Table 4

Types of adverse events occurring in patients with spondylarthritis and rheumatoid arthritis treated with biologics

Spondylarthritis

Rheumatoid arthritis



Biologic and total exposure

Infliximab 1,915

Etanercept 507

Adalimumab 5.7

Infliximab 5,521

Etanercept 1,724

Adalimumab 526







Type of adverse event

Cases

IR [95% CI]

Cases

IR [95% CI]

Cases

IR [95% CI]

Cases

IR [95% CI]

Cases

IR [95% CI]

Cases

IR [95% CI]







Infusion reaction

72

4.14 [3.29–5.22]

1

0.20 [0.03–1.4]

0

-

252

5.09 [4.50–5.76]

7

0.43 [0.21–0.91]

6

1.36 [0.61–3.03]

Infection

102

5.87 [4.83–7.13]

5

1.01 [0.42–2.43]

1

18.90 [2.66–134.14]

350

7.07 [6.37–7.85]

28

1.74 [1.20–2.52]

56

12.71 [9.78–16.52]

Cutaneous

22

1.27 [0.83–1.92]

2

0.40 [0.10–1.61]

1

18.90 [2.66–134.14]

50

1.01 [0.77–1.33]

21

1.30 [0.85–2.00]

40

9.08 [6.66–12.38]

Cytopenia

2

0.12 [0.03–0.46]

0

-

0

-

27

0.54 [0.37–0.80]

3

0.19 [0.06–0.58]

3

0.68 [0.22–2.11]

Neoplastic

6

0.35 [0.16–0.77]

1

0.20 [0.03–1.4]

0

-

20

0.40 [0.26–0.63]

8

0.50 [0.25–0.99]

1

0.23 [0.03–1.61]

Pulmonary

4

0.23 [0.09–0.61]

0

-

0

-

21

0.42 [0.28–0.65]

4

0.25 [0.09–0.66]

3

0.68 [0.22–2.11]

Cardiovascular

13

0.75 [0.43–1.29]

3

0.61 [0.20–1.88]

0

-

64

1.29 [1.01–1.65]

8

0.50 [0.25–0.99]

13

2.95 [1.71–5.08]

Endocrine

1

0.06 [0.01–0.41]

0

-

0

-

5

0.10 [0.04–0.24]

0

-

0

-

Gastrointestinal

25

1.44 [0.97–2.13]

3

0.61 [0.20–1.88]

0

-

32

0.64 [0.46–0.91]

5

0.31 [0.13–0.75]

19

4.31 [2.75–6.76]

Ophthalmologic

4

0.23 [0.09–0.61]

0

-

0

-

2

0.04 [0.01–0.16]

3

0.19 [0.06–0.58]

2

0.45 [0.11–1.82]

Psychiatric

3

0.17 [0.06–0.54]

0

-

0

-

2

0.04 [0.01–0.16]

0

-

6

1.36 [0.61–3.03]

Neurological

5

0.29 [0.12–0.69]

1

0.20 [0.03–1.43]

0

-

15

0.30 [0.18–0.50]

1

0.06 [0.01–0.44]

8

1.82 [0.91–3.63]

Gynecological

0

-

0

-

0

-

3

0.06 [0.02–0.19]

0

-

1

0.23 [0.03–1.61]

Urological

4

0.23 [0.09–0.61]

0

-

0

-

4

0.08 [0.03–0.22]

1

0.06 [0.01–0.44]

3

0.68 [0.22–2.11]

Others

17

Not estimated

2

Not estimated

0

Not estimated

83

Not estimated

10

Not estimated

23

Not estimated


Data are presented as cases documented and as incidence rate (IR) and 95% confidence interval (CI) per 100 patient-years of exposure.

Carmona et al. Arthritis Research & Therapy 2006 8:R72   doi:10.1186/ar1941

Open Data