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.
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.