#ECTRIMS2016 – MS Patients on Oral Gilenya Stick Longer with Treatment in Phase 4 Study

A recent study showed that after one year, the majority of multiple sclerosis (MS) patients taking oral Gilenya (fingolimod) therapy stuck with their treatment, while a large proportion of those using injectable disease-modifying drugs did not.

The data, presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2016 Congress in London (Sept. 14–17), also showed that Gilenya-treated patients were more satisfied with the treatment, and had less brain volume loss than patients on injectable drugs.

The PREFER-MS trial (NCT01623596) was a Phase 4 study evaluating treatment retention — how long patients stick with a given therapy — in the largest study of its kind to date. The study included 875 relapsing MS patients, who were randomized to receive either 0.5 mg Gilenya, or injections of interferon beta or Copaxone (glatiramer acetate); 422 started with Gilenya and 428 with injections. Its primary endpoint, treatment retention, found that 81.3% of participants remained on Gilenya for the year, compared to 29.2% who stayed with  injected therapies.

In contrast to most randomized trials, patients had the opportunity to switch treatments after at least three months. A switch was permitted only once, but if a patient had problems with side effects or a lack of treatment effect, switches were allowed anytime during the study.

In the injectable group, 257 patients (90.5%) decided to switch to Gilenya, while only 9.5% changed from Gilenya to injectable therapies.

The aim of the study was not to examine how effective the two types of treatments were in relation to each other, or how a switch impacted treatment effectivity, as the number of patients included was too small to detect such changes.

At the study’s end, 77.4% of the patients taking Gilenya stated that they were satisfied with their treatment, while only 47.7% of those being treated with injectable drugs expressed satisfaction.

The trial also measured brain volume loss in the participants, and researchers noted that Gilenya-treated patients had significantly lower rates of brain volume loss than patients treated with other disease-modifying drugs: 0.48% and 0.75%, respectively.

“These additional analyses from our large well-controlled study demonstrate our ongoing commitment to help improve patient outcomes in MS and address some of the key challenges healthcare providers face on a day-to-day basis,” Marcia Kayath, MD, vice president and head of U.S. Clinical Development and Medical Affairs at Novartis, said in a news release.

In the group that switched from injectables to Gilenya, the rates of adverse events became lower, although the rates of side effects that led patients to stop treatment, as well as the rate of severe side effects, remained unchanged. No new safety issues emerged during the study.