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Adalimumab Cuts Uveitis Flares: Presented at EULAR

By Jill Stein

PARIS -- June 15, 2008 -- Adalimumab helps prevent anterior uveitis (AU) flares in patients with ankylosing spondylitis (AS), said researchers on June 14 at the EULAR 2008, the Annual Congress of the European League Against Rheumatism.

Martin Rudwaleit, MD, Charité - University Medicine Berlin, Berlin, Germany, and colleagues examined the effect of adalimumab on the frequency of uveitis episodes in 1,250 patients with AS who were enrolled in an open-label study intended to be representative of routine clinical care.

Adalimumab, a fully human monoclonal antibody against tumour necrosis factor (TNF), is highly effective in treating patients with AS.

While a meta-analysis of 7 clinical trials and a retrospective study have shown that the rate of uveitis flares in patients with AS decreases during treatment with TNF antagonists, a preventive effect of adalimumab on AU flares in this population was not evaluated, as only a few patients in the prior studies were treated with adalimumab, the investigators wrote in their poster presentation.

The study included patients with active AS, defined as (Bath AS Disease Activity Index [BASDAI] >= 4) despite previous treatment with at least 1 nonsteroidal anti-inflammatory drug (NSAID).

Subjects received open-label adalimumab 40 mg sc every other week for 12 weeks.

Uveitis episodes within the past year prior to baseline (BL) were reported as 0 flares,

1 to 2 flares, or >= 3 flares. The mean treatment duration for the complete study population (1,250 patients with AS) was 106 days.

Overall, 25 patients (2%) reported 27 AU flares. Of 274 patients with a history of uveitis, 23 patients (8%) described 25 AU flares. Of 106 patients with symptomatic AU in the prior 12 months, 19 patients (18%) reported 21 AU flares. Nine of 28 patients with active AU at baseline (32%) reported 10 AU flares.

New-onset uveitis occurred in 2 patients. Of the 274 patients with prior uveitis, 43 had chronic uveitis; this subset experienced 10 uveitis flares during adalimumab therapy.

Adalimumab therapy was associated with a significant reduction in AU flares. There was a 58% reduction (P < .001) in uveitis flares per 100 patient-years after adalimumab therapy in patients with a history of uveitis, a 68% reduction (P < .001) in patients with uveitis in the past 12 months, a 50% reduction (P < .001) in patients with symptomatic uveitis at enrolment, and a 45% reduction in patients with a chronic history of uveitis (P < .002).

Overall, the results demonstrate adalimumab's broad effectiveness in decreasing the AU flare rate in patients with active AS, the authors concluded.

Funding for the study was provided by Abbott.

[Presentation title: Adalimumab (Humira) Inhibits Uveitis Flares in Patients With Anklylosing Spondylitis (AS). Abstract SAT0261.]

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