Effects of Adalimumab versus Placebo on Risk of Symptom Worsening in Psoriasis and Subsequent Impacts on Health-Related Quality-of-Life Analysis of Pooled Data from Two Randomized, Double-Blind, Placebo-Controlled, Multicentre Clinical Trials

Background: Rates and impacts of worsening symptoms in patients with psoriasis have not been well characterized. Objectives: To assess the risk of clinically relevant worsening of psoriasis symptoms in patients treated with adalimumab versus placebo and to determine the health-related quality-of-life (HROOL) impacts of such worsening. Methods: The cumulative incidence of worsening was compared for adalimumab (40 mg every other week following an 80 mg induction dose) versus placebo using data from two phase III randomized, placebo-controlled trials (CHAMPION and REVEAL). Clinically relevant worsening of psoriasis was defined as a follow-up visit with a >= 25% increase in the Psoriasis Area and Severity Index (PAST) from baseline or a >= 5-unit increase in the Dermatology Life Quality Index from baseline during the initial 16-week double-blind treatment periods. Patients with versus without worsening were compared in terms of pain, work productivity and activity impairment (WPAI) and the mental and physical component summary (MCS and PCS) scores of the Short-Form 36 Health Survey. A subgroup analysis was performed for patients with PAST 10-20 at baseline. Results: The 17-week risk of clinically relevant worsening was 37.0% (95% CI 26.1, 46.3) for placebo (n = 445) and 4.2% (95% CI 2.0, 6.3) for adalimumab-treated patients (n = 914) [p < 0.0001]. Patients with versus without worsening experienced substantially increased pain, increased WPAI and greater impairment in MCS and PCS. Results were similar for patients with PASI 10-20 at baseline. Limitations: The short study duration may not reflect long-term outcomes. Conclusion: Clinically relevant worsening of psoriasis symptoms was associated with substantial worsening of HRQOL. Adalimumab treatment was associated with a substantially reduced risk of clinically relevant worsening.