March 18, 2023
2 min read
Eichenfield LF. Efficacy and safety of roflumilast cream 0.15% in adults and children aged ≥ 6 with mild to moderate atopic dermatitis in two phase 3 trials (INTEGUMENT-1 and INTEGUMENT-2). Presented at: American Academy of Dermatology Annual Meeting; March 17-21, 2023; New Orleans.
Eichenfield reports being a consultant or investigator or having other financial relationships with AbbVie, Almirall, Amryt Pharma, Arcutis Biotherapeutics, ASLAN Pharmaceuticals, Bristol Myers Squibb, Cutera Inc., Dermavant Sciences, Eli Lilly, Elsevier Inc., Forte Biosciences, Galderma Laboratories L.P., Incyte Corporation, Krystal Biotech Inc., LEO Pharma US, Lilly ICOS LLC, Nobelpharma, Ortho Dermatologics, Pfizer Inc., Sanofi/Regeneron, TopMD, TrialSpark Inc., UCB, Verrica Pharmaceuticals Inc. and Wiley-Blackwell.
- Roflumilast cream 0.15% showed rapid itch reduction within 24 hours of first application.
- More than 40% of patients treated with roflumilast cream achieved EASI 75 by week 4.
NEW ORLEANS — Patients with atopic dermatitis experienced a rapid and sustained reduction in itch with topical roflumilast cream treatment, according to phase 3 study results presented at the American Academy of Dermatology Annual Meeting.
“The study supports that roflumilast cream 0.15% showed efficacy, good safety and very good tolerance for children and adults with atopic dermatitis with a daily application, and with rapid response,” Lawrence F. Eichenfield, MD, FAAD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego and one of the study’s lead investigators, told Healio.
Eichenfield presented data from the INTEGUMENT-1 and INTEGUMENT-2 phase 3 clinical trials, two identical, parallel group, double blind, vehicle-controlled trials of roflumilast cream 0.15% in patients aged 6 years and older with moderate to severe atopic dermatitis.
Lawrence F. Eichenfield
A validated IGA score of clear or almost clear, with a 2-grade or more improvement from baseline, was reported in 32% of patients treated with roflumilast compared with 15.2% of those treated with vehicle in the first trial. In the second trial, this endpoint was reached by 28.9% of the treatment group vs. 12% of the vehicle group.
As early as week 2, success rates were observed with 21.2% and 17.7% of the treatment cohorts achieving early success, whereas only 6.4% and 5.3% of the vehicle groups achieved the same.
Worst Itch Numeric Scale success was achieved by more than 30% pf those in the treatment cohorts, with a significant improvement observed in many patients at 24 hours after treatment.
At week 4, EASI 75 was achieved by 43.2% and 42% of those treated with roflumilast compared with 22% and 19.7% of those treated with vehicle. Additionally, significant improvements in EASI 75 were recorded after week 1 in 14% and 13.3% of roflumilast-treated patients, whereas this outcome was only achieved in 5.5% and 7.8% of those treated with vehicle.
Treatment emergent adverse events were mostly mild to moderate, and local tolerability was reported by more than 90% of the treatment groups.
“Given the broad data on roflumilast, including its approval for ages 12 and older in psoriasis and relatively limited discontinuations and adverse events in this atopic dermatitis trial, the safety of this drug, along with the efficacy, set the stage for it being a useful treatment in our armamentarium of atopic dermatitis in childhood through adulthood,” Eichenfield told Healio. “We can be excited that we will have a new novel non-steroidal agent for atopic dermatitis that is designed to be used daily, has rapid effects on itch and dermatitis, and can be used without body surface area limitation or concerns of systemic absorption.”