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Randomized controlled trial of rituximab in patients with Graves' orbitopathy.

CONTEXT: Graves' orbitopathy (GO) is a potentially sight-threatening disease for which available medical therapy is not uniformly successful. Multiple case series suggest that rituximab (RTX) may be effective therapy for GO patients.

OBJECTIVE: To determine the efficacy of RTX in GO.

DESIGN: It is a prospective, randomized, double-masked, placebo-controlled trial.

SETTING: The study was conducted at a large academic private practice.

PATIENTS: Twenty five patients with active moderate to severe GO were enrolled, and 21 completed the study to the primary endpoint.

INTERVENTIONS: Two RTX infusions (1000 mg each) or two saline infusions were given 2 weeks apart.

MAIN OUTCOME MEASURES: The primary endpoint was a reduction in clinical activity score (CAS) assessed as a continuum and separately as improvement by ≥ 2 points at 24 weeks. Secondary endpoints included success and failure rates, proportions showing clinically significant improvement in proptosis, lid fissure width, diplopia score, lagophthalmos and disease severity, and changes in those parameters, orbital fat/ muscle volume and quality-of-life.

RESULTS: The treatment groups were similar in all parameters at baseline. The last observation was carried forward if the patient discontinued prematurely. No differences were found in the proportions of patients showing CAS improvement at 24 weeks (25% placebo; 31% RTX, P = .75) or in CAS decrease from baseline to 24 or 52 weeks [mean 1.5 points (1.8 SD) placebo; 1.2 (2 SD) RTX at 24 weeks, P = .73]. Similarly, there were no differences between groups in any of the secondary endpoints at either 24 or 52 weeks. There were four adverse events (AE) in 3/12 placebo patients and 11 AE in 8/13 RTX-treated patients; 5/6 moderate or severe AE occurred in the RTX group.

CONCLUSION: RTX offered no additional benefit over placebo to our patients with active and moderate to severe GO and carried with it non-negligible adverse effects.

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