EFFICACY PROFILE AND SAFETY OF VERY LOW DOSE RITUXIMAB IN PATIENTS WITH GRAVES’ ORBITOPATHY

Background : Rituximab (RTX), a chimeric human-murine anti-CD20 monoclonal antibody, has been used for treatment of active moderate-severe Graves’ orbitopathy (GO) since 2004 as second line therapy in patients unresponsive to intravenous steroids. We conducted an open label, prospective study (EUDRACT 2012-001980-53) in which patients were treated with a single infusion of only 100 mg RTX to analyze the efficacy and safety of this low dose. Methods : Seventeen patients, of whom nine had disease that was unresponsive to intravenous methylprednisolone, and eight with newly diagnosed GO were enrolled. Disease activity was assessed with the clinical activity score (CAS) and severity with a composite ophthalmic score. Long term surgical treatment and quality of life

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