Table 3.
Summary of adverse events up to final database lock
| Part 1 | Part 2 | Part 3 | Part 1–3 | |||
| Golimumab | Placebo* | Golimumab | Placebo* | Golimumab | Total | |
| Treated pts, n | 173 | 76 | 78 | 73 | 72 | 173 |
| PY of follow-up | 53.7 | 46.2 | 46.9 | 86.7 | 90.5 | 325.6 |
| Pts with ≥1 AE | 118 (68.2) | 63 (82.9) | 61 (78.2) | 56 (76.7) | 59 (81.9) | 160 (92.5) |
| AE incidence/100 PY (95% CI) |
564.7 (502.9 to 632.0) |
526.3 (462.2 to 596.9) |
358.5 (306.3 to 417.0) |
261.7 (228.8 to 298.1) |
320.4 (284.6 to 359.5) |
339.4 (319.6 to 360.0) |
| Common AEs† | ||||||
| Infections and infestations | 67 (38.7) | 48 (63.2) | 37 (47.4) | 41 (56.2) | 40 (55.6) | 135 (78.0) |
| Upper respiratory tract infection | 12 (6.9) | 21 (27.6) | 13 (16.7) | 12 (16.4) | 13 (18.1) | 49 (28.3) |
| Nasopharyngitis | 16 (9.2) | 9 (11.8) | 6 (7.7) | 13 (17.8) | 12 (16.7) | 44 (25.4) |
| Gastrointestinal disorders | 34 (19.7) | 22 (28.9) | 12 (15.4) | 20 (27.4) | 21 (29.2) | 73 (42.2) |
| Vomiting | 7 (4.0) | 5 (6.6) | 1 (1.3) | 7 (9.6) | 9 (12.5) | 25 (14.5) |
| Nausea | 10 (5.8) | 4 (5.3) | 3 (3.8) | 3 (4.1) | 3 (4.2) | 22 (12.7) |
| Abdominal pain | 8 (4.6) | 7 (9.2) | 1 (1.3) | 3 (4.1) | 0 | 17 (9.8) |
| Diarrhoea | 6 (3.5) | 5 (6.6) | 1 (1.3) | 1 (1.4) | 5 (6.9) | 16 (9.2) |
| Musculoskeletal and connective tissue disorders | 19 (11.0) | 17 (22.4) | 14 (17.9) | 16 (21.9) | 21 (29.2) | 63 (36.4) |
| Worsening of JIA | 6 (3.5) | 10 (13.2) | 10 (12.8) | 6 (8.2) | 13 (18.1) | 39 (22.5) |
| General disorders | 21 (12.1) | 16 (21.1) | 7 (9.0) | 10 (13.7) | 11 (15.3) | 54 (31.2) |
| Fever | 8 (4.6) | 11 (14.5) | 4 (5.1) | 4 (5.5) | 3 (4.2) | 24 (13.9) |
| Nervous system disorders | 14 (8.1) | 6 (7.9) | 8 (10.3) | 5 (6.8) | 8 (11.1) | 33 (19.1) |
| Headache | 10 (5.8) | 6 (7.9) | 6 (7.7) | 3 (4.1) | 6 (8.3) | 26 (15.0) |
| Pts with ≥1 SAE | 8 (4.6) | 10 (13.2) | 8 (10.3) | 7 (9.6) | 13 (18.1) | 39 (22.5) |
| SAE incidence/100 PY (95% CI) |
16.8 (7.7 to 31.8) |
32.5 (18.2 to 53.6) |
17.1 (7.4 to 33.6) |
10.4 (4.8 to 19.7) |
24.3 (15.2 to 36.8) |
18.1 (13.8 to 23.4) |
| Musculoskeletal and connective tissue disorders | 4 (2.3) | 7 (9.2) | 4 (5.1) | 2 (2.7) | 7 (9.7) | 21 (12.1) |
| Worsening of JIA | 3 (1.7) | 5 (6.6) | 3 (3.8) | 2 (2.7) | 5 (6.9) | 17 (9.8) |
| Arthritis | 1 (0.6) | 2 (2.6) | 1 (1.3) | 0 | 2 (2.8) | 4 (2.3) |
| Infections and infestations | 2 (1.2) | 2 (2.6) | 1 (1.3) | 3 (4.1) | 3 (4.2) | 11 (6.4) |
| Pneumonia | 0 | 1 (1.3) | 0 | 0 | 1 (1.4) | 2 (1.2) |
| Upper respiratory tract infection | 0 | 1 (1.3) | 0 | 0 | 1 (1.4) | 2 (1.2) |
| Gastrointestinal disorders | 0 | 0 | 1 (1.3) | 2 (2.7) | 0 | 3 (1.7) |
| Constipation | 0 | 0 | 1 (1.3) | 1 (1.4) | 0 | 2 (1.2) |
| Pts with ≥1 injection site reaction | 10 (5.8) | 3 (3.9) | 2 (2.6) | 1 (1.4) | 6 (8.3) | 20 (11.6) |
Data are presented as n (%) unless otherwise noted.
*At week 16, 76 patients were randomised to receive placebo; 10 patients remained on placebo through the week-48 database lock and were discontinued, 33 patients crossed over to golimumab before week 48 and 33 patients crossed over to golimumab after week 48.
†Preferred terms occurring in>10% of all treated patients by system-organ class/preferred term.
AE, adverse event; CI, confidence interval; JIA, juvenile idiopathic arthritis; pts, patients; PY, patient-year; SAE, serious adverse event.