Safety and Efficacy of Bimekizumab in Patients With Active Ankylosing Spondylitis: Three‐Year Results From a Phase IIb Randomized Controlled Trial and Its Open‐Label Extension Study

Abstract

and Désirée van der Heijde 11Objective. To assess the long-term safety, tolerability, and efficacy of bimekizumab in patients with active ankylosing spondylitis (AS).Methods. Patients with active AS who completed the dose-ranging, 48-week BE AGILE randomized controlled trial were eligible to participate in an open-label extension (OLE) study, in which patients received 160 mg of bimekizumab every 4 weeks. We present the safety and efficacy results through 156 weeks. Missing efficacy data were imputed using nonresponder imputation analysis for binary outcomes and multiple imputation for continuous outcomes.Results. From weeks 0-156, 280 of 303 patients (exposure-adjusted incidence rate 141.0 per 100 patient-years) experienced ≥1 treatment-emergent adverse event; the most frequent adverse events were nasopharyngitis (8.1 per 100 patient-years) and upper respiratory tract infection (5.0 per 100 patient-years). Additionally, 67 of 303 patients (9.8 per 100 patient-years) had mild to moderate localized fungal infections (28 of 303 patients had Candida infections [3.7 per 100 patient-years] and 23 of 303 patients had oral candidiasis [3.0 per 100 patient-years]), 10 patients had serious infections (1.3 per 100 patient-years), and no cases of active tuberculosis were reported. Active inflammatory bowel disease (1.1 per 100 patient-years), anterior uveitis (0.7 per 100 patient-years), and adjudicated major adverse cardiovascular events (0.3 per 100 patient-years) were infrequent. The efficacy of bimekizumab treatment demonstrated at week 48 was sustained in the OLE study. At week 156, nonresponder imputation analysis showed that 53.7% of patients (72.6% of observed cases) met the Assessment of SpondyloArthritis international Society criteria for 40% improvement and 28.0% of patients (37.9% of observed cases) achieved partial remission; Ankylosing Spondylitis Disease Activity Scores were reduced from baseline (mean ± SEM 3.9 ± 0.1) to week 48 (2.1 ± 0.1) and week 156 (1.9 ± 0.1) (multiple imputation). Patients showed sustained improvements in pain, fatigue, physical function, and health-related quality of life.Conclusion. The safety profile of bimekizumab was found to be consistent with previously demonstrated findings, and no new safety signals were identified. The efficacy of bimekizumab in patients with AS was sustained through 3 years of treatment.

Minimal Impact of the COVID‐19 Pandemic on Disease Activity and Health‐Related Quality of Life in Patients With Ankylosing Spondylitis Receiving Bimekizumab: Exploratory Analyses From a Phase 2b Open‐Label Extension Study

“…Our analysis showed that, at a group level, disease activity and HRQoL remained stable through the COVID-19 pandemic. This was consistent with the sustained and stable efficacy of bimekizumab reported for up to 3 years of treatment (12,15), which followed the improvements in efficacy outcomes achieved in the first 12 and 48 weeks (11). We also found that there were no notable increases in missed study assessments during the pandemic.…”

“…Bimekizumab, a monoclonal immunoglobulin G1 antibody that selectively inhibits interleukin-17F, in addition to interleukin-17A, to date has demonstrated clinically meaningful and sustained efficacy and was well tolerated in patients with active AS treated for up to 3 years in the phase 2b BE AGILE study and its ongoing open-label extension (OLE) (11)(12)(13). At the start of the pandemic in March 2020, patients were in the OLE receiving 160 mg of subcutaneous bimekizumab every 4 weeks (Q4W); most had received more than 3 years of bimekizumab treatment and outcomes were stable.…”

Efficacy and safety of bimekizumab in axial spondyloarthritis: results of two parallel phase 3 randomised controlled trials

“…13 15-17 In the phase 2b BE AGILE trial in patients with active ankylosing spondylitis and its open-label extension, bimekizumab 160 mg every 4 weeks led to rapid disease control compared with placebo, with efficacy sustained for up to 3 years of treatment. 18 19 Here, we present the first phase 3 efficacy and safety data for bimekizumab across the full axSpA spectrum from two parallel trials in patients with nr-axSpA (BE MOBILE 1) and r-axSpA (BE MOBILE 2).…”

“…TEAEs, SAEs and prespecified safety topics of interest are defined in the online supplemental appendix. Adverse events were coded according to the Medical Dictionary for Regulatory Activities (MedDRA V. 19…”

Bimekizumab treatment in patients with active axial spondyloarthritis: 52-week efficacy and safety from the randomised parallel phase 3 BE MOBILE 1 and BE MOBILE 2 studies

“…In the parallel phase 3 studies BE MOBILE 1 (nr-axSpA) and BE MOBILE 2 (r-axSpA), patients receiving subcutaneous 160 mg BKZ Q4W achieved the primary and all ranked secondary endpoints at Week 16 22. At Week 24, no new safety signals were observed with BKZ treatment, compared with the 3-year phase 2b BE AGILE study of BKZ in r-axSpA 23. Here, we present the clinical efficacy and safety of BKZ in patients with active axSpA up to Week 52 of BE MOBILE 1 and BE MOBILE 2.…”