Roflumilast improves atopic dermatitis symptoms in children aged 2 to 5 years
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Key takeaways:
- Once-daily roflumilast 0.05% cream improved atopic dermatitis in children aged 2 to 5 years compared with vehicle.
- Reduction of pruritus was seen as early as 1 day after treatment.
SAN DIEGO — In children aged 2 to 5 years with atopic dermatitis, roflumilast cream 0.05% significantly improved symptoms compared with vehicle, with improvement seen as early as 1 week after treatment, according to a speaker here.
In the first randomized controlled trial assessing roflumilast cream 0.05% (Arcutis) in very young children, researchers also observed a reduction in pruritus 24 hours after the first application, with low rates of application site pain. The findings were presented at the American Academy of Dermatology Annual Meeting.
As Healio previously reported, roflumilast cream 0.05% achieved positive results in a pediatric trial of a phase 3 program treating children aged 2 to 5 years with mild to moderate atopic dermatitis, with more children treated with roflumilast vs. vehicle achieving an IGA of 0 or 1 (25.4% vs. 10.7%). Of the 93.8% of patients who completed the study, 93.4% elected to continue to the open-label, extension trial.
“There is a significant unmet need for a safe, tolerable, and efficacious topical treatment that can be used anywhere on the body for these young children,” Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis, told Healio. “The results from our INTEGUMENT-PED trial demonstrate the potential of roflumilast cream 0.05% to address this unmet need and advance the standard of care of the treatment of atopic dermatitis in children between the ages of 2 to 5, once approved.”
Atopic dermatitis treatments can be limited by dosing frequency, tolerability, restrictions or problems with applications as well as concern about long-term use, Lawrence Eichenfield, MD, FAAD, chief of pediatric and adolescent dermatology at Rady Childrens Hospital-San Diego professor of dermatology and pediatrics and vice-chair of the department of dermatology at UC San Diego School of Medicine, said during a late-breaking research presentation. Topical roflumilast, a potent PDE4 inhibitor, is formulated as a water-based, once-daily nonsteroidal cream and foam.
For INTEGUMENT-PED, researchers analyzed data from 652 children (mean age, 3 years; mean body surface area involvement, 22%) who received once-daily roflumilast cream 0.05% (n = 437) or vehicle (n = 215) for 4 weeks. Results showed that 25.4% of those treated with roflumilast achieved the primary endpoint of an IGA score of 0 or 1 (clear or almost clear) plus a 2-point improvement from baseline by week 4, whereas only 10.7% of vehicle-treated patients achieved the same (P < .0001).
The secondary endpoint of EASI 75 was also achieved by 39.4% of roflumilast-treated patients by week 4 compared with 20.6% of vehicle-treated patients (P < .0001). A greater proportion of children treated with roflumilast also saw a 4-point reduction in itch according to the Worst Itch Numeric Rating Scale by week 4 compared with vehicle-treated children (35.3% vs. 18%; P = .0002).
“These findings show the consistent and effective response of roflumilast cream across Arcutis’ atopic dermatitis development program,” Burnett told Healio. “INTEGUMENT-PED met the primary endpoint of validated Investigator Global Assessment-Atopic Dermatitis success, as defined by a score of clear or almost clear with 2-grade improvement at week 4, as well as all secondary endpoints. The study also found that treatment with this once-daily, steroid-free roflumilast cream 0.05% resulted in disease clearance as early as week 1 and reduction in itch in the first 24 hours following application. Additionally, 39.4% of children treated with roflumilast cream 0.05% achieved a 75% improvement in EASI-75 at week 4 compared to the vehicle.”
Eichenfield said roflumilast cream 0.05% was well tolerated, with low incidence of treatment-emergent adverse events. Local tolerability was also favorable.
“Most important, the safety profile was consistent with what was seen in the 0.15% roflumilast trial in 6-year-olds up to adult age,” Eichenfield said.
Burnett said that Arcutis intends to submit a supplemental new drug application for roflumilast cream 0.05% in ages 2 to 5 years after the anticipated approval of roflumilast cream 0.15%, which is currently under FDA review for the treatment of adults and children aged 6 years and older.