Peñuelas Leal Rodrigo, Labrandero Hoyos Carolina, Peñuelas Ruiz Jose Amancio, Bagán Leticia, Zaragoza Ninet Violeta, Sánchez Carazo Jose Luis, Pérez Pastor Gemma, Grau Echevarría Andrés, Esteve Martínez Altea, Finello Malena, Blaya Imbernon Daniel, Dios Guillán Víctor, Aguilar González Lucía, Bagán José, Alegre De Miquel Victor
Dermatology Department, Consorci Hospital General Universitari de Valencia, Valencia, Spain.
Gandia Public Health Centre, Gandía, Spain.
Clin Exp Dermatol. 2024 Dec 23;50(1):62-68. doi: 10.1093/ced/llae284.
Mucocutaneous Behçet disease often presents a therapeutic challenge. Roflumilast has shown promise in the treatment of other inflammatory dermatological conditions.
The objective of this study was to evaluate the characteristics, effectiveness and safety of roflumilast in the treatment of Behçet disease-associated aphthosis in routine clinical practice.
We performed a single-cohort ambispective observational study. Eleven patients with Behçet disease treated with roflumilast participated. Data collection included demographic, clinical and outcome variables. Statistical analysis compared 12 weeks of treatment with roflumilast with a previous period without treatment and with a period when the previous treatment was used.
During treatment with roflumilast, a reduction in flare-ups and oral ulcers was observed compared with the untreated period and the previous treatment period. A reduction in genital ulcers, pain and ulcer duration was observed between the without treatment period and the roflumilast treatment period. Adverse effects occurred in 54% of patients, most of which were self-limiting or manageable with dose adjustment. No patients withdrew treatment.
Roflumilast appears to be a potential option in the treatment of Behçet disease with favourable effectiveness, safety and tolerability profiles. Although further research is needed, roflumilast offers a promising treatment option for Behçet disease-associated aphthosis, which could improve the patients' quality of life and address unmet therapeutic needs.
黏膜皮肤型白塞病常常带来治疗挑战。罗氟司特在治疗其他炎症性皮肤病方面已显示出前景。
本研究的目的是在常规临床实践中评估罗氟司特治疗白塞病相关性口疮的特征、有效性和安全性。
我们进行了一项单队列双向观察性研究。11名接受罗氟司特治疗的白塞病患者参与其中。数据收集包括人口统计学、临床和结局变量。统计分析将罗氟司特治疗12周与未治疗的前期以及使用先前治疗的时期进行了比较。
在罗氟司特治疗期间，与未治疗期和先前治疗期相比，发作次数和口腔溃疡有所减少。在未治疗期和罗氟司特治疗期之间，观察到生殖器溃疡、疼痛和溃疡持续时间有所减少。54%的患者出现了不良反应，其中大多数是自限性的或可通过调整剂量控制的。没有患者退出治疗。
罗氟司特似乎是治疗白塞病的一个潜在选择，具有良好的有效性、安全性和耐受性。尽管还需要进一步研究，但罗氟司特为白塞病相关性口疮提供了一个有前景的治疗选择，有望改善患者生活质量并满足未满足的治疗需求。
