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- Title
Efficacy and Safety of Tralokinumab in Adolescents With Moderate to Severe Atopic Dermatitis: The Phase 3 ECZTRA 6 Randomized Clinical Trial.
- Authors
Paller, Amy S.; Flohr, Carsten; Cork, Michael; Bewley, Anthony; Blauvelt, Andrew; Hong, H. Chih-ho; Imafuku, Shinichi; Schuttelaar, Marie L. A.; Simpson, Eric L.; Soong, Weily; Arlert, Petra; Lophaven, Katja Wendicke; Kurbasic, Azra; Soldbro, Lise; Vest, Natacha Strange; Wollenberg, Andreas
- Abstract
This randomized clinical trial evaluates the efficacy and safety of interleukin-13–targeted treatment with tralokinumab monotherapy in adolescents with atopic dermatitis. Key Points: Question: What is the efficacy and safety of targeted interleukin-13 treatment with tralokinumab monotherapy in adolescents with moderate to severe atopic dermatitis? Findings: In this randomized clinical trial of 289 patients aged 12 to 17 years, a statistically significant higher number of patients treated with tralokinumab vs placebo achieved an Investigator's Global Assessment score of 0 (clear) or 1 (almost clear) and 75% or more improvement in the Eczema Area and Severity Index at week 16. No new safety signals were identified, and there was a low frequency of conjunctivitis through 52 weeks. Meaning: This trial showed that interleukin-13–targeted treatment with tralokinumab was efficacious and well tolerated in adolescents with moderate to severe atopic dermatitis, suggesting that it is a valuable treatment option in this age group. Importance: Safe and effective long-term treatments for adolescents with moderate to severe atopic dermatitis (AD) are limited. Objective: To evaluate the efficacy and safety of interleukin-13–targeted treatment with tralokinumab monotherapy in adolescents with AD. Design, Setting, and Participants: 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 in North America, Europe, Asia, and Australia. Enrolled patients were 12 to 17 years old with moderate to severe AD (Investigator's Global Assessment [IGA] score ≥3; Eczema Area and Severity Index [EASI] ≥16). Interventions: Patients were randomized (1:1:1) to tralokinumab (150 or 300 mg) or placebo every 2 weeks for 16 weeks. Patients with an IGA score of 0 (clear) or 1 (almost clear) and/or 75% or higher improvement in EASI (EASI 75) at week 16 without rescue medication received maintenance treatment; other patients switched to open-label tralokinumab, 300 mg, every 2 weeks. Main Outcomes and Measures: Primary end points at week 16 were an IGA score of 0 or 1 and/or achieving EASI 75. Key secondary end points were a reduction of Adolescent Worst Pruritus Numeric Rating Scale of 4 or more, change in SCORing AD, and change in Children's Dermatology Life Quality Index from baseline to week 16. Safety end points were the number of adverse events and serious adverse events. Results: Of 301 patients randomized, 289 comprised the full analysis set (median [IQR] age, 15.0 [13.0-16.0] years; 149 [51.6%] male). More patients receiving tralokinumab, 150 mg, (n = 98), and tralokinumab, 300 mg (n = 97), achieved an IGA score of 0 or 1 without rescue medication at week 16 (21 [21.4%] and 17 [17.5%], respectively) vs placebo (n = 94; 4 [4.3%]) (adjusted difference, 17.5% [95% CI, 8.4%-26.6%]; P <.001 and 13.8% [95% CI, 5.3%-22.3%]; P =.002, respectively). More patients receiving tralokinumab, 150 mg (28 [28.6%]), and tralokinumab, 300 mg, (27 [27.8%]) vs placebo (6 [6.4%]) achieved EASI 75 without rescue at week 16 (adjusted difference, 22.5% [95% CI, 12.4%-32.6%]; P <.001 and 22.0% [95% CI, 12.0%-32.0%]; P <.001, respectively). Proportions of patients with Adolescent Worst Pruritus Numeric Rating Scale reduction of 4 or more from baseline were greater with tralokinumab, 150 mg (23.2%), and tralokinumab, 300 (25.0%), vs placebo (3.3%), and adjusted mean changes were greater in SCORing AD with tralokinumab, 150 mg (–27.5), and tralokinumab, 300 mg (–29.1), vs placebo (–9.5) and in Children's Dermatology Life Quality Index with tralokinumab, 150 mg (–6.1), and tralokinumab, 300 mg (–6.7), vs placebo (–4.1) at week 16. At week 52, tralokinumab efficacy was maintained without rescue in more than 50% of patients meeting primary end point(s) at week 16. In the open-label phase, IGA score of 0 or 1 and EASI 75 were achieved in 33.3% and 57.8%, respectively, at week 52. Tralokinumab was well tolerated, without frequency of conjunctivitis increasing through week 52. Conclusions and Relevance: In this randomized clinical trial, tralokinumab was efficacious and well tolerated, supporting its value for treating adolescents with moderate to severe AD. Trial Registration: ClinicalTrials.gov Identifier: NCT03526861
- Publication
JAMA Dermatology, 2023, Vol 159, Issue 6, p596
- ISSN
2168-6068
- Publication type
Article
- DOI
10.1001/jamadermatol.2023.0627