, Target-Solution, 1, 2, 12, Investigator, UCB, 1, 2, 12, Investigator; J. Walsh: AbbVie, 5, Amgen, 2, Eli Lilly, 2, Janssen, 2, Merck, 5, Novartis, 2, Pfizer, 2, 5, UCB Pharma, 2; B. Ink: AbbVie, 11, GSK, 11, UCB Pharma, 3, 11; R. Bajracharya: UCB Pharma, 3, 11; J. Coarse: UCB Pharma, 3, 11; C. Ritchlin: AbbVie, 2, 12, Research, Amgen, 2, Eli Lilly, 2, Gilead, 2, Janssen, 2, Novartis, 2, Pfizer, 2, UCB Pharma, 2.