Gilenya Continues to Demonstrate Effectiveness as Therapy for RRMS Patients in Study

Gilenya (fingolimod) is an effective treatment for relapsing-remitting multiple sclerosis (RRMS) in everyday clinical practice, a new study shows. The therapy was shown to be effective even in patients switching from Tysabri (natalizumab) treatment.

The study, “Effectiveness and baseline factors associated to fingolimod response in a real-world study on multiple sclerosis patients,” was published in the Journal of Neurology.

The number of therapeutic options for patients with MS has increased significantly. However, the way patients react to certain medications in terms of efficacy and side effects can vary widely.

Therefore, early detection of patients who would actually benefit from a specific MS drug would be very useful in managing the disease.

Gilenya (marketed by Novartis) was the first oral drug to be approved for the treatment of RRMS, and its safety and efficacy has been demonstrated in several clinical trials.

Now, researchers in Italy set out to assess Gilenya’s effectiveness in a real-life setting by determining its effect on clinical and MRI parameters of disease activity. Researchers also wanted to investigate the predictors of persisting disease activity despite treatment, which is crucial in MS management.

Researchers evaluated 367 RRMS patients who started Gilenya treatment at San Raffaele Hospital in Milan, Italy, and underwent clinical and MRI evaluations for two years.

Treatment response was evaluated based on the proportion of patients who had no evidence of disease activity (NEDA) and the time it took to their first relapse after starting treatment. MRIs were conducted to see if there were any new lesions, which would indicate evidence of disease activity.

Some patients had been taking Tysabri the year before, which could confound the results. So for primary analysis, participants were divided into two groups according to their use of Tysabri — the Tysabri and no-Tysabri groups.

Results showed that almost half of the patients reached NEDA after two years. This was stratified by 53.4% in the no-Tysabri group and 36.2% in the Tysabri group.

In the no-Tysabri group, Gilenya’s impact on disease activity was observed after just six months of treatment, with a decrease in both the occurrence of relapses and new and enlarging lesions, as measured by brain MRI.

But in patients in the Tysabri group, researchers found increased disease activity in the first six months after the start of Gilenya treatment. This is in line with previous data, and can be explained by drug interactions between both therapies.

Nonetheless, at the two-year follow-up, both groups were comparable regarding relapse rate and number of new/enlarging lesions.

When looking at the efficacy of Gilenya as whole, researchers observed a significant decrease in annualized relapse rate. It was 0.78 at baseline before treatment, and 0.19 in the following two years, representing a 75% reduction.

Furthermore, there was a significant overall decrease in the mean number of new/enlarging lesions assessed by brain MRI scans performed at one and two years after treatment start.

In addition, only 8.8% of the entire patient cohort displayed a confirmed disability progression relapse.

Researchers also found that parameters of higher disease activity at baseline — like higher annualized relapse rate and more lesions — were associated with an increased likelihood of shorter time to relapse and failure to reach NEDA criteria.

“Our data strengthen [Gilenya] effectiveness in everyday clinical practice, even in patients switching from [Tysabri] treatment,” the researchers wrote.

The team also emphasized that baseline parameters of inflammatory activity are the most important prediction factors for disease reactivation, which can help guide how to select therapies toward more personalized care.