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Interleukin-17 Inhibitor Scores in Rheumatoid Arthritis Trial
Major Finding: The investigational interleukin-17 blocker ixekizumab brought improvement in multiple outcome measures within as little as 3 days...
The investigational anti-interleukin-17 monoclonal antibody ixekizumab proved efficacious and as safe as other biologic therapies in treating rheumatoid arthritis both in patients who had never received a biologic and in patients who had an inadequate response to previous treatment with a tumor necrosis factor–alpha inhibitor, in a study recently published in Arthritis & Rheumatology.
The 12-week, phase II trial, whose results were previously reported by Dr. Mark C. Genovese at the 2012 European Congress of Rheumatology, tested five different doses of ixekizumab against placebo and found that each dose produced significantly better rates of American College of Rheumatology (ACR) 20 responses after 12 weeks than did placebo.
Dr. Mark C. Genovese
The ACR 20 response rates were significantly different from those produced by placebo in both biologic-naive patients and those with an inadequate response to a TNF-alpha inhibitor. The ACR 20 response rates also followed a dose-response relationship in biologic-naive patients. ACR 20 responses, as well as decreases in 28-joint Disease Activity Score and C-reactive protein levels, occurred within 3 days of starting ixekizumab. No unforeseen adverse events occurred, according to first author Dr. Genovese, of the division of immunology and rheumatology at Stanford (Calif.) University, and his coinvestigators (Arthritis Rheumatol. 2014 March 12 [doi: 10.1002/art.38617]).
More recently, investigators at the 2013 ACR annual meeting presented data from an open-label extension of the trial out to 64 weeks. ACR 20 response rates were maintained or improved after patients went on a treatment hiatus during weeks 10-16 and then restarted ixekizumab at 160 mg once every 4 weeks out through 64 weeks. In the 202 biologic-naive patients who completed the extension phase, 89% of the 107 who had an ACR 20 response at 16 weeks maintained it through 64 weeks. The corresponding rate in 99 patients formerly on TNF-alpha inhibitors was 76% of 41 patients. Those who were formerly assigned to placebo treatment had responses that were similar to those observed in patients who were originally randomized to ixekizumab in the randomized trial (Arthritis Rheum. 2013;65[Suppl. S10]:S188).
Eli Lilly sponsored the trial. Dr. Genovese reported receiving research funding and consulting compensation from Eli Lilly. Another two investigators reported receiving research grants from the company. Other investigators are or were employees of Eli Lilly.