Dupilumab effective in adults with moderate to severe atopic dermatitis: JAMA

A recent trial by Lisa Beck and team found that continued long-term dupilumab therapy was safe and effective for individuals with moderate to severe atopic dermatitis (AD). The findings of this study were published in the Journal of American Medical Association.

Atopic dermatitis is a chronic inflammatory skin condition which is marked by recurring eczematous lesions and persistent itching. The patients with moderate to severe AD typically require long-term therapy since this is chronic and recurring. Thereby, this research was set to evaluate the safety and effectiveness of dupilumab therapy in persons with moderate to severe AD for up to five years.

The LIBERTY AD open-label extension research lasted from September 2013 to June 2022 at 550 locations across 28 countries. The research included adult patients with moderate to severe AD who had previously participated in dupilumab clinical trials. The regimen was changed to dupilumab, 300 mg, weekly (600-mg loading dose) in June 2014 based on a dosage-ranging study, and then again in November 2019 to dupilumab, 300 mg, every two weeks to comply with regulatory regimen approval.

These data were evaluated between August 2022 and February 2023 where the key outcomes included the incidence and rate of treatment-emergent adverse events (TEAEs). The secondary end points covered the incidence and rate of serious TEAEs and adverse events of special interest, the proportion of patients who achieved an Investigator's Global Assessment (IGA) score of 0 or 1 (clear or nearly clear), and the proportion of patients who improved the Eczema Area and Severity Index (EASI) by 75% or more from the parent study baseline.

This open-label extension trial enrolled and treated a total of 2677 patients, of which 1611 (60.2%) were male, with a mean (SD) age of 39.2 (13.4) years. From this group, 334 patients (12.5%) completed therapy through week 260.

The most prevalent reasons for withdrawal were the regulatory approval of dupilumab in accordance with the research protocol (58.7%), patient withdrawal (18.0%) and adverse events (8.4%).

Worsening AD, Nasopharyngitis, upper respiratory tract infection, conjunctivitis allergic, conjunctivitis, oral herpes, headache and injection-site response were among the most common TEAEs (incidence 5% or more).

By week 260, 220 out of 326 patients (67.5%) had an IGA score of 0 or 1, and 288 out of 324 patients (88.9%) had improved their EASI by 75% or more. At baseline, the mean (SD) EASI grade was 16.39 (14.60) and at the conclusion of the study it was 2.75 (5.62). Overall, the outcome of this study suggests that dupilumab is safe and effective for up to 5 years of therapy for persons with moderate to severe AD.

Reference:

Beck, L. A., Bissonnette, R., Deleuran, M., Nakahara, T., Galus, R., Coleman, A., Gherardi, G., Xiao, J., Dingman, R., Xu, C., Avetisova, E., Dubost-Brama, A., & Shabbir, A. (2024). Dupilumab in Adults With Moderate to Severe Atopic Dermatitis. In JAMA Dermatology. American Medical Association (AMA). https://doi.org/10.1001/jamadermatol.2024.1536