Lambert J, Hol C W, Vink J
Department of Dermatology, Ghent University Hospital, Ghent, Belgium.
J Eur Acad Dermatol Venereol. 2014 Dec;28(12):1723-31. doi: 10.1111/jdv.12387. Epub 2014 Feb 17.
Psoriasis is most often treated using topical therapies such as the once-daily fixed combination of calcipotriol and betamethasone dipropionate, which is available as a gel and an ointment. To date, there have been no direct comparisons of patient perspectives on the two formulations.
To describe and compare patients' perspectives on calcipotriol and betamethasone gel and ointment formulations, including real-life effectiveness, adherence behaviour, treatment satisfaction and health-related quality of life (QoL), during long-term psoriasis vulgaris management, according to interim findings from the PRO-long study.
PRO-long is a multicentre, prospective, observational, 52-week cohort study in patients prescribed fixed-combination calcipotriol (50 μg/g) and betamethasone (0.5 mg/g; as dipropionate) gel or ointment for long-term psoriasis management. Difference in effectiveness at 4 and 12 weeks was assessed by comparing the proportion of patients with controlled (mild or very mild) disease, according to the Patient's Global Assessment. Additional patient questionnaires were used to assess adherence behaviour, treatment satisfaction (nine-item Treatment Satisfaction Questionnaire for Medication) and health-related QoL (Skindex-29).
A total of 156 patients were included in the analysis. In single items of the adherence behaviour and treatment satisfaction questionnaires, patients preferred the gel over the ointment as convenient, easy to use and fast to apply. Post hoc analysis demonstrated significant differences between gel and ointment for convenience and application time. More patients had controlled disease at week 12 with gel (71.9%) vs. ointment (65.7%); however, the difference was not statistically significant (primary end point; P = 0.40).
This interim analysis supports fixed-combination calcipotriol and betamethasone gel as more convenient, easier to use and faster to apply than the ointment formulation in real-life conditions according to patients with psoriasis vulgaris. Furthermore, a numerical difference in patient-reported real-life effectiveness was seen in favour of the gel, although this was not statistically significant.
银屑病通常采用局部治疗,如每日一次的卡泊三醇和二丙酸倍他米松固定复方制剂,有凝胶和软膏两种剂型。迄今为止,尚未对患者对这两种剂型的看法进行直接比较。
根据PRO-long研究的中期结果,描述并比较患者对卡泊三醇和倍他米松凝胶及软膏剂型的看法,包括在寻常型银屑病长期管理中的实际疗效、依从行为、治疗满意度和健康相关生活质量(QoL)。
PRO-long是一项多中心、前瞻性、观察性、为期52周的队列研究,纳入了因寻常型银屑病长期治疗而使用卡泊三醇(50μg/g)和倍他米松(0.5mg/g;以二丙酸酯形式)固定复方凝胶或软膏的患者。根据患者整体评估,通过比较疾病得到控制(轻度或非常轻度)的患者比例,评估4周和12周时的疗效差异。使用额外的患者问卷来评估依从行为、治疗满意度(九项药物治疗满意度问卷)和健康相关生活质量(Skindex-29)。
共有156名患者纳入分析。在依从行为和治疗满意度问卷的单项中,患者认为凝胶比软膏更方便、易用且涂抹速度快。事后分析表明,凝胶和软膏在便利性和涂抹时间方面存在显著差异。在第12周时,使用凝胶(71.9%)的患者疾病得到控制的比例高于使用软膏(65.7%);然而,差异无统计学意义(主要终点;P = 0.40)。
这项中期分析表明,对于寻常型银屑病患者,在实际情况中,卡泊三醇和倍他米松固定复方凝胶比软膏剂型更方便、易用且涂抹速度快。此外,虽然患者报告的实际疗效在数值上有利于凝胶,但差异无统计学意义。