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)
Journal of the American Academy of Dermatology Sep 20, 2017
Blauvelt A, et al. - This paper scrutinized the efficacy and safety of ixekizumab through 108 weeks of treatment for moderate-to-severe plaque psoriasis. It was concluded that ixekizumab was well tolerated. It illustrated persistent efficacy through 108 weeks.
Methods
- The enrollees (N = 1346) were randomized 2:2:2:1 to 80 mg ixekizumab every 2 or 4 weeks, 50 mg etanercept twice weekly, or placebo.
- The candidates switched to ixekizumab every 4 weeks during a long-term extension (LTE) period, at week 12.
- Efficacy data were abridged through as-observed, multiple imputation (MI), and modified MI (mMI) methods.
Results
- It was found that for patients (N = 385) receiving the recommended dose (ixekizumab every 2 weeks on weeks 0-12 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 patients achieving ≥75% improvement from baseline in the Psoriasis Area and Severity Index, and the 108-week as-observed, MI, and mMI response rates were 82.6%, 78.3%, and 74.1%, respectively.
- It was noted that for patients with a static Physician's Global Assessment score of 0 or 1.
- During LTE, 1077 (84.5%) patients reported ≥1 treatment-emergent adverse event, and 85% were mild or moderate in severity.
- Discontinuation was reported due to the occurrence of adverse events in 6.4% of patients.
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