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银屑病患者对局部治疗有不同的偏好,这凸显了个体化治疗方法的重要性:随机 IIIb 期 PSO-INSIGHTFUL 研究。

Patients with psoriasis have different preferences for topical therapy, highlighting the importance of individualized treatment approaches: randomized phase IIIb PSO-INSIGHTFUL study.

机构信息

University of British Columbia, Department of Dermatology and Skin Science and Probity Medical Research, Surrey, Canada.

Probity Medical Research and K Papp Clinical Research, Waterloo, ON, Canada.

出版信息

J Eur Acad Dermatol Venereol. 2017 Nov;31(11):1876-1883. doi: 10.1111/jdv.14515. Epub 2017 Sep 14.

Abstract

BACKGROUND

Poor adherence to topical therapy in psoriasis remains an issue; it is associated with poor clinical outcomes, reduced quality of life and increased costs. Treatment-related factors leading to poor adherence include lack of efficacy, excessive time applying medication and poor cosmetic characteristics (e.g. slow absorption, greasiness).

OBJECTIVE

To assess the topical treatment attributes that influence patient preference for fixed combination calcipotriol 50 μg/g (Cal) and betamethasone 0.5 mg/g as dipropionate (BD) foam vs. gel, as well as in comparison with the latest topical treatment (LTT) a patient received.

METHODS

PSO-INSIGHTFUL was a Phase IIIb, prospective, multicentre (Canada/Germany), open-label, randomized, two-arm crossover study in patients aged ≥18 years with mild-to-severe psoriasis (NCT02310646). Following a washout period of up to 4 weeks, patients were randomized 1 : 1 to once-daily Cal/BD foam for 1 week, followed by Cal/BD gel for 1 week, or vice versa. Patients completed six questionnaires evaluating patient preferences.

RESULTS

A total of 213 patients were randomized; 118 had received a topical treatment in the previous 3 months. Based on the Subject's Preference Assessment, 50% of patients preferred Cal/BD foam and 50% preferred Cal/BD gel. Based on the Topical Product Usability Questionnaire (TPUQ), overall mean scores were high for both Cal/BD foam and gel, and were often significantly in favour of both products compared with LTT. Greater differences between Cal/BD foam and gel vs. LTT occurred when the previous treatment was an ointment or cream. Cal/BD foam was generally preferred by younger patients (aged 18-39 years), whereas Cal/BD gel tended to be preferred by older patients (aged ≥40 years). Results from other questionnaires were aligned with the TPUQ.

CONCLUSIONS

Patients with psoriasis have diverse needs and different preferences for topical treatment. This knowledge may help prescribers to choose the right formulation for the right patient, potentially leading to improved adherence and better treatment outcomes.

摘要

背景

银屑病患者的局部治疗依从性仍然存在问题;它与不良临床结局、生活质量下降和成本增加有关。导致治疗依从性差的治疗相关因素包括疗效不足、涂抹药物时间过长和美容特性差(例如吸收缓慢、油腻)。

目的

评估影响患者对固定复方卡泊三醇 50μg/g(Cal)和倍他米松 0.5mg/g 二丙酸酯(BD)泡沫与凝胶偏好的局部治疗属性,以及与患者最近接受的最新局部治疗(LTT)相比。

方法

PSO-INSIGHTFUL 是一项在年龄≥18 岁的轻度至重度银屑病患者中进行的 IIIb 期、前瞻性、多中心(加拿大/德国)、开放性、随机、双臂交叉研究(NCT02310646)。在长达 4 周的洗脱期后,患者以 1:1 的比例随机接受 Cal/BD 泡沫每日一次治疗 1 周,然后 Cal/BD 凝胶治疗 1 周,或反之。患者完成了六项评估患者偏好的问卷。

结果

共有 213 名患者被随机分组;118 名患者在过去 3 个月内接受了局部治疗。根据患者的偏好评估,50%的患者更喜欢 Cal/BD 泡沫,50%的患者更喜欢 Cal/BD 凝胶。根据局部产品可用性问卷(TPUQ),Cal/BD 泡沫和凝胶的总体平均评分都很高,并且通常明显优于 LTT。与 LTT 相比,当之前的治疗是软膏或乳膏时,Cal/BD 泡沫和凝胶之间的差异更大。Cal/BD 泡沫通常更受年轻患者(18-39 岁)的欢迎,而 Cal/BD 凝胶则更受老年患者(≥40 岁)的欢迎。其他问卷的结果与 TPUQ 一致。

结论

银屑病患者有不同的需求和对局部治疗的不同偏好。这些知识可能有助于医生为合适的患者选择合适的配方,从而提高治疗的依从性和改善治疗效果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b633/5698702/0705ce38383a/JDV-31-1876-g001.jpg

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