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] |
|
Copyright of British Journal of Dermatology is the property of Oxford University Press / USA and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) |
| قاعدة البيانات: |
Complementary Index |
