Tralokinumab a ‘game changer’ in adolescent atopic dermatitis treatment
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Tralokinumab significantly improved atopic dermatitis in adolescents, according to phase 3 trial results presented at the 2021 Fall Clinical Dermatology Conference.
A high-affinity, human monoclonal antibody that binds and inhibits interleukin-13 (IL-13), tralokinumab has previously shown positive results in adult patients with AD.
“These studies that show the efficacy of tralokinumab really position interleukin-13 as the key molecule for driving atopic dermatitis,” Amy S. Paller, MD, chair of the department of dermatology at the Feinberg School of Medicine at Northwestern University in Chicago and the international coordinating investigator for the study, told Healio. “Atopic dermatitis is such a common disorder for children and adolescents and it’s great to have this option for our adolescent patients.”
The randomized, double-blind, placebo-controlled, parallel-group ECZTRA 6 trial included 301 adolescent patients aged 12 to 17 years.
Patients were randomly assigned to receive tralokinumab 150 mg or 300 mg or placebo subcutaneously every two weeks for 16 weeks. A loading dose of 300 mg or 600 mg preceded the tralokinumab treatments.
A clinical response, defined as an Investigator Global Assessment score of 0/1, was experienced by 21.4% of those in the tralokinumab 150 mg group (P < .001) and 17.5% of the 300 mg treatment group (P = .002). This compared with 4.3% of the placebo group.
A 75% improvement in Eczema Area Severity Index (EASI75) was reported in 28.6% of the 150 mg treatment group (P < .001) and 27.8% of the 300 mg group (P = .001), compared with 6.4% of the placebo group.
Secondary endpoints such as an improvement in AD severity and a 4-point or greater improvement in adolescent weekly average worse daily pruritus NRS score and quality of life improvement were all met in the tralokinumab groups, according to a LEO Pharma press release.
If approved by the FDA, tralokinumab will be the second biologic available for AD treatment.
“The adolescents that I’ve been able to treat with a biologic for atopic dermatitis have really had a change in their lives. They’ve developed confidence, they’ve been able to participate in sports and social activities that were impossible when their moderate to severe atopic dermatitis was controlling their lives,” Paller said. “It truly is a game changer. Adolescence is such an important time for development. ... so this is a critical age for having good options therapeutically and it’s great to have another biologic.”