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

Summary Author: Nancy Shen

    Type of Study    

Original Investigation – Phase 3 RCT

    Brief Summary    

The purpose of this investigation was to evaluate the efficacy and safety of IL-13-targeted
treatment with tralokinumab monotherapy in adolescents with atopic
dermatitis (AD). This was
a 52-week-long, randomized, double-blinded, placebo-controlle
d phase 3 trial held at 72
institutions in 10 countries. The patient populatio
n included adolescents ages 12 to 17 with
moderate to severe AD based on either an Investigator’s Global Assessment (IGA) score >=3 or
an Eczema Area and Severity Index (EASI) >=16. Patients received either tralokinumab (150 or
300 mg) or placebo every 2 weeks for 16 weeks. At 16 weeks, patients found to have an IGA
score of 0 or 1 and/or 75% or higher improvement with EASI at week 16 without rescue
medication received maintenance treatment. Patients that did not meet these criteria at 16
weeks were switched to open-label tralokinumab, receiving 300 mg every two weeks.

    What did they find?    

  • Primary end points measured were proportions of patients achieving IGA score of 0 
    (clear) or 1 (almost clear) at week 16 and/or 75% or higher improvement in EASI (EASI 75) at week 16.

  • Secondary end points measured changes to Adolescent Worst Pruritus Numeric Rating
    Scale, SCORing AD, and Children’s Dermatology Life Quality Index.

  • Two hundred eighty-nine of 301 randomized patients were analyzed at final time stamp.
    A higher proportion of patients receiving tralokinumab 150 mg or 300 mg achieved an
    IGA score of 0 or 1 at week 16 compared to placebo (p <0.001). A higher proportion of
    patients in the tralokinumab group also achieved an EASI 75 without rescue medication
    at week 16 compared to placebo (p <0.001).

  •  Tralokinumab treatment was associated with statistically significant improvements in all
    key secondary end points compared with placebo (itch, sleep, anxiety/depression,
    overall quality of life).

  •  Tralokinumab was well-tolerated with a low rate of adverse effects, and it did not have
    high rates of discontinuation.

    Limitations    

There was a small sample size and a lack of a placebo group in the maintenance phase. There
was also no direct comparison with similar immunotherapeutic treatments and whether it was
more, less, or equally effective as what was already being offered on the market. There was no
mention of cost compared to similar agents.

Main Takeaway

Tralokinumab, a monoclonal antibody directed against IL-13, is a well-
tolerated and efficacious agent in treating moderate to severe atopic dermatitis in adolescents.

Reference: 

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. 2023;159(6):596–605. doi:10.1001/jamadermatol.2023.0627

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