Simpson Eric L, Eichenfield Lawrence F, Papp Kim A, Forman Seth B, Hebert Adelaide A, Gonzalez Mercedes E, Gooderham Melinda J, Hong H Chih-Ho, Prajapati Vimal H, Guttman-Yassky Emma, Silverberg Jonathan I, Seal Melissa S, Krupa David, Almaraz Erin, Hanna Diane, Burnett Patrick, Snyder Scott, Chu David H, Higham Robert C, Berk David R
From the Oregon Health & Science University, Portland, OR, USA.
Departments of Dermatology and Pediatrics, Rady's Children's Hospital-San Diego, University of California San Diego, La Jolla, CA, USA.
Dermatitis. 2025 Jan 10. doi: 10.1089/derm.2024.0418.
Safety and efficacy of roflumilast cream 0.15% for atopic dermatitis (AD) were demonstrated in two 4-week phase 3 trials. Evaluate long-term safety, tolerability, and efficacy of roflumilast cream 0.15% in AD. In this open-label extension (OLE) trial (INTEGUMENT-OLE; NCT04804605), patients aged ≥6 years who completed one of the 4-week phase 3 trials applied roflumilast for up to 52 weeks. After 4 weeks of once-daily application, patients who achieved Validated Investigator Global Assessment for AD (vIGA-AD) of clear (0) switched to twice-weekly (BIW) application to normal-appearing flare-prone areas (proactive treatment). Among 657 patients treated, 36.7% reported adverse events, including 4.7% that were treatment related. Application site pain and stinging/burning that caused definite discomfort at any visit were reported for 0.5% and 0.4%-2.1% of patients, respectively. Patients who achieved vIGA-AD 0 and switched to proactive BIW application maintained vIGA-AD 0/1 (almost clear) for a median of 281 days (Kaplan-Meier estimate). Roflumilast cream 0.15% was well tolerated for up to 56 weeks. BIW application to normal-appearing flare-prone sites maintained improvement in AD signs and symptoms, showing that proactive treatment represents an alternative to the current standard practice of reactive treatment.
两项为期4周的3期试验证明了0.15%罗氟司特乳膏治疗特应性皮炎（AD）的安全性和有效性。评估0.15%罗氟司特乳膏治疗AD的长期安全性、耐受性和有效性。在这项开放标签扩展（OLE）试验（INTEGUMENT - OLE；NCT04804605）中，年龄≥6岁且完成了一项为期4周的3期试验的患者应用罗氟司特长达52周。在每日一次应用4周后，达到特应性皮炎验证研究者整体评估（vIGA - AD）为清除（0）的患者改为每两周一次（BIW）应用于外观正常的易出现皮疹区域（预防性治疗）。在657例接受治疗的患者中，36.7%报告了不良事件，其中4.7%与治疗相关。分别有0.5%和0.4% - 2.1%的患者报告在任何一次就诊时出现导致明确不适的应用部位疼痛和刺痛/烧灼感。达到vIGA - AD 0并改为预防性BIW应用的患者维持vIGA - AD 0/1（几乎清除）的中位时间为281天（卡普兰 - 迈耶估计）。0.15%罗氟司特乳膏在长达56周的时间内耐受性良好。对外观正常的易出现皮疹部位进行BIW应用可维持AD体征和症状的改善，表明预防性治疗是当前反应性治疗标准做法的一种替代方案。
