New data show Gilenya® (fingolimod) reduced brain volume loss by one third and confirm link between brain volume loss and MS disability

Novartis has announced new data indicating that continued treatment with Gilenya® (fingolimod) led to a reduction in brain volume loss in people with relapsing remitting multiple sclerosis (RRMS), and was associated with a higher proportion of people remaining free of disability progression compared to placebo.¹ These data were presented at the 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark.

Brain volume loss is emerging as a significant indicator of disability progression over the long-term in MS, and is a topic of much interest within the MS medical community.³ Loss of brain volume 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%.⁴

Increasingly, research focus is on treatments that will reduce the rate of brain volume loss. Fingolimod is the only NICE recommended oral treatment for RRMS that has shown early and consistent slowing of brain volume loss,5-8 and the new data presented at ECTRIMS add to the growing evidence base for fingolimod's efficacy and reinforce the correlation between brain volume loss and disability progression over the long-term.²

Professor of Neurology, Gavin Giovannoni from Barts and the London School of Medicine and Dentistry, London, commented: "Sophisticated imaging techniques, and in a depth neuropsychological assessments, have shown that MS is characterised by progressive brain volume loss and cognitive impairment, which impact on both the social and occupational functioning of people with the disease."

Key findings

• Collective four-year results from the pivotal FREEDOMS and FREEDOMS extension studies showed that people with MS who were treated continuously with fingolimod 0.5 mg experienced up to one-third less brain volume loss than those who switched to fingolimod after receiving placebo for two years. Thus, a delay in starting treatment with fingolimod by two years was associated with increased brain volume loss.¹
• Overall, people with MS who remained free of disease had consistently lower rates of brain volume loss compared to those who experienced disease activity and MS progression. However, the benefit of fingolimod on brain volume loss was seen irrespective of whether people with MS were disease-free or had active disease.¹ (Disease activity was evaluated by assessing measures that give a broad evaluation of MS: disability progression, relapses and new brain lesions detected on magnetic resonance imaging scans.)
• A separate analysis of three key studies (FREEDOMS, FREEDOMS II and TRANFORMS) showed a correlation between disability progression and increased brain volume loss, and this correlation increased over time.²
• Higher baseline MRI lesion volume and baseline active lesions both predicted subsequent loss of brain volume during the studies but people with MS treated with fingolimod had less brain volume loss than those treated with placebo or IFN beta 1a IM, irrespective of baseline lesion volume and count.⁹
• Minimising disease progression in people with MS is a key treatment goal because MS can have a significant impact on the quality of life for patients, families and carers. Many people with MS may increasingly lose their independence due to diminished mobility, and some may lose their ability to walk or have problems with their sight. MS is also associated with a substantial economic burden. In the UK the cost per MS patient per year is estimated to cost nearly £20,000. This is due to direct and indirect medical costs as well as productivity losses such as sick leave.¹⁰

Additional information on fingolimod

• Fingolimod is an effective once-daily oral MS treatment without market authorisation restrictions specific to treatment duration, making it a valuable option for appropriate people with highly active RRMS and the neurologists who treat them^6,7
• Fingolimod addresses a clinical need for an oral medication as a funded treatment option for patients with highly active RRMS who continue to relapse despite treatment with an interferon therapy¹¹
• There is increasing experience of fingolimod's long-term effectiveness and safety profile, and approximately 71,000 patients have received the treatment worldwide to date¹²
• Fingolimod has been approved in more than 75 countries. In the EU, fingolimod has been launched and reimbursed in a number of markets, including Germany, France, Denmark, Sweden, Norway, Austria, Greece, Italy, Spain, Belgium, Portugal and the Netherlands. Fingolimod has also been launched and reimbursed in other key markets including the United States, Canada, Australia and Switzerland.^12,13

The SmPC for fingolimod can be accessed here.