Long-term Systemic Treatment for Atopic Dermatitis Does Not Raise Infection Risk

Long-term continuous treatment with dupilumab does not increase the overall risk of skin infections in adults with moderate-to-severe atopic dermatitis, according to 4-year study results published in Advances in Therapy.

“Patients with atopic dermatitis have an increased risk of bacterial or viral skin infections, which can cause further serious infections in the entire body,” wrote corresponding author Sonya L. Cyr, PhD, of Regeneron Pharmaceuticals Inc., Tarrytown, New York, and study coauthors. “This study investigated the rates of infections in adults with moderate-to-severe atopic dermatitis after 204 weeks (almost 4 years) of dupilumab treatment.”

The analysis included 2677 patients treated with dupilumab 300 mg weekly or the approved regimen of every 2 weeks. Participants were also allowed to use topical corticosteroids and calcineurin inhibitors. Some 2207 patients completed up to week 52, 1065 patients to week 100, 557 patients to week 148, and 352 patients to week 204. Over the course of the trial, 226 patients switched from weekly to every-2-week dosing.

Consistent with an earlier 3-year analysis of the study, rates of overall infections, serious or severe infections, and infections leading to discontinuation were lower than in a previous 1-year study in adults with atopic dermatitis treated with placebo and topical corticosteroids, researchers reported.

Over 4 years of dupilumab treatment, the cumulative number of patients with total skin infections decreased, according to the study, along with the number of patients with treatment-emergent serious or severe infections, herpes viral infections, and infections not involving herpes virus.

Researchers noted several study limitations, however, including the open-label design, the absence of a placebo arm, decreasing participants after the sponsor opted to close sites following regulatory approval of dupilumab, the difference in weekly and approved every-2-week dosing, and potential participant use of topical corticosteroids and calcineurin inhibitors.

Reference:
Blauvelt A, Wollenberg A, Eichenfield LF, et al. No increased risk of overall infection in adults with moderate-to-severe atopic dermatitis treated for up to 4 years with dupilumab. Adv Ther. Published online November 1, 2022. doi:10.1007/s12325-022-02322-y