A randomized clinical trial comparing methotrexate and mycophenolate mofetil for noninfectious uveitis
Objective: To compare the relative effectiveness of methotrexate and mycophenolate mofetil for noninfectious intermediate uveitis, posterior uveitis, or panuveitis.
Design: Multicenter, block-randomized, observer-masked clinical trial.
Participants: Eighty patients with noninfectious intermediate, posterior, or panuveitis requiring corticosteroid-sparing therapy at Aravind Eye Hospitals in Madurai and Coimbatore, India.
Intervention: Patients were randomized to receive 25 mg weekly oral methotrexate or 1 g twice daily oral mycophenolate mofetil and were monitored monthly for 6 months. Oral prednisone and topical corticosteroids were tapered.
Main Outcome Measures: Masked examiners assessed the primary outcome of treatment success, defined by achieving the following at 5 and 6 months: (1)
Results: Forty-one patients were randomized to methotrexate and 39 to mycophenolate mofetil. A total of 67 patients (35 methotrexate, 32 mycophenolate mofetil) contributed to the primary outcome. Sixty-nine percent of patients achieved treatment success with methotrexate and 47% with mycophenolate mofetil (P = 0.09). Treatment failure from adverse events or tolerability was not different by treatment arm (P = 0.99). There were no differences between treatment groups in time to corticosteroid-sparing control of inflammation (P = 0.44), change in best spectacle-corrected visual acuity (P = 0.68), or resolution of macular edema (P = 0.31).
Conclusions: There was no statistically significant difference in corticosteroid-sparing control of inflammation between patients receiving methotrexate or mycophenolate mofetil. However, there was a 22% difference in treatment success favoring methotrexate. (C) 2014 by the American Academy of Ophthalmology.
Rathinam, S. R., Babu, M., Thundikandy, R., Kanakath, A., Nardone, N., Esterberg, E., ... Acharya, N. R. (2014). A randomized clinical trial comparing methotrexate and mycophenolate mofetil for noninfectious uveitis. Ophthalmology, 121(10), 1863-1870. DOI: 10.1016/j.ophtha.2014.04.023