Oral roflumilast for psoriasis: a real-world 24-week prospective cohort study.

Ana Maria Lé, Orhan Yilmaz, Martim Luz, Tiago Torres
{"title":"Oral roflumilast for psoriasis: a real-world 24-week prospective cohort study.","authors":"Ana Maria Lé, Orhan Yilmaz, Martim Luz, Tiago Torres","doi":"10.1080/09546634.2025.2464107","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>Psoriasis is a chronic inflammatory skin disease with significant physical and psychological burden, often associated with comorbidities such as obesity and cardiovascular disease. Current treatments include conventional systemic therapies and targeted biologic and non-biologic therapies, with several limitations related to safety, efficacy, and cost. Roflumilast, a selective PDE4 inhibitor, shows potential as an oral therapy for psoriasis due to its anti-inflammatory effects and favorable safety profile. This study aimed to evaluate the real-world effectiveness and safety of oral roflumilast in moderate-to-severe plaque psoriasis.</p><p><strong>Methods: </strong>Prospective cohort study at a single center in Portugal including adults with moderate-to-severe psoriasis treated with oral roflumilast 500 mcg once daily.</p><p><strong>Results: </strong>Among fifty-eight patients (baseline median PASI 13.7 ± 5.5), 63.0% achieved PASI < 5, 47.8% PASI < 3, and 21.7% PASI < 1 by week 24 (mNRI). Weight loss occurred in 53.4%, with a mean reduction of 6 kg ± 4.3. Mild gastrointestinal symptoms were common but rarely caused discontinuation. No serious adverse events were reported.</p><p><strong>Conclusion: </strong>Roflumilast demonstrated real-world effectiveness and a favorable safety profile in moderate-to-severe plaque psoriasis. Additional benefits, including weight loss and no need for laboratory monitoring, make it a promising treatment option, particularly for patients with comorbidities or limited access to biologic therapies.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"36 1","pages":"2464107"},"PeriodicalIF":0.0000,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"The Journal of dermatological treatment","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1080/09546634.2025.2464107","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/2/11 0:00:00","PubModel":"Epub","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0

Abstract

Objective: Psoriasis is a chronic inflammatory skin disease with significant physical and psychological burden, often associated with comorbidities such as obesity and cardiovascular disease. Current treatments include conventional systemic therapies and targeted biologic and non-biologic therapies, with several limitations related to safety, efficacy, and cost. Roflumilast, a selective PDE4 inhibitor, shows potential as an oral therapy for psoriasis due to its anti-inflammatory effects and favorable safety profile. This study aimed to evaluate the real-world effectiveness and safety of oral roflumilast in moderate-to-severe plaque psoriasis.

Methods: Prospective cohort study at a single center in Portugal including adults with moderate-to-severe psoriasis treated with oral roflumilast 500 mcg once daily.

Results: Among fifty-eight patients (baseline median PASI 13.7 ± 5.5), 63.0% achieved PASI < 5, 47.8% PASI < 3, and 21.7% PASI < 1 by week 24 (mNRI). Weight loss occurred in 53.4%, with a mean reduction of 6 kg ± 4.3. Mild gastrointestinal symptoms were common but rarely caused discontinuation. No serious adverse events were reported.

Conclusion: Roflumilast demonstrated real-world effectiveness and a favorable safety profile in moderate-to-severe plaque psoriasis. Additional benefits, including weight loss and no need for laboratory monitoring, make it a promising treatment option, particularly for patients with comorbidities or limited access to biologic therapies.

口服罗氟司特治疗牛皮癣:一项现实世界24周的前瞻性队列研究
目的:银屑病是一种慢性炎症性皮肤病,具有显著的生理和心理负担,常伴有肥胖和心血管疾病等合并症。目前的治疗包括传统的全身治疗和靶向生物和非生物治疗,在安全性、有效性和成本方面存在一些局限性。罗氟米司特是一种选择性PDE4抑制剂,由于其抗炎作用和良好的安全性,显示出作为口服治疗银屑病的潜力。本研究旨在评估口服罗氟司特治疗中重度斑块型银屑病的实际疗效和安全性。方法:在葡萄牙的一个单一中心进行前瞻性队列研究,包括每日一次口服罗氟米司特500 mcg治疗的中度至重度牛皮癣的成年人。结果:在58例患者(基线PASI中位数13.7±5.5)中,63.0%的患者在第24周(mNRI)达到PASI < 5, 47.8%的PASI < 3, 21.7%的PASI < 1。体重减轻的占53.4%,平均减少6 kg±4.3。轻微的胃肠道症状很常见,但很少引起停药。无严重不良事件报告。结论:罗氟司特在治疗中重度斑块型银屑病中具有实际疗效和良好的安全性。额外的好处,包括体重减轻和不需要实验室监测,使其成为一种有希望的治疗选择,特别是对于患有合并症或获得生物治疗机会有限的患者。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
自引率
0.00%
发文量
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信