New data from a pivotal phase 3 trial indicates roflumilast cream 0.05% is associated with significantly improved atopic dermatitis (AD) in children 2 to 5 years of age with mild-to-moderate AD.

Researchers for the Interventional Trial Evaluating Roflumilast Cream for the Treatment of Atopic Dermatitis in Pediatric Patients (INTEGUMENT-PED) study enrolled 652 patients 2 to 5 years of age, with a mean Body Surface Area of 22% (range, 3% to 82%). The primary endpoint was achievement of Investigator’s Global Assessment (IGA) Success, defined as vIGA-AD score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at week 4. A key secondar endpoint included patients who attained at least 75% reduction in EASI-75 at week 4.

“The results from the INTEGUMENT-PED trial in patients 2 to 5 years old are consistent with the results from the INTEGUMENT-1 and INTEGUMENT-2 studies of patients with atopic dermatitis ages 6 years and older,” Lawrence F. Eichenfield, MD, a professor of dermatology and pediatrics and vice-chair of the department of dermatology at UC San Diego School of Medicine, and study investigator, told Practical Dermatology. “In young atopic dermatitis patients, tradeoffs between efficacy, safety and tolerability are crucial considerations when evaluating treatment options. Based on these findings, roflumilast cream 0.05%, if approved, will help provide an effective and tolerable atopic dermatitis treatment option for clinicians, caregivers and this young patient population."

Source: Eichenfield L. Efficacy and Safety of Once-Daily Roflumilast Cream 0.05% in Pediatric Patients 2 to 5 Years of Age with Mild to Moderate Atopic Dermatitis (INTEGUMENT-PED): A Phase 3 Randomized Controlled Trial. Session S050. Presented at: American Academy of Dermatology 2024 Annual Meeting; March 8-12, 2024; San Diego.

Disclosures: Dr. Eichenfield reports the following relationships: AbbVie – Consultant(Honoraria); Abbvie – Investigator(Grants/Research Funding); Almirall – Consultant(Honoraria); Amgen – Consultant (1099 relationship)(Honoraria), Investigator(Grants/Research Funding); Amryt Pharma – Consultant(Honoraria); Arcutis Biotherapeutics – Investigator(Grants/Research Funding); ASLAN Pharmaceuticals – Advisory Board(Honoraria), Consultant (1099 relationship)(Honoraria); Bristol-Myers Squibb – Consultant(Honoraria); Castle Biosciences, Inc – Investigator(Grants/Research Funding); Dermata Therapeutics – Consultant (1099 relationship)(Stock); Dermavant Sciences, Inc. – Consultant(Honoraria); Eli Lilly – Consultant(Honoraria), Investigator(Grants/Research Funding); Elsevier Inc. – Other(Patent royalties or other compensation for Intellectual Property Rights); Forte Biosciences – Board of Directors(Fees), Board of Directors(Stock Options); Galderma Laboratories, L.P. – Consultant(Honoraria), Investigator(Fees); Incyte Corporation – Consultant(Honoraria); Janssen Pharmaceuticals, Inc – Consultant (1099 relationship)(Honoraria); Krystal Biotech, Inc – Consultant(Honoraria); LEO Pharma, US – Consultant(Honoraria), Investigator(Fees); Lilly ICOS LLC – Consultant(Honoraria); Nobelpharma – Consultant(Honoraria); Ortho Dermatologics – Investigator(Grants/Research Funding); Pfizer Inc. – Consultant(Honoraria), Investigator(Grants/Research Funding); Sanofi/Regeneron – Consultant(Honoraria), Investigator(Fees); TopMD – Consultant(Stock Options); TrialSpark, Inc. – Consultant(Honoraria); UCB – Consultant(Honoraria); Verrica Pharmaceuticals Inc – Board of Directors(Fees), Board of Directors(Stock Options); Wiley-Blackwell – Other(Honoraria)