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Table 3 Rates of serious infections (overall and by baseline characteristics) in the all-control population

From: Integrated safety in tocilizumab clinical trials

  Exposure, PY Control
n= 1,555
Exposure, PY Tocilizumab
4 mg/kg + DMARDs
n= 774
Exposure, PY Tocilizumab
8 mg/kg + DMARDs
n= 1,870
Rate/100 PYa (number of eventsb)
Overall 824.6 3.5 (29) 564.6 3.5 (20) 1,194.1 4.9 (59)
Rate/100 PYa (95% CIa), (number of eventsb)
Age, years
< 50 340.2 1.5 (0.5, 3.4), (5) 244.2 1.6 (0.5, 4.2), (4) 431.3 1.9 (0.8, 3.7), (8)
≥ 50-64 354.2 3.7 (2.0, 6.3), (13) 229.9 3.5 (1.5, 6.9), (8) 572.8 5.9 (4.1, 8.3), (34)
≥ 65 130.1 8.5 (4.2, 15.1), (10) 90.6 8.8 (3.8, 17.4), (8) 189.9 9.0 (5.2, 14.3), (17)
BMI,c kg/m2
< 18.5 29.2 -- 9.6 -- 31.3 16.0 (5.2, 37.3), (5)
18.5-24.9 282.1 2.8 (1.2, 5.6), (7) 209.4 3.8 (1.7, 7.5), (8) 414.4 2.7 (1.3, 4.8), (11)
25-29.9 275.6 3.6 (1.7, 6.7), (10) 187.2 3.2 (1.2, 7.0), (6) 412.5 5.3 (3.3, 8.1), (22)
≥ 30 234.2 4.7 (2.3, 8.4), (11) 154.7 3.9 (1.4, 8.4), (6) 327.8 6.1 (3.7, 9.4), (20)
Background corticosteroid use
Yes 570.5 3.3 (2.0, 5.2), (18) 426.6 4.7 (2.9, 7.2), (20) 788.3 5.3 (3.8, 7.2), (42)
No 254.0 3.9 (1.9, 7.2), (10) 138.0 -- 405.8 4.2 (2.4, 6.7), (17)
Previous TNF-α inhibitor therapy
Yes 134.6 6.7 (3.1, 12.7), (9) 114.4 5.3 (1.9, 11.4), (6) 200.1 8.5 (5.0, 13.6), (17)
No 690.0 2.9 (1.8, 4.5), (19) 450.2 3.1 (1.7, 5.2), (14) 994.0 4.2 (3.1, 5.7), (42)
Chronic pulmonary disease
Yes 38.9 10.3 (2.8, 26.3), (3) 28.4 10.6 (2.2, 30.8), (3) 54.1 7.4 (2.0, 18.9), (4)
No 785.6 3.2 (2.1, 4.7), (25) 536.2 3.2 (1.9, 5.1), (17) 1,140.0 4.8 (3.6, 6.3), (55)
Serious infections
Yes -- 10.3 (2.8, 26.3), (3) -- 10.6 (2.2, 30.8), (3) -- 7.4 (2.0, 18.9), (4)
No -- 3.2 (2.1, 4.7), (25) -- 3.2 (1.9, 5.1), (17) -- 4.8 (3.6, 6.3), (55)
Serious pneumonia
Yes -- 7.7 (1.6, 22.5) -- 3.5 (0.1, 19.6) -- 5.6 (1.1, 16.2)
No -- 0.4 (0.1, 1.1) -- 0.9 (0.3, 2.2) -- 0.9 (0.4, 1.6)
Diabetes
Yes 66.6 7.5 (2.4, 17.5), (5) 54.1 1.9 (0.1, 10.3), (1) 99.4 12.1 (6.2, 21.1), (12)
No 758.0 3.2 (2.0, 4.7), (23) 510.5 3.7 (2.2, 5.8), (19) 1,094.7 4.3 (3.2, 5.7), (47)
  1. BMI, body mass index; CI, confidence interval; DMARD, disease-modifying antirheumatic drug; PY, patient-years; TNF, tumor necrosis factor.
  2. aMultiple occurrences of the same adverse event (AE) in one individual are counted. bMultiple occurrences of the same AE in one individual are counted only once. cTwenty-two patients did not have BMI values.