Twice-weekly Enstilar effective maintenance for psoriasis
Twice-weekly Enstilar Foam was safe and effective as a maintenance treatment for plaque psoriasis, according to a study presented at the American Academy of Dermatology virtual meeting.
The long-term, vehicle-controlled, double-blind, phase 3 PSO-LONG trial compared twice-weekly Enstilar foam (calcipotriene and betamethasone dipropionate, LEO Pharma) to vehicle in patients who had completed a 4-week open label phase of daily Enstilar foam use.
“The regimen that was designed is one that has been used, but never studied in a placebo-controlled trial for a year-long period,” Mark Lebwohl, MD, the study’s principal investigator and Waldman Chair of Dermatology at the Icahn School of Medicine at Mount Sinai, told Healio.
Out of 650 total patients, 521 achieved treatment success in the first month and were moved on to the long-term trial, with 251 completing the study.
The median time for relapse for patients in the trial’s active arm was 56 days, compared to 30 days for the vehicle arm, while the rate of relapse over one year was 46% lower in the treatment arm than in the control arm (P < .001), according to a press release from LEO Pharma.
The number of days before 75% of subjects experienced relapse was 169 for those in the treatment arm and 57 for those in the vehicle arm, Lebwohl said.
“It was a dramatic improvement in the increase in relapse-free time,” he added.
Serious adverse events per 100 patient-years was 8.3 in the treatment arm and 7.9 in the vehicle arm.
“Until now, no one knew what to do once the period of treatment approved in the package insert ran out,” Lebwohl said. “We now have a proven regimen that has been tested for a year to keep psoriasis away.”