Lé Ana Maria, Yilmaz Orhan, Luz Martim, Torres Tiago
Department of Dermatology, Centro Hospitalar Universitário do Porto, Porto, Portugal.
College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.
J Dermatolog Treat. 2025 Dec;36(1):2464107. doi: 10.1080/09546634.2025.2464107. Epub 2025 Feb 11.
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.
Prospective cohort study at a single center in Portugal including adults with moderate-to-severe psoriasis treated with oral roflumilast 500 mcg once daily.
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.
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.
银屑病是一种慢性炎症性皮肤病，会带来严重的身心负担，常伴有肥胖和心血管疾病等合并症。目前的治疗方法包括传统的全身疗法以及靶向生物和非生物疗法，但在安全性、疗效和成本方面存在一些局限性。罗氟司特是一种选择性磷酸二酯酶4（PDE4）抑制剂，因其抗炎作用和良好的安全性，显示出作为银屑病口服疗法的潜力。本研究旨在评估口服罗氟司特治疗中度至重度斑块状银屑病的真实疗效和安全性。
在葡萄牙的一个单一中心进行前瞻性队列研究，纳入接受每日一次口服500微克罗氟司特治疗的中度至重度银屑病成人患者。
在58例患者中（基线银屑病面积和严重程度指数[PASI]中位数为13.7±5.5），到第24周时，63.0%的患者达到PASI<5，47.8%的患者达到PASI<3，21.7%的患者达到PASI<1（改良静态医师全面评估[mNRI]）。53.4%的患者体重减轻，平均减轻6千克±4.3千克。轻度胃肠道症状常见，但很少导致停药。未报告严重不良事件。
罗氟司特在中度至重度斑块状银屑病中显示出真实疗效和良好的安全性。包括体重减轻和无需实验室监测在内的额外益处，使其成为一种有前景的治疗选择，特别是对于有合并症或难以获得生物疗法的患者。
