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Rheumatology Advance Access published online on November 11, 2009
Rheumatology, doi:10.1093/rheumatology/kep325
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© The Author 2009. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

Initiation of rheumatoid arthritis treatments and the risk of serious infections

Carlos G. Grijalva1, Lisa Kaltenbach2, Patrick G. Arbogast1,2, Edward F. Mitchel, Jr1 and Marie R. Griffin1,3,4

1Department of Preventive Medicine, Center for Education and Research on Therapeutics, 2Department of Biostatistics, 3Department of Medicine, Vanderbilt University School of Medicine and 4Mid-South Geriatric Research Education and Clinical Center, VA TN Valley Health Care System, Nashville, TN, USA

Correspondence to: Carlos G. Grijalva, Department of Preventive Medicine, Center for Education and Research on Therapeutics, Vanderbilt University School of Medicine, 1500 21st Avenue Suite 2600, The Village at Vanderbilt, Nashville, TN 37232-2637, USA. E-mail: carlos.grijalva{at}vanderbilt.edu


  Abstract

Objective. In clinical trials of RA patients on traditional DMARDs, the addition of TNF-{alpha} antagonists increased infections compared with addition of placebo. Our objective was to compare serious infections following initiation of different RA regimens. Prior comparative studies of DMARD initiation have yielded conflicting results.

Methods. We estimated hospitalization rates for infections following initiation of TNF-{alpha} antagonists, other DMARDs and oral glucocorticoids in Tennessee Medicaid-enrolled RA patients (1995–2005). Exposure time was measured using pharmacy information and infections were identified using validated definitions. Initiation of RA regimens was compared using Cox regression models with MTX as the reference. Sensitivity analyses excluded glucocorticoid users, applied a first exposure carried forward approach, restricted observations to 2002–05 and first episodes of use and explored effects of unmeasured confounders.

Results. We identified 28 906 new episodes of medication use, including TNF-{alpha} antagonists (8%), MTX alone (15%) and glucocorticoids alone (57%). Compared with MTX initiation, TNF-{alpha} antagonist initiation did not significantly increase the risk of hospitalizations for pneumonia [adjusted hazard ratio (aHR) 1.61; 95% CI 0.85, 3.03] or any infection (aHR 1.31; 95% CI 0.78, 2.19). Initiation of LEF, SSZ or HCQ did not increase serious infections, compared with MTX. Both initiation and concurrent glucocorticoid use were associated with a dose-dependent increase in serious infections. Sensitivity analyses showed consistent results.

Conclusions. Compared with initiation of MTX alone, initiation of TNF-{alpha} antagonists was not associated with a large increase in the risk of serious infections. Glucocorticoid use was associated with a dose-dependent increase in the risk of these infections.

KEY WORDS: Rheumatoid arthritis, Biologic therapies, Epidemiology, Infections

Submitted 26 June 2009; revised version accepted 8 September 2009.
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