TY - JOUR
T1 - 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
AU - Marzo-Ortega, Helena
AU - Navarro-Compan, Victoria
AU - Dubreuil, Maureen
AU - Mease, Philip J.
AU - Magrey, Marina
AU - Rudwaleit, Martin
AU - D’Agostino, Maria Antonietta
AU - Gaffney, Karl
AU - Kay, Jonathan
AU - de la Loge, Christine
AU - Massow, Ute
AU - Taieb, Vanessa
AU - Vaux, Tom
AU - Deodhar, Atul
N1 - Data availability statement:
Data are available on reasonable request. Data are available on reasonable request. Underlying data from this manuscript may be requested by qualified researchers 6 months after product approval in the USA and/or Europe, or global development is discontinued, and 18 months after study completion. Investigators may request access to anonymised individual patient-level data and redacted trial documents which may include analysis-ready datasets, trial protocols, annotated case report forms, statistical analysis plans, dataset specifications and clinical study reports. Prior to the use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password-protected portal.
PY - 2025/11/28
Y1 - 2025/11/28
N2 - 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 160mg 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.
AB - 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 160mg 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.
KW - Axial Spondyloarthritis
KW - Fatigue
KW - Health-Related Quality Of Life
KW - Pain
KW - Patient Reported Outcome Measures
UR - http://www.scopus.com/inward/record.url?scp=105023330441&partnerID=8YFLogxK
U2 - 10.1136/rmdopen-2025-006013
DO - 10.1136/rmdopen-2025-006013
M3 - Article
C2 - 41314667
AN - SCOPUS:105023330441
SN - 2056-5933
VL - 11
JO - RMD Open
JF - RMD Open
IS - 4
M1 - e006013
ER -