RCT CZP (n=2965) | RCT+OLE CZP (n=4049) | |||
---|---|---|---|---|
ER/100 PY | No of events | ER/100 PY | No of events | |
Bronchopulmonary aspergillosis | 0.23 | 3 | 0.03 | 3 |
Oesophageal or oral candidiasis | 0.15 | 2 | 0.08 | 7 |
Fungal oesophagitis or gastrointestinal infection | 0 | 0 | 0.02 | 2 |
Herpes zoster disseminated | 0 | 0 | 0.03 | 3 |
Histoplasmosis disseminated | 0 | 0 | 0.02 | 2 |
Nocardiosis | 0 | 0 | 0.01 | 1 |
Pneumocystis jiroveci pneumonia | 0 | 0 | 0.01 | 1 |
Soft tissue salmonella | 0 | 0 | 0.01 | 1 |
Gastroenteritis salmonella | 0 | 0 | 0.01 | 1 |
Tuberculosis infections | 0.69 | 9 | 0.47 | 44 |
Pulmonary tuberculosis* | 0.38 | 5 | 0.32 | 30 |
Extrapulmonary or disseminated tuberculosis* | 0.31 | 4 | 0.15 | 14 |
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.