Table 4. Selected safety findings through week 104 of the maintenance study extension from week 0 of an induction study by treatment group.
|
Placebo induction |
Golimumab induction |
Any Golimumaba | |||||||
|---|---|---|---|---|---|---|---|---|---|
| No Maintenance |
Maintenance |
No Maintenance |
Maintenance |
||||||
| Placebob | Golimumabc | Placebod | 50 mgd | 100 mgc,d | 200 mgc,e | ||||
| Treated patients | 49 | 358 | 293 | 77 | 157 | 155 | 681 | 22 | 1,240 |
| Mean weeks of follow-up | 12.3 | 24.0 | 63.3 | 11.9 | 51.1 | 78.6 | 67.2 | 50.4 | 69.8 |
| Mean exposure (number of administrations) | 1.6 | 6.1 | 15.1 | 1.6 | 12.9 | 19.9 | 16.2 | 13.0 | 16.9 |
| Total patient-years of follow-up | 12 | 165 | 356 | 18 | 154 | 234 | 880 | 21 | 1,664 |
| Number of specified events per hundred patient-years of follow-up (95% confidence interval)f | |||||||||
| Adverse events | 1,024.99 (849.12, 1,226.55) | 397.18 (367.34, 428.80) | 348.11 (329.01, 368.04) | 828.56 (699.62, 974.39) | 376.89 (346.86, 408.82) | 323.15 (300.53, 347.01) | 340.71 (328.62, 353.12) | 459.93 (373.39, 560.50) | 349.87 (340.94, 358.97) |
| Serious adverse events | 223.95 (146.29, 328.13) | 13.34 (8.36, 20.20) | 16.27 (12.35, 21.03) | 221.33 (157.39, 302.56) | 15.57 (9.98, 23.16) | 11.10 (7.25, 16.26) | 19.65 (16.83, 22.81) | 9.39 (1.14, 33.91) | 19.35 (17.29, 21.58) |
| Infectionsg | 232.56 (153.26, 338.36) | 69.13 (57.02, 83.04) | 100.42 (90.29, 111.38) | 255.38 (186.28, 341.72) | 83.03 (69.27, 98.73) | 89.22 (77.53, 102.17) | 80.77 (74.95, 86.94) | 145.49 (98.85, 206.51) | 89.06 (84.58, 93.71) |
| Serious infectionsg | 68.91 (29.75, 135.77) | 1.21 (0.15, 4.38) | 2.81 (1.35, 5.16) | 73.78 (39.28, 126.16) | 5.19 (2.24, 10.23) | 4.70 (2.34, 8.40) | 3.64 (2.49, 5.13) | 0.00 (0.00, 14.06) | 4.45 (3.49, 5.58) |
| Neoplasms (malignant) | 0.00 (0.00, 25.80) | 0.61 (0.02, 3.38) | 0.56 (0.07, 2.03) | 11.35 (1.37, 41.00) | 0.00 (0.00, 1.94) | 0.43 (0.01, 2.38) | 0.57 (0.18, 1.33) | 0.00 (0.00, 14.06) | 0.60 (0.29, 1.11) |
| Injection-site reaction | 0.00 (0.00, 25.80) | 9.10 (5.09, 15.00) | 2.24 (0.97, 4.42) | 0.00 (0.00, 17.00) | 24.00 (16.90, 33.08) | 16.22 (11.48, 22.27) | 16.81 (14.21, 19.75) | 56.32 (29.10, 98.38) | 14.60 (12.82, 16.56) |
| Adverse events leading to discontinuation of study agent | 43.07 (13.98, 100.50) | 5.46 (2.50, 10.36) | 16.83 (12.84, 21.66) | 34.05 (12.50, 74.11) | 9.08 (4.97, 15.24) | 5.98 (3.27, 10.03) | 12.72 (10.48, 15.31) | 4.69 (0.12, 26.15) | 12.44 (10.80, 14.25) |
| Death | 0.00 (0.00, 25.80) | 0.61 (0.02, 3.38) | 0.56 (0.07, 2.03) | 5.68 (0.14, 31.62) | 0.00 (0.00, 1.94) | 0.43 (0.01, 2.38) | 0.68 (0.25, 1.48) | 0.00 (0.00, 14.06) | 0.60 (0.29, 1.11) |
Includes data from the time of the first golimumab dose onward.
Includes data up to the time of the first golimumab dose.
Includes data from the time of dose adjustment onward for those who increased to the indicated dose.
Includes data up to the time of dose adjustment for those who increased dose from the indicated dose.
Includes data from the time of dose increase for patients who were dose adjusted to golimumab 200 mg from golimumab 100 mg and subsequently had their dose decreased from 200 mg to 100 mg.
Confidence intervals based on exact method.
Infection as assessed by the investigator.