Adverse events and serious adverse events reported for CZP-treated patients (all doses) in the placebo-controlled population (RCT) and all studies (RCT+OLE) population
| RCT | RCT+OLE | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo (n=1137) | All CZP doses (n=2965) | All CZP doses (n=4049) | ||||||||||
| Total exposure (PY) | 373 | 1302 | 9277 | |||||||||
| Mean exposure (days) | 110 | 152 | 782 | |||||||||
| Median exposure (days) | 111 | 112 | 267 | |||||||||
| IR/100 PY (95% CI) | ER/100 PY (95% CI) | N pts | % pts | IR/100 PY (95% CI) | ER/100 PY (95% CI) | N pts | % pts | IR/100 PY (95% CI) | ER/100 PY (95% CI) | N pts | % pts | |
| AE | 362.27 (336.16 to 389.86) | 589.10 (N/A) | 713 | 62.7 | 335.86 (321.47 to 350.72) | 568.30 (N/A) | 2048 | 69.1 | 188.83 (182.68 to 195.14) | 328.93 (N/A) | 3561 | 87.9 |
| Mild | 217.37 (199.25 to 236.69) | 342.30 (N/A) | 530 | 46.6 | 218.81 (208.28 to 229.73) | 352.35 (N/A) | 1620 | 54.6 | 109.88 (106.02 to 113.84) | 191.84 (N/A) | 3059 | 75.5 |
| Moderate | 134.97 (121.81 to 149.17) | 212.73 (N/A) | 384 | 33.8 | 115.85 (109.17 to 122.84) | 186.70 (N/A) | 1120 | 37.8 | 61.00 (58.65 to 63.42) | 119.31 (N/A) | 2546 | 62.9 |
| Severe | 26.24 (21.18 to 32.14) | 34.07 (29.31 to 39.16) | 93 | 8.2 | 20.50 (18.07 to 23.17) | 29.26 (26.82 to 31.83) | 256 | 8.6 | 10.77 (10.07 to 11.52) | 17.77 (17.00 to 18.57) | 867 | 21.4 |
| AE leading to death | 0.27 (0.01 to 1.49) | 0.27 (0.01 to 1.72) | 1 | 0.1 | 0.84 (0.42 to 1.51) | 1.08 (0.61 to 1.84) | 11 | 0.4 | 0.63 (0.47 to 0.81) | 0.67 (0.52 to 0.86) | 58 | 1.4 |
| SAE | 17.01 (13.01 to 21.85) | 21.73 (17.72 to 26.33) | 61 | 5.4 | 20.97 (18.50 to 23.68) | 29.49 (27.04 to 32.06) | 260 | 8.8 | 13.96 (13.14 to 14.83) | 21.31 (20.48 to 22.16) | 1063 | 26.3 |
| SIE | 1.35 (0.44 to 3.14) | 1.34 (0.49 to 3.28) | 5 | 0.4 | 5.61 (4.39 to 7.06) | 6.14 (4.93 to 7.62) | 72 | 2.4 | 3.65 (3.26 to 4.07) | 4.33 (3.93 to 4.77) | 324 | 8.0 |
| All malignancies excluding NMSC | 0.81 (0.17 to 2.36) | 1.34 (0.49 to 3.28) | 3 | 0.3 | 0.77 (0.37 to 1.41) | 0.84 (0.44 to 1.56) | 10 | 0.3 | 0.76 (0.59 to 0.96) | 0.78 (0.61 to 0.98) | 70 | 1.7 |
| OI excluding tuberculosis | 0 | 0 | 0 | 0 | 0.31 (0.08 to 0.79) | 0.38 (0.14 to 0.95) | 4 | 0.1 | 0.19 (0.12 to 0.31) | 0.23 (0.14 to 0.35) | 18 | 0.4 |
| Tuberculous infections | 0 | 0 | 0 | 0 | 0.69 (0.32 to 1.31) | 0.69 (0.34 to 1.36) | 9 | 0.3 | 0.47 (0.34 to 0.64) | 0.47 (0.35 to 0.64) | 44 | 1.1 |
| MACE | 0.54 (0.07 to 1.94) | 0.54 (0.09 to 2.14) | 2 | 0.2 | 1.08 (0.59 to 1.81) | 1.15 (0.67 to 1.94) | 14 | 0.5 | 0.71 (0.55 to 0.91) | 0.82 (0.65 to 1.03) | 66 | 1.6 |
*Treatment-emergent adverse events of oesophageal candidiasis were included as OI.
AE, adverse events; CZP, certolizumab pegol; ER, event rate (includes repeat occurrences of the same AE in individual patients, with the denominator being the total duration of exposure); IR, incidence rate (the number of new cases per 100 PY, with the denominator being the exposure duration up to the first occurrence of a particular AE); MACE, major adverse cardiovascular event; N/A, not available, due to number of events being greater than the number of time units; NMSC, non-melanoma skin cancer; OI, opportunistic infection; OLE, open-label extension; pts, patients; PY, patient-years; RCT, randomised controlled trial; SAE, serious adverse event; SIE; serious infectious event.