Bimekizumab Linked to 12-Week Clinical Improvements in Ankylosing Spondylitis
Dual neutralization of IL-17A and IL-17F by bimekizumab provided clinically meaningful improvements in disease outcome measures among patients with active ankylosing spondylitis. Credit: BSIP
|The following article is part of conference coverage from the European League Against Rheumatism (EULAR) Congress 2018 in Amsterdam, The Netherlands. Rheumatology Advisor's staff will be reporting breaking news associated with research conducted by leading experts in rheumatology. Check back for the latest news from EULAR 2018.|
Dual neutralization of interleukin (IL)-17A and IL-17F by the humanized monoclonal antibody bimekizumab provided clinically meaningful improvements in disease outcome measures among patients with active ankylosing spondylitis (AS), according to data presented at the European League Against Rheumatism (EULAR) Congress held in Amsterdam, June 13 to 16, 2018.
In a phase 2b, ongoing 48-week study (ClinicalTrials.gov identifier: NCT02963506), investigators assessed the 12-week efficacy and safety of bimekizumab in patients with active AS. The primary outcome was to assess the Assessment in Spondyloarthritis international Society 40% (ASAS40) dose-response relationship at 12 weeks. Researchers also assessed safety and secondary endpoints, including ASAS20 and ASAS5/6 response rates and the change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score with C-reactive protein (ASDAS-CRP) at 12 weeks.
A total of 303 patients with active AS who fulfilled the modified New York criteria were randomly assigned to receive subcutaneous bimekizumab 16mg, 64mg, 160mg, or 320 mg or placebo once every 4 weeks for 12 weeks. Overall, 297 patients (84.5% men; mean age, 42.2 years; median symptom duration, 13.3 years) completed the 12-week double-blind period. Baseline characteristics were similar between treatment groups.
Results showed a significant dose-response for ASAS40 at 12 weeks (P <.001). A greater percentage of patients treated with 16 mg (29.5%), 64 mg (42.6%), 160 mg (46.7%), and 320 mg (45.9%) bimekizumab achieved ASAS40 compared with those treated with placebo (13.3%; P <.05 for all doses).
More patients receiving bimekizumab also achieved ASAS20 compared with placebo (P <.05 for doses 64-320 mg) and ASAS5/6 (16 mg, 29.5%; 64 mg, 39.3%; 160 mg, 50.0%; 320 mg, 52.5%; placebo, 5.0%; P <.05 for all comparisons). Greater reductions were also achieved with bimekizumab for both BASDAI and ASDAS-CRP compared with placebo.
The overall incidence of treatment-emergent adverse events was 35.4% for bimekizumab-treated patients vs 36.7% for placebo. The most frequently reported events were nasopharyngitis and headache.
This study was funded by UBC Pharma.
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van der Heijde D, Gensler LS, Deodhar A, et al. Dual neutralization of IL-17A and IL-17F with bimekizumab in patients with active ankylosing spondylitis (AS): 12-week results from a phase 2b, randomised, double-blind, placebo-controlled, dose-ranging study. Presented at: European League Against Rheumatism (EULAR) Congress 2018; June 13-16, 2018; Amsterdam, The Netherlands. Abstract LB0001.