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 |