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Table 2 Occurrence of SAEs in patients with RA treated with TCZ or TNFIs a

From: Head-to-head comparison of the safety of tocilizumab and tumor necrosis factor inhibitors in rheumatoid arthritis patients (RA) in clinical practice: results from the registry of Japanese RA patients on biologics for long-term safety (REAL) registry

Types of SAEs TCZ group, 224.68 PY TNFI group, 231.01 PY TCZ versus TNFI
IR (/100PY) IR (/100PY) Crude IRR (95% CI)
Total SAEs 21.36 (15.94 to 28.07) 14.72 (10.37 to 20.32) 1.45 (0.94 to 2.25)
Serious infection (SI) 10.68 (7.02 to 15.63) 3.03 (1.35 to 5.95) 3.53 (1.52 to 8.18)
Pulmonary infection 3.12 (1.39 to 6.12) 1.30 (0.36 to 3.46) 2.40 (0.62 to 9.28)
Non-pulmonary infection 7.57 (4.57 to 11.84) 1.73 (0.58 to 4.12) 4.37 (1.47 to 12.99)
Skin infection 1.78 (0.60 to 4.23) 0.43 (0.04 to 2.02) 4.11 (0.46 to 36.80)
Urinary tract infection 0.89 (0.18 to 2.85) 0.43 (0.04 to 2.02) 2.06 (0.19 to 22.68)
Gastrointestinal infection 0.89 (0.18 to 2.85) 0.43 (0.04 to 2.02) 2.06 (0.19 to 22.68)
Bone and joint infections 2.23 (0.84 to 4.88) 0 NA
Sepsis 1.34 (0.37 to 3.56) 0 NA
Other infection 0.45 (0.04 to 2.08) 0.43 (0.04 to 2.02) 1.03 (0.06 to 16.44)
Pulmonary disease, except infection 2.23 (0.84 to 4.88) 2.16 (0.82 to 4.74) 1.03 (0.30 to 3.55)
Cardiovascular or cerebrovascular disease 0.45 (0.04 to 2.08) 2.16 (0.82 to 4.74) 0.21 (0.02 to 1.76)
Malignancy 0.89 (0.18 to 2.85) 1.30 (0.36 to 3.46) 0.69 (0.11 to 4.10)
Death 1.78 (0.60 to 4.23) 0.87 (0.17 to 2.78) 2.06 (0.38 to 11.23)
Others 7.12 (4.24 to 11.29) 6.06 (3.47 to 9.90) 1.18 (0.57 to 2.41)
  1. aCrude incidence rate per 100 PYs and crude incidence rate ratio with their 95% CI were calculated for each category of serious adverse events. CI: confidence interval; IR: incidence rate; IRR: incidence rate ratio; NA: not applicable; PY: patient-year; RA: rheumatoid arthritis; SAEs: serious adverse events; TCZ: tocilizumab; TNFIs: tumor necrosis factor inhibitors.