Long-term safety and effectiveness of natalizumab redosing and treatment in the STRATA MS Study.

ABSTRACT:

Objectives

Report long-term safety and effectiveness of natalizumab over 240 weeks in the prospective, observational, open-label Safety of TYSABRI Re-dosing and Treatment (STRATA) Study.

Methods

Patients (N = 1,094) previously enrolled in natalizumab multiple sclerosis clinical trials received natalizumab 300 mg IV every 4 weeks, up to 240 weeks. Serious adverse events, Expanded Disability Status Scale (EDSS) scores, and annualized relapse rates were analyzed.

Results

At data cutoff (February 9, 2012), natalizumab exposure was 3,460 patient-years; a median of 56 (range 1-70) infusions were received. Serious adverse events, including progressive multifocal leukoencephalopathy, were consistent with natalizumab's known profile. Upon natalizumab re-exposure, rates of anti

SUBMITTER: O'Connor P 

PROVIDER: S-EPMC4114173 | biostudies-literature | 2014 Jul

REPOSITORIES: biostudies-literature