medwireNews: The results of two phase 3 studies suggest that dual inhibition of interleukin (IL)-17A and IL-17F with bimekizumab may represent a promising treatment option for nonradiographic axial spondyloarthritis (axSpA) and ankylosing spondylitis (AS).
Both trials were presented at the EULAR 2022 Congress in Copenhagen, Denmark. BE MOBILE 1 included 254 patients with active nonradiographic axSpA and objective signs of inflammation, while BE MOBILE 2 involved 332 patients with active AS and an inadequate response or intolerance to two nonsteroidal anti-inflammatory drugs and prior exposure to no more than one tumor necrosis factor (TNF) inhibitor.
Click through for a guide to the patient populations and treatment groups in the phase 3 bimekizumab trials
As outlined in a poster presentation, Xenofon Baraliakos (Ruhr-University Bochum, Germany) and BE MOBILE 1 co-investigators found that ASAS40 response rates at week 16 were significantly higher among participants randomly assigned to receive subcutaneous bimekizumab 160 mg every 4 weeks than in those given placebo, at 47.7% versus 21.4%.Baraliakos said that between-group differences in ASAS40 response rates were seen “as early as week 1,” and responses at week 16 were consistent irrespective of prior exposure to TNF inhibitors, which occurred in 10.6% of participants.
He also noted significant improvements in a number of secondary endpoints with bimekizumab versus placebo at week 16, including reductions from baseline in BASDAI and BASFI scores and sacroiliac joint inflammation as measured by magnetic resonance imaging.
At week 16, placebo-treated participants were switched to bimekizumab, and at the 24-week follow-up ASAS40 response rates increased to 52.3% in patients initially assigned to bimekizumab and 46.8% in those initially assigned to placebo.
The BE MOBILE 2 trial, presented by Désirée van der Heijde (Leiden University Medical Center, the Netherlands) found similar efficacy results in the AS population. Specifically, ASAS40 response rates at week 16 were 44.8% in the bimekizumab arm compared with 22.5% in the placebo arm, a significant difference. The study drugs were administered at the same dose and schedule as those in BE MOBILE 1.
Désirée van der Heijde outlines the findings of two phase 3 trials demonstrating that bimekizumab may be beneficial for patients with nonradiographic axial spondyloarthritis or ankylosing spondylitis (2:54).
At the 24-week follow-up, ASAS40 response rates were 53.8% for participants given bimekizumab throughout the study and 56.8% for those who switched from placebo at week 16.
Similar to what was observed in BE MOBILE 1, van der Heijde said that patients with AS experienced consistent ASAS40 response rates irrespective of whether they had previously been treated with TNF inhibitors. A total of 15% and 17% of participants in the bimekizumab and placebo arms, respectively, had prior TNF inhibitor exposure.
Both presenters said that no new safety signals were seen with bimekizumab in the two studies. Treatment-emergent adverse events (TEAEs) at week 0–16 occurred in 62.5% of bimekizumab-treated patients and 56.3% of placebo-treated patients in BE MOBILE 1, and in a corresponding 54.3% and 43.2% of patients in BE MOBILE 2. Nasopharyngitis was the most common TEAE during this period in both studies, affecting 9.4% of bimekizumab-treated patients in BE MOBILE 1 and 7.7% in BE MOBILE 2.
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