The Food and Drug Administration has extended approval of ixekizumab (Taltz) to the treatment of nonradiographic axial spondyloarthritis (nr-axSpA), according to a press release from its manufacturer, Eli Lilly. Specifically, this supplemental biologics license application refers to nr-axSpA with objective signs of inflammation.
The monoclonal interleukin-17A antagonist has three other indications, including ankylosing spondylitis in adults, psoriatic arthritis in adults, and plaque psoriasis in adults and children aged 6 years and older. It is the first IL-17A antagonist to receive FDA approval for nr-axSpA.
Approval for this indication was based on the phase 3, randomized, double-blind COAST-X trial, which put 96 nr-axSpA patients on 80-mg injections of ixekizumab every 4 weeks and 105 on placebo. After 52 weeks, ixekizumab was superior on the trial’s primary endpoint: 30% of patients had achieved a 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS 40), compared with 13% of patients on placebo (P = .0045).
Warnings and precautions for ixekizumab include considering potentially increased risk of infection and inflammatory bowel disease, as well as evaluating patients for tuberculosis before treatment. The most common adverse reactions (≥1%) are injection-site reactions, upper respiratory tract infections, nausea, and tinea infections. The safety profile for ixekizumab among nr-axSpA patients is mostly consistent with that seen among patients receiving it for other indications, according to Lilly. The full prescribing information is available on Lilly’s website.