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

Baraliakos, Xenofon; Deodhar, Atul; van der Heijde, Désirée; Magrey, Marina; Maksymowych, Walter P; Tomita, Tetsuya; Xu, Huji; Massow, Ute; Fleurinck, Carmen; Ellis, Alicia M; Vaux, Thomas; Shepherd-Smith, Julie; Marten, Alexander; Gensler, Lianne S

doi:10.1136/ard-2023-224803

Cited by 19 publications

(7 citation statements)

References 45 publications

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“…Together with previously published efficacy and safety data, 13 results from the BE MOBILE 1 and BE MOBILE 2 studies support the long-term efficacy of bimekizumab in improving clinical outcomes and alleviating the impact of axSpA on patients’ lives. Results from open-label extension studies and real-world evidence reporting will be important to confirm these findings.…”

Section: Discussionsupporting

confidence: 67%

“… 11 12 Bimekizumab has demonstrated sustained efficacy and was well tolerated up to 52 weeks in patients with nr-axSpA and r-axSpA in the parallel phase 3 studies BE MOBILE 1 (NCT03928704) and BE MOBILE 2 (NCT03928743), and up to 5 years in patients with r-axSpA in the phase 2b trial BE AGILE (NCT02963506) and its open-label extension (NCT03355573). 13 14 …”

Section: Introductionmentioning

confidence: 99%

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Improved physical functioning, sleep, work productivity and overall health-related quality of life with bimekizumab in patients with axial spondyloarthritis: results from two phase 3 studies

Dubreuil,

Navarro-Compán,

Boonen

et al. 2024

RMD Open

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ObjectiveTo assess the impact of bimekizumab on physical functioning, sleep, work productivity and overall health-related quality of life (HRQoL) in patients with non-radiographic (nr-) and radiographic (r-) axial spondyloarthritis (axSpA) in the phase 3 studies BE MOBILE 1 and 2.MethodsPatients were randomised to subcutaneous bimekizumab 160 mg or placebo every 4 weeks; from Week 16, all patients received bimekizumab 160 mg every 4 weeks. We report the following outcomes to Week 52: Bath Ankylosing Spondylitis Functional Index (BASFI), Medical Outcomes Study Sleep Scale Revised (MOS-Sleep-R) Index II, Work Productivity and Activity Impairment: axSpA (WPAI:axSpA), Short Form-36 Physical and Mental Component Summary (SF-36 PCS/MCS) and Ankylosing Spondylitis Quality of Life (ASQoL).ResultsAt Week 16, bimekizumab-randomised patients demonstrated significantly greater improvement from baseline versus placebo in BASFI, SF-36 PCS and ASQoL (p<0.001), and numerically greater improvements in MOS-Sleep-R Index II and WPAI:axSpA scores. Higher proportions of bimekizumab-randomised versus placebo-randomised patients at Week 16 achieved increasingly stringent thresholds for improvements in BASFI (0 to ≤4), and thresholds for meaningful improvements in SF-36 PCS (≥5-point increase from baseline) and ASQoL (≥4-point decrease from baseline). Responses were sustained or further improved to Week 52, where 60%–70% of bimekizumab-treated patients achieved BASFI ≤4 and meaningful improvements in SF-36 PCS and ASQoL, regardless of whether originally randomised to bimekizumab or placebo.ConclusionBimekizumab treatment led to early improvements in physical function, sleep, work productivity and overall HRQoL at Week 16 in patients across the full axSpA disease spectrum. Improvements were sustained to Week 52.Trial registration numbersNCT03928704;NCT03928743.

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Section: Discussionsupporting

confidence: 67%

Section: Introductionmentioning

confidence: 99%

Improved physical functioning, sleep, work productivity and overall health-related quality of life with bimekizumab in patients with axial spondyloarthritis: results from two phase 3 studies

Dubreuil,

Navarro-Compán,

Boonen

et al. 2024

RMD Open

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“…Bimekizumab, which recently completed the phase III program in axSpA, selectively inhibits both IL-17A and IL-17F cytokines. Recently, a placebo-controlled trial demonstrated the clinical efficacy of bimekizumab in both r-axSpA and nr-axSpA [54]. Nevertheless, the study did not yet focus on the impact of bimekizumab on structural damage in axSpA; therefore, this remains an ongoing area of research.…”

Section: Disease-modifying Anti-rheumatic Drugsmentioning

confidence: 99%

Disease modification in axial spondyloarthritis – still a controversy?

de Hooge,

van der Heijde

2024

Current Opinion in Rheumatology

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Purpose of review This review evaluates recent advancements in disease-modifying therapies for axial spondyloarthritis (axSpA). Recent findings A recent study could not demonstrate an additional effect of NSAID therapy on golimumab [Tumor Necrosis Factor-α inhibitor (TNFi)] on structural progression; however, this might be due to the fact that the study was underpowered. While DMARDs have shown promise in suppressing inflammation, their impact on structural progression remains uncertain. A well powered trial showed no difference in spinal progression between secukinumab [Interleukin17A inhibitor (IL17Ai)] and adalimumab-biosimilar (TNFi). Preliminary data on Janus kinase inhibitors (JAKi) focus on MRI findings but lack evidence on radiographic spinal progression. While some studies suggest promising outcomes, others reveal limitations and inconclusive findings. Summary Recent studies explore the effectiveness of NSAIDs, biological disease-modifying antirheumatic drugs like TNFi and IL-17i, as well as JAK inhibitors in axSpA. Conflicting evidence surrounds these therapies’ ability to impede structural progression, with challenges in study design and interpretation. Moreover, changes in demographics and treatment methods underscore the importance of examining trends over time when assessing disease outcomes. Ultimately, ongoing research could benefit from new imaging tools when evaluating therapeutic strategies for modifying disease progression in axSpA.

