FDA gives nod to ixekizumab for ankylosing spondylitis
medwireNews: The indication for ixekizumab has been expanded to include ankylosing spondylitis (AS) in the USA.
Previously indicated for the treatment of plaque psoriasis and psoriatic arthritis, the interleukin (IL)-17A inhibitor may now be given to adult patients with active AS. This approval was based on the results of the COAST-V and COAST-W trials, which demonstrated the efficacy and safety profiles of ixekizumab in AS patients who were biologic-naïve and those with an inadequate response to TNF inhibitors, respectively.
The recommended dose of ixekizumab for AS is two 80 mg subcutaneous injections at week 0, followed by one 80 mg injection every 4 weeks thereafter. The label includes warnings for infections (including tuberculosis), hypersensitivity reactions, and inflammatory bowel disease.
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