Efficacy and safety of ixekizumab through 52 weeks in two phase 3, randomised, controlled clinical trials in patients with active radiographic axial spondyloarthritis (COAST-V and COAST-W)
Annals of Rheumatic Diseases Nov 14, 2019
Dougados M, Wei JCC, Landewé R, et al. - The present analysis was conducted to test the safety and effectiveness of ixekizumab for up to 52 weeks in two phase 3 studies of patients with active radiographic axial spondyloarthritis (r-axSpA) who were biological disease-modifying antirheumatic drug (bDMARD)-naive (COAST-V) or tumour necrosis factor inhibitor (TNFi)-experienced (COAST-W). For this investigation, individuals with active r-axSpA were randomised 1:1:1:1 (n = 341) to 80 mg ixekizumab every 2 (IXE Q2W) or 4 weeks (IXE Q4W), placebo (PBO) or 40 mg adalimumab Q2W (ADA) in COAST-V and 1:1:1 (n = 316) to IXE Q2W, IXE Q4W or PBO in COAST-W. In bDMARD-naive and TNFi-experienced patients, the significant effectiveness shown with ixekizumab at week 16 was sustained for up to 52 weeks. After switching to ixekizumab, bDMARD-naive individuals initially treated with ADA showed further numerical improvements. The safety results are consistent with ixekizumab's established safety profile.
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