Treatment of Behçet disease with oral roflumilast: an observational study.

Background: Mucocutaneous Behçet disease often presents a therapeutic challenge. Roflumilast has shown promise in the treatment of other inflammatory dermatological conditions.

Objectives: 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.

Methods: 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.

Results: 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.

Conclusions: 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.