Table 4.
Safety findings up to week 16 and week 160: pooled data from five phase III studies of SC golimumab in rheumatological indications (RA, PsA and AS)
| Week 16 (placebo-controlled) | Week 160 | |||||
|---|---|---|---|---|---|---|
| Placebo±MTX | Golimumab 50 mg±MTX |
Golimumab 100 mg±MTX |
Placebo±MTX | Golimumab 50 mg±MTX |
Golimumab 100 mg±MTX |
|
| Number of treated patients* | 639 | 683 | 977 | 639 | 1249 | 1501 |
| Patients with ≥1 AE | 410 (64.2) | 464 (67.9) | 642 (65.7) | 470 (73.6) | 1069 (85.6) | 1302 (86.7) |
| Most common AE† | ||||||
| Upper respiratory tract infection | 37 (5.8) | 51 (7.5) | 69 (7.1) | 56 (8.8) | 263 (21.1) | 346 (23.1) |
| Nasopharyngitis | 31 (4.9) | 37 (5.4) | 54 (5.5) | 42 (6.6) | 167 (13.4) | 219 (14.6) |
| Nausea | 28 (4.4) | 35 (5.1) | 51 (5.2) | 51 (8.0) | 104 (8.3) | 159 (10.6) |
| Cough | – | – | – | 38 (5.9) | 124 (9.9) | 149 (9.9) |
| Headache | – | – | – | 38 (5.9) | 114 (9.1) | 149 (9.9) |
| Back pain | – | – | – | 22 (3.4) | 110 (8.8) | 146 (9.7) |
| Bronchitis | – | – | – | 24 (3.8) | 113 (9.0) | 145 (9.7) |
| Sinusitis | – | – | – | 16 (2.5) | 101 (8.1) | 142 (9.5) |
| Hypertension | – | – | – | 16 (2.5) | 84 (6.7) | 135 (9.0) |
| Diarrhoea | – | – | – | 37 (5.8) | 92 (7.4) | 123 (8.2) |
| Injection-site erythema | – | – | – | 7 (1.1) | 56 (4.5) | 113 (7.5) |
| Urinary tract infection | – | – | – | 19 (3.0) | 70 (5.6) | 109 (7.3) |
| ALT increased | – | – | – | 33 (5.2) | 108 (8.6) | 107 (7.1) |
| RA | – | – | – | 25 (3.9) | 58 (4.6) | 107 (7.1) |
| Fatigue | – | – | – | 25 (3.9) | 66 (5.3) | 101 (6.7) |
| Rash | – | – | – | 23 (3.6) | 62 (5.0) | 88 (5.9) |
| Pharyngitis | – | – | – | 16 (2.5) | 57 (4.6) | 80 (5.3) |
| Influenza | – | – | – | 15 (2.3) | 47 (3.8) | 77 (5.1) |
| AST increased | – | – | – | 23 (3.6) | 76 (6.1) | 72 (4.8) |
| Patients with ≥1 SAE | 31 (4.9) | 30 (4.4) | 35 (3.6) | 57 (8.9) | 192 (15.4) | 325 (21.7) |
| Treatment discontinued due to ≥1 AE | 18 (2.8) | 18 (2.6) | 18 (1.8) | 31 (4.9) | 92 (7.4) | 158 (10.5) |
| Injection-site reactions | ||||||
| Patients with reactions‡ | 14 (2.2) | 32 (4.7) | 65 (6.7) | 18 (2.8) | 107 (8.6) | 174 (11.6) |
| Mild | 14 (2.2) | 32 (4.7) | 64 (6.6) | 18 (2.8) | 102 (8.2) | 169 (11.3) |
| Moderate | 0 (0.0) | 1 (0.1) | 3 (0.3) | 0 (0.0) | 11 (0.9) | 18 (1.2) |
| Severe | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.1) |
| Patients with ≥1 hepatobiliary AE§ | 0 (0.0) | 1 (0.1) | 1 (0.1) | 1 (0.2) | 3 (0.2) | 5 (0.3) |
| ALT ≥3×ULN and bilirubin ≥2×ULN | 0 (0.0) | 1 (0.1) | 0 (0.0) | 1 (0.2) | 1 (0.1) | 2 (0.1) |
| ALT ≥3×ULN and serious hepatobiliary AE | 0 (0.0) | 0 (0.0) | 1 (0.1) | 0 (0.0) | 2 (0.2) | 3 (0.2) |
Data shown are number (%) of patients.
*Patients may appear in ≥1 treatment column.
†Defined as AE occurring in ≥5% of patients in any treatment group up to week 16 or week 160. Common AEs are presented in decreasing order of frequency in the golimumab 100 mg group up to week 160. AEs with ‘–’ did not meet the criterion for ‘common’ at that time point.
‡Patients may have reported ≥1 injection-site reaction.
§Hepatobiliary AE defined as ALT ≥3×ULN in combination with either bilirubin ≥2×ULN or the occurrence of an AE within the hepatobiliary system-organ class of the Medical dictionary for regulatory activities that was classified as serious by the investigator in accordance with regulatory guidelines. For the latter criterion, two patients (one RA, one AS) had cholelithiasis, one RA patient had hepatitis leading to acute hepatic failure of unknown cause and ultimately death, one AS patient had hepatic stenosis, and one AS patient had hepatitis.
AE, adverse event; ALT, alanine aminotransferase; AS, ankylosing spondylitis; AST, aspartate aminotransferase; MTX, methotrexate; PsA, psoriatic arthritis; RA, rheumatoid arthritis; SAE, serious adverse event; SC, subcutaneous; ULN, upper limit of normal.