Update on the safety profile of certolizumab pegol in rheumatoid arthritis: an integrated analysis from clinical trials.

ABSTRACT:

Objective

To report the long-term safety data of certolizumab pegol (CZP) in rheumatoid arthritis (RA) accumulated as of 30 November 2011.

Design

Data from 10 completed randomised controlled trials (RCT) of CZP in RA and several open-label extensions (OLE) were pooled across all doses. Reported adverse events (AE) occurred between the first dose and 84 days after the last dose. All deaths, serious infectious events (SIE) and malignancies were reviewed by external experts, classified according to predefined rules, and validated by an external steering committee. Incidence rates (IR) and event rates (ER) per 100 patient-years (PY) are presented.

Results

4049 RA patients who received CZP were included in the safety pooling; total exposure 9277 PY, mean exposure 2.1 years

SUBMITTER: Bykerk VP 

PROVIDER: S-EPMC4283674 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature