A randomized clinical trial comparing methotrexate and mycophenolate mofetil for noninfectious uveitis
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
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.