Summary of key safety findings through Week 104. Data presented are number (%) of patients unless specified otherwise.
| Golimumab + MTX | ||||||
|---|---|---|---|---|---|---|
| Placebo1, Wks 0–24 | Golimumab 100 mg + Placebo | Golimumab 50 mg + MTX | Golimumab 100 mg + MTX | All Golimumab + MTX | All Golimumab | |
| Golimumab-treated pts2 | 125 | 132 | 212 | 239 | 387 | 434 |
| Average no. golimumab injections | — | 16.4 | 18.4 | 14.8 | 19.4 | 21.6 |
| Average followup time (wks) | — | 66.0 | 76.6 | 58.8 | 78.3 | 89.9 |
| Average cumulative golimumab dose (mg) | — | 1634.5 | 919.3 | 1466.8 | 1407.0 | 1699.9 |
| Total pt-yrs of followup | 51.4 | 167.6 | 312.3 | 270.4 | 582.7 | 750.3 |
| AE | — | 109 (82.6) | 181 (85.4) | 154 (64.4) | 314 (81.1) | 388 (89.4) |
| Common AE3 | ||||||
| Upper respiratory tract infection | 21 (15.9) | 40 (18.9) | 35 (14.6) | 74 (19.1) | 93 (21.4) | |
| Cough | 13 (9.8) | 25 (11.8) | 20 (8.4) | 45 (11.6) | 58 (13.4) | |
| Nasopharyngitis | 13 (9.8) | 20 (9.4) | 22 (9.2) | 42 (10.9) | 55 (12.7) | |
| Bronchitis | 11 (8.3) | 26 (12.3) | 16 (6.7) | 42 (10.9) | 50 (11.5) | |
| Headache | 8 (6.1) | 19 (9.0) | 19 (7.9) | 37 (9.6) | 45 (10.4) | |
| Discontinuation of SC study agent because of AE(s) | 13 (9.8) | 14 (6.6) | 15 (6.3) | 29 (7.5) | 41 (9.4) | |
| Serious AE | — | 26 (19.7) | 33 (15.6) | 41 (17.2) | 73 (18.9) | 98 (22.6) |
| Death | ||||||
| No. patients | 0 (0.0) | 3 (2.3) | 0 (0.0) | 1 (0.4) | 1 (0.3) | 4 (0.9) |
| Incidence (95% CI) per 100 pt-yrs | 0.00 (0.00, 5.83) | 1.79 (0.37, 5.23) | 0.00 (0.00, 0.96) | 0.37 (0.01, 2.06) | 0.17 (0.00, 0.96) | 0.53 (0.15, 1.37) |
| Any infection | 75 (56.8) | 131 (61.8) | 103 (43.1) | 227 (58.7) | 293 (67.5) | |
| Treated infection(s) | — | 58 (43.9) | 98 (46.2) | 83 (34.7) | 177 (45.7) | 229 (52.8) |
| Serious infection(s) | 0 (0.0) | 8 (6.1) | 7 (3.3) | 14 (5.9) | 21 (5.4) | 29 (6.7) |
| Incidence (95% CI) per 100 pt-yrs | 0.00 (0.00, 5.83) | 4.77 (2.06, 9.41) | 2.24 (0.90, 4.62) | 5.18 (2.83, 8.69) | 3.60 (2.23, 5.51) | 3.87 (2.59, 5.55) |
| Malignancies4 | ||||||
| No. patients | 2 (1.6) | 3 (2.3) | 6 (2.8) | 5 (2.1) | 11 (2.8) | 14 (3.2) |
| Incidence (95% CI) per 100 pt-yrs | 3.89 (0.47, 14.05) | 1.79 (0.37, 5.23) | 1.92 (0.71, 4.18) | 1.85 (0.60, 4.32) | 1.89 (0.94, 3.38) | 1.87 (1.02, 3.13) |
| SIR (95% CI) vs SEER5 | 0.00 (0.00, 8.40) | 0.00 (0.00, 2.91) | 1.04 (0.13, 3.76) | 1.85 (0.38, 5.41) | 1.41 (0.46, 3.29) | 1.09 (0.35, 2.54) |
| Injection site reactions6 | ||||||
| Reaction to golimumab injection | 14 (10.6) | 10 (4.7) | 12 (5.0) | 22 (5.7) | 36 (8.3) | |
| Reaction to placebo injection | 9 (6.8) | 6 (2.8) | 7 (2.9) | 13 (3.4) | 21 (4.8) | |
↵1 Because of vast differences in length of followup for placebo versus golimumab treatment, incidence by length of followup is provided for AE of interest, i.e., death, serious infection, malignancy.
↵2 Patients may appear in more than 1 column. Thus, treatment groups are not mutually exclusive.
↵3 Absolute numbers and percentages of patients with 1 or more AE reported in 10% or more of golimumab-treated patients. The Medical Dictionary for Regulatory Activities (MedDRA) preferred terms are sorted by decreasing frequency in the “All Golimumab” group.
↵4 Two (1.5%) additional patients in the placebo + MTX group had malignancies through Week 52, yielding a total of 16 patients with malignancy.
↵5 SIR: standardized incidence ratio, i.e., observed/expected incidences of malignancy (excluding nonmelanoma skin cancer).
↵6 Injection site reactions were defined as any adverse reaction at a subcutaneous study agent injection site. MTX: methotrexate; pt-yrs: patient-years; SC: subcutaneous; SEER: Surveillance, Epidemiology and End Results; AE: adverse events.