A study analyzing results from three Phase 3 clinical trials shows that Gilenya (fingolimod) effectively prevents relapses in different types of relapsing multiple sclerosis (MS) patients, with the therapy being most efficient in younger patients and those without previous treatment. The findings highlight the importance of starting treatment early, and not reserving the therapy for patients who fail to respond to other treatments.
Despite differences between patient groups, the study, “Relapse rates in patients with multiple sclerosis treated with fingolimod: Subgroup analyses of pooled data from three phase 3 trials,” published in the journal Multiple Sclerosis and Related Disorders, demonstrated that Gilenya is superior to Avonex (interferon-beta 1a) in preventing relapses in most patients, including those who have already progressed into disability.
FREEDOMS (NCT00289978), FREEDOMSII (NCT00355134), and TRANSFORMS (NCT00340834) were Phase 3 trials exploring if Gilenya was more effective than placebo or intramuscular Avonex. All three studies found Gilenya (produced by Novartis) to be superior to both placebo and Avonex, but so far, researchers have not performed a detailed analysis of how the treatment performs in particular subgroups of patients.
In many countries, including those in the European Union, Gilenya is considered a second line of treatment when other treatments fail, a practice based on financial incentives. There is, however, not much data showing if this order of treatment is beneficial for patients.
Researchers at the University Hospital Basel divided patients by age (younger or older than 40), sex, previous treatment, the number of gadolinium-enhancing brain lesions. the number of relapses before study start, and the level of disability at study start.
Gilenya was found to be 64 percent more effective than placebo in preventing relapses in those age 40 or younger. This efficiency dropped to 35 percent in older patients. Compared to Avonex, Gilenya was 55 percent more effective in the younger age group, but only 23 percent superior among patients older than 40 — a difference in this age group that was not statistically significant. Gilenya was also not more effective than Avonex in men or patients previously treated for one year or less.
In untreated patients, Gilenya was found to be 63 percent more effective than placebo and 51 percent better than Avonex in preventing relapses. Among all previously treated patients, no matter the length of earlier therapy, Gilenya was 48 and 44 percent better than Avonex and placebo, respectively. The type of previous treatment did not impact the results.
As could be suspected, patients who had a high level of disability or disease activity — with more numbers of brain lesions and relapses before study start — had more relapses than other patients when treated with Gilenya. Nevertheless, the drug was 46 percent to 59 percent better than placebo, and 39 percent to 51 percent better than Avonex in preventing relapses in these groups of patients as well.
Disease duration also turned out to impact treatment responses. In those who had experienced symptoms less than three years before the study’s start, Gilenya was 69 percent better than placebo and 50 percent better than Avonex in keeping relapses at bay. These numbers dropped to 49 percent compared to placebo and 46 percent for Avonex in patients who had been sick for more than three years, suggesting that the current praxis of reserving Gilenya as a drug for those failing to respond to first-line drugs should be revised.
In the U.S., Gilenya was approved as a first-line relapsing MS treatment by the U.S. Food and Drug Administration (FDA) in September 2010.