Alemtuzumab, an anti-CD52 monoclonal antibody, provides a more effective treatment for individuals with relapsing-remitting multiple sclerosis than the immunomodulating drug interferon beta 1a, but has significant side effects, show findings from a phase III trial.
Administration of once-daily alemtuzumab (12 mg) for 5 days at baseline and for 3 days at 12 months was more effective at reducing clinical relapses, MRI-detected lesion activity, and brain volume loss than subcutaneous interferon beta 1a (44 µg) given three times per week, report Jeffrey Cohen (Cleveland Clinic, Ohio, USA) and colleagues in The Lancet.
Of 1089 patients randomly allocated to the therapies, the rate of relapse was 22% among patients who received alemtuzumab, compared with 40% among those who received the interferon.
After 2 years, 78% of the alemtuzumab patients were still relapse-free compared with 59% of the interferon patients.
However, there was no significant difference in effect between the two drugs on the rate of sustained accumulation of disability, as assessed by the expanded disability status scale.
Furthermore, a significant 90% of patients in the alemtuzumab group had infusion-associated reactions, 12% of which were considered serious, and infections, which were generally mild or moderate in severity, occurred in 67% versus 45% of those in the alemtuzumab and interferon groups, respectively.
At 24 months, three times more alemtuzumab patients had thyroid-associated adverse events than interferon patients and three individuals had thrombocytopenia compared with none in the interferon group.
"The substantial efficacy of alemtuzumab in relapsing-remitting multiple sclerosis needs to be balanced against potentially serious but treatable adverse effects," warn the researchers.
In an associated commentary, Till Sprenger and Ludwig Kappos (University Hospital, Basel, Switzerland) say: "Therapeutic decisions will not only depend on comparative efficacy but also increasingly on the assessment of treatment-related risks and the development of risk stratification algorithms and risk-management plans."
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