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Arthritis Res Ther. 2011;13(5):R141. doi: 10.1186/ar3455. Epub 2011 Sep 1.

Integrated safety in tocilizumab clinical trials.

Author information

1
Rheumatology Division, University of Colorado School of Medicine, 5400 South Monaco Street, Greenwood Village, CO 80111, USA. Lmschiff@aol.com

Abstract

INTRODUCTION:

The efficacy and safety of tocilizumab in patients with rheumatoid arthritis have been evaluated in a comprehensive phase 3 program. Patients from these randomized trials could receive tocilizumab treatment in open-label extension trials. Here, the long-term safety profile of tocilizumab, using pooled data from all of these trials, is reported.

METHODS:

Cumulative safety data (as of February 6, 2009) from five core phase 3 trials, two ongoing extension trials, and one clinical pharmacology study were analyzed. Two patient populations were evaluated: an all-control population (n = 4,199), which included all patients randomly assigned in the placebo-controlled portions of the five core studies, and an all-exposed population (n = 4,009), which included patients from any of the eight studies who received at least one dose of tocilizumab.

RESULTS:

Total exposure to tocilizumab was 8,580 patient years (PY), and total duration of observation was 9,414 PY. Overall adverse event (AE) and serious AE (SAE) rates were 278.2/100 PY and 14.4/100 PY, respectively. These events included serious infections (4.7/100 PY), opportunistic infections (0.23/100 PY), gastrointestinal perforations (0.28/100 PY), malignancy (1.1/100 PY), myocardial infarction (0.25/100 PY), and stroke (0.19/100 PY). The rates of SAEs and serious infections were stable over time; no increase with prolonged exposure was noted.

CONCLUSIONS:

The longer-term safety profile of tocilizumab (mean treatment duration, 2.4 years) is consistent with that observed in the phase 3 studies (duration up to 1 year).

PMID:
21884601
PMCID:
PMC3308069
DOI:
10.1186/ar3455
[Indexed for MEDLINE]
Free PMC Article

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