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Fingolimod (Gilenya) Achieves ‘No Evidence of Disease Activity’ in MS Patients

Drug targets both focal and diffuse CNS damage

New analyses have supported the efficacy of fingolimod (Gilenya, Novartis) in achieving “no evidence of disease activity” (NEDA) in patients with relapsing-remitting multiple sclerosis (RRMS) across four key disease measures: relapses, magnetic resonance imaging (MRI) lesions, brain shrinkage (i.e., brain volume loss), and disability progression.

Specifically, patients treated with fingolimod had a more than four-times greater likelihood of achieving NEDA across these four key measures compared with patients given placebo (odds ratio: 4.41; P < 0.0001).

The findings were presented at the sixth Triennial Joint Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis and the European Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS–ECTRIMS) in Boston.

NEDA is currently defined as the absence of relapses, MRI lesions, or disability progression. The new analyses from the phase III FREEDOMS and FREEDOMS II trials support the inclusion of brain shrinkage in the definition of NEDA, which allows physicians to obtain a more complete assessment of a patient's disease, including the underlying damage in MS.

The loss of physical and cognitive function in MS is driven by two types of damage that result in the loss of neurons and brain tissue: distinct inflammatory lesions (focal damage), and more widespread inflammatory neurodegenerative processes (diffuse damage). Inflammatory lesions result in the loss of brain tissue and can clinically present as relapses. Widespread inflammatory damage starts early in the disease, often goes unnoticed, and is associated with the loss of brain tissue and the accumulated loss of function. Redefining NEDA to include four key measures of MS addresses both types of damage.

MS is a chronic disorder of the central nervous system (CNS) that disrupts the normal functioning of the brain, optic nerves, and spinal cord through inflammation and tissue loss. The evolution of MS results in an increasing loss of both physical (e.g., walking) and cognitive (e.g., memory) functions. This has a substantial negative effect on the approximately 2.3 million people worldwide affected by MS, a disease that begins in early adulthood, most often between the ages of 20 and 40.

Fingolimod targets both focal and diffuse CNS damage. The drug prevents cells that cause focal inflammation from reaching the brain (“peripheral” activity). It also enters the CNS and reduces diffuse damage by preventing the activation of harmful cells residing in the CNS (“central” activity).

Source: Novartis; September 12, 2014.

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