Novel interleukin (IL)-17A inhibitor brodalumab may be a potential treatment option for patients with axial spondyloarthritis (axSpA), according to study results published in Annals of the Rheumatic Diseases.
Investigators sought to explore the efficacy and safety of brodalumab compared with placebo in patients with axSpA.
A 16-week, multicenter, randomized, double-blind, placebo-controlled, phase 3 trial (ClinicalTrials.gov Identifier: NCT02985983) was conducted at 48 sites in Japan, Korea, and Taiwan. Patients from 25 sites in Japan, 12 sites in Korea, and 11 sites in Taiwan were enrolled in the study between October 2016 and December 2019. All eligible patients were randomly assigned in a 1:1 ratio to receive 210 mg subcutaneous brodalumab or placebo at baseline, week 1, week 2, then every 2 weeks thereafter for 16 weeks.
To qualify for study enrollment, patients were 18 years or older and had axSpA, as diagnosed by a rheumatologist (according to the Assessment of SpondyloArthritis International Society [ASAS] classification criteria). The primary study endpoint was the percentage of patients with axSpA who attained an ASAS40 response at week 16. Secondary endpoints included the percentage of patients with axSpA who achieved an ASAS20 response and a change in Ankylosing Spondylitis Disease Activity Score using C-reactive protein (ASDAS-CRP) at week 16 and safety.
A total of 159 patients were enrolled in the study — 80 participants in the brodalumab group and 79 in the placebo group. Of these individuals, 3 in the brodalumab group and 10 in the placebo group discontinued, with 77 and 69 participants, respectively, completing the 16-week study. A majority of participants were men (82.5% and 77.2%, respectively), and mean participant age was 36.6 years and 38.3 years, respectively.
Results of the study showed that an ASAS40 response at week 16 was achieved in 35 patients (43.8%; 95% CI, 32.7%-55.3%) with axSpA in the brodalumab group vs 19 patients (24.1%; 95% CI, 15.1%-35.0%) with axSpA in the placebo group (P =.018). The ASAS20 response rate among patients with axSpA was higher with brodalumab than with placebo (67.5%; 95% CI, 56.1%-77.6% vs 41.8%; 95% CI, 30.8%-53.4%, respectively). At week 16, the least squares mean change from baseline in ASDAS-CRP was -1.127 (95% CI, -1.322 to -0.931) with brodalumab vs -0.672 (95% CI, -0.872 to -0.473) with placebo.
The occurrence of treatment-related adverse events was similar in the brodalumab and placebo group (55% and 57%, respectively).
A major limitation of the study was the restricted generalizability of the results because the population was specific to Japan, Korea, and Taiwan. In addition, since the current findings demonstrated the short-term efficacy and safety of brodalumab therapy in patients with axSpA, 52-week results from the open-label extension may serve to further validate the long-term safety and efficacy of brodalumab.
Investigators concluded, “…this study demonstrated that brodalumab is a potential therapeutic option for patients with axSpA.”
Disclosure: This clinical trial was supported by Kyowa Kirin. Please see the original reference for a full list of authors’ disclosure.
Wei JC-C, Kim T-H, Kishimoto M, Ogusu N, Jeong H, Kobayashi S; 4827-006 study group. Efficacy and safety of brodalumab, an anti-IL17RA monoclonal antibody, in patients with axial spondyloarthritis: 16-week results from a randomised, placebo-controlled, phase 3 trial. Ann Rheum Dis. Published online April 7, 2021. doi:10.1136/annrheumdis-2020-219406