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25th April 2023
Adolescent atopic eczema (AE) gives rise to a negative impact on patient’s quality of life. There is already good evidence to suggest that interleukin-13 (IL-13) creates inflammation in AE. Tralokinumab (TK) specifically neutralises IL-13 and therefore reduces inflammation. Previous work has demonstrated efficacy for the drug adults with moderate to severe AE. However, it remains uncertain whether TK is effective for adolescents with moderate to severe disease.
The current randomised, double-blinded, placebo-controlled enrolled adolescents (12 – 17 years) with moderate to severe AE. Individuals received monotherapy with TK either 150 or 300mg 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 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) and of whom, 97 and 98 had 150 and 300 mg of TK respectively.
At week 16, significantly more patients receiving TK 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 TK 150 mg patients had an EASI75, 27.8% of the TK 300 mg group but only 6.4% of those in the placebo arm. 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 2 or 4 weeks. The drug was tolerable with a similar proportion of adverse events in all three arms.
Tralokinumab therefore appears effective for adolescents with moderate to severe AE.
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