Sustained improvements in spinal pain, morning stiffness, fatigue, sleep, physical function and overall health-related quality of life with bimekizumab in patients with axial spondyloarthritis: 2-year results from two phase 3 studies.
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All Authors
Marzo-Ortega, H.
Navarro-Compan, V.
Dubreuil, M.
Mease, PJ.
Magrey, M.
Rudwaleit, M.
D'Agostino, MA.
Gaffney, K.
Kay, J.
de la Loge, C.
LTHT Author
Marzo-Ortega, Helena
LTHT Department
NIHR Leeds Biomedical Research Centre
Rheumatology
Rheumatology
Non Medic
Publication Date
2025
Item Type
Journal Article
Clinical Trial
Randomised Controlled Trial
Clinical Trial
Randomised Controlled Trial
Language
Subject
Subject Headings
Abstract
OBJECTIVE: To assess the long-term effect of bimekizumab, a dual inhibitor of IL-17A and IL-17F, on patient-reported symptoms, function and health-related quality of life (HRQoL) in patients with axial spondyloarthritis (axSpA) from phase 3 studies and their open-label extension.
METHODS: BE MOBILE 1 (non-radiographic-axSpA) and 2 (radiographic-axSpA) comprised 16-week double-blind placebo-controlled and 36-week maintenance periods. From week 16, all patients received subcutaneous bimekizumab 160 mg every 4 weeks. At week 52, eligible patients could enrol in the open-label extension BE MOVING and continue bimekizumab treatment. Spinal pain (rated on a numerical rating scale from 0 (no pain) to 10 (maximum pain)), morning stiffness (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) average of Q5/6), fatigue (BASDAI Q1; Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue subscale), sleep quality (Medical Outcomes Study (MOS) Sleep Scale Index II), physical function (Bath Ankylosing Spondylitis Functional Index (BASFI)) and HRQoL (36-Item Short Form Survey (SF-36) physical component summary (PCS)/mental component summary (MCS); Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire) were reported to week 104.
RESULTS: In total, 494/586 (84.3%) patients entered BE MOVING at week 52; 456 completed week 104. Patients reported substantial changes from baseline to week 104 in total spinal pain (-4.3), nocturnal spinal pain (-4.3), morning stiffness (-4.3) and fatigue (BASDAI Q1: -3.4; FACIT-Fatigue: +9.9). Over half reported total and nocturnal spinal pain scores <=3 at week 104. Similar improvements to week 104 were shown in sleep (MOS-Sleep Scale: +10.2), physical function (BASFI: -2.9) and HRQoL (SF-36 PCS: +12.4; ASQoL: -5.6).
CONCLUSIONS: Bimekizumab treatment resulted in sustained improvements in patient-reported symptoms and their impacts across the full disease spectrum of axSpA over 2 years, underscoring its long-term potential for improving patients' daily lives.
TRIAL REGISTRATION NUMBERS: NCT03928704, NCT03928743, NCT04436640.
Journal
RMD Open