Irsogladine is effective for recurrent oral ulcers in patients with Behçet's disease : an open-label, single-centre study.

UNLABELLED: BACKGROU nd and objective: Behçet's disease (BD) is a polysymptomatic condition characterized by recurrent oral and genital ulceration and uveitis. Aphthous stomatitis, a common complication, is painful, recurrent and sometimes resistant to treatment. Topical or intralesional corticosteroids and local anaesthetics are used for palliative therapy. We investigated whether irsogladine, a drug for the treatment of gastritis and peptic ulcers, reduced aphthous stomatitis lesions in patients with BD.

METHODS: Irsogladine 2-4 mg/day was administered orally to ten BD patients (cases 1-10), three men and seven women, with a mean age of 48.5 years, with recurrent aphthous stomatitis as the main symptom. Pre-existing treatments were not changed. All patients were followed up at our outpatient clinic once a month. The patients had no systemic neurological, gastrointestinal or vascular symptoms. Efficacy was evaluated on the basis of the macroscopic findings of aphthous lesions. We counted the number of aphthous lesions three times prior to administration of irsogladine and three times after treatment at the outpatient clinic, i.e. six times in total, and compared pre- and post-treatment mean numbers of lesions for each patient.

RESULTS: Irsogladine was effective in all ten patients. The mean aphthous ulcer count decreased in all patients 3 months after administration (p < 0.0003). Cases 5 and 6 stopped taking irsogladine of their own accord when the stomatitis disappeared; however, the stomatitis reappeared, and in both patients, aphthous stomatitis healed completely soon after re-administration of irsogladine. In case 8, aphthous stomatitis reappeared 2 months after administration of irsogladine 2 mg/day. The dose of irsogladine in this patient was then increased to 4 mg/day, after which aphthous stomatitis resolved. Taking irsogladine continuously prevented recurrence of stomatitis in these three patients.

CONCLUSION: Irsogladine reduces aphthous stomatitis/oral ulcers in patients with BD. The improvement in gap-junctional intercellular communication by irsogladine may contribute to the treatment of aphthous stomatitis in patients with BD. Increasing the dose of irsogladine may resolve ulcers resistant to low doses of irsogladine.