Alemtuzumab Continues to Decrease Progression of MS at 4 Years

TORONTO: April 17, 2010

Patients in this extension study had participated in a previous study, CAMMS223 trial, where alemtuzumab, administered intravenously, was compared to subcutaneous injection of interferon (IFN) beta-1a in a 3-year, phase 2 trial. Data from that trial demonstrated that alemtuzumab was more effective in suppressing relapses and warding off disability in patients with MS.

At year 4 of this extension trial, investigators observed that 77% of patients who had been treated with either 2 or 3 brief annual cycles of a 12- or 24-mg/day dose of intravenous alemtuzumab remained relapse-free, while only 49% of those who had been treated 3 times weekly with 44 mcg of subcutaneous IFN beta-1a were free of relapses, a difference that was statistically significant.

In addition, 91% of alemtuzumab patients were free of risk for sustained accumulation of disability compared with 68% of IFN beta-1a patients (P < .001). A total of 71% of alemtuzumab patients were deemed clinically disease-free versus 35% of patients on IFN beta-1a at year 4 (P < .001).

"In all measures, [the 2 doses of alemtuzumab] appeared to be equivalent," noted investigator Alasdair Coles, PhD, Department of Clinical Neurosciences, University of Cambridge, United Kingdom, speaking here at a poster presentation on April 14.

"These are people who are early on in the course of their disease, when they are just losing their ability to perform in their profession, and we are restoring them to where they were," explained Dr. Coles. "We are able to reverse the progression of the disease."

The most common adverse event observed with alemtuzumab was either underactive or overactive thyroid gland, which Dr. Coles said could be detected early on, in advance of symptoms appearing. "It's an inconvenience to our patients, but we can start them on oral therapies to treat the thyroid gland," said Dr. Coles. "None of them, however, complained that they would rather have a normal thyroid and not have alemtuzumab."

Another adverse event that Dr. Coles described as "disconcerting" was the 2.8% of patients (6 out of 216) receiving alemtuzumab patients who developed immune thrombocytopenia (ITP).

"This bleeding problem [ITP] is treatable with steroids if we pick it up," said Dr. Coles, noting one patient died of a brain haemorrhage in the original study. "It's all about monitoring and picking it up." Patients would get a monthly blood test to check their platelet counts, explained Dr. Coles. "If the counts start to go down, we can initiate therapy in the form of steroids," said Dr. Coles.

Dr. Coles described alemtuzumab as a "highly effective, intensive treatment that needs a lot of monitoring."

Funding for this study was provided by Genzyme.

By Louise Gagnon

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Presentation title: Alemtuzumab Reduces Disease Progression in RRMS: Long-Term Results of the CAMMS223 Trial. Abstract P04.213