NATIONAL HARBOR, MD—Patients with highly active relapsing-remitting multiple sclerosis (RRMS) have durable improvement for more than five years with alemtuzumab use, according to data presented at the 2016 CMSC Annual Meeting. In a phase III trial, 45% of patients treated with alemtuzumab also sustained a six-month reduction in disability.
Barry A. Singer, MD
In the CARE-MS II study, alemtuzumab was associated with more significant improvement in clinical and MRI outcomes over two years, compared with subcutaneous interferon beta-1a, in patients with active RRMS who had had a poor response to prior therapy at baseline. An extension study was initiated to evaluate the five-year efficacy of alemtuzumab treatment in a subset of patients with RRMS and highly active disease at baseline. Barry A. Singer, MD, Assistant Professor of Clinical Neurology at Washington University in St. Louis, and his colleagues defined highly active disease as two or more relapses in the year before randomization and gadolinium-enhanced lesions at baseline. In the study, 24% of patients receiving alemtuzumab met the criteria for highly active disease.
During the trial, patients randomized to alemtuzumab (12 mg/day) were given two courses of treatment for five consecutive days at baseline and treatment for three consecutive days in the 12th month. In the extension study, patients were only allowed to receive alemtuzumab retreatment if they had a relapse or MRI activity on disease-modifying treatment.
In more than five years, at least 80% of patients receiving alemtuzumab who had had an inadequate response to prior therapy were free of relapses in each individual year. Sixty-two percent of patients had no alemtuzumab retreatment or other disease-modifying therapies. Results also showed that 97% of patients did not receive another disease-modifying therapy.
In this cohort, no evidence of disease activity was reported in 71%, 63%, and 67% of patients during years three, four, and five, as well as in 53% of patients during years zero to five. Arrhythmias remained low in each individual year of the extension study. Expanded Disability Status Scale (EDSS) scores also showed improvement with alemtuzumab use through years zero to five. In addition, sustained reduction in disability was achieved by 53% of patients during years zero to five.
“Based on these findings, alemtuzumab may provide a unique treatment approach with durable efficacy in the absence of continuous treatment for patients with highly active RRMS,” said Dr. Singer and his colleagues.
This study was supported by Genzyme and Bayer HealthCare Pharmaceuticals.
—Erica Robinson