Abstract
N/A
Highlights
Roflumilast is a selective and highly potent phosphodiesterase-4 inhibitor investigated as a once-daily, nonsteroidal, topical treatment for various inflammatory dermatologic conditions – In a phase 2b, randomized, double-blind, vehicle-controlled trial, roflumilast cream provided Significant and rapid improvement of psoriasis Demonstrated efficacy for intertriginous plaques Reduction of itch2
BSA: body surface area; IGA: Investigator Global Assessment; I-IGA: intertriginous-Investigator Global Assessment; Psoriasis Area Severity Index (PASI): Psoriasis Area and Severity Index; PASI-75: 75% reduction from baseline in PASI; PASI-90: 90% reduction from baseline in PASI; PSD: Psoriasis Symptom Diary; QD: once daily; WI-NRS: Worst Itch-Numeric Rating Scale
The primary endpoint was analyzed using a Cochran-Mantel-Haenszel test stratified by site, baseline Investigator Global Assessment (IGA), and baseline intertriginous involvement – Statistical significance was concluded at the 5% significance level (2-sided) – Missing IGA scores were imputed using multiple imputation
Summary
No nonsteroidal topical therapies with novel mechanism of action for psoriasis have been approved in more than 20 years – Available topical treatments are less than ideal, necessitating a trade-off between efficacy and tolerability[1]. This poster presents efficacy and safety results from DERMIS-1 (ClinicalTrials.gov Identifier: NCT04211363) and DERMIS-2 (ClinicalTrials.gov Identifier: NCT04211389) – These were 2 identical phase 3, randomized, double-blind, vehicle-controlled studies of once-daily roflumilast cream 0.3% in patients with psoriasis (Figure 1). ELIGIBILITY Diagnosis of plaque psoriasis for ≥6 months (3 months for children). BSA: body surface area; IGA: Investigator Global Assessment; I-IGA: intertriginous-Investigator Global Assessment; PASI: Psoriasis Area and Severity Index; PASI-75: 75% reduction from baseline in PASI; PASI-90: 90% reduction from baseline in PASI; PSD: Psoriasis Symptom Diary; QD: once daily; WI-NRS: Worst Itch-Numeric Rating Scale
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
