Safety findings through 5 years: pooled data from phase 3 studies of SC GOL (with or without MTX) in rheumatological indications. Values are n (%) or n/N (%) of patients.
| Variables | Placebo | GOL 50 mg Only | GOL 50 and 100 mg | GOL 100 mg Only | All GOL |
|---|---|---|---|---|---|
| Treated patients in 5 trials1 | 639 | 671 | 765 | 792 | 2228 |
| Patients with ≥ 1 AE | 470 (73.6) | 623 (92.8) | 704 (92.0) | 756 (95.5) | 2083 (93.5) |
| Most common AE2 | |||||
| Upper respiratory tract infection | 56 (8.8) | 215 (32.0) | 227 (29.7) | 246 (31.1) | 688 (30.9) |
| Nasopharyngitis | 41 (6.4) | 117 (17.4) | 152 (19.9) | 164 (20.7) | 433 (19.4) |
| Bronchitis | 24 (3.8) | 92 (13.7) | 114 (14.9) | 114 (14.4) | 320 (14.4) |
| Back pain | 22 (3.4) | 91 (13.6) | 116 (15.2) | 112 (14.1) | 319 (14.3) |
| Cough | 38 (5.9) | 93 (13.9) | 97 (12.7) | 112 (14.1) | 302 (13.6) |
| Headache | 39 (6.1) | 91 (13.6) | 88 (11.5) | 114 (14.4) | 293 (13.2) |
| Sinusitis | 15 (2.3) | 86 (12.8) | 108 (14.1) | 95 (12.0) | 289 (13.0) |
| Arthralgia | 29 (4.5) | 87 (13.0) | 98 (12.8) | 99 (12.5) | 284 (12.7) |
| Nausea | 51 (8.0) | 63 (9.4) | 94 (12.3) | 127 (16.0) | 284 (12.7) |
| Hypertension | 17 (2.7) | 66 (9.8) | 112 (14.6) | 101 (12.8) | 279 (12.5) |
| Diarrhea | 36 (5.6) | 69 (10.3) | 80 (10.5) | 96 (12.1) | 245 (11.0) |
| Urinary tract infection | 20 (3.1) | 53 (7.9) | 75 (9.8) | 87 (11.0) | 215 (9.6) |
| RA | 26 (4.1) | 34 (5.1) | 88 (11.5) | 75 (9.5) | 197 (8.8) |
| Fatigue | 26 (4.1) | 48 (7.2) | 51 (6.7) | 84 (10.6) | 183 (8.2) |
| Injection site erythema | 7 (1.1) | 39 (5.8) | 50 (6.5) | 86 (10.9) | 175 (7.9) |
| ALT increased | 33 (5.2) | 80 (11.9) | 65 (8.5) | 83 (10.5) | 228 (10.2) |
| Patients with ≥ 1 SAE | 58 (9.1) | 177 (26.4) | 230 (30.1) | 275 (34.7) | 682 (30.6) |
| Most common SAE2 | |||||
| Pneumonia | 5 (0.8) | 11 (1.6) | 22 (2.9) | 13 (1.6) | 46 (2.1) |
| RA | 6 (0.9) | 6 (0.9) | 14 (1.8) | 14 (1.8) | 34 (1.5) |
| Osteoarthritis | 0 | 6 (0.9) | 16 (2.1) | 8 (1.0) | 30 (1.3) |
| Basal cell carcinoma | 3 (0.5) | 5 (0.7) | 8 (1.0) | 13 (1.6) | 26 (1.2) |
| Cholelithiasis | 1 (0.2) | 4 (0.6) | 5 (0.7) | 11 (1.4) | 20 (0.9) |
| Sepsis | 0 | 1 (0.1) | 7 (0.9) | 11 (1.4) | 19 (0.9) |
| Arthralgia | 0 | 2 (0.3) | 6 (0.8) | 8 (1.0) | 16 (0.7) |
| Patients discontinued due to ≥ 1 AE | 33 (5.2) | 103 (15.4) | 73 (9.5) | 158 (19.9) | 334 (15.0) |
| Injection site reactions | |||||
| Injections with reactions | 31/8403 (0.4) | 260/39,944 (0.7) | 392/54,005 (0.7) | 398/50,999 (0.8) | 1050/144,948 (0.7) |
| Patients with reactions3 | 18 (2.8) | 74 (11.0) | 89 (11.6) | 122 (15.4) | 285 (12.8) |
| Mild | 18 (2.8) | 68 (10.1) | 85 (11.1) | 119 (15.0) | 272 (12.2) |
| Moderate | 0 (0.0) | 9 (1.3) | 11 (1.4) | 10 (1.3) | 30 (1.3) |
| Severe | 0 (0.0) | 0 (0.0) | 1 (0.1)4 | 0 (0.0) | 1 (< 0.1) |
| Treated patients in 3 RA trials1 | 449 | 374 | 542 | 565 | 1481 |
| Patients with ≥ 1 AE | 341 (75.9) | 349 (93.3) | 502 (92.6) | 541 (95.8) | 1392 (94.0) |
| Patients with ≥ 1 SAE | 45 (10.0) | 121 (32.4) | 182 (33.6) | 224 (39.6) | 527 (35.6) |
| Patients discontinued due to ≥ 1 AE | 27 (6.0) | 70 (18.7) | 58 (10.7) | 125 (22.1) | 253 (17.1) |
| Injection site reactions | |||||
| Injections with reactions | 19/6623 (0.3) | 78/19,756 (0.4) | 284/36,304 (0.8) | 313/34,097 (0.9) | 675/90,157 (0.7) |
| Patients with reactions3 | 13 (2.9) | 37 (9.9) | 64 (11.8) | 91 (16.1) | 192 (13.0) |
↵1 Note that some patients received placebo followed by GOL in early escape or following crossover per trial design.
↵2 Defined as AE and SAE occurring in ≥ 10% and ≥ 1%, respectively, of patients in any treatment group. Common AE and SAE are presented in decreasing order of frequency in the GOL combined group.
↵3 Patients may have reported ≥ 1 injection reaction.
↵4 A serious event of erythema on the thigh in a patient with early RA receiving GOL 100 mg at the time of the reaction (Day 368). SC: subcutaneous; GOL: golimumab; MTX: methotrexate; AE: adverse event; ALT: alanine aminotransferase; SAE: serious AE; RA: rheumatoid arthritis.