Results from three, Phase 3 clinical trials showed that patients with moderate-to-severe psoriasis who were treated with Taltz (ixekizumab) reported significant improvements in work productivity over those treated with placebo.
The randomized, double-blind, studies were led by April W. Armstrong, MD, MPH, of the Keck School of Medicine at University of South California (USC), and colleagues between December 2011 and April 2015, and involved 3,866 adult outpatients with moderate-to-severe chronic plaque psoriasis. Taltz, developed by Eli Lilly, was approved by U.S. Food and Drug Administration (FDA) for this indication in March on the basis of these results.
One trial, called UNCOVER-1 (NCT01474512), enrolled 1,296 patients (mean age, 45.7 years; 68.1% male) who were randomized to receive either subcutaneous Taltz 80 mg or placebo every two or four weeks. UNCOVER-2 (NCT01597245) enrolled 1,224 patients (mean age, 45 years; 67.1% male) and UNCOVER-3 (NCT01646177) enrolled 1,346 (mean age, 45.8 years; 68.2% male); in these trials, patients were divided into three injection treatment groups — Taltz 80 mg, Enbrel (etanercept, Amgen) 50 mg, or placebo.
Patients completed the Work Productivity and Activity Impairment-Psoriasis (WPAI-PSO) questionnaire, administered at baseline and week 12 for all studies. In UNCOVER-1 and -2 trials, the questionnaire also was administered at weeks 24, 36, 52 and 60, while the patients were in a randomized withdrawal period.
Results showed that:
- WPAI-PSO scores showed improvements at week 12 were sustained thoughout the 60-week study
- In the UNCOVER-1 trial, significantly greater improvements were reported in WPAI-PSO by those under Taltz treatment versus placebo, including absenteeism, presenteeism, work productivity loss and activity impairment
- In the UNCOVER-2 and -3 trials, significant improvements over placebo were found in the Taltz group for productivity measures, except for absenteeism in those given Taltz every four weeks in UNCOVER-2
- Compared to Enbrel, patients receiving Taltz in UNCOVER-2 had greater improvements in WPAI-PSO scores for presenteeism, work productivity loss and activity impairment, and improvement in activity impairment compared to Enbrel in UNCOVER-3
“The positive effect of ixekizumab treatment on WPAI-PSO scores that are reported here are consistent with other biologic agents,” the researchers concluded, according to a press release. “Although not directly tested here, it is expected that less impairment in work productivity would be associated with a reduction in the productivity-related cost burden to the patients, the patient’s family and to society.”