Atopic dermatitis symptoms, severity improve with tralokinumab plus corticosteroids
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Patients with moderate to severe atopic dermatitis experienced improvement in symptoms when treated with tralokinumab plus topical corticosteroids, according to a study presented at the Winter Clinical Dermatology Conference.
“These patients are miserable because they itch, and itch is about the worst feeling you can have,” study author Boni E. Elewski, MD, of the department of dermatology at the University of Alabama at Birmingham, told Healio. “It’s a horrible condition. Fortunately, in the last few years, there are drugs looking to stop the itch cascade.”
The phase 3 ECZTRA 3 study included 380 patients with atopic dermatitis randomly assigned 2:1 to receive subcutaneous tralokinumab 300 mg (Leo Pharma) every 2 weeks plus topical corticosteroids as needed or placebo every 2 weeks plus topical corticosteroids as needed for 16 weeks.
A fully human immunoglobulin G4 monoclonal antibody, tralokinumab binds to the IL-13 cytokine, preventing interaction with the IL-13 receptor, a key driver of atopic dermatitis inflammation and skin barrier dysfunction, according to the study.
In the U.S. cohort, which was more racially diverse compared with the full study population, 72 patients were in the study group, while 28 were in the placebo group. Of these, 53% were white, 29% were Black or of African descent, and 12% were Asian.
“Patients of different ethnicities respond differently to treatment, and it’s important to gather data on that,” Elewski said.
In the U.S. cohort, 40.8% of patients in the study group achieved Investigator’s Global Assessment score of 0 or 1 (clear or almost) compared with 10.7% of those in the placebo group (P < .05) at week 16. Eczema Area and Severity Index-75 was achieved in 56.3% of the study group compared with 21.4% of those in the placebo group (P < .01).
“Treatment with tralokinumab plus [topical corticosteroids] as needed allowed U.S. patients with moderate to severe atopic dermatitis to achieve and maintain improvements in disease severity compared to placebo plus [topical corticosteroids] and was well tolerated,” the authors wrote.
Adverse events in the study group were mild or moderate, and the drug was well tolerated in the U.S. population.
“We have a novel drug in development that offers help to patients with atopic dermatitis,” Elewski said. “It’s safe and effective, and it appears to work in our U.S. population, which includes a diverse group. “