TYSABRI® (natalizumab) Data at ECTRIMS Reaffirm Positive Effects of Treatment for People with Relapsing Forms of MS

Posted: Published on October 12th, 2012

This post was added by Dr Simmons

WESTON, Mass. & DUBLIN--(BUSINESS WIRE)--

Today, Biogen Idec (BIIB) and Elan Corporation, plc (ELN) announced that results from 11 company-sponsored TYSABRI presentations, including 10 posters and one platform, will be available for viewing at the 28TH Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Lyon, France, October 10 13.

Key data highlights from ECTRIMS include:

These data further establish the benefits of TYSABRI in reducing relapse rates and slowing disease progression, said Alfred Sandrock, M.D., Ph.D., senior vice president, Development Sciences and Chief Medical Officer, Biogen Idec. Data from TOP demonstrate that patients who began TYSABRI earlier had better outcomes than patients in the study who were switched to TYSABRI at two years, further demonstrating the positive effect TYSABRI can make for those living with MS.

Multiple sclerosis (MS) is an often debilitating disease of the brain and spinal cord that affects nearly 2.1 million people worldwide. While a number of disease modifying therapies are currently available, an unmet need remains for effective treatment options.

Common symptoms of MS, such as cognitive difficulties, fatigue and visual function can have a tremendous impact on people living with MS. said Hans Peter Hasler, Chief Operating Officer, Elan Corporation, plc. The encouraging outcomes from the data presented at ECTRIMS, together with TYSABRIs proven efficacy, continue to support its strength as a valuable treatment for MS patients around the world.

SELECT TYSABRI PRESENTATIONS AT ECTRIMS:

The objective of the TYSABRI Observational Program (TOP) is to evaluate long-term safety, efficacy, associations between baseline treatment history and post baseline annualized relapse rate (ARR), and overall two-year clinical disease-activityfree status in RRMS patients treated with TYSABRI. As of June 1, 2012, 4434 patients were enrolled.

Results from TOP demonstrate that in the post marketing setting TYSABRI treatment has an effect on ARR, which is also accompanied by stable EDSS over four years. ARRs were lower in treatment-nave patients than in previously treated patients, and lower in patients with EDSS score <3.0 at baseline. Overall, the incidence of serious adverse events, including infections, reported in TOP are consistent with the known safety profile of TYSABRI.

The objective of the TYNERGY trial was to evaluate whether improvement in MS-related fatigue during TYSABRI treatment is associated with significant improvement of health-related quality of life (HRQoL) in a multicenter, single-arm, non-randomized, open-label, prospective, observational study (TYNERGY) in patients with RRMS who are TYSABRI treatment nave at baseline.

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TYSABRI® (natalizumab) Data at ECTRIMS Reaffirm Positive Effects of Treatment for People with Relapsing Forms of MS

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