COAST-V results support ixekizumab for the treatment of ankylosing spondylitis
medwireNews: Phase III trial results indicate that ixekizumab may be a promising treatment option for biologic-naïve patients with ankylosing spondylitis and an inadequate response or intolerance to nonsteroidal anti-inflammatory drugs.
As reported at the 2018 ACR/ARHP Annual Meeting in Chicago, Illinois, USA, and published simultaneously in The Lancet, the COAST-V investigators found that 52% of the 83 patients who were randomly assigned to receive subcutaneous ixekizumab 80 mg every 2 weeks and 48% of the 81 patients who were given the interleukin (IL)-17A inhibitor at a dose of 80 mg every 4 weeks achieved an ASAS40 response at week 16.
These rates were significantly higher than the ASAS40 response rate in the placebo group, in which 18% of 87 participants experienced a response. And the response rate of 36% for the 90 patients treated with the tumor necrosis factor (TNF) inhibitor adalimumab at a dose of 40 mg every 2 weeks was also a significant improvement over placebo treatment.
“Also, [for the] secondary endpoints, all mean changes showed significant improvement with the active treatment arms,” said Désirée van der Heijde (Leiden University Medical Centre, the Netherlands) in her presentation of the results.
For example, the proportion of patients who achieved at least a 50% improvement in BASDAI score was 43% for participants given ixekizumab every 2 weeks, 42% for those given ixekizumab every 4 weeks, 32% for the adalimumab group, and 17% for those given placebo. A corresponding 11%, 16%, 16%, and 2% achieved inactive disease according to an ASDAS score below 1.3 points.
Moreover, patients treated with ixekizumab or adalimumab experienced significantly greater average improvements in magnetic resonance imaging spine and sacroiliac joint Spondyloarthritis Research Consortium of Canada (SPARCC) scores than those given placebo, noted van der Heijde.
She reported that ixekizumab “showed no unexpected safety findings,” with 43%, 42%, 49%, and 40% of patients in the ixekizumab every 2 weeks, ixekizumab every 4 weeks, adalimumab, and placebo groups, respectively, experiencing adverse events (AEs). The most common treatment-emergent AEs occurring in at least 5% of patients receiving ixekizumab were nasopharyngitis and upper respiratory tract infection. A total of four patients discontinued treatment due to AEs, including three given ixekizumab every 2 weeks and one in the adalimumab group.
“The results of COAST-V validate the inhibition of IL-17A as a potential therapeutic approach in patients [with ankylosing spondylitis],” concluded van der Heijde.
Discussing these findings in an accompanying commentary published in The Lancet, Xenofon Baraliakos and Juergen Braun, both from Ruhr-University Bochum in Germany, say that “[i]xekizumab has already followed the other IL-17A antibody, secukinumab, in two other indications, psoriasis and psoriatic arthritis, and it seems likely that an approval for [ankylosing spondylitis] will follow” on the basis of the COAST-V results.
The commentators note that although adalimumab was included as “an active reference group” in the trial, it was not powered to show a difference between adalimumab and ixekizumab.
“In any case, the data suggest that the efficacy of ixekizumab in patients with [ankylosing spondylitis] is at least similar to the efficacy with TNF inhibitors,” they add.
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