Cumulative summary of golimumab safety through week 160 of the GO-AFTER trial
| Week 52 golimumab | Week 100 golimumab | Week 160 golimumab | ||||
|---|---|---|---|---|---|---|
| 50 mg | 100 mg | 50 mg | 100 mg | 50 mg | 100 mg | |
| Number of treated patients* | 279 | 259 | 279 | 314 | 279 | 330 |
| Average duration of follow-up (weeks) | 32.3 | 36.2 | 48.3 | 64.9 | 59.5 | 101.6 |
| Average number of injections | 7.7 | 8.7 | 11.5 | 15.4 | 14.1 | 23.9 |
| Average cumulative dose (mg) | 511.4 | 877.0 | 575.3 | 1539.5 | 705.9 | 2391.5 |
| Patients with 1 or more AEs | 211 (75.6%) | 198 (76.4%) | 223 (79.9%) | 259 (82.5%) | 226 (81.0%) | 296 (89.7%) |
| Common AEs† | ||||||
| Upper respiratory tract infection | 30 (10.8%) | 42 (16.2%) | 43 (15.4%) | 55 (17.5%) | 44 (15.8%) | 68 (20.6%) |
| RA | 30 (10.8%) | 20 (7.7%) | 34 (12.2%) | 37 (11.8%) | 39 (14.0%) | 53 (16.1%) |
| Nasopharyngitis | 22 (7.9%) | 28 (10.8%) | 26 (9.3%) | 36 (11.5%) | 27 (9.7%) | 45 (13.6%) |
| Sinusitis | 21 (7.5%) | 17 (6.6%) | 26 (9.3%) | 30 (9.6%) | 28 (10.0%) | 41 (12.4%) |
| Diarrhoea | 15 (5.4%) | 19 (7.3%) | 16 (5.7%) | 27 (8.6%) | 17 (6.1%) | 35 (10.6%) |
| Death‡ | ||||||
| Observed number of patients | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 4 (1.2%) |
| Incidence (95% CI) per 100 pt-yrs | 0.00 (0.00 to 0.94) | 0.62 (0.17 to 1.59) | ||||
| Discontinuation due to AE(s) | 18 (6.5%) | 8 (3.1%) | 23 (8.2%) | 16 (5.1%) | 25 (9.0%) | 38 (11.5%) |
| Serious AEs | 36 (12.9%) | 20 (7.7%) | 45 (16.1%) | 52 (16.6%) | 49 (17.6%) | 83 (25.2%) |
| Common serious AEs§ | ||||||
| Pneumonia | 4 (1.4%) | 2 (0.8%) | 5 (1.8%) | 4 (1.3%) | 5 (1.8%) | 8 (2.4%) |
| RA | 4 (1.4%) | 0 (0.0%) | 6 (2.2%) | 3 (1.0%) | 6 (2.2%) | 7 (2.1%) |
| Osteoarthritis | 3 (1.1%) | 0 (0.0%) | 4 (1.4%) | 4 (1.3%) | 4 (1.4%) | 5 (1.5%) |
| Arthralgia | 1 (0.4%) | 1 (0.4%) | 1 (0.4%) | 3 (1.0%) | 1 (0.4%) | 3 (0.9%) |
| Infections | 118 (42.3%) | 122 (47.1%) | 140 (50.2%) | 176 (56.1%) | 149 (53.4%) | 205 (62.1%) |
| Serious infections¶ | ||||||
| Observed number of patients | 10 (3.6%) | 8 (3.1%) | 14 (5.0%) | 18 (5.7%) | 14 (5.0%) | 30 (9.1%) |
| Observed number of serious infections | 10 | 11 | 15 | 26 | 15 | 52 |
| Incidence (95% CI) per100 pt-yrs | 5.78 (2.77 to 10.63) | 6.10 (3.05 to 10.92) | 5.79 (3.24 to 9.95) | 6.63 (4.33 to 9.72) | 4.70 (2.63 to 7.75) | 8.07 (6.02 to 10.58) |
| Common serious infections** | ||||||
| Pneumonia | 4 (1.4%) | 2 (0.8%) | 5 (1.8%) | 4 (1.3%) | 5 (1.8%) | 8 (2.4%) |
| Urinary tract infection | 2 (0.7%) | 0 (0.0%) | 2 (0.7%) | 2 (0.6%) | 2 (0.7%) | 3 (0.9%) |
| Sepsis | 0 (0.0%) | 1 (0.4%) | 0 (0.0%) | 2 (0.6%) | 0 (0.0%) | 4 (1.2%) |
| Diverticulitis | 0 (0.0%) | 1 (0.4%) | 0 (0.0%) | 2 (0.6%) | 0 (0.0%) | 3 (0.9%) |
