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In this interview, Eichenfield discussed the recent pooled analysis from two phase 3 studies looking at once-daily, topical roflumilast for patients 6 and older with eczema.
In his latest interview with the HCPLive editorial team, Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego, spoke on his team’s recent pooled analyses of the 2 pivotal phase 3 INTEGUMENT-1 and INTEGUMENT-2 studies.
This new analysis of the 2 trials showed that 91.5% of atopic dermatitis (AD) patients had improvement in Eczema Area and Severity Index (EASI) scores following 4-weeks of treatment with once-daily, topical roflumilast cream, 0.15%.1
“It was (patients) 6 years up through to adulthood, and single-day application,” Eichenfield noted. “Four-week time period. So it’s a quick time period, because they think were comfortable. They showed differentiation from vehicle in that short timeframe.”
Eichenfield explained that this 4-week timeframe was enough to notice a 50% EASI score (EASI-50) reduction for 69.2% of participants treated versus 44.4% in the vehicle group. At the same endpoint, the investigators had found there was a 75% EASI score (EASI-75) reduction seen in 44.5% of the treatment arm compared to 21.2% with vehicle.
“I think that, rounding out our experience with this drug, we'll see what happens in terms of the speed of the approval,” Eichenfield said. “But hopefully this drug will be approved. And we'll have something else nonsteroidal in our armamentarium.”
Later, Eichenfiled was asked about whether there were any potential limitations or challenges identified during both trials, as well as how they might influence the generalizability and application of the findings.
“One of the limitations in the roflumilast studies, they only went for 4 weeks in this part of the study, though there was an open label extension study,” Eichenfield said. “I think that we have so many different drugs, and they're studied in different ways, ruxolitinib was studied for 8 weeks BID, tapinarof for 8 weeks quaque die. So you have these mixtures. The advantage of quaque die in studies is that it's really practical in clinical practices.”
To learn more about the findings from Eichenfield’s team, view the full discussion above.
The quotes contained in this summary were edited for the purposes of clarity.