Table 3

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.

Schiff et al. Arthritis Research & Therapy 2011 13:R141   doi:10.1186/ar3455

Open Data