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

ABSTRACT:

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 (C

SUBMITTER: Stan MN 

PROVIDER: S-EPMC4318907 | biostudies-literature | 2015 Feb

REPOSITORIES: biostudies-literature