Safety of Mycophenolate Mofetil in the Treatment of Non-Infectious Uveitis and Sclerouveitis in Japanese Patients: A Feasibility Study.

PURPOSE: To evaluate the incidence rate and severity of adverse events associated with mycophenolate mofetil (MMF) in the treatment of non-infectious uveitis and sclerouveitis in Japanese patients.

METHODS

This open-label, single-centre feasibility study was performed at Hiroshima University Hospital (jRCTs061220030). Patients started MMF at 1000 mg/day, increasing up to 3000 mg/day. Primary endpoints were the incidence rate and severity of adverse events associated with MMF. Secondary endpoints were the overall rate of treatment success (defined as controlled ocular inflammation according to the Standardization of Uveitis Nomenclature criteria for uveitis and standardised grading system for sclerouveitis in patients on oral prednisolone at ≤ 5 mg/day and/or topical betamethasone 0.1% up to twice daily) and the reason for discontinuation. Patients were followed up for 12 months.

RESULTS

Ten patients (7 women; median age, 54.5 years) with Vogt-Koyanagi-Harada disease (n = 4), retinal vasculitis (n = 3) sarcoidosis (n = 1), sympathetic ophthalmia (n = 1), or sclerouveitis (n = 1) were enrolled. At 12 months, treatment was successful in 7 of the 10 patients. The reasons for treatment failure were lack of safety (n = 1) and insufficient therapeutic effect (n = 2). One patient discontinued MMF due to elevated liver enzymes. No serious adverse events (death, hospitalization, life-threatening events) or systemic symptoms (gastrointestinal issues, headache, fatigue) occurred. The median MMF dose was 2500 mg/day, with a maximum of 3000 mg/day.

CONCLUSION

MMF may be safely used as a steroid-sparing agent in Japanese patients with non-infectious uveitis or sclerouveitis.