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.
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.
(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%).
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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