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 eventsBaseline 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)
 Pulmonary TB cases22422
 Non-pulmonary or disseminated TB cases10040
 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.