Roflumilast holds therapeutic potential for severe recurrent aphthous stomatitis

In the treatment of severe recurrent aphthous stomatitis (RAS), roflumilast appears to reduce the number of flare-ups and ulcers, their duration, and ulcer-related symptoms, according to a study.

Researchers conducted a single cohort ambispective observational study across five centres in Spain. A total of 22 patients (mean age 44.7 years, 54.5 percent female) with RAS who received treatment with oral roflumilast were included. Demographic, clinical, and outcome variables were collected.

The primary outcome of the number of flare-ups, defined as the occurrence of at least one oral ulcer after a period of remission, was assessed during the first 12 weeks of treatment with roflumilast and compared with that during the 12 weeks prior to receiving treatment. Secondary outcomes included the number of oral ulcers, pain on the numeric rating scale (NRS), and the duration of ulcers in days. Safety was also assessed.

During treatment with roflumilast, the number of flare-ups decreased by 88 percent and the number of oral ulcers dropped by 94 percent relative to the untreated period. Furthermore, there was a 66-percent reduction in pain on the NRS and a 63-percent decline in ulcer duration.

In terms of safety, 13 patients experienced adverse effects (AEs), which were mostly headache and gastrointestinal disturbances. Most of these events were self-limiting or manageable with dose adjustment. AEs led to treatment withdrawal in three patients.

The findings demonstrate that roflumilast is a promising therapeutic option in severe recurrent aphthous stomatitis, according to the researchers.