Table 3

Opportunistic infections (including tuberculosis) for CZP-treated patients (all doses) in RCT and RCT+OLE

 ER/100 PYNo of eventsER/100 PYNo of events
Bronchopulmonary aspergillosis0.2330.033
Oesophageal or oral candidiasis0.1520.087
Fungal oesophagitis or gastrointestinal infection000.022
Herpes zoster disseminated000.033
Histoplasmosis disseminated000.022
Pneumocystis jiroveci pneumonia000.011
Soft tissue salmonella000.011
Gastroenteritis salmonella000.011
Tuberculosis infections0.6990.4744
 Pulmonary tuberculosis*0.3850.3230
 Extrapulmonary or disseminated tuberculosis*0.3140.1514
  • No OI occurred in patients receiving placebo.

  • *Pulmonary tuberculosis includes pleural and mediastinum lymph node tuberculosis. The other 14 tuberculous events were either extrapulmonary only or disseminated tuberculosis. Of the 44 tuberculous events, 11 events were diagnosed after 1 January 2008.

  • CZP, certolizumab pegol; ER, event rate; OI, opportunistic infection; OLE, open-label extension; PY, patient-years; RCT, randomised controlled trial.