Table 4 |
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|
Types of adverse events occurring in patients with spondylarthritis and rheumatoid arthritis treated with biologics |
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|
Spondylarthritis |
Rheumatoid arthritis |
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|
|
|
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|
Biologic and total exposure |
Infliximab 1,915 |
Etanercept 507 |
Adalimumab 5.7 |
Infliximab 5,521 |
Etanercept 1,724 |
Adalimumab 526 |
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|
|
|
|
|
|
|
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|
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] |
|
|
|
|
|
|
|
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|
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 |
|
|
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|
Data are presented as cases documented and as incidence rate (IR) and 95% confidence interval (CI) per 100 patient-years of exposure. |
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|
Carmona et al. Arthritis Research & Therapy 2006 8:R72 doi:10.1186/ar1941 |
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