Tralokinumab safe and effective in treating atopic dermatitis: JAMA

A new study published in the Journal of American Medical Association suggests that when used to treat adolescents with moderate to severe atopic dermatitis (AD), tralokinumab was effective and well tolerated.

Up to 20% of kids have atopic dermatitis, which often starts in early infancy. Recurrent eczematous skin lesions and severe itching are its defining features, and it can also cause anxiety, despair, and a worse quality of life. Adolescents with AD experience extra challenges, such as psychological effects on familial, social, and academic functioning. In order to assess the effectiveness and safety of tralokinumab monotherapy, an interleukin-13-targeted medication, in AD adolescents, Amy Paller and colleagues undertook this research.

The double-blinded, randomized, placebo-controlled, 52-week phase 3 ECZTRA 6 study took place at 72 facilities in 10 nations in North America, Europe, Asia, and Australia from July 17, 2018, to March 16, 2021. Patients with moderate to severe AD between the ages of 12 and 17 were enrolled. Every two weeks for 16 weeks, patients were randomly assigned (1:1:1) to receive tralokinumab (150 or 300 mg) or a placebo. Patients who had an IGA score of 0 (clear) or 1 (nearly clear) and/or an improvement in EASI score of 75% or greater (EASI 75) at week 16 without rescue medicine got maintenance therapy; other patients went to open-label tralokinumab, 300 mg every two weeks. Achieving an EASI score of 75 or receiving an IGA score of 0 or 1 were the main end points in week 16.

The key findings of this study were:

1. 301 patients were randomly assigned, and 289 made up the whole analytic set.

2. In comparison to placebo, more patients receiving tralokinumab, 150 mg and 300 mg, were able to reach an IGA score of 0 or 1 at week 16.

3. At week 16, a greater proportion of patients receiving tralokinumab, 150 mg, and tralokinumab, 300 mg, compared to placebo, reached EASI 75 without rescue.

4. At week 16, adjusted mean changes in SCORing AD with tralokinumab, 150 mg, and tralokinumab, 300 mg, vs placebo, and in Children's Dermatology Life Quality Index with tralokinumab, 150 mg, and tralokinumab, 300 mg, vs placebo, were greater with tralokinumab, 150 mg, and tralokinumab, 300 mg, vs placebo.

5. More than 50% of patients who met the primary end point(s) at week 16 still had tralokinumab effectiveness at week 52 without rescue.

6. At week 52 of the open-label phase, 33.3% of participants achieved an IGA score of 0 or 1, and 57.8% did so for the EASI 75.

7. Through week 52, talokinumab was well tolerated and conjunctivitis episodes did not become more frequent.

Reference:

Paller, A. S., Flohr, C., Cork, M., Bewley, A., Blauvelt, A., Hong, H. C., Imafuku, S., Schuttelaar, M. L. A., Simpson, E. L., Soong, W., Arlert, P., Lophaven, K. W., Kurbasic, A., Soldbro, L., Vest, N. S., & Wollenberg, A. (2023). Efficacy and Safety of Tralokinumab in Adolescents With Moderate to Severe Atopic Dermatitis. In JAMA Dermatology. American Medical Association (AMA). https://doi.org/10.1001/jamadermatol.2023.0627