Bimekizumab Shows Consistent Efficacy With Or Without Concomitant Methotrexate in PsA

Iain B. McInnes, MD, PhD

Credit: University of Glasgow

Bimekizumab was well-tolerated and yielded consistent, sustained efficacy in patients with psoriatic arthritis (PsA) with disease naive to biologic disease-modifying antirheumatic drugs (bDMARDs) or with prior inadequate response or intolerance to tumor necrosis factor inhibitors (TNFi-IR), with or without concomitant methotrexate (+/−MTX), for up to 52 weeks.¹

“With the growing repertoire of bDMARD treatments available for patients with PsA, there is a need to understand the impact of concomitant MTX on efficacy and safety when used in combination with bDMARDs,” first author Iain B. McInnes, MD, PhD, College of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, United Kingdom, and coauthors wrote.¹

McInnes and colleagues conducted a post hoc analysis of patients in 3 trials of bimekizumab: BE OPTIMAL (NCT03895203), in which patients had bDMARD-naïve disease; BE COMPLETE (NCT03896581), in which patients had TNFi-IR disease; and the BE VITAL open-label extension (NCT04009499) study. Participants received either bimekizumab 160 mg every 4 weeks, placebo, or a reference drug (adalimumab 40 mg every 2 weeks in BE OPTIMAL only). In the interventional arms, BE OPTIMAL included 252 participants with +MTX disease and 179 with –MTX disease and BE COMPLETE included 119 participants with +MTX disease and 148 with –MTX disease. After week 16, participants receiving placebo (n = 414 total) received bimekizumab.¹

The investigators found that, at week 52, bimekizumab yielded a similar rate of American College of Rheumatology 50% (ACR50) responses in both patients with +MTX disease (BE OPTIMAL, 54.4%; BE COMPLETE, 56.3%) and −MTX disease (BE OPTIMAL, 54.7%; BE COMPLETE, 48.0%). Similarly, bimekizumab yielded similar rates of complete skin clearance (Psoriasis Area and Severity Index 100% [PASI100] response) sustained from Week 16 in both patients with +MTX disease (BE OPTIMAL, 61.1%; BE COMPLETE, 68.8%) and with -MTX disease (BE OPTIMAL, 60.4%; BE COMPLETE, 63.5%). The proportions of minimal disease activity (MDA) were also similar between patients with +MTX disease (BE OPTIMAL, 54.8%; BE COMPLETE, 47.9%) and with –MTX disease (BE OPTIMAL, 55.3%; BE COMPLETE, 46.6%). Similar trends were seen in placebo/bimekizumab-treated patients.¹

Looking at safety, the incidence of at least 1 treatment-emergent adverse event (AE) was similar between both +MTX (BE OPTIMAL, 79.3%; BE COMPLETE, 62.5%) and −MTX groups (BE OPTIMAL, 78.8%; BE COMPLETE, 62.7%). The trend remained consistent between subgroups and the overall safety profile was consistent with that seen in previous studies.¹

“The results presented here contribute to the understanding of the impact of concomitant MTX on the efficacy and safety of biologics. This is of particular importance given the emphasis on safety in current treatment guidelines and the adverse events and tolerability concerns associated with MTX, which can result in discontinuation,” McInnes and coauthors concluded.¹

McInnes was also involved with a recent retrospective analysis comparing bimekizumab and guselkumab in patients with bDMARD-naïve or TNFi-IR PsA published in March 2024. At that time, the investigators found that treatment with bimekizumab demonstrated a more favorable likelihood of achieving treatment outcomes than guselkumab at weeks 48/52.²

Initiation of bimekizumab was linked to a greater likelihood of ACR50 (odds ratio [OR] [95% confidence interval (CI)] 1.62 [1.07, 2.44]; P = .021), ACR70 (2.20 [1.43, 3.38]; P < .001), and MDA (1.82 [1.20, 2.76]; P = .005) for those who were bDMARD-naïve, when compared with guselkumab. Similar results were seen in the TNF-IR cohort for these outcomes with bimekizumab treatment compared with guselkumab at week 48/52 (ACR20, 1.77 [1.15, 2.72]; P = .010; ACR50, 1.56 [1.03, 2.36]; P = .037; ACR70, 1.66 [1.05, 2.61]; P = .028; and MDA, 1.95 [1.27, 3.02]; P = .003).²

“Head-to-head studies of available treatments for PsA are sparse, and no head-to-head trials have been conducted between bimekizumab and guselkumab,” McInnes and coauthors wrote at that time.² “With an increasing number of targeted therapies becoming available in PsA, clinicians face treatment decisions concerning the variety of modes of action available to them.”

REFERENCES

1. McInnes IB, Mease PJ, Tanaka Y, et al. Efficacy and Safety of Bimekizumab in Patients With Psoriatic Arthritis With or Without Methotrexate: 52-Week Results From Two Phase 3 Studies. ACR Open Rheumatol. Published online July 30, 2024doi: 10.1002/acr2.11727
2. Warren RB, McInnes IB, Nash P, et al. Comparative Effectiveness of Bimekizumab and Guselkumab in Patients with Psoriatic Arthritis at 52 Weeks Assessed Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. Published online March 15, 2024. doi:10.1007/s40744-024-00659-0