Director, Neurology Clinical Research Professor, Department of Neurology UNIVERSITY OF COLORADO Co-Director, Rocky Mountain MS Center at Anschutz Medical Director, ROCKY MOUNTAIN MS CENTER

ECTRIMS Congress 2013:  AMSTERDAM -- A low-dose regimen of the leukemia drug alemtuzumab (Lemtrada) slashed annualized relapse rates in patients with newly diagnosed multiple sclerosis in a head-to-head trial against interferon-beta-1a (Rebif), a researcher reported here.

Patients taking alemtuzumab -- first sold under the brand name Campath for treating B-cell chronic lymphocytic leukemia -- had a mean annualized relapse rate of 0.18 during a two-year, phase III trial, compared with 0.39 for patients receiving the standard regimen of interferon. But another neurologist not involved with the study suggested that the drug's safety profile remains a major concern.

Timothy Vollmer, MD, of the University of Colorado in Denver, said the extreme duration of alemtuzumab's effects was itself a potential problem.

"[It] induces long-term if not permanent changes in immunoregulation; it also induces significant generalized immune suppression and disturbance of immunoregulatory circuits," he observed.

As a result, said Vollmer, "once you treat a patient, you can't take it back. Those patients are then at risk for infections and for development of autoimmune disease."

He added that he considered these risks more worrisome than the potential for progressive multifocal leukoencephalopathy with natalizumab (Tysabri).

Coles reported findings from the 581-patient trial, dubbed CARE-MS I, during a late-breaking news session at the joint meeting of the European and Americas Committees for Treatment and Research in Multiple Sclerosis.

Patients in the study had disease duration of no more than five years and EDSS disability scores of 3 or less, but had active disease on the basis of  relapses during the previous two years. Patients who had received disease-modifying therapies previously were excluded.

The difference in relapse rates meant the cancer drug met one of two primary endpoints in the study, which was intended to demonstrate alemtuzumab's superiority to one of the mainstays of first-line MS therapy.
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Labels: Copaxone, ECTRIMS CONGRESS 2013, Lemtrada, Tysabri