A Double-Blind Randomized Controlled Trial To Assess The Efficacy Of Enbrel Versus Placebo In Preventing Relapses Of Chronic Or Recurrent Uveitis

Purpose:To evaluate the efficacy of entanercept (Enbrel®) versus placebo in preventing relapses of chronic or recurrent non-infectious uveitis in patients controlled on and being tapered from methotrexate. Methods:20 patients with chronic or recurrent non-infectious uveitis, and with control of inflammation on low-dose (<0.5mg/kg) methotrexate were tapered off methotrexate and randomized to receive either drug or placebo in a double blind fashion at the Immunology and Uveitis Service of the Massachusetts Eye and Ear Infirmary. The patients were followed for 24 weeks for control of inflammation, visual acuity and adverse reactions. Data were analyzed both as an intent to treat analysis and an analysis only on patients who completed the trial. Results:20 patients were randomized to the drug and placebo groups. Relapse of uveitis occurred in 3 of the 10 Enbrel patients and in 5 of the 10 placebo patients. Two of the10 Enbrel group patients withdrew prematurely from the study due to intolerance to drug. There was no significant difference between the treatment and placebo groups with regard to the rate of relapse, the number of relapses suffered and the final visual acuity (p0.05 for all), both in the intent to treat analysis and in the analysis of patients who completed the study only. Although 2 of the 10 Enbrel patients withdrew from the study due to intolerable side effects, none suffered any irreversible, long-term visual or systemic morbidity. Conclusion:Systemic entanercept was not superior to placebo in preventing relapses of uveitis in patients with chronic or recurrent non-infectious uveitis being tapered from methotrexate.