Tralokinumab improves symptoms and quality of life in adolescents with moderate-to-severe AD

In the phase 3 ECZTRA 6 trial, tralokinumab was highly effective in reducing clinical signs and symptoms of atopic dermatitis (AD) among adolescent patients with mild‑to‑moderate disease. The 16-week results further showed greater improvement in quality of life compared with placebo.

In previous phase 3 trials, the fully human, monoclonal antibody tralokinumab demonstrated efficacy and safety in the treatment of AD in adult patients. The current randomised, controlled, 52-week, phase 3 ECZTRA 6 trial (NCT03526861) evaluated the efficacy and safety of tralokinumab in adolescents (aged 12–17 years) with moderate-to-severe AD [1].

The participants were randomised 1:1:1 to 150 mg (n=98) or 300 mg (n=97) every 2 weeks versus placebo (n=94) The coprimary endpoints were an Investigator Global Assessment (IGA) score of 0/1 (i.e. clear/almost clear skin), and a ≥75% improvement in Eczema Area and Severity Index (i.e. EASI75). Secondary endpoints included a ≥4-point improvement in adolescent pruritus Numerical Rating Scale (NRS) and change from baseline in SCORing AD (SCORAD) and Children’s Dermatology Life Quality Index (CDLQI); adverse events (AEs) were monitored throughout.

After the initial treatment period of 16 weeks, the primary endpoint was met by 21.4% of patients in the 150 mg-tralokinumab group (P<0.001) and 17.5% in the 300 mg-tralokinumab group (P=0.002) achieving IGA 0/1 compared with 4.3% in the placebo group. Moreover, 28.6% of patients in the 150 mg-tralokinumab group (P<0.001) and 27.8% in the 300 mg-tralokinumab group (P=0.001) achieved an EASI75 response compared with 6.4% in the placebo group.

The secondary endpoint of a ≥4-point improvement in adolescent pruritus NRS was attained by 23.2% of patients in the 150 mg-tralokinumab group and 25.0% in the 300 mg-tralokinumab group versus 3.3% in the placebo group. Additionally, both tralokinumab groups achieved greater improvements from baseline versus placebo in SCORAD (-27.5 and -29.1, respectively vs -9.5) and CDLQI (-6.1 and -6.7 vs -4.1). Incidence of AEs in the 150 mg- and 300 mg-tralokinumab groups, respectively, compared with placebo was 67.3% and 64.9% vs 61.7%.

Therefore, after 16 weeks, tralokinumab 150 mg and 300 mg every 2 weeks significantly reduced clinical signs and symptoms of AD versus placebo in adolescents with moderate-to-severe AD. Tralokinumab was well tolerated, with efficacy and safety profiles comparable to those observed in phase 3 adult tralokinumab trials. Based on these results, tralokinumab was approved by the European Commission for the treatment of moderate-to-severe AD in adolescents.

Paller A, et al. Efficacy and safety of tralokinumab in adolescents with moderate-to-severe atopic dermatitis: results of the phase 3 ECZTRA 6 trial. SKIN The Journal of Cutaneous Medicine 2022;6(2):s29.

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