Adult patients with moderate to severe atopic dermatitis (AD) who are treated with the interleukin-4 receptor alpha monoclonal antibody dupilumab demonstrate improvements in quality of life (QoL) scores, according to results of a randomized, double-blind, multicenter, placebo-controlled, phase 2a trial published in the British Journal of Dermatology.
Patients in the QoL Index for AD (QoLIAD) study subset were randomly assigned to receive either subcutaneous dupilumab 300 mg (n=32) or placebo (n=32) for 12 weeks. Patients who had AD ≥3 years prior to the initial study screening visit were eligible for inclusion in the trial. QoLIAD score was selected as the exploratory end point for the study. The relationship of QoLIAD score with key efficacy outcomes, including the Eczema Area and Severity Index (EASI), SCORing Atopic Dermatitis (SCORAD), SCORAD visual analogue scale scores for sleep and pruritus, pruritus numeric rating scale, and 5-dimensional pruritus, was also assessed.
Mean QoLIAD scores at baseline were 11.3 and 13.3 in the dupilumab and placebo arms, respectively. After 12 weeks of treatment, dupilumab significantly improved QoLIAD scores vs placebo (mean percent change from baseline in QoLIAD score –64.0 with dupilumab vs –11.1 with placebo). Least squares mean percent difference in baseline vs placebo in QoLIAD score was –52.0 (P <.0001)
QoLIAD scores were significantly associated with changes in efficacy outcomes, including EASI (r =.4355), 5-dimensional pruritus (r =.4937), pruritus numeric rating scale (r =.4064), total SCORAD (r =.5559), and SCORAD visual analogue scale scores for sleep (r =.4681) and pruritus (r =.5400; P <.05 for all parameters).
The investigators concluded that treatment with dupilumab demonstrated efficacy and tolerability in adults with moderate to severe AD. Continued assessments of dupilumab as a treatment for adult patients with AD is warranted.
Disclosure: This study was funded by Sanofi and Regeneron Pharmaceuticals, Inc.
Tsianakas A, Luger TA, Radin A. Dupilumab treatment improves quality of life in adult patients with moderate-to-severe atopic dermatitis: results from a randomized, placebo-controlled clinical trial [published online August 27, 2017]. Br J Dermatol. doi: 10.1111/bjd.15905