A study in Journal of the American Academy of Dermatology reports findings that support dupilumab as a safe long-term treatment in patients with moderate-to-severe atopic dermatitis (AD).
The phase 3, multicenter, open-label extension study examined the long-term treatment of AD with dupilumab in adults (18 years and older) who had previously participated in phase 1, 2 and 3 clinical trials for the drug. The study’s primary endpoint was long-term safety, evaluated as incidence and rate of adverse events (AEs).
A total of 1491 patients from North America, Europe and the Asia-Pacific region participated in the study. Exclusion criteria included AEs related to dupilumab and serious AEs (SAEs) that led to discontinuing dupilumab treatment in previous clinical trials.
Patients received a dupilumab loading dose of 600 mg, then 300 mg weekly, or a loading dose of 400 mg, then 200 mg weekly, before the protocol was amended to 300 mg weekly. Data was collected for up to 76 weeks of treatment. Most patients (98.6%) were at least 80% adherent to treatment.
According to the authors, 4384 AEs were reported. Many patients (70.7%) had at least one AE. Few patients (5%) had one or more SAEs. The most common AEs included conjunctivitis, nasopharyngitis, upper respiratory tract infection, AD and headache. Study drug-related SAEs included Hodgkin disease, prostate cancer, enterocolitis, serum sickness, eczema herpeticum, herpes ophthalmic, epilepsy and eczema. There were no deaths reported.
Deleuran M, Thaçi D, Beck LA, et al. Dupilumab shows long-term safety and efficacy in patients with moderate to severe atopic dermatitis enrolled in a phase 3 open-label extension study. J Am Acad Dermatol. 2019;