Safety with ocrelizumab in rheumatoid arthritis: results from the ocrelizumab phase III program.

ABSTRACT:

Objective

The objective was to determine the safety of ocrelizumab (OCR) in patients with rheumatoid arthritis (RA).

Methods

This was an analysis of the double-blind, placebo-controlled periods and long-term follow-up of 4 OCR phase III trials in RA (SCRIPT, STAGE, FILM and FEATURE). Safety data per study and the results of a meta-analysis of serious infectious events (SIEs) are presented.

Results

Overall, 868 patients received placebo, 1064 patients OCR 200 mg×2 (or 400 mg×1) (OCR200), and 827 patients OCR 500 mg×2 (OCR500) plus background methotrexate (MTX) at baseline and 24 weeks. During the double-blind, placebo-controlled periods, the incidence of adverse events and serious adverse events was comparable between the OCR+MTX and placebo +MTX groups. Infusion-relat

SUBMITTER: Emery P 

PROVIDER: S-EPMC3911947 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature