AbbVie announced results from its Phase 3 study VISUAL-1 investigating the efficacy and safety of Humira (adalimumab) in adults with active non-infectious intermediate, posterior, or panuveitis who still experienced intraocular inflammation while on systemic corticosteroid therapy.
VISUAL-I is a double-masked, randomized, placebo-controlled study designed to investigate the efficacy and safety of Humira in 217 patients. Starting at week 6 and every visit thereafter, all patients were assessed fortreatment failure (TF). The primary endpoint of the study was time to TF, which was defined as having one or more of the following four criteria in at least one eye: New active, inflammatory chorioretinal or vascular lesions; inability to achieve ≤0.5+ AC cell grade at week 6; after week 6, two-step increase relative to best state achieved; inability to achieve ≤0.5+ VH grade at week 6; after week 6, two-step increase relative to best state achieved; best corrected visual acuity (BCVA) decrease by at least 15 letters relative to best state achieved.
Results demonstrated that Humira significantly lowered the risk of uncontrolled uveitis or vision loss. Patients on Humira were less likely to experience TF (HR=0.5; 95% CI, 0.36–0.70; P<0.001) compared to those taking placebo. Median time to TF was prolonged by 87%, from 3 months for placebo to 5.6 months for Humira.
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