MAY 07, 2015
Adalimumab (Humira) has demonstrated that it can extend the time to treatment failure in patients with noninfectious uveitis who continue to experience inflammation despite systemic corticosteroid therapy.
Based on these results, AbbVie expects to file for approval in the United States and Europe later this year. Adalimumab, a TNF blocker, has orphan drug status in the United States and has FDA approval for several nonophthalmic indications.
VISUAL-1 was a phase 3 multicenter, double-masked, randomized, placebo-controlled study that included 217 patients with active, noninfectious intermediate, posterior or panuveitis despite corticosteroid therapy. All patients received an initial 60-mg dose of prednisone followed by a complete taper over 15 weeks. The adalimumab group also received an 80-mg baseline loading dose of adalimumab followed by 40 mg by subcutaneous injection every other week for up to 80 weeks.
Patients in the study group were significantly less likely to experience treatment failure than those in the placebo group (P < 0.001). Median time to treatment failure was extended to 5.6 months in the adalimumab group compared with 3 months in the placebo group.
Treatment failure was based on chorioretinal or vascular lesions, BCVA, anterior chamber cell grade and vitreous haze grade.
An ongoing Phase 3 clinical trial is evaluating the safety and efficacy of adalimumab in patients with inactive, noninfectious intermediate, posterior or panuveitis.