medwireNews: Findings from the COAST-W trial provide support for the interleukin (IL)-17A inhibitor ixekizumab as a treatment option for patients with ankylosing spondylitis and a previous inadequate response or intolerance to tumor necrosis factor (TNF) inhibitor treatment.
These phase III results, which were presented in a late-breaking poster at the 2018 ACR/ARHP Annual Meeting in Chicago, Illinois, USA, are in line with the COAST-V findings demonstrating efficacy of the drug in ankylosing spondylitis patients with prior exposure to nonsteroidal anti-inflammatory drugs, and “confirm that IL-17A plays a role in the pathogenesis” of the disease, said Atul Deodhar (Oregon Health & Science University, Portland, USA) and colleagues.
The COAST-W investigators randomly assigned 316 patients who had previously been treated with one or two TNF inhibitors to receive subcutaneous ixekizumab at a dose of 80 mg every 2 weeks or every 4 weeks, following a loading dose of 80 or 160 mg at baseline, or to receive placebo.
At the 16-week follow-up, a significantly higher proportion of patients given ixekizumab every 2 weeks or every 4 weeks (n=98 and 114, respectively) achieved an ASAS40 response compared with those in the placebo group (n=104), with corresponding rates of 30.6% and 25.4% versus 12.5%.
Similarly, ASAS20 response rates at week 16 were significantly higher among participants receiving ixekizumab every 2 weeks and every 4 weeks versus placebo (46.9% and 48.2% vs 29.8%), and ixekizumab-treated patients experienced significantly greater improvements in disease activity, function, and quality of life over 16 weeks than those given placebo.
High sensitivity C-reactive protein levels and magnetic resonance imaging-based Spondyloarthritis Research Consortium of Canada (SPARCC) spine scores – both objective measures of inflammation – also decreased from baseline to week 16 among ixekizumab-treated patients, but increased in those given placebo.
The investigators said that ixekizumab “showed an acceptable safety profile.” In all, 60.2% of patients given ixekizumab every 2 weeks, 64.0% of those given the drug every 4 weeks, and 49.0% of those who received placebo experienced treatment-emergent adverse events (TEAEs), and a corresponding 3.1%, 8.8%, and 1.9% discontinued the study drug due to AEs.
Infections were the most common type of TEAE, affecting 23.5%, 29.8%, and 9.6% of patients, respectively, followed by injection site reactions and allergic reactions/hypersensitivities.
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