富马酸二甲酯作为中度至重度银屑病的替代疗法:我们的经验。

IF 5.2 Q1 DERMATOLOGY Psoriasis (Auckland, N.Z.) Pub Date : 2022-06-29 eCollection Date: 2022-01-01 DOI:10.2147/PTT.S367060
Pau Rosés Gibert, Francisco Javier de la Torre Gomar, Amaia Saenz Aguirre, Javier Gimeno Castillo, Ricardo González Pérez
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摘要

目的:富马酸二甲酯(DMF)是一种口服制剂,已被批准用于治疗需要系统治疗的成年中重度银屑病患者。在此,我们介绍了西班牙使用 DMF 治疗中重度银屑病的临床经验:这是一项回顾性研究,包括2018年9月至2020年1月期间接受DMF治疗的30名中重度银屑病成年患者。患者按照 DMF 的产品特性摘要接受治疗,中位治疗时间为 15 周(4-55 周)。从基线到第36周对银屑病面积和严重程度指数(PASI)和体表面积(BSA)严重程度量表进行了评估,并对治疗期间发生的不良事件(AEs)进行了描述:第8周评估了DMF的疗效,第36周时(n = 5),PASI和BSA均为0。第24周时,最后观察结转病例(LOCF;n = 23)和观察病例(OC)(n = 10)的PASI中值均有所下降:分别从10降至6和从10降至1.5。BSA 中位数也有所下降,LOCF 从 19 例降至 10 例,OC 从 17 例降至 3 例。最常见的不良反应是腹泻(40.0%)、潮红(13.3%)和淋巴细胞减少(3.3%)。47.1%的患者通过调整DMF剂量解决了AEs。因AEs而中断治疗的比例为43.3%:我们的临床经验表明,DMF可以有效、安全地治疗成年中重度银屑病患者。
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Dimethyl Fumarate as Therapeutic Alternative in Moderate-to-Severe Psoriasis: Our Experience.

Purpose: Dimethyl fumarate (DMF) is an oral formulation approved for the treatment of moderate-to-severe psoriasis in adult patients requiring systemic therapy. Here, we describe our clinical experience with DMF for moderate-to-severe psoriasis in Spain.

Patients and methods: This is a retrospective study including 30 adult patients with moderate-to-severe psoriasis under treatment with DMF between September 2018 and January 2020. Patients were treated with DMF as per its Summary of Product Characteristics and the median duration of treatment was 15 weeks (4-55 weeks). Psoriasis Area and Severity Index (PASI) and body surface area (BSA) severity scales were evaluated from baseline to week 36 and adverse events (AEs) developed during treatment were described.

Results: The efficacy of DMF was assessed at week 8 and at week 36 (n = 5), both PASI and BSA were 0. At week 24, median PASI showed a decrease in both the last observation carried forward (LOCF; n = 23) and the observed cases (OC) (n = 10): from 10 to 6 and from 10 to 1.5, respectively. Median BSA also showed a decrease from 19 to 10 in LOCF and from 17 to 3 in OC. The most frequent AEs were diarrhoea (40.0%), flushing (13.3%) and lymphopenia (3.3%). In 47.1% patients, AEs have been solved by adjusting the DMF dose. Treatment discontinuation rate due to AEs was 43.3%.

Conclusion: Our clinical experience indicates that DMF could be an effective and safe treatment for moderate-to-severe psoriasis in adult patients.

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