Arthritis & Rheumatism, Volume 60,
October 2009 Abstract Supplement
The 2009 ACR/ARHP Annual Scientific Meeting
Philadelphia October 16-21, 2009.
The Risk for Hospitalized and Outpatient Infections Related to Anti-TNF Therapy and Newer Biologics
Solomon8, Daniel H., Patkar1, Nivedita, Kremer7, Joel M., Jain1, Archana, Hochberg6, Marc C., Greenberg5, J., Furst4, D. E.
UAB, Birmingham, AL,
Baylor Research Institute, Dallas, TX,
Texas Health, Dallas, TX,
UCLA, Los Angeles, CA,
NYU, New York, NY,
University of Maryland School of Medicine, Baltimore, MD,
Albany Medical College, Albany, NY,
Brigham & Women's Hospital, Boston, MA
There have been inconsistent results regarding the association between anti-TNF therapies and the risk of serious infection. Several prior studies had relatively poor adjustment for RA disease severity, while other analyses may have had biased ascertainment of infectious outcomes. We compared the risk of infection associated with anti-TNF therapies and other biologics to non-biologic DMARDs in a cohort with substantial information about disease severity.
Data from the Consortium of Rheumatology Researchers of North America (CORRONA) registry was used to identify a cohort of rheumatoid arthritis (RA) patients, RA disease factors, and their relevant DMARD exposures. For patients with reported hospitalized infections, medical records were requested. Cox proportional hazards models estimated the risk for hospitalized infections associated with current use of various biologic DMARDs compared to non-biologic DMARDs. Disease activity (CDAI), functional status (mHAQ), duration of RA, diabetes, lung disease, prior infection, prednisone dose, and number of previous infections were included in adjusted analyses. Sensitivity analysis considered how recently each of the drugs was initiated (< 1 year, >= 1 year), and also restricted eligible participants to new users of various medications. Additional analyses using Poisson regression evaluated the risk for all infections (hospitalized and outpatient).
Among 18,305 RA patients with 32,911 years of observation, 586 hospitalized infections and 21,258 outpatient infections were reported. A total of 91% of the hospitalized infections had hospital record evidence to confirm the event; the remaining 9% were not counted as cases. In adjusted analyses, no significant increase in serious infection risk associated was observed for anti-TNF therapy or other biologics compared to non-biologic DMARDs. Factors that were associated with infections included age, RA clinical disease activity index (CDAI), mHAQ, duration of RA, lung disease, prior infection, prednisone dose, and number of previous non-biologic DMARDs. Consistent with the hospitalized infection results, there was no significant difference in the rate associated with the various biologics for the endpoint of all infections.
In an observational cohort of RA patients, we found no significant increase in the adjusted risk for hospitalized or outpatient infections associated with anti-TNF therapy or other biologics compared to MTX and other non-biologic DMARDs. The infection-related safety profiles of the various biologic agents appear to be similar.
To cite this abstract, please use the following information:
Solomon, Daniel H., Patkar, Nivedita, Kremer, Joel M., Jain, Archana, Hochberg, Marc C., Greenberg, J., et al; The Risk for Hospitalized and Outpatient Infections Related to Anti-TNF Therapy and Newer Biologics [abstract]. Arthritis Rheum 2009;60 Suppl 10 :2059