Efficacy and Safety of Tralokinumab in Adolescents With Moderate to Severe Atopic Dermatitis

• DOI: 10.1001/jamadermatol.2023.0627
• Publication Date: 2023-04-19T15:02:20Z
• Authors: Amy S. Paller; Carsten Flohr; Michael Cork; Anthony Bewley; Andrew Blauvelt; H. Chih-ho Hong; Shinichi Imafuku; Marie L. A. Schut...; Eric L. Simpson; Weily Soong; Petra Arlert; Katja Wendicke Lo...; Azra Kurbasic; Lise Soldbro; Natacha Strange Vest; Andreas Wollenberg
• Keywords: Clinical endpoint

Safe and effective long-term treatments for adolescents with moderate to severe atopic dermatitis (AD) are limited.To evaluate the efficacy safety of interleukin-13-targeted treatment tralokinumab monotherapy in AD.The 52-week, randomized, double-blinded, placebo-controlled, phase 3 ECZTRA 6 trial was conducted from July 17, 2018, through March 16, 2021, at 72 centers across 10 countries North America, Europe, Asia, Australia. Enrolled patients were 12 17 years old AD (Investigator's Global Assessment [IGA] score ≥3; Eczema Area Severity Index [EASI] ≥16).Patients randomized (1:1:1) (150 or 300 mg) placebo every 2 weeks 16 weeks. Patients an IGA 0 (clear) 1 (almost clear) and/or 75% higher improvement EASI (EASI 75) week without rescue medication received maintenance treatment; other switched open-label tralokinumab, mg, weeks.Primary end points achieving 75. Key secondary a reduction Adolescent Worst Pruritus Numeric Rating Scale 4 more, change SCORing AD, Children's Dermatology Life Quality baseline 16. Safety number adverse events serious events.Of 301 289 comprised full analysis set (median [IQR] age, 15.0 [13.0-16.0] years; 149 [51.6%] male). More receiving 150 (n = 98), mg 97), achieved (21 [21.4%] [17.5%], respectively) vs 94; [4.3%]) (adjusted difference, 17.5% [95% CI, 8.4%-26.6%]; P < .001 13.8% 5.3%-22.3%]; .002, respectively). (28 [28.6%]), (27 [27.8%]) (6 [6.4%]) 75 22.5% 12.4%-32.6%]; 22.0% 12.0%-32.0%]; .001, Proportions more greater (23.2%), (25.0%), (3.3%), adjusted mean changes (-27.5), (-29.1), (-9.5) (-6.1), (-6.7), (-4.1) At 52, maintained than 50% meeting primary point(s) In phase, 33.3% 57.8%, respectively, 52. Tralokinumab well tolerated, frequency conjunctivitis increasing 52.In this clinical trial, efficacious supporting its value treating AD.ClinicalTrials.gov Identifier: NCT03526861.