An international, head-to-head clinical trial funded by the National Eye Institute has demonstrated similar performance by two uveitis drugs, methotrexate and mycophenolate mofetil.
The FAST Uveitis trial compared methotrexate with the more expensive mycophenolate mofetil for the treatment of patients with non-infectious uveitis, which could lead to blindness.
While the drugs showcased similar performance, methotrexate was observed to be more effective for controlling inflammation in more severe cases of posterior uveitis and panuveitis.
Lead study author Nisha Acharya said: “Based on this head-to-head clinical trial, methotrexate is as good as or better than mycophenolate for treating uveitis.
“That’s important because the prior literature and a survey on treatment preferences suggests most clinicians believe the opposite. Now we have a randomised trial to provide guidance on treatment.
“Additionally, there’s a cost difference in the US where mycophenolate to control uveitis is over five times more expensive.”
Patients with intermediate and posterior or panuveitis are initially given oral corticosteroids such as prednisone to control inflammation in the eye.
The therapy is later changed to a low dose and switched to non-steroid medication such as methotrexate and mycophenolate mofetil. This is due to the risk of serious side effects associated with long-term, high-dose corticosteroid use.
During the FAST Uveitis trial, a total of 216 intermediate or posterior/panuveitis patients were enrolled across the US, India, Australia, Mexico and Saudi Arabia.
Participants received a maximum dose of 7.5mg prednisone daily along with either 3g of oral mycophenolate daily or 25mg methotrexate weekly over six months.
The dose was decreased to control any side effects.
At six months, 67% of the patients on methotrexate and 57% on mycophenolate experienced inflammation control and successfully tapered steroids. Investigators observed no statistically significant differences in success rates between the treatment methods.
In addition, 69% of subjects who switched from mycophenolate to methotrexate demonstrated therapy success at 12 months, while only 35% of those who switched from methotrexate to mycophenolate showed success.
Moreover, 74% of patients with posterior or panuveitis achieved inflammation control with methotrexate compared to 55% in the mycophenolate group at six months.
Based on this finding, the researchers concluded that methotrexate was significantly more effective in patients with this severe form of uveitis.
However, both treatment methods showed side effects such as fatigue, nausea, and headaches.