Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis.

ABSTRACT:

Background

Adalimumab has been used in patients with moderately to severely active rheumatoid arthritis (RA) for over 10 years and has a well-established safety profile across multiple indications.

Objective

To update adverse events (AEs) of special interest from global adalimumab clinical trials in patients with RA.

Methods

This analysis includes 15 132 patients exposed to adalimumab in global RA clinical trials. AEs of interest included overall infections, laboratory abnormalities and AEs associated with influenza vaccination. Pregnancy outcome data were collected from the Adalimumab Pregnancy Registry.

Results

Serious infections and tuberculosis occurred at a rate of 4.7 and 0.3 events/100 patient-years, respectively. Two patients experienced hepatitis B rea

SUBMITTER: Burmester GR 

PROVIDER: S-EPMC5284339 | biostudies-literature | 2017 Feb

REPOSITORIES: biostudies-literature