Comparative efficacy and safety of bimekizumab in axial spondyloarthritis: a systematic literature review and network meta-analysis

Abstract

Objectives To compare the efficacy and safety of bimekizumab 160 mg every 4 weeks, a selective inhibitor of interleukin‑17F and 17A, with biologic/targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs) in non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS). Methods A systematic literature review identified randomised controlled trials until January 2023 for inclusion in Bayesian network meta-analyses (NMAs), including three b/tsDMARDs exposure networks: predominantly-naïve, naïve, and experienced. Outcomes were Assessment of SpondyloArthritis international Society (ASAS)20, ASAS40, and ASAS partial remission (PR) response rates at 12–16 weeks. A safety NMA investigated discontinuations due to any reason and serious adverse events at 12–16 weeks. Results The NMA included 36 trials. The predominantly-naïve network provided the most comprehensive results. In the predominantly-naïve nr-axSpA analysis, bimekizumab had significantly higher ASAS20 response rates vs secukinumab 150 mg (with loading dose [LD]/without LD), and comparable response rates vs other active comparators. In the predominantly-naïve AS analysis, bimekizumab had significantly higher ASAS40 response rates vs secukinumab 150 mg (without LD), significantly higher ASAS-PR response rates vs secukinumab 150 mg (with LD), and comparable response rates vs other active comparators. Bimekizumab demonstrated similar safety to other b/tsDMARDs. Conclusion Across ASAS outcomes, bimekizumab was comparable to most b/tsDMARDs, including ixekizumab, TNF inhibitors and upadacitinib, and achieved higher response rates vs secukinumab for some ASAS outcomes in predominantly b/tsDMARD-naïve nr-axSpA and AS patients at 12–16 weeks. In a pooled axSpA network, bimekizumab demonstrated comparable safety vs other b/tsDMARDs.

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

“…The analyses with BKZ versus IXE 80 mg from COAST-V only (i.e., TNFi-naïve patients) suggested that patients treated with BKZ may have a significantly higher likelihood of achieving greater increases from baseline in SF-36 PCS, however differences observed in 52-week efficacy for all other analyzed outcomes were nonsignificant. These findings are consistent with those from the NMA at weeks 12-16, in which BKZ demonstrated similar relative efficacy versus IXE 80 mg across ASAS outcomes [17,18]. In contrast, analyses comparing BKZ with IXE 80 mg (COAST-V/-W) suggested that patients treated with BKZ may have a significantly higher likelihood of 52-week efficacy across ASAS20, ASAS40, BASDAI change from baseline and SF-36 PCS change from baseline.…”

“…The analyses of BKZ versus SEC 150 mg (MEASURE 1/2/3/4) provide evidence that patients with r-axSpA treated with BKZ may have a significantly greater likelihood of achieving longer-term ASAS40 response, greater reductions from baseline in BASDAI, and greater increases from baseline in SF-36 PCS. These MAIC results at week 52 are consistent with the NMA analyses at weeks 12-16, in which BKZ achieved higher response rates compared with SEC 150 mg across a range of outcomes in patients with r-axSpA, and provide further evidence supporting the use of BKZ as an effective treatment option in patients with axSpA [17,18]. However, in the separate analyses with BKZ versus SEC 150 mg Fig.…”

“…Studies reporting 52-week efficacy outcomes for BKZ, SEC, and IXE in phase 3 RCTs in r-axSpA were identified through a published SLR conducted in January 2023, which followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 framework [17,26]. The identified trials were subsequently assessed for suitability for inclusion in the MAIC analyses (Supplementary Table 1).…”

“…In the absence of head-to-head data, efficacy and safety of interventions can be compared indirectly using analytical frameworks such as network meta-analysis (NMA) and matchingadjusted indirect comparison (MAIC) [15,16]. In the comparison of BKZ with SEC and IXE, a recent NMA demonstrated significantly higher relative efficacy with BKZ versus SEC and similar relative efficacy versus IXE in selected Assessment of SpondyloArthritis international Society (ASAS) responses up to weeks 12-16 in patients with axSpA [17,18]. However, comparison of these treatments using NMA is not feasible beyond this timepoint due to a disconnected network (i.e., lack of placebo arm data beyond week 16 in the BKZ phase 3 randomized controlled trials [RCTs]) [19].…”