Table 4

Malignancies reported for CZP-treated patients (all doses) in RCT+OLE, by type and time of occurrence

CancerRCT
Placebo
(n=1137)
RCT
CZP
(n=2965)
RCT+OLE
CZP
(n=4049)
IR/100 PY (95% CI)No of eventsIR/100 PY (95% CI)No of eventsIR/100 PY (95% CI)No of events
All malignancies excluding NMSC0.81 (0.17 to 2.36)50.77 (0.37 to 1.41)110.76 (0.59 to 0.96)72
Solid tumour*0.81 (0.17 to 2.36)50.69 (0.32 to 1.31)100.71 (0.55 to 0.91)67
NMSC0.27 (0.01 to 1.49)10.23 (0.05 to 0.67)60.27 (0.18 to 0.40)34
Lymphoma000.08 (0.00 to 0.43)10.05 (0.02 to 0.13)5
All malignancies including NMSC
Time of occurrence (months on CZP)No of patients in safety poolingIR/100 PY (95% CI)No of events during time period
0–<340491.13 (0.57 to 2.03)12
≥3–<638861.10 (0.53 to 2.03)11
≥6–<1234491.01 (0.54 to 1.72)18
≥12–<1819601.38 (0.71 to 2.42)12
≥18–<2416551.32 (0.63 to 2.42)11
≥24–<3614660.87 (0.45 to 1.53)12
≥36–<4813340.95 (0.49 to 1.67)13
≥48–<6012191.00 (0.50 to 1.79)11
≥609411.24 (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.