E069 Bimekizumab maintained efficacy responses through 52 weeks in patients with psoriatic arthritis and inadequate response or intolerance to tumour necrosis factor inhibitors who were responders at week 16: results from a phase 3, randomised study
Authors: Tillett William R , Merola Joseph F , Tanaka Yoshiya , Favalli Ennio G , McGonagle Dennis , Thaçi Diamant , Walsh Jessica A , Ink Barbara , Bajracharya Rajan , Coarse Jason , Ritchlin Christopher T 
Published: April 2024

Abstract

Background/Aims
Psoriatic arthritis (PsA) is a chronic disease affecting multiple domains; however, patients can experience loss of response with long-term therapy. 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 16, vs placebo (PBO), that were sustained to Week 52. The objective of this analysis was to report maintenance of response in joint, skin and composite efficacy outcomes to 52 weeks in BKZ-treated patients with PsA who were Week 16 responders.

Methods
BE COMPLETE (NCT03896581), a 16-week double-blind phase 3 study, included patients with active PsA who had inadequate response or intolerance to 1-2 TNF inhibitors (TNFi-IR). Patients were randomised 2:1 to subcutaneous BKZ 160 mg every 4 weeks (Q4W) or PBO. Patients completing Week 16 were eligible to enter an open-label extension, BE VITAL (NCT04009499). Maintenance of response is reported as the percentage of BKZ-treated patients who achieved a response at Week 16 and maintained response at Week 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 Week 52 are reported for patients who received ≥1 dose of BKZ, including those who entered BE VITAL (PBO/BKZ).

Results
Overall, 267 pts were randomised to BKZ 160 mg Q4W; 263 (98.5%) and 236 (88.4%) completed Weeks 16 and 52, respectively. Of BKZ-treated pts who were Week 16 responders, ≥80% maintained response across all joint and skin outcomes, as well as MDA and DAPSA REM+LDA. At Week 16, 179 (67.0%), 116 (43.4%), and 71 (26.6%) patients achieved ACR20/50/70, respectively. Over 80% of responders maintained ACR20/50/70 response at Week 52: 81.6%, 80.2%, 83.1% (NRI); 89.6%, 86.1%, 85.5% (OC). Of 176 patients 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 Week 16; 88.3%, 88.4%, 84.5% (NRI); 97.0%, 96.4%, 91.6% (OC) maintained a PASI 75/90/100 response at Week 52. Similar results were observed for composite measures; 118 (44.2%) patients achieved MDA at Week 16; 81.4%/87.3% (NRI/OC) maintained their response at Week 52. High proportions of Week 16 VLDA/DAPSA REM+LDA/DAPSA REM responders also maintained response at Week 52. To Week 52, 243/388 (62.6%) BKZtreated patients reported ≥1 TEAE; 23 (5.9%) reported serious TEAEs.

Conclusion
BKZ demonstrated robust maintenance of response at Week 52 in TNFi-IR patients with PsA who responded to BKZ treatment at Week 16. The safety profile was consistent with previous reports.

Disclosure
W.R. Tillett: Consultancies; AbbVie, Amgen, Celgene, Eli Lilly, GSK, Janssen, MSD, Novartis, Ovo Pharma, Pfizer and UCB Pharma. Honoraria; AbbVie, Amgen, Celgene, Eli Lilly, GSK, Janssen, MSD, Novartis, Ovo Pharma, Pfizer and UCB Pharma. Grants/research support; AbbVie, Amgen, Celgene, Eli Lilly, GSK, Janssen, MSD, Novartis, Ovo Pharma, Pfizer and UCB Pharma. Other; Speaking fees AbbVie, Amgen, Celgene, Eli Lilly, GSK, Janssen, MSD, Novartis, Ovo Pharma, Pfizer and UCB Pharma. J.F. Merola: Consultancies; AbbVie, Amgen, Biogen, BMS, Dermavant, Eli Lilly, Janssen, LEO Pharma, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma and UCB Pharma. Other; Investigator for AbbVie, Amgen, Biogen, BMS, Dermavant, Eli Lilly, Janssen, LEO Pharma, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma and UCB Pharma. Y. Tanaka: Honoraria; AbbVie, AstraZeneca, BMS, Boehringer Ingelheim, Chugai, Eisai, Eli Lilly, Gilead, GSK, Pfizer, Taiho and Taisho. Grants/research support; Chugai, Eisai, Mitsubishi-Tanabe and Taisho. Other; Speaking fees from AbbVie, AstraZeneca, BMS, Boehringer Ingelheim, Chugai, Eisai, Eli Lilly, Gilead, GSK, Pfizer, Taiho and Taisho. E.G. Favalli: Consultancies; AbbVie, BMS, Celltrion, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Pfizer and UCB Pharma. Other; Speaking fees AbbVie, BMS, Celltrion, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Pfizer and UCB Pharma. D. McGonagle: Consultancies; AbbVie, Celgene, Janssen, Merck, Novartis, Pfizer and UCB Pharma. Honoraria; AbbVie, Celgene, Janssen, Merck, Novartis, Pfizer and UCB Pharma. Member of speakers’ bureau; AbbVie, Celgene, Janssen, Merck, Novartis, Pfizer and UCB Pharma. Grants/research support; AbbVie, Celgene, Janssen, Merck, Novartis and Pfizer. D. Thaçi: Consultancies; AbbVie, Almirall, Amgen, BMS, Boehringer Ingelheim, Celltrion, Eli Lilly, Galapagos, Galderma, Janssen-Cilag, Kyowa Kirin, LEO Pharma, Novartis, Pfizer, Regeneron, Samsung, Sandoz, Sanofi, Target-Solution and UCB Pharma. Grants/research support; AbbVie, LEO Pharma and Novartis. Other; Investigator for AbbVie, Almirall, Amgen, BMS, Boehringer Ingelheim, Celltrion, Eli Lilly, Galapagos, Galderma, Janssen-Cilag, Kyowa Kirin, LEO Pharma, Novartis, Pfizer, Regeneron, Samsung, Sandoz, Sanofi, Target-Solution and UCB Pharma. J.A. Walsh: Consultancies; AbbVie, Amgen, Eli Lilly, Janssen, Merck, Novartis, Pfizer and UCB Pharma. Grants/research support; AbbVie, Amgen, Eli Lilly, Janssen, Merck, Novartis, Pfizer and UCB Pharma. B. Ink: Shareholder/stock ownership; AbbVie, GSK and UCB Pharma. Other; Employee of UCB Pharma. R. Bajracharya: Shareholder/stock ownership; UCB Pharma. Other; Employee of UCB Pharma. J. Coarse: Shareholder/stock ownership; UCB Pharma. Other; Employee of UCB Pharma. C.T. Ritchlin: Consultancies; AbbVie, Amgen, Eli Lilly, Gilead, Janssen, Novartis, Pfizer and UCB Pharma. Grants/research support; AbbVie.