Table 1.
Incidence and type of active TB by PPD skin test subgroup for CZP-treated patients with RA in the pooled RA safety database (N=4049)
| TB events | Baseline PPD status |
|||
|---|---|---|---|---|
| <5 mm (n=3278) | 5–10 mm (n=219) | >10 mm (n=151) | PPD missing/unknown (n=401) | |
| Positive TB cases | ||||
| n (%) | 32*(1.0) | 4 (1.8) | 6 (4.0) | 2† (0.5) |
| IR/100 PY (95% CI) | 0.42 (0.29 to 0.59) | 0.49 (0.13 to 1.25) | 1.27 (0.47 to 2.77) | 0.54 (0.07 to 1.95) |
| Time from start of CZP treatment to TB onset (days) | ||||
| Mean (SD) | 552.5 (404.7) | 519.3 (318.8) | 473.7 (404.3) | 171.0 (41.0) |
| Median | 435.5 | 617.5 | 352.0 | 171.0 |
| Q1–Q3 | 204.0–838.5 | 319.0–719.5 | 148.0–806.0 | 142.0–200.0 |
| Minimum–maximum | 50–1473 | 58–784 | 71–1113 | 142–200 |
| Pulmonary TB cases | 22 | 4 | 2 | 2 |
| Non-pulmonary or disseminated TB cases | 10 | 0 | 4 | 0 |
| Positive TB cases/patients treated with INH (%) | 1/126 (0.8) | 0/153 (0.0) | 0/89 (0.0) | 1/19 (5.3) |
| Positive TB cases/patients not treated with INH (%) | 31/3152 (1.0) | 4/66 (6.1) | 6/62 (9.7) | 1/382 (0.3) |
*One patient who developed TB received INH administration. INH treatment started 393 days after the first CZP dose was administered and 517 days before the onset of TB.
†One patient with unknown PPD who developed TB was administered INH treatment before study baseline; INH was administered 141 days prior to the first CZP dose and 340 days before the onset of TB.
%, percentage of patients; CZP, certolizumab pegol; INH, isoniazid; IR, incidence rates; N, number of patients; PPD, purified protein derivative; PY, patient-years; RA, rheumatoid arthritis; TB, tuberculosis.