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“…Patients in the BE MOBILE 2 trial were adults diagnosed with active axSpA, defined as BAS-DAI ≥ 4 and spinal pain (BASDAI Q2) ≥ 4, who had r-axSpA fulfilling modified New York (mNY) criteria [14]. All patients in BE MOBILE 2 also fulfilled ASAS criteria [13].…”

Section: Populations Of Interestmentioning

confidence: 99%

“…Bimekizumab (BKZ), a humanized monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A, has recently received European Medicines Agency approval as a novel treatment of axSpA, providing a new therapeutic option to the approved IL-17A inhibitors secukinumab (SEC) and ixekizumab (IXE) [7][8][9]. BKZ treatment has demonstrated sustained long-term efficacy, safety, and tolerability up to 5 years in the phase 2b BE AGILE trial and its openlabel extension in patients with active r-axSpA [10][11][12], and up to 52 weeks in patients across the axSpA spectrum in the parallel phase 3 studies BE MOBILE 1 (nr-axSpA) and BE MOBILE 2 (r-axSpA) [13,14].…”

Section: Introductionmentioning

confidence: 99%

Matching-Adjusted Indirect Comparison of the 52-Week Efficacy of Bimekizumab Versus Secukinumab and Ixekizumab for the Treatment of Radiographic Axial Spondyloarthritis

Maksymowych,

Thom,

Mørup

et al. 2024

Rheumatol Ther

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Introduction A previous network meta-analysis established 16-week relative efficacy with bimekizumab, an inhibitor of interleukin (IL)-17F in addition to IL-17A, versus other treatments for patients with radiographic axial spondyloarthritis (r-axSpA; i.e., ankylosing spondylitis), including the IL-17A inhibitors secukinumab and ixekizumab. This matching-adjusted indirect comparison (MAIC) assessed 52-week relative efficacy of bimekizumab versus secukinumab and ixekizumab. Methods Individual patient data from BE MOBILE 2 (bimekizumab 160 mg; N = 220) were matched to pooled summary data from MEASURE 1/2/3/4 (secukinumab 150 mg), MEASURE 3 (secukinumab 300 mg; escalated dose for inadequate responders), COAST-V (ixekizumab) and COAST-V/-W (ixekizumab). BE MOBILE 2 patients were reweighted using propensity score weights based on age, sex, ethnicity, tumor necrosis factor inhibitor (TNFi) exposure, weight, baseline ASDAS and BASFI (secukinumab) and baseline BASDAI (ixekizumab), and 52-week efficacy outcomes from the trial recalculated. Odds ratios (OR) or mean difference for unanchored comparisons are reported with 95% confidence intervals (CI). Results At week 52, MAIC demonstrated that patients may have higher likelihood of improvement in key efficacy outcomes with bimekizumab versus secukinumab 150 mg (e.g., ASAS40: [OR (95% CI): 1.48 (1.05, 2.10); p = 0.026]; effective sample size [ESS] = 177). Differences in 52-week efficacy outcomes between bimekizumab and secukinumab 300 mg dose escalation were non-significant (ESS = 120). Bimekizumab versus ixekizumab 80 mg comparisons (COAST-V only; ESS = 84) also suggested that differences were non-significant for most key efficacy outcomes. Other ixekizumab comparisons (COAST-V/-W; ESS = 45) suggested bimekizumab may have higher comparative efficacy for many of the same efficacy outcomes, however ixekizumab analyses were limited by poor population overlap, likely due to the greater proportion of patients with previous TNFi exposure. Conclusions Patients treated with bimekizumab may have a higher likelihood of achieving improved longer-term efficacy versus secukinumab 150 mg, suggesting bimekizumab may be a favorable therapeutic option for r-axSpA. Differences in efficacy outcomes with bimekizumab versus ixekizumab 80 mg were mostly non-significant, depending on the populations considered. Supplementary Information The online version contains supplementary material available at 10.1007/s40744-024-00684-z.

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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

Cited by 19 publications

References 45 publications

Improved physical functioning, sleep, work productivity and overall health-related quality of life with bimekizumab in patients with axial spondyloarthritis: results from two phase 3 studies

Improved physical functioning, sleep, work productivity and overall health-related quality of life with bimekizumab in patients with axial spondyloarthritis: results from two phase 3 studies

Disease modification in axial spondyloarthritis – still a controversy?

Matching-Adjusted Indirect Comparison of the 52-Week Efficacy of Bimekizumab Versus Secukinumab and Ixekizumab for the Treatment of Radiographic Axial Spondyloarthritis

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