Table 3 |
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|
Rates of serious infections (overall and by baseline characteristics) in the all-control population |
||||||
|
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) |
|
|
||||||
|
BMI, body mass index; CI, confidence interval; DMARD, disease-modifying antirheumatic drug; PY, patient-years; TNF, tumor necrosis factor. 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. |
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|
Schiff et al. Arthritis Research & Therapy 2011 13:R141 doi:10.1186/ar3455 |
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