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It has long been observed that patients receiving monoclonal antibody based anti-TNF (TNFi) therapies for spondylitis or psoriatic disease have less inflammatory eye complications, such as uveitis. These agents have become common interventions based on these observational results. But now we have randomized controlled trials to prove the efficacy of TNF blockade in non-infectious uveitis.
The VISUAL II trial is a worldwide, multicenter, blinded, randomised, placebo-controlled phase 3 study of 229 adults with inactive, non-infectious intermediate, posterior, or panuveitic uveitis controlled by 10–35 mg/day of prednisone. All patients underwent a mandatory prednisone taper and the primary endpoint was time to treatment failure, based on ocular assessments.
After a median follow-up time was 155 days, treatment failure occurred in 55% of the placebo group and 39% of those on adalimumab. The time to treatment failure was significantly longer in the adalimumab group compared with the placebo group (>18 months vs 8·3 months, respectively).
There were no unusual or notable safety signals from either group.
Adalimumab significantly lowered the risk of uveitic flare or loss of visual acuity upon corticosteroid withdrawal in patients with inactive, non-infectious intermediate, posterior, or panuveitic uveitis.
Adalimumab is FDA approved for the treament of on-infectious intermediate, posterior, or panuveitic uveitis.