NEW YORK (Reuters Health) – Brodalumab may be a potential therapeutic option for patients with axial spondyloarthritis (axSpA), according to interim results of a phase-3 study.
Brodalumab, which selectively inhibits interleukin-17 receptor A (IL-17RA), is approved for the treatment of plaque psoriasis in North America, Canada, Europe, Japan and other Asian countries.
In Annals of the Rheumatic Diseases, researchers report 16-week efficacy and safety results from a randomized placebo-controlled study of 159 patients with axSpA; 80 received brodalumab (210 mg) and 79 received placebo given via subcutaneous injection at baseline, weeks one and two and every two weeks thereafter, during the 16-week double-blind period.
At week 16, the proportion of patients with Assessment of SpondyloArthritis International Society (ASAS) 40 response (primary endpoint) was significantly higher in the brodalumab group (43.8% vs. 24.1%), the investigators report.
At 16 weeks, more patients on brodalumab also achieved ASAS 20 response (67.5% vs. 41.8%), a key secondary endpoint.
ASAS 40 and ASAS 20 responses were observed as early as two weeks in patients treated with brodalumab, Dr. Shigeto Kobayashi of Juntendo University Koshigaya Hospital, in Saitama, Japan, and colleagues report.
The ASAS 40 response rate with brodalumab at week 16 was comparable in the subpopulations with ankylosing spondylitis (AS, 46.0%) and non-radiographic axSpA (35.3%).
Disease activity, measured with the Ankylosing Spondylitis Disease Activity Score using C-reactive protein (ASDAS-CRP) score started improving as early as two weeks after the start of brodalumab and consistently improved over 16 weeks, the investigators report.
At 16 weeks, 76.3% of patients on brodalumab had inactive disease or low disease activity and 41.3% of patients had major and/or clinically important improvement.
The incidence of treatment-related adverse events (TEAEs) was similar in both groups, “with no new safety signals identified with brodalumab treatment over 16 weeks. Importantly, no TEAEs related to suicidal ideation or behavior were reported, as cautioned in the brodalumab label,” they note.
They caution that the current 16-week results demonstrate only the short-term efficacy and safety of brodalumab for axSpA. The 52-week results (treatment weeks 16 to 68) from the open-label extension of this study will provide data on long-term efficacy and safety of the drug in this patient population.
The study was funded by Japanese pharmaceutical company Kyowa Kirin. Several authors have disclosed financial relationships with the company.
SOURCE: https://bit.ly/3arRJ35 Annals of the Rheumatic Diseases, online April 7, 2021.
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