PMC

Investigation of SI outcomes. Boxes in colour indicate the outcomes of interest and boxes in black indicate the reference population. Approach A examined the risks of sepsis and death after SI simultaneously; this approach accounts for possibly undetected but fatal cases of sepsis (see: objectives & methods). Approach B focuses on the mortality risk of sepsis. Overall mortality after SI was examined in approach C. All sensitivity analyses were applied in the setting of approach A. GEE, generalised estimating equations; SI, serious infection.

Results of sensitivity analyses show ORs and respective confidence intervals of TNFi vs. csDMARDs and other bDMARDs vs. csDMARDs. Approach [1]: analysis in a subsample of patients with pneumonia, approach [2]: patients at csDMARD treatment were restricted to biologic naïve patients; approach [3]: 108 infections with unknown date and exposure were included, the last known DMARD exposure was ‘carried forward’ to the respective event of sepsis (n=47) or death (n=19), in approach [4] we assumed in a most conservative manner that all patients who dropped out but were previously treated with bDMARDs had a sepsis (n=29). bDMARD, biologic DMARD; csDMARD, conventional synthetic DMARD; DMARD, disease-modifying antirheumatic drug; TNFi, tumour necrosis factor α inhibitors.