This NEI-funded trial compared 2 commonly used, steroid-sparing, immunosuppressive drugs as a first-line treatment for noninfectious uveitis.
Study design
The randomized trial comprised 216 adults with noninfectious intermediate uveitis, posterior uveitis or panuveitis who were treated at 9 referral eye centers in India, the United States, Australia, Saudi Arabia and Mexico. One-hundred and seven patients received methotrexate while 109 patients received mycophenolate mofetil.
Treatment success was defined as control of inflammation in both eyes, less than trace vitreous haze and AC cells, no active chorioretinal lesions, 7.5 mg or less of prednisone daily and 2 or fewer drops of prednisolone acetate 1%, and no treatment failure due to safety or intolerability.
Outcomes
The mean corticosteroid dose at the start of the trial was 50 mg daily. At 6 months treatment success was reached by 66.7% of patients in the methotrexate group and 57.1% in the mycophenolate group (P=0.20).
In the subgroup of patients with posterior uveitis or panuveitis, 74.4% of the methotrexate group and 55.3% of the mycophenalate group were controlled at 6 months, which was a statistically significant difference. There was no significant difference in success rates among the subgroup of patients with anterior/intermediate uveitis
There were no differences in vision and central subfield thickness between groups at 6 months. There was a higher incidence of lab-related abnormalities such as liver function tests in the methotrexate group.
Of the patients with 6-month treatment success who were followed for 12 months, 80% of the methotrexate group and 74.1% of the mycophenlate group remained controlled. For patients who switched medications at 6 months due to treatment failure, there was greater treatment success at 12 months in the methotrexate group.
Limitations
The cohort was not masked to treatment and had a heterogeneous mixture of uveitic disorders. While there were multiple sites and countries involved, a majority of participants were from India.
Clinical significance
These findings suggest there is little difference in inflammation control between mycophenolate and methotrexate. More studies are needed to assess if these drugs are more effective for different uveitis subtypes.