Tysabri Superior to Gilenya at Easing Activity in RRMS, Study Reports

Treatment with Tysabri (natalizumab) was more effective than Gilenya (fingolimod) in helping people with relapsing–remitting multiple sclerosis (RRMS) achieve no evidence of disease activity, a head-to-head study suggested.

The study, “BEST-MS: A prospective head-to-head comparative study of natalizumab and fingolimod in active relapsing MS,” was published in the Multiple Sclerosis Journal.

A wide range of treatment options are available for RRMS patients, including Tysabri (marketed by Biogen) and Gilenya (by Novartis).

Comparing efficacy between treatments is the most efficient way to determine which might be best in patient groups. However, previous similar retrospective studies had contradictory findings, with some suggesting better results with Tysabri and others finding no difference.

A team of researchers in France led a prospective study (NCT01981161) — known as BEST-MS (Best Escalation STrategy in Multiple Sclerosis) — to directly compare the effectiveness of Tysabri and Gilenya in people with “active” RRMS.

In total, 223 patients (average age of 38.2) were enrolled: 109 who started being treated with Tysabri and 114 with Gilenya between January 2013 and January 2015. All were followed for 12 months.

Its main goal was to determine the percentage of people with no evidence of disease activity (NEDA) after a year of treatment. NEDA was defined using a combination of criteria: an absence of relapses, stable or lesser disability (assessed through the expanded disability status scale, EDSS, score), and absence of new or enlarged MRI lesions.

Active RRMS, in turn, was defined in this study as evidence of disease activity within the previous year according to these criteria.

Clinical and MRI data were available for 186 patients at the study’s end.

Results showed a greater percentage of people achieving NEDA in the group using Tysabri (47.8%) compared with those using Gilenya (30.4%).

“This superiority was driven by annualized relapse rate and MRI activity,” the researchers wrote.

Specifically, the annualized relapse rate (AAR, the average number of relapses per year) was not significantly different between the two treatments during the overall study — 0.2 in the Tysabri group and 0.27 in the Gilenya group.

However, patients in the Tysabri group had a significantly lower risk of a relapse after six months of treatment compared with those receiving Gilenya — 0.02 vs. 0.09 in the Gilenya group.

“The result we observed regarding relapses activity suggests that [Tysabri] superiority over [Gilenya] seems to be prominent after the first 6 months of treatment,” the researchers wrote.

An absence of new lesions seen on MRI scans at 12 months was also higher among Tysabri-treated patients (70%) than among those on Gilenya (61.6%). The Tysabri-treated group also had a higher percentage of people with no enlarged MRI lesions (98.4% vs. 86.2% in the Gilenya group).

Health-related quality of life (HRQoL) scores showed no significant differences between these treatments after 12 months of use.

In terms of disability, a mean EDSS score of 2.5 was reported in people treated with Tysabri and 2.3 in those treated with Gilenya, representing minimal to mild disability. This difference was not statistically significant.

Treatment withdrawal rates were significantly higher in people treated with Gilenya (19.9%) compared with those receiving Tysabri (8.2%), the researchers found.  Reasons given for stopping these treatments were mainly related to a lack of efficacy and side effects.

Overall, the “results highlight the superiority of natalizumab [Tysabri] on clinical and radiological outcomes,” the team wrote.

Similar findings were recently observed in a Phase 4 head-to-head trial  (NCT02342704, EUCTR2013-004622-29-IT) comparing the two therapies, but this study was terminated early due to low enrollment.

Researchers emphasized that additional head-to-head studies — including comparisons of newer approved MS therapies, like Ocrevus (ocrelizumab), Mavenclad (cladribine), and Lemtrada (alemtuzumab) — should be considered.

“Including those drugs in future head-to-head comparison studies would be relevant to determine the best therapeutic strategies,” the researchers wrote.

BEST-MS study limitations, they added, include its open-label, “real-life” nature and subsequent lack of randomization of enrolled patients, which may have biased its findings.