Alemtuzumab for patients with relapsing MS after disease-modifying therapy: a randomised controlled phase 3 trial

This randomised controlled phase 3 trial assessed the efficacy and safety of alemtuzumab compared with interferon beta 1a in people with relapsing remitting MS who have relapsed despite first-line treatment.

Alemtuzumab, a humanised monoclonal antibody targeting CD52, causes depletion and repopulation of B lymphocytes, leading to long-lasting changes in adaptive immunity. 667 patients were randomly allocated with an interactive voice system in a 2:1 scheme to receive alemtuzumab 12mg and interferon 1a. Randomisation to the alemtuzumab 24mg arm was discontinued to accelerate recruitment to the other two groups. Primary endpoints included relapse rate and time to 6 month sustained accumulation of disability.

Results from this study showed that 51% of patients in the interferon 1a group relapsed compared with 35% of patients in the alemtuzumab group. 47% of the interferon 1a group were relapse free at 2 years, compared with 65% in the alemtuzumab group. 20% of patients in the interferon 1a group had sustained accumulation of disability compared with 13% in the alemtuzumab group. This corresponds to a 42% improvement in the alemtuzumab group.

Most patients (90%) treated with alemtuzumab had mild to moderate infusion associated reactions, 3% had serious infusion associated events. Infection (mild-moderate) was more common after receipt of alemtuzumab (77%) than they were after receipt of interferon 1a (66%).

Overall, alemtuzumab could be used in people with relapsing remitting MS, refractory to first-line treatment, with the appropriate monitoring to decrease the risk of potentially serious yet treatable adverse effects of secondary autoimmunity.

Authors: Coles AJ, Twyman CL, Arnold DL, Cohen JA, Confavreux C, Fox EJ, Hartung HP, Havrdova E, Selmaj KW, Weiner HL, Miller T, Fisher E, Sandbrink R, Lake SL, Margolin DH, Oyuela P, Panzara MA, Compston DA; for the CARE-MS II investigators.

Source: Lancet. 2012 Oct 31 [Epub ahead of print]

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