There has never been a randomized, controlled study that compared natalizumab and fingolimod for relapsing-remitting multiple sclerosis (RRMS) â€“ until now at ECTRIMS 2016 in London, England.
There has never been a randomized, controlled study that compared natalizumab and fingolimod for relapsing-remitting multiple sclerosis (RRMS) — until now at the 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS 2016) in London, England.
Research has shown that both natalizumab and fingolimod perform significantly better than placebo when it comes to clinical and magnetic resonance imaging (MRI) measures for at least two years. A collaborative team from Switzerland and Italy compared the two medications as a second-line disease modifying treatment (DMT) in a phase 3 trial.
The cohort included 428 patients with RRMS who had a history of DMT with Interferon Beta or Glatiramer aceteate for at least one year and had at least one relapse within the previous year. Half of the patients switched to natalizumab and the other half switched to fingolimod as their second-line treatment. The groups were matched for age, gender, disease duration, Expanded Disability Status Scale (EDSS), number of relapses in the previous year, time to last relapse, previous DMT, and number of and time of previous DMTs.
Most of the participants were female (74.4%) with an average age of 38 and disease duration of almost eight years. At baseline, the median EDSS score was 3.0 and the average patient had two relapses in the previous year.
Overall, the 219 patients who received natalizumab had better clinical outcomes than the 219 patients who received fingolimod. Relapse-free rates measured in at 88% and 76%, respectively, after one year. Those percentages came in at 83% and 64% after two years and 78% and 60% after three years.
“EDSS data were complete in 132 patients with natalizumab and 132 patients with fingolimod,” the authors explained. EDSS progression was similar between the groups at the one-year mark, but differed as time went on. “The cumulative proportions of patients with EDSS progression on fingolimod vs. natalizumab were 2.3% vs. 4.2% after one year, 6.4% vs. 10.8% after two years, 9.6% vs. 17.6% after three years, respectively.”
Lower relapse rates were observed with natalizumab compared with fingolimod over three years for patients with RRMS who switched from previous treatments. Disability progression was similar in both treatment groups.
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