التفاصيل البيبلوغرافية
العنوان: |
638 - Long-term safety and efficacy of roflumilast cream 0.15% in adults and children aged ≥6 years with mild to moderate atopic dermatitis: a 52-week, phase 3, open-label extension trial. |
المؤلفون: |
Simpson, Eric L, Eichenfield, Lawrence F, Papp, Kim A, Forman, Seth, Hebert, Adelaide A, Gonzalez, Mercedes E, Gooderham, Melinda, Hong, H Chih-ho, Prajapati, Vimal H, Guttman, Emma, Silverberg, Jonathan, Seal, Melissa, Krupa, David, Burnett, Patrick, Synder, Scott, Chu, David H, Higham, Robert C, Berk, David R |
المصدر: |
British Journal of Dermatology; 2024 Supplement, Vol. 191, p1-1, 1p |
مصطلحات موضوعية: |
RESPIRATORY infections, CLINICAL trials, PHOSPHODIESTERASE inhibitors, ATOPIC dermatitis, PATIENT safety |
مستخلص: |
Background Roflumilast, a highly potent phosphodiesterase-4 inhibitor, is being investigated as a non-steroidal, once-daily cream for atopic dermatitis (AD). Methods INTEGUMENT-OLE (NCT04804605) was an open-label 52-week safety trial. Patients (N=658) with mild to moderate AD who completed a 4-week randomized vehicle-controlled phase 3 trial of roflumilast cream continued or switched to once-daily roflumilast cream 0.15% in this open-label extension trial. Starting at Week 4, patients achieving Validated Investigator Global Assessment for AD (vIGA-AD) score of 0 (Clear) switched to twice-weekly (BIW) maintenance dosing. The primary endpoint was safety; secondary endpoints included vIGA-AD, Worst Itch-Numeric Rating Scale (WI-NRS), and Eczema Area and Severity Index (EASI). "Disease control" was defined as duration of vIGA-AD=0/1 on BIW dosing following achievement of vIGA-AD=0. Results With cumulative treatment up to 56 weeks, 36.7% of patients reported treatment-emergent adverse events (AEs); most were mild to moderate in severity. Overall, 4.7% of patients had AEs deemed treatment-related and 3.0% discontinued due to AEs. The most common AEs (>2%) were COVID-19, upper respiratory tract infection, nasopharyngitis, and headache. At Week 52, 55.7%, 61.1%, and 53.6% of patients achieved vIGA-AD=0/1 (Clear/Almost Clear), ≥75% reduction in EASI, and ≥4-point reduction in WI-NRS (among patients aged ≥12 years with baseline WI-NRS ≥4), respectively. Of the 130 (19.8%) patients who achieved disease control, 50% maintained "disease control" for at least 281 days. Conclusion Treatment with roflumilast cream 0.15% demonstrated long-term safety in patients with AD consistent with parent trials and durable efficacy through 52 weeks, including patients who switched to BIW dosing. [ABSTRACT FROM AUTHOR] |
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قاعدة البيانات: |
Complementary Index |