Table 2.
TB cases in CZP-treated patients with RA in the pooled RA safety database (N=4049) by region and country (risk vs incidence)
| Baseline PPD status (n) |
Incidence of TB within CZP treatment groups |
|||||||
|---|---|---|---|---|---|---|---|---|
| Geographic region | TB incidence rate in general population (per 105)* | Patients (n) | <5 mm | ≥5 mm | missing/ unknown | IR/100 PY (95% CI) | Number of events (in patients with PPD<5 mm) | INH-treated, no active TB (no TB/INH treated) |
| Overall | 4049 | 3278 | 370 | 401 | 0.47 (0.34 to 0.64) | 44 (32) | 385/387 | |
| Western Europe† | 7.9 | 800 | 464 | 42 | 294 | 0.23 (0.05 to 0.68) | 3 (2) | 19/19 |
| Austria | 6.9 | 125 | 40 | 1 | 84 | – | 0 (−) | 0/0 |
| Belgium | 8.5 | 19 | 18 | 1 | 0 | – | 0 (−) | 0/0 |
| Finland | 4.9 | 8 | 8 | 0 | 0 | – | 0 (−) | 0/0 |
| France | 7.7 | 69 | 24 | 2 | 43 | – | 0 (−) | 0/0 |
| Germany | 4.9 | 351 | 294 | 19 | 38 | 0.34 (0.04 to 1.22) | 2 (2) | 6/6 |
| Ireland | 7.5 | 8 | 4 | 4 | 0 | – | 0 (−) | 2/2 |
| Italy | 5.8 | 20 | 18 | 2 | 0 | – | 0 (−) | 2/2 |
| The Netherlands | 5.5 | 4 | 4 | 0 | 0 | – | 0 (−) | 0/0 |
| Spain | 12.0 | 32 | 26 | 5 | 1 | – | 0 (−) | 5/5 |
| Sweden | 6.3 | 32 | 0 | 0 | 32 | – | 0 (−) | 0/0 |
| UK | 14.0 | 132 | 28 | 8 | 96 | 0.35 (0.01 to 1.94) | 1 (0) | 4/4 |
| Central Europe | 25.1 | 810 | 633 | 177 | 0 | 0.58 (0.34 to 0.92) | 18 (13) | 150/151 |
| Bulgaria | 28.0 | 52 | 45 | 7 | 0 | 0.50 (0.01 to 2.79) | 1 (1) | 0/0 |
| Czech Republic | 4.7 | 314 | 220 | 94 | 0 | 0.36 (0.12 to 0.84) | 5 (2) | 76/77 |
| Estonia | 20.0 | 25 | 18 | 7 | 0 | 2.10 (0.25 to 7.59) | 2 (1) | 6/6 |
| Hungary | 16.0 | 72 | 53 | 19 | 0 | – | 0 (−) | 10/10 |
| Latvia | 49.0 | 44 | 44 | 0 | 0 | 2.24 (0.46 to 6.54) | 3 (3) | 0/0 |
| Lithuania | 58.0 | 92 | 83 | 9 | 0 | 1.30 (0.42 to 3.04) | 5 (5) | 7/7 |
| Poland | 19.0 | 132 | 118 | 14 | 0 | 0.55 (0.07 to 2.00) | 2 (1) | 20/20 |
| Slovakia | 5.9 | 79 | 52 | 27 | 0 | – | 0 (−) | 31/31 |
| Eastern Europe | 46.8 | 503 | 413 | 90 | 0 | 1.02 (0.63 to 1.56) | 21 (16) | 135/135 |
| Croatia | 13.0 | 14 | 11 | 3 | 0 | 1.94 (0.05 to 10.82) | 1 (0) | 2/2 |
| Russia | 77.0 | 226 | 171 | 55 | 0 | 1.00 (0.48 to 1.83) | 10 (7) | 79/79 |
| Serbia | 20.0 | 104 | 92 | 12 | 0 | 0.99 (0.27 to 2.54) | 4 (4) | 10/10 |
| Ukraine | 77.0 | 159 | 139 | 20 | 0 | 1.00 (0.37 to 2.17) | 6 (5) | 44/44 |
| North America‡ | 3.6 | 1673 | 1552 | 45 | 76 | 0.05 (0.00 to 0.30) | 1 (0) | 55/56 |
| Canada | 4.0 | 157 | 111 | 9 | 37 | – | 0 (−) | 10/10 |
| USA | 3.2 | 1516 | 1441 | 36 | 39 | 0.06 (0.00 to 0.33) | 1 (0) | 45/46 |
| Rest of the World§ | 16.7 | 263 | 216 | 16 | 31 | 0.11 (0.00 to 0.60) | 1 (1) | 26/26 |
| Argentina | 21.0 | 132 | 131 | 1 | 0 | 0.19 (0.00 to 1.06) | 1 (1) | 10/10 |
| Australia | 5.7 | 43 | 14 | 2 | 27 | – | 0 (−) | 2/2 |
| Chile | 14.0 | 12 | 12 | 0 | 0 | – | 0 (−) | 2/2 |
| Israel | 6.7 | 45 | 37 | 8 | 0 | – | 0 (−) | 6/6 |
| Mexico | 19.0 | 7 | 5 | 2 | 0 | – | 0 (−) | 4/4 |
| New Zealand | 6.6 | 20 | 17 | 3 | 0 | – | 0 (−) | 2/2 |
| Singapore | 44.0 | 4 | 0 | 0 | 4 | – | 0 (−) | 0/0 |
*Based on UN statistics for the lower bound of incidence in 2012 per 100 000 population in individual countries within each geographic region.28
†PPD test results missing for 294 patients, including the patient in the UK who developed TB.
‡PPD test results missing for 76 patients, including the patient who developed TB.
§PPD test results missing for 31 patients.
CZP, certolizumab pegol; INH, isoniazid; IR, incidence rates; PPD, purified protein derivative; PY, patient-years; RA, rheumatoid arthritis; TB, tuberculosis.