Summary of adverse events through week 104*
| Placebo → golimumab 50 mg (group 1) | Golimumab 50 mg (group 2) | Golimumab 100 mg (group 3) | ||||
|---|---|---|---|---|---|---|
| Early escape (week 16–104)† | Crossover (week 24–104)‡ | 50 mg only§ | Early escape (50 mg →100 mg)† | 100 mg¶ | All golimumab | |
| Patients treated with golimumab | 41 | 34 | 138 | 25 | 140 | 353 |
| Mean duration of follow-up (weeks) | 79.0 | 77.6 | 79.2 | 72.0 | 95.9 | 90.7 |
| Mean exposure (number of administrations) | 19.1 | 18.6 | 19.2 | 17.1 | 23.0 | 21.8 |
| Patients with one or more adverse events | 36 (87.8) | 29 (85.3) | 130 (94.2) | 23 (92.0) | 135 (96.4) | 332 (94.1) |
| Patients with one or more serious adverse events | 4 (9.8) | 2 (5.9) | 10 (7.2) | 3 (12.0) | 21 (15.0) | 40 (11.3) |
| Patients who discontinued study agent due to an adverse event | 1 (2.4) | 0 (0.0) | 6 (4.3) | 2 (8.0) | 10 (7.1) | 19 (5.4) |
| Patients with one or more infections | 28 (68.3) | 10 (29.4) | 90 (65.2) | 17 (68.0) | 101 (72.1) | 241 (68.3) |
| Patients with one or more serious infections | 2 (4.9) | 0 (0.0) | 1 (0.7) | 1 (4.0) | 6 (4.3) | 11 (3.1) |
| Patients with one or more injection-site reactions to golimumab | 3 (7.3) | 3 (8.8) | 11 (8.0) | 6 (24.0) | 16 (11.4) | 38 (10.8) |
| Injections with one or more injection-site reactions to golimumab | 3/784 (0.4) | 19/634 (3.0) | 16/2640 (0.6) | 29/427 (6.8) | 39/3220 (1.2) | 106/7705 (1.4) |
| Patients with one or more malignancies | 1 (2.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.7) | 2 (0.6) |
| Patients with markedly abnormal**: | ||||||
| Alanine aminotransferase | 1 (2.4) | 1 (2.9) | 1 (0.7) | 0 (0.0) | 7 (5.0) | 10 (2.8) |
| Aspartate aminotransferase | 1 (2.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 4 (2.9) | 5 (1.4) |
| Total bilirubin | 0 (0.0) | 1 (2.9) | 4 (2.9) | 0 (0.0) | 3 (2.1) | 8 (2.3) |
| Patients negative for antinuclear antibodies at baseline | 31 | 27 | 80 | 14 | 90 | 232 |
| Patients positive for antinuclear antibodies at week 104 | 1 (3.2) | 3 (11.1) | 2 (2.5) | 1 (7.1) | 5 (5.6) | 11 (4.7) |
| Patients positive for anti-double-stranded DNA at week 104 | 1 (100) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (9.1) |
Data presented as n (%) unless otherwise noted.
↵* Patients are counted in the dosing group in which they were assigned at the time of the event.
↵† Patients in these groups met the early escape criteria at week 16.
↵‡ Patients in this group did not discontinue study agent prior to week 24 and crossed over at week 24.
↵§ This group included patients randomised to golimumab 50 mg irrespective of early escape status. Adverse events for patients who met early escape are only counted up to week 16.
↵¶ This group included all patients randomised to golimumab 100 mg.
↵** Predefined as postbaseline values of ≥2 times the baseline value and >150 IU/mL (alanine/aspartate aminotransferase) or ≥2 times the baseline value and >1.5 mg/dl (total bilirubin).