RMD Open. 2026 May 13;12(2):e006670. doi: 10.1136/rmdopen-2025-006670.
ABSTRACT
OBJECTIVE: To assess the sustained, long-term efficacy of bimekizumab in improving patient symptoms and health-related quality of life (HRQoL) in axial spondyloarthritis (axSpA) to 3 years.
METHODS: Both BE MOBILE 1 (non-radiographic axSpA) and 2 (radiographic axSpA) comprised a 16-week double-blind, placebo-controlled treatment period and a 36-week maintenance period. From week 16, all patients received subcutaneous bimekizumab 160 mg every 4 weeks. At week 52, eligible patients could enter the open-label extension (OLE), BE MOVING and continue bimekizumab treatment. Here, we report pooled results for changes in spinal pain, morning stiffness (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Q5 and Q6), physical function (Bath Ankylosing Spondylitis Functional Index (BASFI)), fatigue (BASDAI Q1 and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue), sleep quality (Medical Outcomes Study Sleep (MOS-Sleep-R) Index II) and HRQoL (36-Item Short Form Questionnaire (SF-36) Physical Component Summary (PCS)/Mental Component Summary; Ankylosing Spondylitis Quality of Life (ASQoL)) to 3 years in the overall study population; for spinal pain and physical function, patient-level data are also reported.
RESULTS: Of the 494/586 (84.3%) randomised patients who entered the OLE, 425/494 (86.0%) completed week 164. At week 164, patients reported mean improvements from baseline in total (-4.3) and nocturnal (-4.3) spinal pain, morning stiffness (-4.3), physical function (BASFI: -2.9), fatigue (BASDAI Q1: -3.5, FACIT-Fatigue: +9.7), sleep (MOS-Sleep-R Index II: +10.8) and HRQoL (SF-36 PCS: +12.3; ASQoL: -5.6). Rapid and sustained patient-level improvements to week 164 in spinal pain and physical function levels were observed.
CONCLUSIONS: Bimekizumab treatment led to rapid and sustained improvements in key patient symptoms and HRQoL to 3 years, emphasising its long-term value in controlling symptoms which profoundly affect patients’ experience and daily lives.
TRIAL REGISTRATION NUMBERS: BE MOBILE 1 (NCT03928704), BE MOBILE 2 (NCT03928743) and BE MOVING (NCT04436640).
PMID:42128532 | DOI:10.1136/rmdopen-2025-006670
