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C. Stephen Foster, MD; Fehma Tufail, MD; Nadia Khalida Waheed, MD; David Chu, MD; Elisabetta Miserocchi, MD; Stefanos Baltatzis, MD; Cindy M. Vredeveld, BA

Arch Ophthalmol. 2003;121:437-440.

Objective  To evaluate the efficacy of etanercept vs placebo in preventing relapses of uveitis in patients taking methotrexate with control of uveitis and whose methotrexate dosage was being tapered.

Methods  Patients with chronic or recurrent noninfectious uveitis with inflammation controlled by low-dose methotrexate were randomized to either the drug or placebo group in a double-masked manner, given a methotrexate taper schedule, and followed for 24 weeks. The main outcome measures were control of inflammation, visual acuity, and adverse reactions. Data were analyzed both as an attempt-to-treat analysis and an analysis only of those patients who completed the study.

Results  A total of 20 patients were randomized to the drug and placebo groups. Relapse of uveitis occurred in 3 of 10 patients in the treatment group and 5 of 10 patients in the control group. Two patients in the treatment group withdrew prematurely from the study due to adverse effects. There was no significant difference between the treatment and placebo groups with regard to the rate of relapse and the final visual acuity. No patient suffered from any irreversible, long-term morbidity or mortality.

Conclusion  Etanercept has no significant efficacy over placebo in preventing relapses of uveitis in patients being tapered from methotrexate.

From the Ocular Immunology and Uveitis Service, Massachusetts Eye and Ear Infirmary, Boston. The authors have no relevant financial interest in this article.

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