This phase 3 extension of the VISUAL trials evaluated the safety and efficacy of adalimumab in patients with noninfectious intermediate, posterior or panuveitis.
Study design
This VISUAL III trial included 371 intent-to-treat patients from the VISUAL I and II trials who met the criteria for treatment failure or who completed a previous VISUAL trial without treatment failure. This study includes data through 78 weeks of follow-up.
All patients received 40-mg adalimumab every other week regardless of their original assignment. Physicians could alter corticosteroids and immunosuppression during the trial. The primary outcome measure was clinical quiescence.
Outcomes
Three-quarters of the patients completed follow-up to week 78, while 25% had premature discontinuation. At week 0, 93% of patients who had previously met treatment failure criteria had active uveitis; however, 60% reached clinical quiescence by week 12 and remained stable at week 78.
The percentage of eyes with a BCVA better than 0.05 logMAR increased from 35% at week 0 to 49% at week 78. By the final week, 66% of the patients were corticosteroid free. Adalimumab reduced the mean dose of systemic corticosteroids in more than 80% of patients to less than 3mg/day. There were no new safety concerns.
Limitations
This was an open-label trial without a control group. The study was designed to mirror real-life practice—therefore topical, systemic, and injectable steroids as well as other immunosuppresssion was allowed, which makes interpretation of data more difficult. Not all patients respond to adalimumab.
Clinical significance
The VISUAL trials confirm that adalimumab enables steroid tapering while achieving disease control in many patients. Adalimumab was able to control inflammatory lesions, improve vitreous haze, reduce anterior chamber cells and decrease central retinal thickening.