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

摘要

Summary Background Dupilumab, a human antiinterleukin4 receptor alpha monoclonal antibody, significantly improved clinical signs and symptoms in adults with moderatetosevere atopic dermatitis in a randomized, doubleblind, placebocontrolled, phaseII a trial.Objectives We evaluate healthrelated quality of life (HRQ oL) and correlation ofHRQ oL with secondary clinical and patientreported 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 (trial registration:NCT 01548404). 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;SCOR ing Atopic Dermatitis (SCORAD ),SCORAD visual analogue scale (VAS ) scores for sleep and pruritus, pruritus numerical rating scale (NRS ) and 5dimensional pruritus] were assessed in 64 adults with moderatetosevere atopic dermatitis.Results Mean QoLIAD scores at baseline ?standard error (SE ) were 13? ?1?4 and 11? ?1?9 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 : 64? ?6?1 vs. 11? ?9?1). Least squares mean % difference from baseline vs. placebo in QoLIAD score ?SE was 52? ?11?3,P 0?01). QoLIAD scores significantly correlated with changes in efficacy outcomes, includingEASI (r = 0?4), 5dimensional pruritus (r = 0?9), pruritusNRS (r = 0?1), totalSCORAD (r = 0?6) andSCORAD VAS scores for sleep (r = 0?7) and pruritus (r = 0?4); allP 0?5.Conclusions Dupilumab improved QoLIAD scores in adults with atopic dermatitis and was significantly associated with improvements in study outcomes.