Background Serious (SI) and opportunistic (OI) infections as well as tuberculosis (TB) reactivation are important side effects of biologic therapy in rheumatoid arthritis (RA) patients. Most previous studies, meta-analyses, or literature reviews focused on whether biologic therapy increases the risk of infection but no summary of the absolute incidence rate of infection is available.
Objectives To summarize the incidence density (i.e. incidence per person-year (PY)) of SI, OI, and TB after treatment with each of the nine biologic therapies indicated in RA patients.
Methods A systematic review of the literature was conducted with search on PubMed and Embase from January 1998 to November 2011. Incidence density was extracted and reported using the definition from the respective publications. If the incidence density was not reported, estimation was made using available information.
Results 68 published studies met the inclusion criteria and were reviewed, including 43 clinical trials, open label extension studies, or meta-analyses, and 25 observational studies. Additional calculation of the incidence was done in 13 studies for SI and in 11 studies for OI or TB. The incidence of SI was consistent across studies and biologic therapies, ranging from 2 to 12/100 PY but mainly clustered from 2 to 6/100 PY. Much less incidence data were available for OI and TB, both ranging widely from 0.01 to 2.6/100 PY.
Conclusions This data about SI may be used to evaluate the public health risk and benefit of each biologic treatment. It may also serve as a point of reference for future studies. The limited data on OI and the lack of a consistent definition of OI invite cautions for a benchmark rate for OI as a composite category.
Disclosure of Interest T. Tran Employee of: MedImmune LLC, H. Caspard Employee of: MedImmune LLC, F. Magrini Employee of: MedImmune LLC
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