Fresh analysis of data on Novartis’ Gilenya and Sanofi/Genzyme’s Lemtrada back their long-term efficacy in keeping multiple sclerosis at bay.

An analysis of data from two Phase III trials looked at the proportion of Gilenya (fingolimod) patients with relapsing multiple sclerosis (RMS) achieving no evidence of disease activity (NEDA-4) - i.e. no relapses, MRI lesions, MS-related brain shrinkage and disability progression - every year over seven years.

In the first year, 27.1% of patients on Gilenya achieved NEDA-4 compared to 9.1% on placebo. Switching from placebo to Gilenya after year two doubled the proportion of patients achieving NEDA-4 (12.7% to 27.4%) in year three. And of those patients on continuous Gilenya treatment, 31.2% to 44.8% had NEDA-4-status in each of the years three to seven.  

A separate follow-up analysis of data has also confirmed - for the first time - that assessing RMS on the NEDA-4 measure allowed physicians to better predict long-term disability and brain shrinkage outcomes than just looking at relapses, MRI lesions and disability progression, the Swiss drug giant said.

The data were presented at the Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Spain.

Sanofi/Genzyme showcase data

Also at the Congress, Sanofi and its subsidiary Genzyme released data this week showing that the treatment effect of Lemtrada (alemtuzumab) in patients with relapsing remitting multiple sclerosis (RRMS) was maintained for five years.

According to the extension studies, the low annualised relapse rates observed in those taking the drug in the CARE-MS I (0.18) and CARE-MS II (0.27) Phase III studies were maintained from year three (0.19 and 0.22) to year five (0.15 and 0.18).

It was also found that 68% and 60% of Lemtrada-treated patients had not taken any more of the drug after initial doses at month zero and month 12, and that 80% and 76% did not experience worsening of disability progression through year five, the firms noted.

In other data, the firm said Aubagio (teriflunomide) significantly slowed brain volume loss versus placebo over two years in people with RMS. 

Magnetic resonance imaging data from the Phase III TEMSO study showed that, by month 12, reductions in brain volume were 0.39, 0.40, and 0.61 for Aubagio 14mg, 7mg, and placebo, respectively, and that a significant difference was maintained through two years.