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Adalimumab in Patients with Active Noninfectious Uveitis

Jaffe, GJ; Dick, AD; Brezin, AP; Quan, DN; Thorne, JE; Kestelyn, P; Barisani-Asenbauer, T; ... Suhler, EB; + view all (2016) Adalimumab in Patients with Active Noninfectious Uveitis. New England Journal of Medicine , 375 (10) pp. 932-943. 10.1056/NEJMoa1509852. Green open access

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Abstract

BACKGROUND: Patients with noninfectious uveitis are at risk for long-term complications of uncontrolled inflammation, as well as for the adverse effects of long-term glucocorticoid therapy. We conducted a trial to assess the efficacy and safety of adalimumab as a glucocorticoid-sparing agent for the treatment of noninfectious uveitis. METHODS: This multinational phase 3 trial involved adults who had active noninfectious intermediate uveitis, posterior uveitis, or panuveitis despite having received prednisone treatment for 2 or more weeks. Investigators and patients were unaware of the study-group assignments. Patients were randomly assigned in a 1:1 ratio to receive adalimumab (a loading dose of 80 mg followed by a dose of 40 mg every 2 weeks) or matched placebo. All patients received a mandatory prednisone burst followed by tapering of prednisone over the course of 15 weeks. The primary efficacy end point was the time to treatment failure occurring at or after week 6. Treatment failure was a multicomponent outcome that was based on assessment of new inflammatory lesions, best corrected visual acuity, anterior chamber cell grade, and vitreous haze grade. Nine ranked secondary efficacy end points were assessed, and adverse events were reported. RESULTS: The median time to treatment failure was 24 weeks in the adalimumab group and 13 weeks in the placebo group. Among the 217 patients in the intention-to-treat population, those receiving adalimumab were less likely than those in the placebo group to have treatment failure (hazard ratio, 0.50; 95% confidence interval, 0.36 to 0.70; P<0.001). Outcomes with regard to three secondary end points (change in anterior chamber cell grade, change in vitreous haze grade, and change in best corrected visual acuity) were significantly better in the adalimumab group than in the placebo group. Adverse events and serious adverse events were reported more frequently among patients who received adalimumab (1052.4 vs. 971.7 adverse events and 28.8 vs. 13.6 serious adverse events per 100 person-years). CONCLUSIONS: In our trial, adalimumab was found to be associated with a lower risk of uveitic flare or visual impairment and with more adverse events and serious adverse events than was placebo.

Type: Article
Title: Adalimumab in Patients with Active Noninfectious Uveitis
Open access status: An open access version is available from UCL Discovery
DOI: 10.1056/NEJMoa1509852
Publisher version: http://doi.org/10.1056/NEJMoa1509852
Language: English
Additional information: From New England Journal of Medicine, Jaffe, GJ; Dick, AD; Brezin, AP; Quan, DN; Thorne, JE; Kestelyn, P; Barisani-Asenbauer, T;, Adalimumab in Patients with Active Noninfectious Uveitis, 375:10, Copyright © 2016 Massachusetts Medical Society. Reprinted with permission.
Keywords: Science & Technology, Life Sciences & Biomedicine, Medicine, General & Internal, General & Internal Medicine, OCULAR INFLAMMATORY DISORDERS, REFRACTORY UVEITIS, EXPERT PANEL, MULTICENTER, THERAPY, STANDARDIZATION, RECOMMENDATIONS, MANAGEMENT
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > Institute of Ophthalmology
URI: https://discovery.ucl.ac.uk/id/eprint/1516107
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