RCT finds tralokinumab effective in adolescents with atopic eczema

25th April 2023

Tralokinumab targets interleukin-13 (IL-13) and appears to be both effective and tolerable in adolescents aged 12-17 with moderate-to-severe atopic eczema.

Adolescent atopic eczema gives rise to a negative impact on patient’s quality of life. There is already good evidence to suggest that IL-13 creates inflammation in atopic eczema.

Tralokinumab specifically neutralises IL-13 and therefore reduces inflammation. Previous work has demonstrated efficacy for the drug adults with moderate-to-severe atopic eczema. However, it remains uncertain whether tralokinumab is effective for adolescents with moderate-to-severe disease.

The current randomised, double-blinded, placebo-controlled enrolled adolescents aged 12-17 years with moderate-to-severe atopic eczema. Individuals received monotherapy with tralokinumab either 150 mg or 300 mg, or matching placebo, every two weeks for 16 weeks.

The primary endpoint was an Investigator’s Global Assessment (IGA) score of 0 or 1 (clear/almost clear) at week 16.

An alternative primary endpoint was a 75% or higher improvement in EASI (i.e. an EASI 75). Those meeting the primary outcome at week 16 continued in a maintenance phase until week 52.

Tralokinumab and atopic eczema outcomes

There were 289 participants with a median age of 15 years (51.6% male). Some 97 participants were given 150 mg of tralokinumab, and 98 were assigned to 300 mg of tralokinumab.

At week 16, significantly more patients receiving tralokinumab had an IGA of 0 or 1 than placebo: 21.4% (150 mg) and 17.5% (300 mg) vs 4.3% for placebo (p < 0.01 and p = 0.002 respectively).

In addition, 28.6% of tralokinumab 150 mg patients had an EASI75, as did 27.8% of the tralokinumab 300 mg group. Only 6.4% of those in the placebo arm achieved EASI75.

Larger improvements were seen for both doses of the drug compared to placebo for itch and quality of life scores.

At week 52, 62.9% of all tralokinumab participants maintained their IGA score of 0 or 1 with doses administered either every two or four weeks. The drug was tolerable with a similar proportion of adverse events in all three arms.

The researchers concluded that tralokinumab therefore appears effective for adolescents with moderate-to-severe atopic eczema.

Citation
Paller AS 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.