Novartis’’ Gilenya reduces brain volume loss by one third in MS patients: Study

Basel

Novartis announced new data indicating that continued treatment with Gilenya (fingolimod) led to a reduction in brain volume loss in patients with relapsing forms of multiple sclerosis (MS), and was associated with a higher proportion of patients remaining free of disability progression [1],[2]. 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 one of the best indicators of disability progression over the long-term in MS, and is a topic of much interest within the MS medical community[3]. Increasingly, research focus is on treatments that will reduce the rate of brain volume loss. Gilenya is the only oral treatment for MS that has shown early and consistent slowing of brain volume loss, and the new data presented at ECTRIMS add to the growing evidence base of Gilenya’s efficacy in MS and reinforce the correlation between brain volume loss and disability progression over the long-term[1].

“The data presented are very encouraging because they are from studies that took place over four years and show that Gilenya both reduces brain volume loss and slows the pace of disability progression for patients with MS,” said Dr Timothy Wright, Global Head Development, Novartis Pharmaceuticals. “These are key treatment goals for patients with this chronic and debilitating illness.”

The key findings

Collective four-year results from the pivotal FREEDOMS and FREEDOMS extension studies showed that patients who were treated continuously with Gilenya 0.5 mg experienced up to one-third less brain volume loss than patients who switched to Gilenya after receiving placebo for two years. Thus, delay in starting treatment with Gilenya by two years was associated with more brain volume loss[2].

• Overall, patients who remained free of disease had consistently lower rates of brain volume loss compared to patients who experienced disease activity and MS progression. However, the benefit of Gilenya on brain volume loss was seen irrespective of whether patients were disease-free or had active disease[2]. (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[1].
• Higher baseline MRI lesion volume and baseline active lesions both predicted subsequent loss of brain volume during the studies but patients treated with Gilenya had less brain volume loss than those treated with placebo or IFN beta 1a IM, irrespective of baseline lesion volume and count[4].

MS patients with higher brain volume loss were more likely to experience disability progression[1].

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 careers. Many patients 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, with studies in several European countries reporting annual costs equivalent to approximately ¤ 30,000-40,000 per patient[5].

References:

1. Barkhof F, Cohen JA et al. Brain volume changes, on-study correlations and the link to disability in three fingolimod phase 3 studies. ECTRIMS 2013, Copenhagen, Denmark.
2. Radue E-W, de Stefano N et al. Brain atrophy and disease-free status over 4 years: analyses of the FREEDOMS core and extension trial data. ECTRIMS 2013, Copenhagen, Denmark.
3. Preventing brain atrophy should be the gold standard of effective therapy in multiple sclerosis (after the first year of treatment): Commentary. Controversies in Multiple Sclerosis. Multiple Sclerosis Journal19(8) 1007-1008.
4. Radue E-W, Cohen J et al. Baseline predictors of brain atrophy in phase 3 studies of fingolimod. ECTRIMS 2013, Copenhagen, Denmark.
5. Karampampa K et al. Treatment experience, burden and unmet needs (TRIBUNE) in MS study: results from five European countries. Mult Scler. 2012 Jun;18(2 Suppl):7-15.