A Tsianakas1, T A Luger1, A Radin2. 1. Department of Dermatology, University of Münster, Münster, Germany. 2. Regeneron Pharmaceuticals Inc., Tarrytown, NY, U.S.A.
Abstract
BACKGROUND: Dupilumab, 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. 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 (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. RESULTS:Mean QoLIAD scores at baseline ± standard error (SE) were 13·3 ± 1·34 and 11·3 ± 1·09 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: -64·0 ± 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 < 0·001). QoLIAD scores significantly correlated with changes in efficacy outcomes, including EASI (r = 0·44), 5-dimensional pruritus (r = 0·49), pruritus NRS (r = 0·41), total SCORAD (r = 0·56) and SCORAD VAS scores for sleep (r = 0·47) and pruritus (r = 0·54); all P < 0·05. CONCLUSIONS: Dupilumab improved QoLIAD scores in adults with atopic dermatitis and was significantly associated with improvements in study outcomes.
RCT Entities:
BACKGROUND:Dupilumab, 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. 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 (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. RESULTS: Mean QoLIAD scores at baseline ± standard error (SE) were 13·3 ± 1·34 and 11·3 ± 1·09 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: -64·0 ± 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 < 0·001). QoLIAD scores significantly correlated with changes in efficacy outcomes, including EASI (r = 0·44), 5-dimensional pruritus (r = 0·49), pruritus NRS (r = 0·41), total SCORAD (r = 0·56) and SCORAD VAS scores for sleep (r = 0·47) and pruritus (r = 0·54); all P < 0·05. CONCLUSIONS:Dupilumab improved QoLIAD scores in adults with atopic dermatitis and was significantly associated with improvements in study outcomes.
Authors: Stephanie Ghazal; Zainab Ridha; Kathleen D'Aguanno; David Nassim; Andrea Quaiattini; Elena Netchiporouk; Yves Poulin; Sunil Kalia; Danielle Marcoux; Vincent Piguet; Carolyn Jack Journal: Front Med (Lausanne) Date: 2022-03-09