Clinical benefits of Roflumilast in recurrent aphthous stomatitis

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Created On: 16/01/2025

Severe recurrent aphthous stomatitis (RAS) poses a substantial therapeutic challenge due to its impact on patients' quality of life, coupled with the lack of approved systemic therapies.

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Key take away

Oral Roflumilast effectively minimizes flare-ups, ulcers, and symptoms in recurrent aphthous stomatitis. It also offers good safety, tolerability, and economic value with minimal monitoring needs.

Background

Severe recurrent aphthous stomatitis (RAS) poses a substantial therapeutic challenge due to its impact on patients' quality of life, coupled with the lack of approved systemic therapies. An ambispective observational study sought to examine the safety, efficiency, and characteristics of Roflumilast in managing RAS in a clinical setting.

Method

This study included a single cohort of 22 RAS patients treated with Roflumilast (phosphodiesterase-4 inhibitor) at 5 Spanish centers. Data collected encompassed outcome, clinical, and demographic variables. Outcomes after 12 weeks of Roflumilast use were compared to those from a similar 12-week period without treatment in the statistical analysis.

Result

Roflumilast use led to a remarkable drop in oral ulcers (94%) and flare-ups (88%) as opposed to the treatment-free period. Pain and ulcer duration also dropped by 66% and 63%, respectively. In 13 cases, adverse events were reported, mainly headaches and gastrointestinal issues, most of which were transient or controllable with dose adjustments. In 3 cases, therapy was halted due to adverse events.

Conclusion

Roflumilast appears to be an effective therapy for RAS, reducing the frequency and duration of flare-ups and ulcers, as well as the associated symptoms. It shows a favorable safety profile, with good tolerability at low doses and minimal need for close monitoring. These attributes, along with its good economic profile, position Roflumilast as a promising therapeutic option for RAS.