Late-breaking data presented from INTEGUMENT-PED phase III trial of roflumilast cream 0.05% in atopic dermatitis in children ages 2 to 5 at the AAD meeting

The study found that treatment with once-daily, steroid-free roflumilast cream 0.05% resulted in significant improvements in atopic dermatitis across multiple efficacy endpoints and all timepoints, including disease clearance as early as Week 1 and reduction in itch in the first 24 hours following application.

Results showed 25.4% of children treated with roflumilast cream 0.05% achieved the primary endpoint of IGA Success, defined as vIGA-AD score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at Week 4, compared to 10.7% treated with the vehicle (P<0.0001), with significant improvements also seen at week 1 and week 2. in the study, 39.4% of children treated with roflumilast cream 0.05% achieved a 75% improvement in easi (easi-75) at week 4 compared to 20.6% treated with vehicle (p><0.0001).></0.0001).></0.0001),>

“For the pediatric patient population, tradeoffs between efficacy, tolerability, and safety are critical aspects of atopic dermatitis treatment decisions. In addition, tolerability is paramount, and if there are problems with tolerability, there is a hurdle for adherence,” said Lawrence F. Eichenfield, MD, professor of dermatology and pediatrics and vice-chair of the department of dermatology at UC San Diego School of Medicine, and study investigator. “These tradeoffs are further amplified in young children, which is why having a well-designed formulation that doesn’t disrupt the skin barrier benefits the patient and decreases the concerns of caregivers. The results from this study of once-daily application of roflumilast cream 0.05% in patients 2 to 5 years old are consistent with the findings from the INTEGUMENT-1 and INTEGUMENT-2 studies of patients down to the age of 6. If approved, this profile will be a welcome, easily adopted option for patients and clinicians alike.”

Roflumilast cream is an investigational once-daily, steroid-free topical cream formulated to deliver drug without disrupting the skin barrier. INTEGUMENT-PED enrolled 652 children ages 2 to 5, with a mean Body Surface Area of 22% overall, and a range from 3% to 82%. The data reinforces the well-established efficacy, safety, and tolerability profile of roflumilast cream in atopic dermatitis across the INTEGUMENT program.

New data highlighted in the session included 35.4% of children treated with roflumilast cream achieved vIGA-AD clear (0) or almost clear (1) compared to 14.6% of vehicle (P<0.0001) at the end of the study (week 4), with improvements seen as early as week 1. in addition, the data show improvement in itch with roflumilast cream 0.05% as early as 24 hours following first application, based on ls mean change from baseline in daily wi-nrs score (p="0.0014" vs vehicle).

Roflumilast cream 0.05% was well tolerated. The incidence of Treatment Emergent Adverse Events (TEAEs) was low, and the only adverse event occurring in greater than 3% of subjects in either active- or vehicle-arm was upper respiratory tract infection. The most frequent adverse events in the roflumilast arm (?2%) included pyrexia, diarrhea, and vomiting. Local tolerability was also favorable, with application site pain only being reported in 1.6% of roflumilast-treated participants vs.1.9% for the vehicle.

About INTEGUMENT-PED: The “INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis in PEDiatric patients” (INTEGUMENT-PED) was a Phase III, parallel group, double blind, vehicle-controlled trial in which roflumilast cream 0.05% or vehicle was applied once daily for four weeks to children 2 to 5 years of age with mild to moderate atopic dermatitis. No moisturizers, emollients, or other products were allowed on treatment sites during the trial. A total of 652 children were enrolled in the study. The primary endpoint was IGA Success, defined as a vIGA-AD score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at Week 4. Multiple secondary endpoints were also evaluated, including the proportion of subjects who attained at least a 75% reduction in the EASI-75 at Week 4.