Bimekizumab sustains axial spondyloarthritis improvements at 52 weeks
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Key takeaways:
- Rapid responses to bimekizumab were sustained over 52 weeks, with a consistent safety profile, in patients with axial SpA.
- The drug’s safety and efficacy are now being tested over a 3-year period.
Patients with axial spondyloarthritis who receive bimekizumab demonstrate sustained improvement through 52 weeks and a safety profile consistent with shorter trials, according to data published in the Annals of the Rheumatic Diseases.
“Treatment options for patients with [axial SpA (axSpA)] who have active disease despite non-steroidal anti-inflammatory drug (NSAID) treatment or who are intolerant to NSAIDs are limited to biologic disease-modifying antirheumatic drugs (bDMARDs) and targeted synthetic DMARDs (tsDMARDs), namely, tumor necrosis factor inhibitors (TNFi), interleukin 17A inhibitors (IL-17Ai)5 6 and Janus kinase inhibitors (JAKi),” Xenofon Baraliakos, MD, PhD, of Ruhr University Bochum, in German, and colleagues wrote. “Many patients treated with existing DMARDs experience adverse events or treatment failure, highlighting an unmet clinical need for treatments with alternative modes of action.
“Bimekizumab (BKZ) is a humanized monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A,” they added. “Preclinical studies suggest superior efficacy of BKZ in reducing inflammation and pathological bone formation compared with IL-17Ai alone.”
To analyze the efficacy and safety of bimekizumab (Bimzelx, UCB) in patients with axial SpA at week 52, Baraliakos and colleagues conducted the randomized, placebo-controlled BE MOBILE 1 and BE MOBILE 2 trials. During the previously reported 16-week double-blind treatment period in both studies, the researchers found that bimekizumab demonstrated superior efficacy vs. placebo in patients with nonradiographic and radiographic axial SpA.
BE MOBILE 1 included 254 patients with nonradiographic axial SpA randomized 1:1 to receive either bimekizumab or placebo, while BE MOBILE 2 featured 332 patients with radiographic SpA, of whom 221 were treated with the study drug and 111 received a placebo. In all, 244 participants from BE MOBILE 1 and 322 from BE MOBLE 2 completed the 16-week double-blind treatment period. All patients who entered the subsequent 36-week maintenance period received subcutaneous bimekizumab 160 mg every 4 weeks.
The primary efficacy endpoint in both trials was achieving at least 40% improvement in the Assessment of Spondyloarthritis International Society (ASAS40) response at week 16. Additional measures were assessed at week 52. In all, 220 patients from BE MOBILE 1 and 298 from BE MOBILE 2 completed all 52 weeks.
According to the researchers, both studies met all primary and secondary endpoints at week 16, with improvements seen with bimekizumab sustained through week 52. Specifically, the proportion of patients treated with bimekizumab who achieved ASAS40 response among patients with radiographic axial SpA rose from 44.8% at week 16 to 58.4% at week 52, and from 47.7% to 60.9% in patients with nonradiographic axial SpA.
Among patients initially treated with placebo who switched to bimekizumab at week 16, those with radiographic axial SpA achieved ASAS40 at a rate of 68.5% at week 52, surpassing those initially treated with the study drug. Meanwhile, patients with nonradiographic axial SpA in the initial placebo group demonstrated a response rate of 50.8% after the switch.
Regarding safety, treatment-emergent adverse events in patients who received at least one bimekizumab dose occurred in 72% of those with nonradiographic axial SpA, and in 75.5% of those with radiographic axial SpA. The most common events during the 52-week period were nasopharyngitis, upper respiratory tract infection and oral candidiasis. In addition, fungal infections were reported in 15.2% and 12.1% of patients with nonradiographic and radiographic disease, respectively. Most infections were oral candidiasis and were mild or moderate, with all managed using standard antifungal therapy.
“Dual inhibition of IL-17A and IL-17F with subcutaneous BKZ 160mg Q4W led to sustained and consistent efficacy in patients with nr-axSpA and r-axSpA across the domains of axSpA over the 52-week period,” Baraliakos and colleagues wrote. “The safety profile over 52 weeks was consistent with previous evidence on BKZ from phase 2b/3 studies in axSpA and phase 3 studies in psoriatic arthritis. Results from the BE MOBILE studies at week 52 along with 3-year and upcoming 5-year results, from the BE AGILE study, will continue to provide further insights into the long-term safety and efficacy of BKZ.”
Perspective
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“Rapid.” That is a huge word in the world of rheumatology, when we see patients who are struggling to find their right “rheumatology recipe,” as I like to call it. It’s a word that our patients desire to hear regarding something — anything — to make them feel better as soon as humanly possible. The data showed great improvement in a very short amount of time, but would bimekizumab (Bimzelx, UCB) sustain patients and maintain its efficacy for longer periods?
After a 52-week randomized controlled trial, improvements that were shown at week 16 in patients initially randomized to bimekizumab, as well as those who switched from placebo to bimekizumab at week 16, were maintained at week 52 across the full disease spectrum of axial spondyloarthritis.
The rapid efficacy of bimekizumab with sustained improvements over a 52-week period is very promising and adds more options for patients. Meanwhile, bimekizumab being a dual inhibitor is an overall added bonus.
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