Bimekizumab achieves significant, rapid improvements in axial spondyloarthritis
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The use of bimekizumab to inhibit both interleukin-17A and IL-17F was well-tolerated and impactful in improving axial spondyloarthritis outcomes across two phase 3 trials, according to data published in the Annals of the Rheumatic Diseases.
“Bimekizumab is a humanized monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A,” Désirée van der Heijde, MD, PhD, of Leiden University Medical Center, in the Netherlands, and colleagues wrote. “Unlike IL-17A-specific inhibitors, bimekizumab enables neutralisation of IL-17A/A, IL-17A/F and IL-17F/F, which preclinical data and clinical trials comparing bimekizumab with IL-17A-specific inhibition in psoriasis suggest may lead to more effective suppression of inflammation.
“In the phase 2b BE AGILE trial in patients with active ankylosing spondylitis and its open-label extension, bimekizumab 160mg every 4weeks led to rapid disease control compared with placebo, with efficacy sustained for up to 3years of treatment,” they added.
To investigate the safety and efficacy of bimekizumab (Bimzelx, UCB) in patients with axial SpA, van der Heijde and colleagues conducted two phase 3 trials in parallel — BE MOBILE 1 and BE MOBILE 2. Both trials were multicenter, randomized, double-blind and placebo controlled. Patients were eligible for inclusion if there were aged 18 years or older and demonstrated active axial SpA and a spinal pain score of four or greater, according to the Bath Ankylosing Spondylitis Disease Activity Index. Patients with definite sacroiliitis were sorted to BE MOBILE 2, while those without were placed in BE MOBILE 1.
Patients in BE MOBILE 1 were randomized 1:1, and patients in BE MOBILE 2 were randomized 2:1, to receive either bimekizumab 160mg every 4 weeks or placebo. Following the screening process, both trials followed a 16-week, placebo-controlled, double-blind treatment period. After this, participants in both trials completed a 36-week active-treatment maintenance period. All patients received bimekizumab 160 mg every 4 weeks from week 16 through 52.
In both trials, the primary efficacy endpoint was Assessment of SpondyloArthritis International Society 40% improvement (ASAS40) at week 16. The researchers also assessed key secondary endpoints, such as ASAS40 responses in patients naïve to TNF inhibitors and change in baseline from Maastricht Ankylosing Spondylitis Enthesitis Index (MASES) score, among patients with a score greater than 0 at baseline.
“BE MOBILE 1 and BE MOBILE 2 represent the first phase 3 studies to evaluate the inhibition of IL-17F in addition to IL-17A with bimekizumab across the spectrum of axial SpA,” Emmanuel Caeymaex, executive vice president of immunology and U.S. solutions at UCB, said in a company press release.
A total of 254 patients were randomized into BE MOBILE 1, while 332 patients were randomized into BE MOBILE 2. At week 16, all primary and secondary endpoints were achieved in both trials, according to the researchers. In BE MOBILE 1, approximately 47.7% of patients receiving bimekizumab achieved ASAS40, compared with 21.4% of patients receiving placebo. In BE MOBILE 2, meanwhile, 44.8% of patients receiving bimekizumab achieved ASAS40, compared with 22.5% of those in the placebo group (P < .001). These scores were similar among the TNF inhibitor-naïve and TNF inhibitor-inadequate responders.
The most common treatment-emergent adverse events for patients receiving bimekizumab occurred in more than 3% of cases and included nasopharyngitis, upper respiratory tract infection, pharyngitis, diarrhea, headache and oral candidiasis, the researchers wrote.
“These first phase 3 trials evaluating the efficacy and safety of dual inhibition of IL-17F in addition to IL-17A with bimekizumab, across the full spectrum of [axial SpA (axSpA)], clearly demonstrate that treatment with bimekizumab resulted in rapid, clinically relevant improvements in disease manifestations, compared with placebo, and was well tolerated,” van der Heijde and colleagues wrote. “Bimekizumab may therefore offer patients with axSpA an effective treatment option with a novel mode of action.”
Reference:
Annals of the Rheumatic Diseases Publishes Results from Two Bimekizumab Phase 3 Studies in Axial Spondyloarthritis. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/annals-of-the-rheumatic-diseases-publishes-results-from-two-bimekizumab-phase-3-studies-in-axial-spondyloarthritis. Jan. 18, 2023. Accessed Jan. 24, 2023.
Perspective
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The efficacy and safety data from bimekizumab’s BE MOBILE 1 and BE MOBILE 2 trials are very encouraging. It is great to see positive results throughout all spondyloarthritis categories. Despite having multiple mechanisms of action approved in these conditions, many patients lack adequate control. Having a dual-acting interleukin (IL)-17A and IL-17F inhibitor in our armament of treatment will benefit our patients and likely help us achieve treatment goals in more patients with spondyloarthritis.
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Van der Heijde D, et al. Ann Rheum Dis. 2023;doi:10.1136/ard-2022-223595.
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