A new analysis from pivotal phase III studies for once daily pill Gilenya (fingolimod) has confirmed that people with highly active relapsing multiple sclerosis (RRMS) treated with fingolimod were nearly six times more likely to achieve no evidence of disease activity across four key measures compared to placebo over two years.1 The analysis was presented at the 67th American Academy of Neurology (AAN) Annual Meeting in Washington, DC, USA.
No evidence of disease activity (NEDA) is a new treatment goal that reflects a shift in expectations to a more complete response to disease modifying therapies (DMTs), such as fingolimod.1,2 NEDA4 incorporates normalised brain volume loss as its fourth component, in addition to relapse reduction, MRI and disability progression.1 NEDA4 is achieved when a patient has no relapses, no new MRI lesions, no MS-related brain volume loss and no disability progression.1
The analysis from the pivotal phase III FREEDOMS and FREEDOMS II studies set out to examine the impact of fingolimod treatment on NEDA4 outcomes in patients with high disease activity, despite prior use of a DMT.1 The results showed that fingolimod-treated patients were almost six times more likely to achieve NEDA4 status (no relapses, no new MRI lesions, no MS-related brain volume loss and no disability progression) compared to patients treated with placebo.1
According to Professor Gavin Giovannoni, Chair of Neurology, Barts and The London School of Medicine and Dentistry and Barts Health NHS Trust: "The realisation that multiple sclerosis affects cognition very early on in the course of the disease, before physical disability becomes apparent, stresses the importance of treatments that don't just reduce relapses and new lesion formation on MRI but which also reduce accelerated brain volume loss. It is therefore very reassuring to note that people with highly-active relapsing-remitting MS are nearly six times more likely to achieve NEDA4 on fingolimod compared to placebo. NEDA4 is new treatment target of no evident disease activity that incorporates 'normalised' brain volume loss as its fourth component, in addition to relapse reduction, MRI and disability progression."
The results from this new analysis confirmed:1
- 20.5% of patients treated with fingolimod (n=218) achieved NEDA4 status compared to 3.9% in the placebo group (n=229)
- Comparing between the two treatment arms, the odds ratio for achieving NEDA4 status was 6.35 (95%CI 3.02, 13.35) favouring fingolimod (p
The concept of NEDA is well established in other conditions such as rheumatoid arthritis, where the aim is to treat people as soon as possible after diagnosis to prevent a build-up of symptoms, rapidly switching to more effective drugs when there is no response to first line treatments.2
The new analysis presented at AAN follows a series of recent decisions by the European Commission, Scottish Medicines Consortium (SMC) and NHS England to extend the use of fingolimod to a wider group of people since its original licence in 2011.3,4,5
To date, more than 100,000 people worldwide have been treated with fingolimod in clinical trials and in the post-marketing setting. Fingolimod has been approved in 80 countries.6