Dupilumab treatment improves quality of life in adult patients with moderate-to-severe atopic dermatitis: results from a randomized, placebo-controlled clinical trial

BackgroundDupilumab, a human anti-interleukin-4 receptor alpha monoclonal antibody, significantly improved clinical signs and symptoms in adults with moderate-to-severe atopic dermatitis in a randomized, double-blind, placebo-controlled, phase IIa trial. ObjectivesWe evaluate health-related quality of life (HRQoL) and correlation of HRQoL with secondary clinical and patient-reported outcomes in a subset of patients from this trial of dupilumab. MethodsPatients were randomized to 300 mg weekly subcutaneous dupilumab or placebo for 12 weeks (trial registration: NCT01548404). The Quality of Life Index of Atopic Dermatitis (QoLIAD) score (exploratory outcome) and its correlation with efficacy outcomes [Eczema Area and Severity Index (EASI); primary end point; SCORing Atopic Dermatitis (SCORAD), SCORAD visual analogue scale (VAS) scores for sleep and pruritus, pruritus numerical rating scale (NRS) and 5-dimensional pruritus] were assessed in 64 adults with moderate-to-severe atopic dermatitis. ResultsMean QoLIAD scores at baseline standard error (SE) were 133 134 and 113 109 for the placebo and dupilumab groups, respectively. Dupilumab significantly improved QoLIAD score after 12 weeks of treatment vs. placebo (mean % change from baseline in QoLIAD score SE: -640 691 vs. -111 931). Least squares mean % difference from baseline vs. placebo in QoLIAD score SE was -520 1143, P < 0001). QoLIAD scores significantly correlated with changes in efficacy outcomes, including EASI (r = 044), 5-dimensional pruritus (r = 049), pruritus NRS (r = 041), total SCORAD (r = 056) and SCORAD VAS scores for sleep (r = 047) and pruritus (r = 054); all P < 005. ConclusionsDupilumab improved QoLIAD scores in adults with atopic dermatitis and was significantly associated with improvements in study outcomes. What's already known about this topic? Dupilumab has demonstrated efficacy and tolerability in phase II and III clinical trials with adults with moderate-to-severe atopic dermatitis. What does this study add? We report results from a 12-week phase IIa study, which shows improvement in quality of life and efficacy outcomes in a subset of patients treated with dupilumab; quality of life was significantly associated with improvements in study outcomes. These data support continued evaluations of dupilumab as a patient-relevant treatment for atopic dermatitis. Linked Comment:Rencz. Br J Dermatol 2018; 178:319-320. Plain language summary available online Respond to this article