Alemtuzumab Is Better Than Interferon Beta-1a in Achieving Clinically Disease-Free State in Patients With Relapsing-Remitting Multiple Sclerosis: Presented at WCTRMS

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Title: Alemtuzumab Is Better Than Interferon Beta-1a in Achieving Clinically Disease-Free State in Patients With Relapsing-Remitting Multiple Sclerosis: Presented at WCTRMS
URL: http://www.pslgroup.com/dg/22D71E.htm
Doctor's Guide
September 24, 2008

By Louise Gagnon

MONTREAL -- September 24, 2007 -- Patients with multiple sclerosis (MS) achieved disease-free status more readily with alemtuzumab therapy than with interferon beta-1a, according to research reported here at the World Congress on Treatment and Research in Multiple Sclerosis (WCTRMS).

In this study, researchers randomised 334 patients with relapsing-remitting multiple sclerosis (RRMS) in a 1:1:1 design to subcutaneous interferon beta-1a (IFNB-1a) 44 mcg 3 times per week (conventional therapy), subcutaneous alemtuzumab 24 mg/day, or alemtuzumab 12 mg/day.

Principal investigator Krzysztof Selmaj, MD, Department of Neurology, University of Lodz, Lodz, Poland, said that the pooled data demonstrated that alemtuzumab was effective in treating patients with RRMS but that careful monitoring is necessary to prevent the development of serious adverse effects.

Patients in the study had no previous MS treatment and a duration of disease of up to 3 years. They also had a score of <=3 on the Expanded Disability Status Scale (EDSS), >=2 MS episodes within the previous 2 years, and >=1 enhancing lesion at baseline detected with magnetic resonance imaging.

Adverse events observed with alemtuzumab therapy included infusion reactions, immune thrombocytopenic purpura, thyroid dysfunction, and predominantly mild and moderate infections. There was 1 fatality due to the development of immune thrombocytopenia, noted Dr. Selmaj.

"The disappointing thing is that 6 patients developed immune thrombocytopenia," said Dr. Selmaj. "This was, paradoxically, because of an autoimmune-mediated reaction. This adverse event can be quite serious."

The 5 other patients who developed immune thrombocytopenia purpura, based on their low platelet counts, were treated adequately, explained Dr. Selmaj.

In ongoing phase 3 research, platelet counts are being carefully monitored in these patients to avoid the development of immune thrombocytopenia purpura, he added. Patients in the current trial who develop low platelet counts stop alemtuzumab therapy and receive steroid therapy, he said.

Study results show that alemtuzumab increased the proportion of relapse-free patients and of patients who were free of sustained accumulation of disability at 3 months, 6 months, 1 year, and 3 years in a highly statistically significant manner compared with interferon beta-1a (P < .0001).

At the end of the 3-year period, alemtuzumab therapy resulted in a substantially higher proportion of clinically disease-free patients than interferon beta-1a (68% vs 63% at year 1; 81% vs 48% at year 2; 71% vs 38% at year 3; P < .0001).

"I think these data are quite impressive," he said. "The patients were free of relapse for 3 years and were free of increased progression or disease activity."

Funding for this study was provided by Genzyme Corporation.

[Presentation title: Alemtuzumab Significantly Increases the Proportion of Clinically Disease-Free Patients With Relapsing-Remitting Multiple Sclerosis Compared With Subcutaneous Interferon Beta-1a: Results From a Phase 2 Study. Abstract 55]

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