Efficacy and Safety of Once-Daily Roflumilast Cream 0.05% in Pediatric Patients Aged 2-5 Years With Mild-to-Moderate Atopic Dermatitis (INTEGUMENT-PED): A Phase 3 Randomized Controlled Trial.

• Tác giả: Erin Almaraz, David R Berk, Mark Boguniewicz, John C Browning, Patrick Burnett, David H Chu, Lawrence F Eichenfield, Tracy Funk, Mercedes E Gonzalez, Diane Hanna, Adelaide A Hebert, Robert C Higham, David Krupa, Mark Lee, Vimal H Prajapati, Melissa S Seal, Rocco Serrao, Eric L Simpson, Scott Snyder, Lisa Swanson
• Ngôn ngữ: eng
• Ký hiệu phân loại: 362.19 Services to patients with specific conditions
• Thông tin xuất bản: United States : Pediatric dermatology , 2025
• Bộ sưu tập: NCBI
• ID: 236656

Tóm tắt

 BACKGROUND/OBJECTIVES: Efficacy and safety of roflumilast cream 0.15% were demonstrated in patients aged ≥ 6 years with atopic dermatitis (AD) in two Phase 3 trials. This Phase 3 parallel-group, double-blind trial (INTEGUMENT-PED
  NCT04845620) compared the efficacy and safety of roflumilast cream 0.05% and a vehicle in patients aged 2-5 years with AD. METHODS: Patients aged 2-5 years with mild-to-moderate AD were treated with once-daily roflumilast cream 0.05% or vehicle for 4 weeks. The primary efficacy endpoint was Validated Investigator Global Assessment for AD (vIGA-AD) Success (0 [Clear] or 1 [Almost Clear] plus ≥ 2-grade improvement from baseline) at Week 4. Other endpoints included ≥ 75% improvement in Eczema Area and Severity Index (EASI-75) and Worst Itch-Numeric Rating Score (WI-NRS) Success (≥ 4-point improvement in patients with baseline ≥ 4). Safety and tolerability were also assessed. RESULTS: Among 437 and 215 patients treated with roflumilast and vehicle, respectively, significantly greater proportions of the roflumilast group achieved Week-4 vIGA-AD Success (25.4% vs. 10.7%
  p <
  0.0001), EASI-75 (39.4% vs. 20.6%
  p <
  0.0001), and WI-NRS Success (35.3% vs. 18.0%
  nominal p = 0.0002). Improvement in pruritus was observed within 24 h after the first application (nominal p = 0.0014). Treatment-emergent adverse event (TEAE) rates were low in both groups, and 98.9% were mild or moderate. At all timepoints, stinging/burning that caused definite discomfort was reported by ≤ 0.7% of caregivers of patients in the roflumilast group. CONCLUSIONS: In this Phase 3 trial, once-daily roflumilast cream 0.05% improved AD signs/symptoms in patients aged 2-5 years, with early pruritus improvement, low AE rates, and local tolerability comparable with vehicle. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04845620.