• Neurology Clinical Trials
• Demyelinating Diseases

• Neurology
• Neurology Clinical Trials
• Demyelinating Diseases

Improvements in annualized relapse rate (ARR) and Expanded Disability Status Scale (EDSS) score were maintained throughout 4 years following treatment with alemtuzumab for 2 years in patients with relapsing-remitting multiple sclerosis (RRMS) who relapsed on prior therapy. Hans-Peter Hartung, MD, Heinrich Heine University, Düsseldorf, Germany, presented data from the Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab trial [NCT00930553; Hartung H-P et al. ECTRIMS 2014 (poster P043)].

A humanized anti-CD52 monoclonal antibody, alemtuzumab is approved for the treatment of specific forms of relapsing MS in multiple countries. In the CARE-MS II trial, the ARR was reduced by 49% compared with subcutaneous interferon beta-1a (SC IFN-β-1a) at 2 years in patients with RRMS who relapsed on prior therapy [Coles AJ et al. Lancet 2012]. In addition, the reduction in relapses and improvement in MRI outcomes were maintained through year 3 during the open-label CARE-MS II extension trial, with around 80% of patients not requiring retreatment or treatment with another therapy [Fox E] et al. AAN 2013 (S41.001)]. The purpose of this analysis was to evaluate the efficacy and safety of alemtuzumab through year 4 in patients who received alemtuzumab in the core study and those who switched to alemtuzumab in the extension trial.

In the phase 3 CARE-MS II trial, patients with RRMS were randomly assigned to receive 2 annual courses of alemtuzumab or SC IFN-β-1a 3 times per week for 2 years [Coles AJ et al. Lancet 2012]. Patients who completed CARE-MS II were eligible to enroll in the extension study, in which patients who had received alemtuzumab in the core trial received alemtuzumab retreatment as needed and patients who switched from SC IFN-β-1a received alemtuzumab at the beginning of the extension period and 12 months later, then retreatment as needed [Fox EJ et al. AAN 2013 (S41.001)].

Of the 393 patients from the alemtuzumab arm in CARE-MS II who enrolled in the extension trial, 68% did not require retreatment with alemtuzumab and only 5% required treatment with another disease-modifying therapy (DMT). The reduction in ARR achieved during CARE-MS II at years 0 to 2 (0.26 with alemtuzumab vs 0.52 with SC IFN-β-1a) was maintained through year 4 with a rate of 0.23. In addition, the change in EDSS from baseline was maintained or improved in 69.2% of patients at year 4.

In patients who switched from SC IFN-β-1a to alemtuzumab, the ARR was decreased by 71% (from 0.52 to 0.15) during the first 2 years of alemtuzumab treatment.

The majority of adverse events (AEs) were mild to moderate and were similar to those observed in the core trial, with common AEs including nasopharyngitis, urinary tract infection, and upper respiratory tract infection throughout 4 years. Thyroid AEs occurred with a cumulative incidence of 34.7% during the 4 years, which peaked in year 3 and decreased in year 4. Discontinuation of alemtuzumab due to treatment-related AEs occurred in 4.1% of patients who received alemtuzumab in the core trial and 4.2% in patients who received SC IFN-β-1a in the core trial.

In conclusion, Prof Hartung indicated that the data from this analysis show that improvements in ARR and EDSS achieved with alemtuzumab treatment for 2 years were maintained throughout 4 years, with a minority of patients requiring retreatment. In addition, there were no unexpected AEs.

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