Safety, Tolerability, and Efficacy of Rituximab in the Treatment of Multiple Sclerosis: 285 Patients Treated in a Single Center. (P3.262)

OBJECTIVE: To assess the safety, tolerability and efficacy of rituximab treatment in multiple sclerosis (MS) in a clinical setting. BACKGROUND: Phase II studies suggest a therapeutic effect of drugs targeting CD20+ B-cells such as rituximab in MS. The safety and efficacy of these medications beyond one year has not been described in MS. METHODS: Retrospective chart review of MS patients at the University of Colorado Denver MS Center who have received treatment with rituximab. Clinical information was collected including demographic information, laboratory data, clinical relapses, MRI lesions, and infusion reactions. RESULTS: 285 patients were treated with rituximab, including 200 patients treated with 蠅2 courses with a median duration of 18 months (range from 6-72 months). The median age was 45.8 years (15-79 years); 67.5[percnt] were women; 83.2[percnt] were Caucasian. Patients had a mean duration of disease of 11 years and had been previously treated with a median of 2 disease modifying treatments. 66.2[percnt], 20.3[percnt], and 13.5[percnt], were diagnosed with relapsing remitting, secondary progressive, and primary progressive MS, respectively. The majority of patients were treated with 1gram initially with subsequent courses of 500mg every 6 months. 18 of 185(9.7[percnt]) patients reconstituted their CD20+ cells (>1[percnt]) prior to their next infusion. 19[percnt] of patients reported minor first dose infusion-related reactions (7[percnt] with follow up courses). 81.6[percnt] had positive JC serology prior to infusion with no cases of progressive multifocal leukoencephalopathy. Two patients experienced 3 clinical relapses. Seven of 140 patients(5[percnt]) with subsequent MRIs demonstrated new T2 lesions with no enhancing lesions seen. Three patients had neutropenic fevers attributable to rituximab. CONCLUSIONS: Rituximab was well tolerated and safe for the treatment of MS in our single center clinical setting. Although this is a retrospective study, rituximab was extremely effective at reducing relapses in MS with minimal clinical relapses or new MRI activity. Disclosure: Dr. Seibert has nothing to disclose. Dr. Blackburn has nothing to disclose. Dr. Vollmer has nothing to disclose. Dr. Bennett has received personal compensation for activities with Teva Neuroscience, EMD Serono, and Biogen Idec as a speaker and/or consultant. Dr. Corboy has received personal compensation for activities with ProCE, Celgene, Teva, Novartis, and Biogen Idec. Dr. Miravalle has nothing to disclose. Dr. Schreiner stands to receive personal compensation for activities with Teva Neuroscience. Dr. Vollmer has received personal compensation for activities with Acorda Therapeutics, Biogen Idec, Genentech, Inc., Novartis, Ono Pharmaceutical, Teva Neuroscience, and XenoPort as a consultant. Dr. Alvarez has received personal compensation for activities with Teva Neuroscience.