OBJECTIVE: To assess the effect of ustekinumab on productivity and work limitations among 1230 psoriasis patients treated withustekinumab 45 mg or 90 mg or placebo during the Phase III PHOENIX 2 trial. METHODS: The self-administered Work Limitations Questionnaire (WLQ) was used to determine the on-the-job limitations at baseline and weeks 12 and 24. Productivity was assessed using a Visual Analog Scale (VAS), and the number of work days missed due to psoriasis was recorded. RESULTS: At baseline, work limitations and productivity were similar across treatment groups. At week 12, improvement in productivity VAS scores was significantly (p < 0.001) higher in the 45 mg (72.6%) and 90 mg (71.4%) ustekinumab groups versus placebo (no change), and the proportion of patients who missed work days was significantly lower (2.0% for each ustekinumab group vs 8.3% for placebo; p < 0.001). Mean improvements from baseline to week 12 were greater with ustekinumab than with placebo for WLQ domains, including time management (6.6/9.1 vs -0.7), mental-interpersonal (7.8/7.5 vs -1.1), and output demands (6.8/7.0 vs -1.1) (p < 0.001 for ustekinumab 45 mg/90 mg vs placebo). Improvements were maintained through week 24. CONCLUSIONS:Ustekinumab 45 mg or 90 mg significantly increased productivity, reduced work days missed, and improved work limitations compared with placebo in patients with moderate-to-severe psoriasis.
RCT Entities:
OBJECTIVE: To assess the effect of ustekinumab on productivity and work limitations among 1230 psoriasispatients treated with ustekinumab 45 mg or 90 mg or placebo during the Phase III PHOENIX 2 trial. METHODS: The self-administered Work Limitations Questionnaire (WLQ) was used to determine the on-the-job limitations at baseline and weeks 12 and 24. Productivity was assessed using a Visual Analog Scale (VAS), and the number of work days missed due to psoriasis was recorded. RESULTS: At baseline, work limitations and productivity were similar across treatment groups. At week 12, improvement in productivity VAS scores was significantly (p < 0.001) higher in the 45 mg (72.6%) and 90 mg (71.4%) ustekinumab groups versus placebo (no change), and the proportion of patients who missed work days was significantly lower (2.0% for each ustekinumab group vs 8.3% for placebo; p < 0.001). Mean improvements from baseline to week 12 were greater with ustekinumab than with placebo for WLQ domains, including time management (6.6/9.1 vs -0.7), mental-interpersonal (7.8/7.5 vs -1.1), and output demands (6.8/7.0 vs -1.1) (p < 0.001 for ustekinumab 45 mg/90 mg vs placebo). Improvements were maintained through week 24. CONCLUSIONS:Ustekinumab 45 mg or 90 mg significantly increased productivity, reduced work days missed, and improved work limitations compared with placebo in patients with moderate-to-severe psoriasis.