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Initiation of Tumor Necrosis Factor-α Antagonists and the Risk of Hospitalization for Infection in Patients With Autoimmune Diseases

作者:Carlos Gabriel Grijalva, Lang Chen, Elizabeth Delzell, John W. Baddley, Timothy Beukelman, Kevin L. Winthrop, Marie R. Griffin, Lisa J. Herrinton, Liyan Liu, Rita Ouellet‐Hellstrom, Nivedita M. Patkar, Daniel H. Solomon, James D. Lewis, Fenglong Xie, Kenneth G. Saag, Jeffrey R. Curtis · 发表于:JAMA · 年份:2011 · DOI:10.1001/jama.2011.1692 · 被引用次数:353 · 研究领域:Rheumatoid Arthritis Research and Therapies、Spondyloarthritis Studies and Treatments、Psoriasis: Treatment and Pathogenesis

CONTEXT: Although tumor necrosis factor (TNF)-α antagonists are increasingly used in place of nonbiologic comparator medications, their safety profile remains incomplete. OBJECTIVES: To determine whether initiation of TNF-α antagonists compared with nonbiologic comparators is associated with an increased risk of serious infections requiring hospitalization. DESIGN, SETTING, AND PATIENTS: Within a US multi-institutional collaboration, we assembled retrospective cohorts (1998-2007) of patients with rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and psoriasis, psoriatic arthritis, or ankylosing spondylitis (psoriasis and spondyloarthropathies) combining data from Kaiser Permanente Northern California, New Jersey and Pennsylvania Pharmaceutical Assistance programs, Tennessee Medicaid, and national Medicaid/Medicare. TNF-α antagonists and nonbiologic regimens were compared in disease-specific propensity score (PS)-matched cohorts using Cox regression models with nonbiologics as the reference. Baseline glucocorticoid use was evaluated as a separate covariate. MAIN OUTCOME MEASURE: Infections requiring hospitalization (serious infections) during the first 12 months after initiation of TNF-α antagonists or nonbiologic regimens. RESULTS: Study cohorts included 10,484 RA, 2323 IBD, and 3215 psoriasis and spondyloarthropathies matched pairs using TNF-α antagonists and comparator medications. Overall, we identified 1172 serious infections, most of which (53%) were pneumonia...