Efficacy and safety of natalizumab in multiple sclerosis: interim observational programme results.

ABSTRACT:

Background

Clinical trials established the efficacy and safety of natalizumab. Data are needed over longer periods of time and in the clinical practice setting.

Objective

To evaluate long-term safety of natalizumab and its impact on annualised relapse rate and Expanded Disability Status Scale (EDSS) progression in patients with relapsing-remitting multiple sclerosis (RRMS).

Methods

The Tysabri (natalizumab) Observational Program (TOP) is an open-label, multinational, 10-year prospective study in clinical practice settings.

Results

In this 5-year interim analysis, 4821 patients were enrolled. Follow-up for at least 4 years from natalizumab commencement in 468 patients and at least 2 years in 2496 patients revealed no new safety signals. There were 18 cases of pr

SUBMITTER: Butzkueven H 

PROVIDER: S-EPMC4215289 | biostudies-literature | 2014 Nov

REPOSITORIES: biostudies-literature