Photo Credit: D-Keine

The following is a summary of “Long-Term Safety and Efficacy of Bimekizumab in Axial Spondyloarthritis: 2-Year Results from Two Phase 3 Studies,” published in the January 2025 issue of Rheumatology by Baraliakos et al.

Bimekizumab, an IgG1 antibody targeting interleukin (IL)-17A and IL-17F, showed efficacy and good tolerance in patients with axial spondyloarthritis (axSpA) for 1 year. Long-term effects are under investigation. 

Researchers conducted a retrospective study on bimekizumab’s safety and efficacy in patients with axSpA. 

They included patients completing week 52 in the BE MOBILE 1 (nr-axSpA; NCT03928704) and BE MOBILE 2 (r-axSpA; NCT03928743) studies, who were eligible for the open-label extension (OLE). All patients with OLE received 160 mg of subcutaneous bimekizumab every 4 weeks. Safety data were collected for patients receiving ≥1 bimekizumab dose, and efficacy data were reported for all randomized patients up to week 104.

The results showed that 70.8% (367/518) of patients reported ≥1 treatment-emergent adverse event (TEAE) in the OLE (Weeks 52–104). The most frequent TEAEs were COVID-19 infection (25.2 EAIR/100PY), nasopharyngitis (11.0), and oral candidiasis (5.4). Fungal infections had an EAIR/100PY of 11.8, with the majority being Candida infections (6.8). Inflammatory bowel disease and uveitis rates were low, and no major adverse cardiovascular events or deaths occurred. TEAE incidence rates were similar between Weeks 0–52 and 52–104. At week 104, >50% of randomized patients (N=586) achieved ASAS40, ~60% achieved ASDAS low disease activity (<2.1), and >30% achieved ASDAS inactive disease (<1.3). Bimekizumab sustained MRI inflammation suppression, with >57% achieving MRI remission. 

Investigators found that bimekizumab maintained a consistent safety profile with no new safety signals. Efficacy observed at 1 year was sustained through 2 years in both patients with nr-axSpA and r-axSpA. 

Source: academic.oup.com/rheumatology/advance-article/doi/10.1093/rheumatology/keaf009/7951894