Risk of serious bacterial infections among rheumatoid arthritis patients exposed to tumor necrosis factor alpha antagonists
Authors
Curtis, Jeffrey R.Patkar, Nivedita M.
Xie, Aiyuan
Martin, Carolyn K.
Allison, Jeroan J.
Saag, Michael S.
Shatin, Deborah
Saag, Kenneth G.
UMass Chan Affiliations
Department of Quantitative Health SciencesDocument Type
Journal ArticlePublication Date
2007-03-30Keywords
Antibodies, MonoclonalAntirheumatic Agents
Arthritis, Rheumatoid
Bacterial Infections
Cohort Studies
Female
Health Maintenance Organizations
Humans
Immunocompromised Host
Immunoglobulin G
Immunosuppressive Agents
Methotrexate
Middle Aged
Receptors, Tumor Necrosis Factor
Retrospective Studies
Risk Factors
Tumor Necrosis Factor-alpha
United States
Bioinformatics
Biostatistics
Epidemiology
Health Services Research
Metadata
Show full item recordAbstract
OBJECTIVE: To evaluate the risk of serious bacterial infections associated with tumor necrosis factor alpha (TNFalpha) antagonists among rheumatoid arthritis (RA) patients. METHODS: A retrospective cohort study of US RA patients enrolled in a large health care organization identified patients who received either TNFalpha antagonists or methotrexate (MTX). Administrative data were used to identify hospitalizations with possible bacterial infections; corresponding medical records were abstracted and reviewed by infectious disease specialists for evidence of definite infections. Proportional hazards models evaluated time-dependent infection risks associated with TNFalpha antagonists. RESULTS: Hospital medical records with claims-identified suspected bacterial infections were abstracted (n=187) among RA patients who received TNFalpha antagonists (n=2,393; observation time 3,894 person-years) or MTX (n=2,933; 4,846 person-years). Over a median followup time of 17 months, the rate of hospitalization with a confirmed bacterial infection was 2.7% among the patients treated with TNFalpha antagonists compared with 2.0% among the patients treated with MTX only. The multivariable-adjusted hazard ratio (HR) of infection among the patients who received TNFalpha antagonists was 1.9 (95% confidence interval [95% CI] 1.3-2.8) compared with patients who received MTX only. The incidence of infections was highest within 6 months after initiating TNFalpha antagonist therapy (2.9 versus 1.4 infections per 100 person-years; multivariable-adjusted HR 4.2, 95% CI 2.0-8.8). CONCLUSION: The multivariable-adjusted risk of hospitalization with a physician-confirmed definite bacterial infection was approximately 2-fold higher overall and 4-fold higher in the first 6 months among patients receiving TNFalpha antagonists versus those receiving MTX alone. RA patients were at increased risk of serious infections, irrespective of the method used to define an infectious outcome. Patients and physicians should vigilantly monitor for signs of infection when using TNFalpha antagonists, particularly shortly after treatment initiation.Source
Arthritis Rheum. 2007 Apr;56(4):1125-33. Link to article on publisher's siteDOI
10.1002/art.22504Permanent Link to this Item
http://hdl.handle.net/20.500.14038/47688PubMed ID
17393394Related Resources
Link to Article in PubMedae974a485f413a2113503eed53cd6c53
10.1002/art.22504