title: A randomized clinical trial comparing methotrexate and mycophenolate mofetil for noninfectious uveitis.
abstract: OBJECTIVE
  To compare the relative effectiveness of methotrexate and mycophenolate mofetil for noninfectious intermediate uveitis, posterior uveitis, or panuveitis.
  
  
  METHODS
  Multicenter, block-randomized, observer-masked clinical trial.
  
  
  METHODS
  Eighty patients with noninfectious intermediate, posterior, or panuveitis requiring corticosteroid-sparing therapy at Aravind Eye Hospitals in Madurai and Coimbatore, India.
  
  
  METHODS
  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.
  
  
  METHODS
  Masked examiners assessed the primary outcome of treatment success, defined by achieving the following at 5 and 6 months: (1) ≤0.5+ anterior chamber cells, ≤0.5+ vitreous cells, ≤0.5+ vitreous haze and no active retinal/choroidal lesions in both eyes, (2) ≤10 mg of prednisone and ≤2 drops of prednisolone acetate 1% a day, and (3) no declaration of treatment failure because of intolerability or safety. Additional outcomes included time to sustained corticosteroid-sparing control of inflammation, change in best spectacle-corrected visual acuity, resolution of macular edema, adverse events, subgroup analysis by anatomic location, and medication adherence.
  
  
  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.
authors.affiliation: Aravind Eye Care System, Madurai, India.
authors.forename: Sivakumar R
authors.initials: SR
authors.lastname: Rathinam
authors.affiliation: Aravind Eye Care System, Coimbatore, India.
authors.forename: Manohar
authors.initials: M
authors.lastname: Babu
authors.affiliation: Aravind Eye Care System, Madurai, India.
authors.forename: Radhika
authors.initials: R
authors.lastname: Thundikandy
authors.affiliation: Aravind Eye Care System, Coimbatore, India.
authors.forename: Anuradha
authors.initials: A
authors.lastname: Kanakath
authors.affiliation: F.I. Proctor Foundation, University of California, San Francisco, California.
authors.forename: Natalie
authors.initials: N
authors.lastname: Nardone
authors.affiliation: F.I. Proctor Foundation, University of California, San Francisco, California.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Esterberg
authors.affiliation: F.I. Proctor Foundation, University of California, San Francisco, California.
authors.forename: Salena M
authors.initials: SM
authors.lastname: Lee
authors.affiliation: F.I. Proctor Foundation, University of California, San Francisco, California.
authors.forename: Wayne T A
authors.initials: WT
authors.lastname: Enanoria
authors.affiliation: F.I. Proctor Foundation, University of California, San Francisco, California; Department of Epidemiology & Biostatistics, University of California, San Francisco, California.
authors.forename: Travis C
authors.initials: TC
authors.lastname: Porco
authors.affiliation: F.I. Proctor Foundation, University of California, San Francisco, California.
authors.forename: Erica N
authors.initials: EN
authors.lastname: Browne
authors.affiliation: F.I. Proctor Foundation, University of California, San Francisco, California.
authors.forename: Rachel
authors.initials: R
authors.lastname: Weinrib
authors.affiliation: F.I. Proctor Foundation, University of California, San Francisco, California; Department of Epidemiology & Biostatistics, University of California, San Francisco, California; Department of Ophthalmology, University of California, San Francisco, California. Electronic address: nisha.acharya@ucsf.edu.
authors.forename: Nisha R
authors.initials: NR
authors.lastname: Acharya
mesh_terms: D000284:Administration, Oral; D000328:Adult; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008269:Macular Edema / Q000188:drug therapy; D008297:Male; D008727:Methotrexate / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D014605:Uveitis / Q000188:drug therapy*; D014792:Visual Acuity; D055815:Young Adult
chemical_list: D007166:Immunosuppressive Agents; D009173:Mycophenolic Acid; D008727:Methotrexate