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Sepsis is a dangerous and potentially fatal consequence of serious infections (SIE), particularly in susceptible populations such as the elderly and immunosuppressed. Published evidence points toward the potential role of TNF in development of sepsis. Given the broad use of multiple biologic and conventional DMARDs in the treatment of RA, there is a need to understand the impact of our current treatments on SIE outcomes.
This cohort study assessed patients with RA who acquired SIE after enrollment into the German biologics register RABBIT (Rheumatoid arthritis: observation of biologic therapy). The contribution of RA treatment and patient characteristics to the three different outcomes of SIE was examined and the overall risk of death within 90 days after the onset of SIE was investigated.
Among all 1017 SIEs, pneumonia was most frequent (n=332; 28.4%), followed by 131 infections of bones and joints (11.2%) and 120 respiratory infections other than pneumonia (10.3%). No difference in the spectrum of SIEs was observed between bDMARDs vs csDMARDs groups. Sepsis within 30 days after SIE was reported in 135 out of 947 patients, 85 of these had a fatal outcome.
Death within 90 days after SIE (without known sepsis) occurred in 53 patients. Compared with conventional synthetic DMARDs (csDMARDs), the risk of death was significantly lower when patients were exposed to biologic DMARDs (bDMARDs) at the time of SIE (OR: 0.56, 95% CI 0.38 to 0.81). Risk factors of fatal SIE were higher age, use of glucocorticoids at higher doses and heart failure.
These study results suggest that patients exposed to bDMARDs at the time of SIE have a reduced risk of sepsis and mortality. This study is a first-report of reduced sepsis risk in patients with RA on bDMARDs. Although being off bDMARDs seems to shift the risk from an increased susceptibility to SIE to more severe outcomes, the authors do not recommend that bDMARDs be continued in case of an SIE since this is the first study to show these results. Additional studies and data are needed to answer the question of drug management in the face of infection.