Tralokinumab Efficacy, Tolerability in Adolescents With AD Evaluated

Tralokinumab is a efficacious and well-tolerated treatment for adolescents living with moderate to severe atopic dermatitis, according to study results published in JAMA Dermatology.¹

Currently, there are only a limited number of safe and effective long-term treatments for adolescents with moderate to severe AD available. Therefore, researchers sought to evaluate the safety and efficacy of tralokinumab monotherapy, an interleukin (IL)-13–targeted treatment, in this patient population.

Participants took part in ECZTRA 6 (NCT03526861), a 52-week, randomized, double-blind, placebo-controlled, phase 3 clinical trial that took place between July 2018 and March 2021 in 10 countries. Patients were aged 12 to 17 and had moderate to severe AD. They were randomly assigned 1:1:1 to receive either tralokinumab 150 mg, tralokinumab 300 mg, or placebo every 2 weeks for a 16-week period. Those who achieved an Investigators Global Assessment score of 0 or 1 (clear or almost clear) and/or a 75% or higher improvement in Eczema Area and Severity Index (EASI 75) at week 16—without the use of rescue medication—received maintenance treatment. All other participants were switched to open-label tralokinumab 300 mg therapy administered every 2 weeks.

Key secondary endpoints were a reduction in Adolescent Worst Pruritis Numeric Rating Scale of 4 or more, a change in SCORing AD, and a change in Children’s Dermatology Life Quality Index from baseline to week 16.

A total of 301 patients were randomly assigned to 1 of the 3 treatment groups; 289 patients were included in the full analysis set (median age, 15 years; 51.6% male). More patients in the tralokinumab groups achieved an IGA score of 0 or 1 at week 16 (21.4% and 17.5%, respectively) compared with placebo (4.3%). More patients in the tralokinumab groups also achieved EASI at week 16 (28.6% and 27.8% vs placebo).

By week 52, efficacy of tralokinumab therapy was maintained without the use of rescue medication in more than 50% of patients who met the primary endpoints at week 16. During the open-label phase, an IGA score of 0 or 1 and EASI 75 were achieved in 33.3% and 57.8% of patients, respectively, at week 52.

In terms of safety, tralokinumab was well tolerated; a majority of adverse events were of mild or moderate severity. During the initial 16-week treatment period, the proportion of patients experiencing 1 or more adverse event were similar across all groups; only 1 treatment-emergent event leading to withdrawal was noted, and it was not considered related to the treatment. The

most frequent adverse events included upper respiratory tract infection, disease exacerbation of atopic dermatitis, injection site reaction, asthma, and headache. Proportions of conjunctivitis—an adverse effect of special interest—were similar between the two treatment arms vs the placebo arm.

Study limitations include the small sample size and the lack of placebo group during the maintenance phase of the study, as well as a lack of an active comparator arm throughout the course of the whole trial.

“These [study results] are consistent with tralokinumab data reported in adults with AD, suggesting that specific targeting of IL-13 with tralokinumab is an effective and well-tolerated long-term treatment option for uncontrolled AD in adolescents,” the researchers concluded.

Reference

1. Paller AS, Flohr C, Cork M, et al. Efficacy and safety of tralokinumab in adolescents with moderate to severe atopic dermatitis. The phase 3 ECZTRA 6 randomized clinical trial. JAMA Dermatol. Published online April 19, 2023. Doi:10.1001/jamadermatol.2023.0627