Every-other-week dose of dupilumab safe, effective over long term

A dosing change from once a week to every other week did not diminish the long-term efficacy or safety of dupilumab in certain patients with atopic dermatitis, according to analysis findings.

“Moderate to severe atopic dermatitis (AD) often requires long-term management with systemic therapies,” Lisa A. Beck, MD, of the department of dermatology at the University of Rochester Medical Center in Rochester, New York, and colleagues wrote.

The interim analysis evaluated the findings of an open-label extension study investigating the safety and efficacy of a change in dosing schedule of dupilumab (Dupixent, Sanofi Genzyme/Regeneron) in this patient population. Participants transitioned from weekly dupilumab 300 mg to a dose every other week.

The analysis included 2,677 enrolled and treated patients. Beck and colleagues reported that 352 of those patients completed efficacy assessments through week 204, while 202 completed follow-up safety assessments through week 244.

Patients complied with treatment at a rate of 98.1%, according to self-reported data.

There were no changes in the safety profile of dupilumab as compared with previous trials. Nasopharyngitis, AD, upper respiratory tract infections, oral herpes, conjunctivitis, injection-site reactions and headaches each occurred in 5% or fewer patients.

Efficacy results from week 204 showed that mean EASI scores were 2.46 (standard deviation [SD], ± 3.98), which the researchers noted was a 91.07% change from parent study baseline.

Pruritis Numerical Rating Scale scores were 2.1 (SD, ± 1.83), which represented a mean percent change from the parent study baseline of 68.74%.

Among 226 patients who transitioned from once-weekly to every-other-week dosing, efficacy of dupilumab was maintained.

The open-label nature of the study, along with the lack of a control arm, may limit the applicability of these findings. In addition, a smaller subset of patients received the approved every-other-week dose.

“These results support dupilumab as continuous long-term treatment for adults with moderate to severe AD,” the researchers concluded.