Arcutis Announces Successful Phase 3 Results for Roflumilast Cream 0.05% in Children with Atopic Dermatitis

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These new results from the pivotal INTEGUMENT-PED trial met both of the investigators' primary and secondary endpoints.

Biopharmaceutical company Arcutis Biotherapeutics announced the successful achievement of the primary and secondary endpoints of the INTEGUMENT-PED phase 3 study on roflumilast cream 0.05% for those in the age range of 2 - 5 years with mild-to-moderate atopic dermatitis (AD).1

Roflumilast cream 0.05% is a steroid-free topical cream that is administered once-per-day to AD patients, and the treatment is specifically crafted to deliver the drug to patients without compromising the integrity of their skin barrier.

Summary of New Findings

  • Arcutis Biotherapeutics successfully met primary and secondary endpoints in the INTEGUMENT-PED phase 3 study of roflumilast cream 0.05% for mild-to-moderate AD in patients aged 2 to 5 years.
  • The study involved 652 children, and defined the primary endpoint as achieving IGA Success, which required a 'clear' or 'almost clear' rating along with a 2-grade improvement from baseline at 4 weeks.
  • Showed that 25.4% of children treated with roflumilast cream 0.05% reached IGA Success at 4 weeks, compared to 10.7% in the vehicle-treated group, with noticeable improvements in first week.
  • Roflumilast cream 0.05% also showed substantial secondary endpoint improvements, including a 39.4% reduction in the EASI-75 and a 35.3% reduction in the Worst Itch Numeric Scale (WI-NRS) at 4 weeks, consistent with previous pivotal trials in pediatric and adult atopic dermatitis patients.

In the INTEGUMENT-PED study, or "INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis in PEDiatric patients,” the investigators used a double-blind, parallel-group, vehicle-controlled design. The study involved a daily application of roflumilast cream 0.05% or vehicle for 4 total weeks in the patient population being assessed.

The investigators recruited a total of 652 children for the study, and the primary endpoint was established as Investigator Global Assessment (IGA) Success. The team defined IGA success as being the achievement of a vIGA-AD rating of 'clear' or 'almost clear' in addition to a 2-grade improvement from the baseline mark at 4 weeks.

The research team also examined several different secondary endpoints, and these included the proportion of participants managing to achieve 75% reduction in the Eczema Area and Severity Index (EASI-75) at 4 weeks.

In their primary endpoint analysis, the team showed that 25.4% of children given a once-per-day treatment of roflumilast cream 0.05% reached IGA Success at 4 weeks, in comparison to the 10.7% of children treated with the vehicle (P<0.0001). Notably, the team found that major improvements were observed as early as the first week.

In addition, the investigators found that 39.4% of those treated with roflumilast showed a substantial 75% improvement in the EASI-75, noted as a key secondary endpoint. What’s more, the team added that roflumilast showed an overall impressive ability to improve pruritus, with 35.3% of children treated with the drug reporting a 4-point diminishment of the Worst Itch Numeric Scale (WI-NRS) at 4 weeks.

“Atopic dermatitis is a chronic disease that is unstable in its course," Jonathan Silverberg, MD, PhD, MPH, the Director of Clinical Research and of Patch Testing at George Washington University School of Medicine and Health Sciences, said in a statement.

"EASI-75 has emerged as an important endpoint in clinical trials and reflects clinically meaningful responses in the real world," Silverberg continued. "EASI incorporates body surface area, and higher body surface area involvement is an important consideration for the severity and impact of the disease for patients suffering from pediatric atopic dermatitis."

The new results aligned closely with those responses reported from the INTEGUMENT-1 and INTEGUMENT-2 pivotal trials, further supporting the well-established track record of roflumilast cream in pediatric as well as adult patients with AD.

The safety profile of roflumilast was strong, with the team noting low incidence of adverse events and with thw most commonly observed event being upper respiratory tract infection in both arms, though it was still low frequency. The majority of participants given roflumilast completed the full 4 weeks, and adverse event-related discontinuations were found to be minimal.

Arcutis Biotherapeutics recently submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration for roflumilast cream 0.15%, targeting the treatment of AD in adults as well as children aged 6 years and older. If this sNDA is approved, the company is set to submit another for roflumilast cream 0.05% for children in the age range of INTEGUMENT-PED.2

References

  1. Arcutis Biotherapeautics, Inc. Globe Newswire. September 19, 2023. https://www.globenewswire.com/news-release/2023/09/19/2745482/0/en/Arcutis-Announces-Positive-Results-from-INTEGUMENT-PED-Pivotal-Phase-3-Trial-of-Roflumilast-Cream-0-05-for-the-Treatment-of-Atopic-Dermatitis-in-Children-Ages-2-to-5.html. Date accessed: September 19, 2023.
  2. Smith T. Arcutis Announces Supplemental New Drug Application of Roflumilast for Atopic Dermatitis in Adults, Children. HCPLive. September 12, 2023. https://www.hcplive.com/view/arcutis-announces-supplemental-new-drug-application-roflumilast-for-atopic-dermatitis-in-adults-children. Date accessed: September 19, 2023.
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