New research on the long-term safety and efficacy of dupilumab in adults with moderate to severe atopic dermatitis (AD) indicates that dupilumab was safe and effective in the long-term treatment of the condition.
The open-label extension study was conducted over a period of 5 years in 28 countries and included 2,677 adult participants who had previously participated in dupilumab clinical trials. Participants were administered the drug subcutaneously with adjustments to dosage during the study period based on regulatory changes.
The primary outcome of interest was the incidence rate of treatment-emergent adverse events (TEAEs). Secondary measures included serious TEAEs, adverse events of special interest, and patient improvements in the Investigator’s Global Assessment (IGA) and Eczema Area and Severity Index (EASI).
According to the study results, dupilumab was well-tolerated with no new safety signals. By week 260, 67.5% of patients achieved an IGA score of 0 or 1, and 88.9% saw at least a 75% improvement in EASI scores. Mean EASI scores declined significantly, from 16.39 at baseline to 2.75, and TEAEs were either stable or decreased over time. Common events included nasopharyngitis, worsening AD, upper respiratory tract infection, conjunctivitis, headache, oral herpes, and injection-site reactions.
"These data support the safety and efficacy of dupilumab treatment for up to 5 years in adults with moderate to severe atopic dermatitis, confirming previous data demonstrating sustained efficacy with an acceptable safety profile," the authors wrote.
Source: Beck L, et al. JAMA Dermatology. 2024. Doi:10.1001/jamadermatol.2024.1536