Malignancies reported for CZP-treated patients (all doses) in RCT+OLE, by type and time of occurrence
| Cancer | RCT Placebo (n=1137) | RCT CZP (n=2965) | RCT+OLE CZP (n=4049) | |||
|---|---|---|---|---|---|---|
| IR/100 PY (95% CI) | No of events | IR/100 PY (95% CI) | No of events | IR/100 PY (95% CI) | No of events | |
| All malignancies excluding NMSC | 0.81 (0.17 to 2.36) | 5 | 0.77 (0.37 to 1.41) | 11 | 0.76 (0.59 to 0.96) | 72 |
| Solid tumour* | 0.81 (0.17 to 2.36) | 5 | 0.69 (0.32 to 1.31) | 10 | 0.71 (0.55 to 0.91) | 67 |
| NMSC | 0.27 (0.01 to 1.49) | 1 | 0.23 (0.05 to 0.67) | 6 | 0.27 (0.18 to 0.40) | 34 |
| Lymphoma | 0 | 0 | 0.08 (0.00 to 0.43) | 1 | 0.05 (0.02 to 0.13) | 5 |
| All malignancies including NMSC | |||
|---|---|---|---|
| Time of occurrence (months on CZP) | No of patients in safety pooling | IR/100 PY (95% CI) | No of events during time period |
| 0–<3 | 4049 | 1.13 (0.57 to 2.03) | 12 |
| ≥3–<6 | 3886 | 1.10 (0.53 to 2.03) | 11 |
| ≥6–<12 | 3449 | 1.01 (0.54 to 1.72) | 18 |
| ≥12–<18 | 1960 | 1.38 (0.71 to 2.42) | 12 |
| ≥18–<24 | 1655 | 1.32 (0.63 to 2.42) | 11 |
| ≥24–<36 | 1466 | 0.87 (0.45 to 1.53) | 12 |
| ≥36–<48 | 1334 | 0.95 (0.49 to 1.67) | 13 |
| ≥48–<60 | 1219 | 1.00 (0.50 to 1.79) | 11 |
| ≥60 | 941 | 1.24 (0.57 to 2.35) | 10 |
*Excluding non-melanoma skin cancer (NMSC).
CZP, certolizumab pegol; IR, incidence rate; OLE, open-label extensions; PY, patient-years; RCT, randomised controlled trial.