Dupilumab has been shown to maintain safety and sustained efficacy in treating moderate to severe atopic dermatitis, with no new safety concerns reported over a 5-year period, according to a recent study.

In the 5-year open-label extension LIBERTY AD study, published in JAMA Dermatology, researchers assessed the long-term safety and efficacy of dupilumab in adult patients with moderate to severe atopic dermatitis. Conducted across 550 sites in 28 countries, the study included 2,677 patients who had previously enrolled in dupilumab trials. Among these patients, 60.2% (n = 1,611) of them were male, with a mean age of 39.2 (standard deviation = 13.4) years.

The study, conducted from September 2013 to June 2022, initially administered 200 mg of dupilumab weekly to patients, later adjusted to 300 mg weekly and then every 2 weeks, according to regulatory guidelines. The primary objectives of the study were to evaluate the incidence and frequency of treatment-emergent adverse events, with additional focus on serious adverse events and measures of atopic dermatitis severity—including the Investigator's Global Assessment (IGA) and the Eczema Area and Severity Index (EASI).

A total of 12.5% (n = 334) of the patients completed treatment up to week 260, with the primary reasons for withdrawal being regulatory approval of dupilumab (58.7%, n = 810/1,380), patient withdrawal (18.0%, n = 248), and adverse events (8.4%, n = 116). The findings indicated that dupilumab was well tolerated—showing no new safety issues—and demonstrated sustained efficacy in improving atopic dermatitis symptoms and quality of life.

The researchers demonstrated that 67.5% of the patients achieved an IGA score of 0 or 1 at week 260, indicating clear or almost clear skin. Additionally, 88.9% of them achieved at least a 75% improvement in EASI scores. The exposure-adjusted treatment-emergent adverse event incidence rate was 252.48 events per 100 patient-years, and common adverse events—such as nasopharyngitis (28.9%), worsening atopic dermatitis (16.7%), upper respiratory tract infections (13.6%), conjunctivitis (10.3%), conjunctivitis allergic (9.0%), headaches (8.1%), oral herpes (7.5%), and injection-site reactions (5.2%)—were stable or decreased over time.

The findings supported the long-term use of dupilumab as a treatment option in adult patients with moderate to severe atopic dermatitis. The study data indicated that dupilumab may be safe and effective for up to 5 years, consistent with previous findings of sustained efficacy and an acceptable safety profile.

Full disclosures can be found in the original study.