| Abdominal abscess | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 2 (0.6%) |
| Cellulitis | 0 (0.0%) | 0 (0.0%) | 1 (0.4%) | 1 (0.3%) | 1 (0.4%) | 1 (0.3%) |
| Gastroenteritis | 1 (0.4%) | 2 (0.8%) | 0 (0.0%) | 2 (0.6%) | 0 (0.0%) | 2 (0.6%) |
| Herpes zoster | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 2 (0.6%) |
| Infection | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 1 (0.3%) | 0 (0.0%) | 2 (0.6%) |
| Urosepsis | 2 (0.7%) | 0 (0.0%) | 2 (0.7%) | 0 (0.0%) | 2 (0.7%) | 0 (0.0%) |
| All malignancies‡ | ||||||
| Observed number of patients | 1 | 2 | 2 | 3 | 3 | 13 |
| Incidence (95% CI) per 100 pt-yrs | 0.58 (0.01 to 3.24) | 1.12 (0.14 to 4.03) | 0.77 (0.09 to 2.80) | 0.77 (0.16 to 2.24) | 0.95 (0.20 to 2.77) | 2.04 (1.09 to 3.49) |
| Lymphoma | ||||||
| Observed number of patients | 0 | 1 | 0 | 1 | 0 | 4 |
| Incidence (95% CI) per 100 pt-yrs | 0.00 (0.00 to 1.74) | 0.56 (0.01 to 3.11) | 0.00 (0.00 to 1.16) | 0.26 (0.01 to 1.42) | 0.00 (0.00 to 0.94) | 0.62 (0.17 to 1.59) |
| Nonmelanoma skin cancers | ||||||
| Observed number of patients | 1 | 0 | 1 | 1 | 1 | 5 |
| Incidence (95% CI) per 100 pt-yrs | 0.58 (0.01 to 3.24) | 0.00 (0.00 to 1.67) | 0.39 (0.01 to 2.16) | 0.26 (0.01 to 1.42) | 0.31 (0.01 to 1.75) | 0.78 (0.25 to 1.82) |
| Other malignancies‡ | ||||||
| Observed number of patients | 0 | 1 | 1 | 1 | 2 | 4 |
| Incidence (95% CI) per 100 pt-yrs | 0.00 (0.00 to 1.74) | 0.56 (0.01 to 3.11) | 0.39 (0.01 to 2.15) | 0.26 (0.01 to 1.42) | 0.63 (0.08 to 2.27) | 0.62 (0.17 to 1.59) |
| Golimumab injection-site reactions | ||||||
| Patients | 20 (7.2%) | 23 (8.9%) | 20 (7.2%) | 30 (9.6%) | 21 (7.5%) | 31 (9.4%) |
| Injections | 26/2157 (1.2%) | 51/2260 (2.3%) | 29/3210 (0.9%) | 73/4835 (1.5%) | 30/3939 (0.8%) | 82/7893 (1.0%) |
Data presented are number (%) of patients unless noted otherwise noted.
↵* Patients could appear in more than one column.
↵† Occurring in ≥10% of patients in either golimumab dose group.
↵‡ As previously reported by Smolen and colleagues,1 an additional patient in the placebo group who did not meet the early escape criteria died of pancreatic cancer. The resulting incidence is 1.73 (95% CI 0.04 to 9.65) and 1.73 (95% CI 0.04 to 9.66) per 100 pt-yrs of follow-up for death and other/all malignancies, respectively.
↵§ Occurring in ≥1% of patients in either golimumab dose group.
↵¶ Serious infections were observed in 5 (3.2%) patients through a total of 58 pt-years of follow-up pertaining to receipt of placebo, equating to an incidence of 8.66 (95% CI 28.1 to 20.22) per 100 pt-yrs of follow-up.
↵** Occurring in ≥2 patients overall.
AE, adverse event; pt-years, patient-years of follow-up; RA, rheumatoid arthritis.