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

Abstract

Background

Dupilumab, a human anti-interleukin-4 receptor α monoclonal antibody, significantly improved clinical signs and symptoms in adults with moderate-to-severe atopic dermatitis (AD) in a randomized, double-blind, placebo-controlled, phase 2a trial.

Objectives

We 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.

Methods

Patients were randomized to 300 mg weekly subcutaneous dupilumab or placebo for 12 weeks (NCT01548404). The QoL Index for AD (QoLIAD) score (exploratory outcome) and its correlation with efficacy outcomes (Eczema Area and Severity Index [EASI; primary endpoint], 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 AD.

Results

Mean QoLIAD scores at baseline (± standard error [SE]) were 13.3 (±1.34) and 11.3 (±1.09) for the placebo and dupilumab group, respectively. Dupilumab significantly improved QoLIAD score after 12 weeks of treatment vs. placebo (mean percent change from baseline in QoLIAD score [±SE]: −64.0 [±6.91] vs. –11.1 [±9.31]). Least squares mean % difference from baseline vs. placebo in QoLIAD score (±SE) was −52.0 (±11.43; P<0.0001). QoLIAD scores significantly correlated with changes in efficacy outcomes, including EASI (r=0.4355), 5-dimensional pruritus (r=0.4937), pruritus NRS (r=0.4064), total SCORAD (r=0.5559), and SCORAD VAS scores for sleep (r=0.4681) and pruritus (r=0.5400); all P<0.05.

Conclusions

Dupilumab improved QoLIAD scores in adults with AD and was significantly associated with improvements in study outcomes

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