The Effect of Body Weight on the Efficacy and Safety of Ixekizumab: Results from an Integrated Database of 3 Randomized, Controlled Phase 3 Studies of Patients with Moderate-to-Severe Plaque Psoriasis

Abstract

Background

There is concern that increased body weight may impact efficacy of some therapies used to treat psoriasis.

Objective

To evaluate the effect of body weight on response to ixekizumab treatment in moderate-to-severe psoriasis patients.

Methods

Patients were characterized under 3 body weight categories (<80 kg, 80 to 100 kg, ≥100 kg) in this preplanned subgroup analysis from an integrated database of 3 multicenter, randomized, double-blind, controlled Phase 3 clinical studies (UNCOVER -1, UNCOVER-2, and UNCOVER-3). In the first 12 weeks of each study, patients were randomly assigned to receive subcutaneous placebo, 80-mg ixekizumab every 2 weeks (IXE Q2W) or every 4 weeks (IXE Q4W) after a starting dose of 160-mg ixekizumab, or 50-mg etanercept twice weekly (UNCOVER-2 and UNCOVER-3 only).

Results

This analysis included 3855 patients with baseline body weight in the IXE Q4W (N=1159), IXE Q2W (N=1168), placebo (N=789), and etanercept (N=739) groups. Distribution of patients across body weight categories was similar between treatment groups. Baseline demographics and patients characteristics were generally consistent across treatment groups within each body weight category. Across all body weight categories, a significantly higher percent of patients treated with IXE Q2W or IXE Q4W than with placebo or etanercept achieved PASI75, PASI90, or PASI100 at Week 12. No meaningful differences in PASI75 response rates were observed across body weight categories. Some numerical differences in PASI 90 and PASI100 response rates were observed between body weight categories with IXE Q2W providing numerically higher response rates than IXE Q4W. The incidence of treatment-emergent adverse events was similar in the treatment groups and across body weight categories.

Conclusion

Ixekizumab was efficacious in the treatment of moderate-to-severe psoriasis regardless of body weight. The safety profile of ixekizumab was also similar across body weight categories and no safety signals were identified specific to any of the body weight categories.

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