Table 1 Cumulative summary of golimumab safety and immunogenicity through week 268 of the GO-AFTER trial
Golimumab | ||||
|---|---|---|---|---|
50 mg only | 50 and 100 mg | 100 mg only | All patients | |
Number of treated patients | 98 | 195 | 138 | 431 |
Mean duration of follow-up (weeks) | 129.82 | 187.45 | 162.06 | 166.22 |
Mean number of injections | 29.4 | 42.9 | 37.0 | 37.9 |
Patients with one or more adverse events | 90 (91.8%) | 186 (95.4%) | 132 (95.7%) | 408 (94.7%) |
Common adverse eventsa | ||||
Upper respiratory tract infection | 25 (25.5%) | 49 (25.1%) | 43 (31.2%) | 117 (27.1%) |
Rheumatoid arthritis | 17 (17.3%) | 57 (29.2%) | 25 (18.1%) | 99 (23.0%) |
Nasopharyngitis | 10 (10.2%) | 37 (19.0%) | 26 (18.8%) | 73 (16.9%) |
Sinusitis | 19 (19.4%) | 35 (17.9%) | 23 (16.7%) | 77 (17.9%) |
Back pain | 8 (8.2%) | 36 (18.5%) | 18 (13.0%) | 62 (14.4%) |
Hypertension | 10 (10.2%) | 34 (17.4%) | 17 (12.3%) | 61 (14.2%) |
Arthrlagia | 13 (13.3%) | 26 (13.3%) | 21 (15.2%) | 60 (13.9%) |
Bronchitis | 12 (12.2%) | 24 (12.3%) | 22 (15.9%) | 58 (13.5%) |
Diarrhea | 5 (5.1%) | 28 (14.4%) | 22 (15.9%) | 55 (12.8%) |
Urinary tract infection | 13 (13.3%) | 25 (12.8%) | 13 (9.4%) | 51 (11.8%) |
Nausea | 10 (10.2%) | 21 (10.8%) | 18 (13.0%) | 49 (11.4%) |
Headache | 14 (14.3%) | 19 (9.7%) | 14 (10.1%) | 47 (10.9%) |
Cough | 10 (10.2%) | 24 (12.3%) | 13 (9.4%) | 47 (10.9%) |
Death | ||||
Observed number of patients | 2 (2.0%) | 6 (3.1%) | 1 (0.7%) | 9 (2.1%) |
Incidence (95% CI)/100 pt-yrsb | 0.82 (0.10, 2.95) | 0.85 (0.31, 1.86) | 0.23 (0.01, 1.30) | 0.65 (0.30, 1.24) |
Discontinuation due to adverse event(s) | 24 (24.5%) | 33 (16.9%) | 24 (17.4%) | 81 (18.8%) |
Serious adverse events | 34 (34.7%) | 71 (36.4%) | 46 (33.3%) | 151 (35.0%) |
Common serious adverse eventsc | ||||
Pneumonia | 3 (3.1%) | 10 (5.1%) | 5 (3.6%) | 18 (4.2%) |
Urinary tract infection | 0 | 5 (2.6%) | 2 (1.4%) | 7 (1.6%) |
Rheumatoid arthritis | 4 (4.1%) | 8 (4.1%) | 2 (1.4%) | 14 (3.2%) |
Osteoarthritis | 2 (2.0%) | 8 (4.1%) | 1 (0.7%) | 11 (2.6%) |
Sepsis | 0 | 5 (2.6%) | 1 (0.7%) | 6 (1.4%) |
Arthralgia | 1 (1.0%) | 1 (0.5%) | 2 (1.4%) | 4 (0.9%) |
Infections | 64 (65.3%) | 149 (76.4%) | 108 (78.3%) | 321 (74.5%) |
Serious infections | ||||
Observed number of patients | 12 (12.2%) | 29 (14.9%) | 19 (13.8%) | 60 (13.9%) |
Observed number of serious infections | 16 | 46 | 35 | 97 |
Incidence (95% CI)/100 pt-yrsd | 6.54 (3.74, 10.62) | 6.54 (4.79, 8.73) | 8.14 (5.67, 11.32) | 7.04 (5.71, 8.59) |
Common serious infectionse | ||||
Pneumonia | 3 (3.1%) | 10 (5.1%) | 5 (3.6%) | 18 (4.2%) |
Urinary tract infection | 0 | 5 (2.6%) | 2 (1.4%) | 7 (1.6%) |
Sepsis | 0 | 5 (2.6%) | 1 (0.7%) | 6 (1.4%) |
Cellulitis | 1 (1.0%) | 2 (1.0%) | 1 (0.7%) | 4 (0.9%) |
Diverticulitis | 0 | 1 (0.5%) | 2 (1.4%) | 3 (0.7%) |
Pneumonitis | 1 (1.0%) | 0 | 1 (0.7%) | 2 (0.5%) |
Colitis ulcerative | 1 (1.0%) | 0 | 0 | 1 (0.2%) |
Diarrhea | 1 (1.0%) | 0 | 0 | 1 (0.2%) |
Vomiting | 1 (1.0%) | 0 | 0 | 1 (0.2%) |
Golimumab injection-site reactions | ||||
Patients with reactions | 11 (11.2%) | 24 (12.3%) | 18 (13.0%) | 53 (12.3%) |
Injections with reactions | 16 (0.6%) | 49 (0.6%) | 64 (1.3%) | 129 (0.8%) |
Antibodies to golimumab | ||||
Week 52 | 5 (5.4%) | 9 (5.4%) | 6 (4.6%) | 20 (5.2%) |
% with neutralizing antibodiesf | 3/4 (75.0%) | 5/5 (100.0%) | 6/6 (100.0%) | 14/15 (93.3%) |
Week 100 | 6 (6.5%) | 12 (7.2%) | 7 (5.4%) | 25 (6.4%) |
% with neutralizing antibodiesf | 4/5 (80.0%) | 10/10 (100.0%) | 6/7 (85.7%) | 20/22 (90.9%) |
Week 268 | 7 (7.6%) | 16 (9.6%) | 8 (6.2%) | 31 (8.0%) |
% with neutralizing antibodiesf | 5/6 (83.3%) | 14/14 (100.0%) | 6/8 (75.0%) | 25/28 (89.3%) |