Early Use of Tecfidera and Tysabri Improves MS Patients’ Outcomes, Studies Suggest

The latest results on Tecfidera (dimethyl fumarate) and Tysabri (natalizumab) use in a clinical practice setting suggest that early treatment can improve outcomes in multiple sclerosis (MS) patients.

This and other recent data on Tecfidera and Tysabri for the treatment of MS will be presented by Biogen at the 2017 Annual Meeting of the American Academy of Neurology (AAN) April 22-28 in Boston.

Based in Cambridge, Massachusetts, Biogen is focused on the development and marketing of therapies for people living with serious neurological and neurodegenerative diseases. The company has a leading portfolio of drugs to treat MS symptoms, including Tecfidera and Tysabri.

“Biogen’s commitment to improving outcomes for people living with MS spans more than two decades, during which time we’ve fundamentally changed the treatment of the disease. We are now applying our expertise in neurology to discover and develop new therapies to address some of the most challenging and complex diseases of the brain,” Alfred Sandrock, executive vice president and chief medical officer at Biogen, said in a press release.

Tecfidera is the world’s most prescribed oral therapy for relapsing forms of MS. Several clinical trials have proven its effectiveness in reducing the rate of MS relapses and slowing disease progression, although the mechanisms of the drug are still unclear. Researchers believe that its beneficial effects are mediated through antioxidant and anti-inflammatory activities.

One of Biogen’s presentations at AAN 2017, titled “Tecfidera modulates short term metabolomic signatures in people with multiple sclerosis,” will show results confirming that Tecfidera treatment induces alterations in blood metabolites that are consistent with an antioxidant activity. This finding suggests that Tecfidera inhibits MS progression via protection of neurological tissues from oxidative damage.

Available for more than 10 years, Tysabri is an antibody that selectively blocks the activity of inflammatory cells in MS patients. Its mechanism of action impairs the migration of immune cells to the sites of inflammation. Although it is a proven drug in the battle against MS, the specific mechanism by which Tysabri exerts its effects have not been fully defined.

The Tysabri Observational Program (TOP) (NCT00493298), an ongoing 10-year observational study providing long-term data on relapsing-remmiting MS (RRMS) patients undergoing treatment in clinical practice settings, aims to evaluate Tysabri’s long-term effects and safety.

Based on TOP results, to be presented in detail at AAN 2017, researchers found that patients who started treatment in an early stage of the disease showed improved outcome compared to those who started later.

“Early MS disability may reflect inflammation that can be mitigated by timely natalizumab [Tysabri] treatment, whereas later disability may be more resistant to recovery,” the researchers wrote.

In addition, a long-term analysis showed that despite the beneficial effects of the treatment, about 16 percent of the patients stopped taking drug. This is mainly due to the risk of contracting an opportunistic viral infection of the brain, called progressive multifocal leukoencephalopathy (PML).

The recent findings on Biogen’s MS therapies not only help understand their underling therapeutic mechanisms, but also support their effectiveness and safety in a clinical practice setting.