Long-term dupilumab safety consistent in atopic dermatitis patients
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Weekly dupilumab showed long-term safety and efficacy in atopic dermatitis patients in an open-label extension study presented at the EADV Congress virtual meeting.
“Atopic dermatitis (AD) is a chronic systemic inflammatory disease requiring long-term management,” Andreas Wollenberg, MD, and colleagues wrote in the poster presentation. “However sustained AD treatment with systemic immunosuppressants can be limited due to safety concerns and side effects.”
A previous open-label extension study provided safety and efficacy data of dupilumab for up to 148 weeks of treatment. This study provided interim data for treatment up to 172 weeks.
Adult AD patients who had previously participated in one of the parent studies were enrolled in this long-term extension in which they continued to receive 300 mg of dupilumab weekly. Topical corticosteroids and topical calcineurin inhibitors were permitted as concomitant AD treatments.
Safety end points were compared with results from the LIBERTY AD CHRONOS 52-week trial since the OLE did not have a control arm.
Adverse events leading to treatment discontinuation were reported in 3.6% of the OLE trial participants, 8.3% of the CHRONOS placebo group and 2.9% of the CHRONOS treatment group.
Conjunctivitis was found in 19.7% of the OLE study group, 7.9% of the CHRONOS placebo group and 19.4% of the CHRONOS treatment group.
“Exposure-adjusted incidence rates of [treatment emergent adverse events] were lower than previously reported rates of [adverse events] at 52 weeks and declined over time,” the authors wrote. “Safety data are consistent with the known safety profile of dupilumab observed in controlled studies.”