• Neurology Clinical Trials
• Demyelinating Diseases

• Neurology Clinical Trials
• Neurology
• Demyelinating Diseases

An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab [NCT00930553; Coles AJ et al. ECTRIMS 2014 (poster P090)], a follow-up to the phase 3, randomized, head-to-head CARE-MS I study [NCT00530348], has demonstrated the continuing efficacy and safety of subcutaneous alemtuzumab in treatment-naïve patients with relapsing-remitting multiple sclerosis (RRMS) who were treated for up to 4 years. The findings of the multinational team of researchers were presented by Alasdair J. Coles, MD, University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom.

Alemtuzumab is a monoclonal antibody that targets CD52 and has received multinational approval as a treatment for relapsing MS. CARE-MS I documented the efficacy of alemtuzumab in significantly reducing the 2-year relapse rate compared with subcutaneous interferon beta-1a (SC IFN-β-1a) [Cohen JA et al. Lancet. 2012]. There were similar findings in the open-label extension phase of the study at year 3. The present data were obtained at year 4.

Patients aged 18 to 50 years with active RRMS and a baseline Expanded Disability Status Scale (EDSS) score ≤ 3.0 had been randomized to SC IFN-β-1a or alemtuzumab. The core study lasted 24 months, followed by the open-label extension phase.

The open-label, as-needed treatment phase involved 349 patients (95%) who had been randomized to the alemtuzumab arm of the core study, and 144 patients (83%) who had received SC IFN-β-1a. Only 21% of the patients in the first group received an additional course of therapy, and only 5% received 2 courses; the remaining patients received treatment only during the 2-year core phase. Of the second group, 139 switched to alemtuzumab in the open-label phase. The baseline characteristics of all patients were similar concerning age, sex, race (white), EDSS score, time since the first episode of MS, and number of relapses in the year prior to study enrollment.

The annualized relapse rates for those receiving alemtuzumab in year 3 (0.19) and year 4 (0.14) were similar (0.18) to that in the 2-year core phase; during the 4 years, the annualized relapse rate was 0.16 (95% CI, 0.13 to 0.19). The relapse rate in patients receiving interferon was 0.39 in the core phase; after switching to alemtuzumab, the open-label phase relapse rate was 0.12. Disability as assessed using the EDSS was stable or improved from baseline in 79.3% of patients from year 3 to year 4 of the core phase, and the improvement in EDSS from year 0 to year 4 was 73.5%.

Concerning safety, the incidence of most adverse events, including infections (most commonly, nasopharyngitis, urinary tract infection, and upper respiratory tract infection), was similar during the core and open-label phases. Most adverse events were mild or moderate in severity. Only 5 of 376 patients (1.3%) withdrew due to adverse events.

The efficacy of alemtuzumab in treatment of RRMS in patients who were treatment-naïve at baseline, which was noted at 2 and 3 years, was maintained at 4 years. Safety was also similar in patients who received alemtuzumab throughout the study and those who switched from interferon after the first 2 years. No new or unexpected adverse events appeared during year 4. The present data further bolster the acceptability of alemtuzumab treatment for this population of patients with MS.

• © 2014 MD Conference Express®