Study: Dupilumab Shows Acceptable Long-term Safety Profile for AD

October 27, 2023

The safety profile of dupilumab is similar to those observed in shorter-term studies, according to data presented at SDPA Annual Fall Dermatology Conference.

Results from a five-year analysis suggested that long-term dupilumab for the treatment of moderate-to-severe atopic dermatitis (AD) in adults is safe and consistent with other placebo-controlled trials.

The analysis was part of a long-term survey of patients from the LIBERTY AD OLE study, a phase 3 multicenter open-label extension trial. Researchers for the trial administered 300mg of dupilumab weekly to an adult study population with moderate-to-severe AD (226 of the patients transferred to 300mg every 2 weeks to align with approved dosages). Because the original study lacked a control arm, the study researchers designed a 52-week safety analysis called LIBERTY AD CHRONOS to provide a comparison. The prior data set for the open-label extension study suggested that dupilumab was safe out to 204 weeks (approximately 4 years); the current analysis sought to assess the data out to 5 years (the end of the study).

The study population (N=2,677) was 60.2% male and 72.3% white, with a mean age of 39.2 and mean AD duration of 29.9 years. Scores on the Mean Eczema Areas and Severity index, the Investigator’s Global Assessment, and the Peak Pruritus Numerical Rating Scale were 16.4, 2.7, and 5.0, respectively. A total of 1,297 patients completed the study’s entire 5-year duration. A total of 1,380 patients withdrew from the study, with 4% due to adverse events.

According to the results, the rates of treatment-emergent adverse events (TEAEs) experienced by patients in the initial CHRONOS data set were similar to those in the final data set. There was a total of 14,717 adverse events in the final data set at 5 years, with 85.0% of patients experiencing more than one adverse event during the study period. This was comparable to the 83.5% reported in the one-year CHRONOS population. Some of the most common reported TEAEs were nasopharyngitis, conjunctivitis, AD, upper respiratory tract infection, headache, oral herpes, and injection site reactions. In patients with conjunctivitis, the overall number of events recovered from or resolved were similar between study groups (87.7% at 5 years vs. 89.0% at 1 year).

“Exposure-adjusted incidence rates of TEAEs overall did not increase over time and were lower than previously reported in the 3- and 4-year analyses of this open-label extension trial and an earlier 52-week placebo-controlled trial,” the authors wrote in their poster, presented at the SDPA 21st Annual Fall Dermatology Conference in Nashville. “In patients with narrow customized MedDRA query conjunctivitis TEAEs, for 95% of patients with at least events the most severe event was assessed as mild or moderate, more than 85% of events were reported as recovered/resolved, and the majority of events were not treatment-limiting.”

Reference

Beck L, Bissonnette R, Deleuran M, Nakahara T, et al. Safety of long-term dupilumab treatment in adults with moderate-top-severe atopic dermatitis: Results from a 5-year open-label extension trial. Poster presentation. Presented at: SDPA 21st Annual Fall Dermatology Conference in Nashville, TN; October 25-29, 2023.

Disclosures

The study was sponsored by Sanofi and Regeneron Pharmaceuticals. The study researchers reported having been/are currently employees of, investigators/PIs for, or having received consulting fees/honoraria from, grants/research funding from, or are shareholders/stock owners in Sanofi and/or Regeneron.

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