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Humira extends time to treatment failure in noninfectious uveitis
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Humira met its primary endpoint of extending the time to treatment failure in patients with noninfectious uveitis who still experienced intraocular inflammation despite systemic corticosteroid therapy, manufacturer AbbVie announced in a press release at the Association for Research in Vision and Ophthalmology meeting in Denver.
The VISUAL-I study, a phase 3 multicenter, double-masked, randomized, placebo-controlled study, included 217 patients with active intermediate uveitis, posterior uveitis or panuveitis while on corticosteroid therapy.
Of the 217 patients, 110 were treated with Humira (adalimumab) and 107 received placebo.
Patients in the Humira group received an 80-mg loading dose and subsequent 40-mg subcutaneous injections every 2 weeks for up to 80 weeks.
All patients received an initial 60-mg dose of prednisone and subsequent tapering over 15 weeks.
The primary endpoint was time to treatment failure, defined as one or more of the following in at least one eye, according to the release: new active, inflammatory chorioretinal or vascular lesions; inability to attain an anterior cell grade of 0.5+ or less at 6 weeks, or a two-step increase relative to best state achieved after 6 weeks; inability to attain a vitreous haze score of 0.5+ or less at 6 weeks, or a two-step increase relative to best state achieved; a decrease in best corrected visual acuity of at least 15 letters relative to the best state achieved.
Patients in the Humira group were significantly less likely to experience treatment failure than those in the placebo group (P < .001). Median time to treatment failure was extended to 5.6 months in the Humira group.
The rates of adverse events were 1,047 events per 100 patient-years in the Humira group and 965 events per 100 patient-years in the placebo group. Rates of serious adverse events were 29 events per 100 patient-years in the Humira group and 13 events per 100 patient-years in the placebo group.
Humira is a tumor necrosis factor blocker whose current therapeutic indications are for moderate to severe rheumatoid arthritis, ankylosing spondylitis, moderate to severe plaque psoriasis, active and progressive psoriatic arthritis, moderate to severely active Crohn's disease and moderate to severely active ulcerative colitis. - by Matt Hasson