How effective is alemtuzumab (Lemtrada) in the treatment of relapsing multiple sclerosis (MS)?

Updated: Oct 08, 2019
  • Author: Christopher Luzzio, MD; Chief Editor: Jasvinder Chawla, MD, MBA  more...
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Answer

Approval was based on 2 randomized Phase III open-label rater-blinded studies comparing treatment with alemtuzumab to high-dose subcutaneous interferon beta-1a (Rebif) in patients with relapsing remitting MS who were either new to treatment (CARE-MS I) or who had relapsed while on prior therapy (CARE-MS II). In CARE-MS I, alemtuzumab was significantly more effective than interferon beta-1a at reducing annualized relapse rates; the difference observed in slowing disability progression did not reach statistical significance. [20] In CARE-MS II, alemtuzumab was significantly more effective than interferon beta-1a at reducing annualized relapse rates, and accumulation of disability was also significantly slowed. [21] The clinical development program for alemtuzumab use in MS involved nearly 1,500 patients with more than 6,400 patient-years of safety follow-up. [22]

In a single-arm, open-label study in 45 patients with MS that was refractory to treatment with interferon, alemtuzumab effectively reduced relapse rates and improved clinical scores. [106]

In subsequent subgroup analysis of 101 MS patients with multiple recent relapses and MRI-detected gadolinium-enhancing lesions, researchers found alemtuzumab to be more effective than interferon. [107] The study showed that after 2 years, almost a quarter of patients had achieved a disease activity–free state, whereas none of those treated with interferon and reached such a state.

In this study, disease activity–free was defined as no relapse, no sustained accumulation of disability (SAD) as measured by the Expanded Disability Status Scale (EDSS), and no new gadolinium-enhancing lesions or new or enlarging T2-hyperintense lesions. [107] Relapses occurred in 35.8% of the alemtuzumab group and 60.0% of the interferon group. Respective percentages for SAD were 7.4% and 17.5%; for gadolinium-enhancing lesion activity, 22.1% and 52.5%; and for T2 lesion activity, 60.0% and 92.5%.


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