Early Response to Calcipotriol and Betamethasone Dipropionate PAD-Cream at Week 4 in Patients with Mild-to-Moderate Plaque Psoriasis: A Post-Hoc Pooled Analysis of Two Phase III Trials.
Maria Esposito, Juan Manuel Morón-Ocaña, Aditya K Gupta, Jordi Galván, Ayoub Bentohami, Frank Freischläger
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引用次数: 0
Abstract
Introduction: Topical therapy plays an essential role in psoriasis management. However, lack of rapid improvement may negatively impact adherence. The calcipotriol and betamethasone dipropionate (CAL/BDP) cream based on polyaphron dispersion (PAD) technology has demonstrated high efficacy, favorable safety, and convenience compared with CAL/BDP gel in phase III trials. This post-hoc analysis aims to assess early treatment response to CAL/BDP PAD-cream at Week (W) 4.
Methods: This was a post-hoc pooled analysis of adults with mild-to-moderate psoriasis from two multicenter, investigator-blind, phase III trials (MC2-01-C2 and MC2-01-C7). Patients were randomized 3:1:3 to CAL/BDP PAD-cream (N = 551), PAD-cream vehicle (N = 178), or CAL/BDP gel (N = 542) once daily for 8 weeks. Physician's Global Assessment (PGA) and Subject's Global Assessment (SGA) were assessed at W1 and W4. At W4, early responders were defined as patients achieving PGA controlled disease (i.e., any improvement from baseline to a PGA score of 0-1), while PGA success was defined as a PGA score of 0-1 combined with a minimum 2-point improvement from baseline. SGA controlled disease and SGA success were also assessed. Comparisons between groups were performed by logistic regression models using multiple imputation. Rates of PGA/SGA concordance were assessed by simple percent agreement.
Results: At W4, CAL/BDP PAD-cream was associated with a significantly higher proportion of patients achieving early response compared with CAL/BDP gel (32.1% vs 21.4%, P < 0.0001). Differences were already significant at W1 (7.8% vs 4.8%, P = 0.0410). PGA success at W4 was also higher with CAL/BDP PAD-cream than with CAL/BDP gel (23.6% vs 14.8%, P < 0.0001). Rates of SGA controlled disease and success were also statistically significantly higher for CAL/BDP PAD-cream at W4. Concordance between PGA/SGA assessments at W4 was observed in 65.5% (controlled disease) and 69.5% (success) of patients treated with CAL/BDP PAD-cream.
Conclusion: CAL/BDP PAD-cream was associated with significantly higher early response rates at W4 than CAL/BDP gel, suggesting earlier clinical improvements.
期刊介绍：
Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged.
Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers.
The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.
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