Abstract
Objective
The study objective was to evaluate and update the safety data from randomized controlled
trials of tumor necrosis factor inhibitors in patients treated for rheumatoid arthritis.
Methods
A systematic literature search was conducted from 1990 to May 2013. All studies included
were randomized, double-blind, controlled trials of patients with rheumatoid arthritis
that evaluated adalimumab, certolizumab pegol, etanercept, golimumab, or infliximab
treatment. The serious adverse events and discontinuation rates were abstracted, and
risk estimates were calculated by Peto odds ratios (ORs).
Results
Forty-four randomized controlled trials involving 11,700 subjects receiving tumor
necrosis factor inhibitors and 5901 subjects receiving placebo or traditional disease-modifying
antirheumatic drugs were included. Tumor necrosis factor inhibitor treatment as a
group was associated with a higher risk of serious infection (OR, 1.42; 95% confidence
interval [CI], 1.13-1.78) and treatment discontinuation due to adverse events (OR,
1.23; 95% CI, 1.06-1.43) compared with placebo and traditional disease-modifying antirheumatic
drug treatments. Specifically, patients taking adalimumab, certolizumab pegol, and
infliximab had an increased risk of serious infection (OR, 1.69, 1.98, and 1.63, respectively)
and showed an increased risk of discontinuation due to adverse events (OR, 1.38, 1.67,
and 2.04, respectively). In contrast, patients taking etanercept had a decreased risk
of discontinuation due to adverse events (OR, 0.72; 95% CI, 0.55-0.93). Although ORs
for malignancy varied across the different tumor necrosis factor inhibitors, none
reached statistical significance.
Conclusions
These meta-analysis updates of the comparative safety of tumor necrosis factor inhibitors
suggest a higher risk of serious infection associated with adalimumab, certolizumab
pegol, and infliximab, which seems to contribute to higher rates of discontinuation.
In contrast, etanercept use showed a lower rate of discontinuation. These data may
help guide clinical comparative decision making in the management of rheumatoid arthritis.
Keywords
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Article info
Publication history
Published online: June 17, 2014
Footnotes
Funding: This research was supported by the National Institutes of Health (RC1AR058601).
Conflict of Interest: None.
Authorship: All authors had access to the data and played a role in writing this manuscript.
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© 2014 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
