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与卡泊三醇/倍他米松气雾剂泡沫治疗相关的斑块状银屑病改善情况:非干预性研究和临床经验的事后分析

Improvements in Plaque Psoriasis Associated with Calcipotriol/Betamethasone Aerosol Foam Treatment: A Post Hoc Analysis of Non-interventional Studies and Clinical Experience.

作者信息

Gerdes Sascha, Campanati Anna, Ratzinger Gudrun, Halioua Bruno, Krogager Eeg Martin, Pesiridis Georgios, Jablonski Bernasconi Marie Y, Lazaridou Elizabeth

机构信息

Center for Inflammatory Skin Diseases, Department of Dermatology, University Medical Center Schleswig-Holstein Campus Kiel, Kiel, Germany.

Dermatology Unit, Department of Clinical and Molecular Sciences, Polytechnic Marche University, Via Conca 70, 60020, Ancona, Italy.

出版信息

Dermatol Ther (Heidelb). 2024 Mar;14(3):793-804. doi: 10.1007/s13555-024-01108-0. Epub 2024 Feb 15.

Abstract

INTRODUCTION

Plaque psoriasis is a chronic relapsing inflammatory skin disease that is associated with extensive disease burden that often requires long-term therapy. Treatment of psoriasis with 4 weeks of the aerosol foam formulation of calcipotriol/betamethasone dipropionate (Cal/BD; Enstilar®, LEO Pharma) has been demonstrated to be effective, well tolerated, and associated with high patient satisfaction. Cal/BD foam is approved as a first-line treatment in multiple countries, where several non-interventional studies (NIS) have corroborated the beneficial efficacy and safety profiles determined in the randomized clinical trials. Heterogenicity in these NIS, however, prevents the use of a data pooling strategy for comparisons of effectiveness outcomes across different patient populations.

METHODS

Therefore, here, we report on a post hoc analysis of effectiveness data consolidated from six prospective NIS to discern any differences in improvement in signs and symptoms of psoriasis attributable to Cal/BD foam treatment across the countries. In addition, we provide real-world experience of clinicians with Cal/BD foam treatment, factoring in changes in usage since these NIS were performed in their local markets.

RESULTS

This post hoc analysis of Cal/BD foam NIS brings together data outside of randomized clinical trials from six countries to provide real-world evidence in 1388 patients showing that 4 weeks of Cal/BD foam is an effective and safe treatment option with quick onset of action for patients with psoriasis.

CONCLUSION

These results show that regardless of NIS location, Cal/BD foam remains a well-tolerated, efficacious option for patient care that could be used as a first-line topical therapy for mild-to-severe psoriasis.

摘要

引言

斑块状银屑病是一种慢性复发性炎症性皮肤病,会带来沉重的疾病负担,通常需要长期治疗。已证明,使用卡泊三醇/倍他米松二丙酸酯气雾剂泡沫制剂(Cal/BD;恩斯迪利尔®,利奥制药公司)治疗银屑病4周有效、耐受性良好且患者满意度高。Cal/BD泡沫制剂在多个国家被批准为一线治疗药物,多项非干预性研究(NIS)证实了随机临床试验中确定的有益疗效和安全性。然而,这些NIS中的异质性使得无法采用数据合并策略来比较不同患者群体的疗效结果。

方法

因此,我们在此报告一项事后分析,该分析整合了六项前瞻性NIS的有效性数据,以辨别各国因Cal/BD泡沫治疗导致的银屑病体征和症状改善方面的差异。此外,我们还提供了临床医生使用Cal/BD泡沫治疗的真实世界经验,并考虑了自这些NIS在其当地市场开展以来使用情况的变化。

结果

这项对Cal/BD泡沫NIS的事后分析汇集了来自六个国家的随机临床试验之外的数据,为1388名患者提供了真实世界的证据,表明4周的Cal/BD泡沫治疗对银屑病患者是一种有效且安全的治疗选择,起效迅速。

结论

这些结果表明,无论NIS的开展地点如何,Cal/BD泡沫制剂仍是一种耐受性良好、有效的患者护理选择,可作为轻至重度银屑病的一线局部治疗药物。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1550/10965852/1db4c972b83d/13555_2024_1108_Fig1_HTML.jpg

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