Health-related quality of life with tralokinumab in moderate-to-severe atopic dermatitis

BackgroundAtopic dermatitis (AD) is associated with a substantial burden on quality of life (QoL).ObjectiveTo evaluate the effects tralokinumab health-related QoL in patients moderate-to-severe AD using patient-reported outcomes.MethodsThis was phase 2b, randomized, double-blind, placebo-controlled, dose-ranging study adults AD. The received subcutaneous or placebo (1:1:1:1) every 2 weeks for 12 and class 3 topical corticosteroid cream ointment at least once daily from run-in to end follow-up. Patient-reported outcome points were change baseline week Dermatology Life Quality Index (dermatology index (DLQI); prespecified secondary objective), Short Form 36 Health Survey (SF-36) version 2, sleep interference numeric rating scale score (prespecified exploratory objectives).ResultsA total 204 randomized (n = 51) (45 mg, n 50; 150 51; 300 52). Tralokinumab mg improved vs (placebo-adjusted mean change, −3.51 [95% confidence interval, −6.00 −1.02]). At 12, both mental component summary (4.23 [0.98-7.47]) physical (4.26 [1.83-6.69]) all 8 domains treated placebo. Sleep doses placebo.ConclusionTralokinumab atopic dermatitis, providing further evidence value targeting interleukin-13 such patients.Trial RegistrationClinicalTrials.gov identifier: NCT02347176; https://clinicaltrials.gov/ct2/show/NCT02347176.