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Updates in Disease Management (CMSC 2016)
Data from recently completed clinical trials were presented at the 2016 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC), held June 1-4 in National Harbor, MD.
Patients of African-American descent typically experience a more-aggressive disease course of MS compared with Caucasians discussed Annette Okai, MD, Multiple Sclerosis Treatment Center of Dallas, Dallas, TX. A subgroup analysis of patients from CARE-MS I and II that were of African American descent and treated with alemtuzumab was performed to evaluate the efficacy of alemtuzumab over 5 years in this subgroup.
There were 32 patients included in the analysis during the study extension. During the extension phase, subjects could receive alemtuzumab or another disease-modifying therapy at the investigator’s discretion. Fifty-three percent of patients did not require treatment during years 3 to 5 of the study. Reasons for retreatment included relapse, MRI, and a combination of MRI and relapse. Eighty-eight percent of patients did not receive another disease-modifying therapy. Over the course of 5 years, the cumulative annualized relapse rate with alemtuzumab was 0.16%. Mean EDSS score was stable over the 5 years of the study. Brain volume loss was also stable. Treatment was well-tolerated.
In conclusion Dr. Okai stated that “In patients of African descent, alemtuzumab had clinical and MRI efficacy compared to the overall cohort in the CARE MS study.” Efficacy was durable over 5 years and further evaluations of alemtuzumab are warranted in this population.
Jai Perumal, MD, Judith Jaffe Multiple Sclerosis Center, New York, NY, discussed interim results from the STRIVE study. STRIVE is a multicenter, observational, open-label single-arm study that was designed to measure the proportion of anti-JC virus antibody-negative patients with relapse-remitting multiple sclerosis (RRMS) initiating natalizumab early in their disease course (within 3 years of disease onset) who demonstrated no evidence of disease activity (NEDA). The interim analysis was carried out at 1 year in 174 patients. The analysis showed that 57.5% of patients had NEDA at year 1. Patients that had EDSS scores of 2 or less at baseline, were more likely to have NEDA after 1 year of treatment.
Dr. Perumal concluded that MS patients that are treated early in their disease course, can attain NEDA with natalizumab treatment.
James D. Bowen, MD, Swedish Medical Center, Seattle, WA, presented 5-year outcome data from HALT-MS. HALT-MS was designed to assess sustained remission in patients treated with high-dose immunosuppressive therapy (HDIT) and autologous hematopoietic cell transplantation (HCT) in patients with highly active RRMS. There were 24 patients that received treatment. At 5 years, progression-free survival was 90.9% and relapse-free survival was 86.3%. There were 2 deaths during the study, but these were deemed not related to study treatment. NEDA, as measured by MRI, was 88.2%. MS disease burden, as measured by T2-weighted lesion volume on MRI was significantly reduced by 6 months as compared to baseline and was sustained over 5 years. EDSS scores were stable over the course of the study. There were slight improvements in quality-of-life of scores in these patients.
Dr. Bowen concluded that HDIT/HCT for highly active RRMS induced a high rate of remission of MS disease activity that was sustained for 5 years without maintenance therapy.