Survival in MS: a randomized cohort study 21 years after the start of the pivotal IFNβ-1b trial.

ABSTRACT:

Objective

To examine the effects of interferon beta (IFNβ)-1b on all-cause mortality over 21 years in the cohort of 372 patients who participated in the pivotal randomized clinical trial (RCT), retaining (in the analysis) the original randomized treatment-assignments.

Methods

For this randomized long-term cohort study, the primary outcome, defined before data collection, was the comparison of all-cause mortality between the IFNβ-1b 250 μg and placebo groups from the time of randomization through the entire 21-year follow-up interval (intention-to-treat, log-rank test for Kaplan-Meier survival curves). All other survival outcomes were secondary.

Results

After a median of 21.1 years from RCT enrollment, 98.4%(366 of 372) of patients were identified, and, of these, 81 de

SUBMITTER: Goodin DS 

PROVIDER: S-EPMC3335454 | biostudies-literature | 2012 Apr

REPOSITORIES: biostudies-literature