The use of ixekizumab for the treatment of moderate to severe plaque psoriasis is safe and effective, according to results of UNCOVER-3, a randomized, double-blind, multicenter, phase 3 trial recently published in the Journal of the American Academy of Dermatology

The aim of the study was to evaluate the efficacy and tolerability of the humanized interleukin-17A antagonist monoclonal ixekizumab through 108 weeks of treatment. A total of 1346 patients were randomly assigned to 1 of the following 4 treatment arms: (1) ixekizumab 80 mg every 2 weeks; (2) ixekizumab 80 mg every 4 weeks; (3) etanercept 50 mg twice weekly; or (4) placebo. At week 4, patients switched to ixekizumab every 4 weeks during a long-term extension (LTE) study period. Efficacy results were evaluated with the use of as-observed, multiple imputation (MI), and modified MI (mMI) techniques.

Among the 355 patients who were treated with the recommended dose (ixekizumab every 2 weeks from week 0 through week 12 and every 4 weeks during LTE), the 108-week as-observed, MI, and mMI response rates were 93.4%, 88.3%, and 83.6%, respectively, for participants achieving ≥75% improvement from baseline in the Psoriasis and Activity Index. For those patients with a static Physician’s Global Assessment score of 0 or 1, the 108-week as-observed, MI, and mMI response rates were 82.6%, 78.3%, and 74.1%, respectively.

During the LTE phase, 84.5% of patients reported ≥1 treatment-emergent adverse event, with 85% of these events deemed to be mild or moderate in severity. Only 6.4% of patients discontinued treatment because of adverse events.

“Overall, the results presented demonstrate that ixekizumab is well tolerated and provides a persistent and long-term clinical response through 108 weeks of treatment in patients with moderate to severe plaque psoriasis,” the researchers concluded.

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Reference

Blauvelt A, Gooderham M, Iversen L, et al. Efficacy and safety of ixekizumab for the treatment of moderate-to-severe plaque psoriasis: results through 108 weeks of a randomized, controlled phase 3 clinical trial (UNCOVER-3). J Am Acad Dermatol. 2017;77(5):855-862.