Gilenya® (Fingolimod) Demonstrates Consistent Benefits In Reduction Of Relapses And Brain Volume Loss In Relapsing-Remitting Multiple Sclerosis

Data presented at the 65th annual meeting of the American Academy of Neurology (AAN) show Gilenya® (fingolimod), the first and only once-daily oral therapy reimbursed to treat highly active relapsing-remitting multiple sclerosis (RRMS), significantly and consistently reduced the rate of brain volume loss and reduced relapse rates compared to interferon beta-1a IM or placebo.(1,2,4) The new data add to the growing body of evidence for fingolimod regarding its early efficacy benefits and long-term safety profile. 

Consistent efficacy: reduction in rate of brain volume loss

Fingolimod continues to show a significant reduction in the rate of brain volume loss by nearly a third and within the first six months of treatment when compared to placebo or interferon beta-1a IM, a commonly prescribed injectable treatment.1 The new analysis of over 3,600 patients from three large Phase III studies (TRANSFORMS, FREEDOMS, and FREEDOMS II) was consistent with previously reported results.(1,5) 

Loss of brain volume (also known as brain atrophy) has been observed to occur at higher rates in patients with MS than in the general population. The average rate of brain volume loss in a person without MS over one year is 0.1% to 0.3%.(6) 

In the TRANSFORMS study over one year, fingolimod reduced the rate of brain volume loss by 31% compared to interferon beta-1a IM (mean percent brain volume change of -0.31 for fingolimod vs. -0.45 for interferon beta-1a IM; p<0.001). Over two years, fingolimod reduced the rate of brain volume loss compared to placebo by 36% (mean percent brain volume change of -0.84% for fingolimod vs. -1.31% for placebo; p<0.001) in the FREEDOMS study, and by 33% (mean percent brain volume change of -0.86% for fingolimod vs. -1.28% for placebo; p<0.001) in the FREEDOMS II study, respectively.(1) 

Consistent efficacy: reduction in relapse rates

Throughout the extensive Phase III programme, fingolimod has consistently shown significant reductions in relapse rates. The most recent addition to this growing body of evidence is new data from the one-year TRANSFORMS extension study (n=341). The study, which included a predictive model to estimate the relapse rate had patients remained on interferon beta-1a IM, showed that patients who were treated with fingolimod experienced a two fold increase in the time-to-first relapse compared with interferon beta-1a IM.(4) 

In addition, a subgroup analysis of FREEDOMS II showed fingolimod consistently reduced annualised relapse rates (ARR) compared to placebo in patients with RRMS, across gender, age, prior treatment, and baseline disease activity.(2) 

Consistent safety profile: no unexpected safety concerns from new analysis New extension data from FREEDOMS II (n=632) reinforce the known safety profile of fingolimod in patients treated up to four years.7 More than eight out of ten patients (83%) completed the extension study, which identified no unexpected safety concerns.7 With up to seven years of clinical trial experience (Phase II and III) and over two years of real-world use, this adds to the increasing experience of the long-term effectiveness and safety profile of fingolimod in more than 56,000 patients worldwide.(3)