Summary of adverse events among treated patients through week 16 (placebo-controlled period) and week 24
| Week 16 | ||
|---|---|---|
| Placebo+MTX | Golimumab 2 mg/kg+MTX | |
| Number of treated patients | 197 | 395 |
| Average duration of follow-up (weeks) | 15.9 | 15.9 |
| Average exposure (number of administrations) | 2.9 | 2.9 |
| Patients with ≥1 adverse event | 86 (43.7%) | 187 (47.3%) |
| System-organ class/preferred term occurring in ≥2% of patients in any treatment group | ||
| Infections and infestations | 41 (20.8%) | 96 (24.3%) |
| Upper respiratory tract infection | 11 (5.6%) | 20 (5.1%) |
| Urinary tract infection | 5 (2.5%) | 10 (2.5%) |
| Nasopharyngitis | 4 (2.0%) | 8 (2.0%) |
| Pharyngitis | 1 (0.5%) | 8 (2.0%) |
| Influenza | 4 (2.0%) | 3 (0.8%) |
| Musculoskeletal and connective tissue disorders | 29 (14.7%) | 27 (6.8%) |
| Arthralgia | 7 (3.6%) | 6 (1.5%) |
| Rheumatoid arthritis | 11 (5.6%) | 6 (1.5%) |
| Back pain | 4 (2.0%) | 4 (1.0%) |
| Nervous system disorders | 8 (4.1%) | 27 (6.8%) |
| Headache | 5 (2.5%) | 17 (4.3%) |
| Gastrointestinal disorders | 11 (5.6%) | 26 (6.6%) |
| Skin and subcutaneous tissue disorders | 7 (3.6%) | 26 (6.6%) |
| Respiratory, thoracic and mediastinal disorders | 5 (2.5%) | 19 (4.8%) |
| Investigations | 8 (4.1%) | 15 (3.8%) |
| Vascular disorders | 5 (2.5%) | 15 (3.8%) |
| Hypertension | 3 (1.5%) | 11 (2.8%) |
| General disorders and administration site disorders | 5 (2.5%) | 11 (2.8%) |
| Pyrexia | 0 (0.0%) | 8 (2.0%) |
| Metabolism and nutrition disorders | 0 (0.0%) | 9 (2.3%) |
| Injury, poisoning and procedural complications | 6 (3.0%) | 7 (1.8%) |
| Week 24 | ||||
|---|---|---|---|---|
| Placebo+MTX | Placebo + MTX→ Golimumab 2 mg/kg + MTX* | Golimumab 2 mg/kg+MTX | Combined Golimumab | |
| Number of treated patients | 197 | 68 | 395 | 463 |
| Average duration of follow-up (weeks) | 20.9 | 8.2 | 23.7 | 21.4 |
| Average exposure (number of administrations) | 4.2 | 2.0 | 3.9 | 3.6 |
| Patients with ≥1 adverse event | 97 (49.2%) | 19 (27.9%) | 226 (57.2%) | 245 (52.9%) |
| Patients with ≥1 serious adverse event | 4 (2.0%) | 0 (0.0%) | 19 (4.8%) | 19 (4.1%) |
| Patients with ≥1 serious infection | 0 (0.0%) | 0 (0.0%) | 4 (1.0%) | 4 (0.9%) |
| System-organ class/preferred term | ||||
| Infections and infestations | 0 (0.0%) | 0 (0.0%) | 3 (0.8%) | 3 (0.6%) |
| Appendicitis | 0 (0.0%) | 0 (0.0%) | 1 (0.3%) | 1 (0.2%) |
| Bacteraemia | 0 (0.0%) | 0 (0.0%) | 1 (0.3%) | 1 (0.2%) |
| Upper respiratory tract infection | 0 (0.0%) | 0 (0.0%) | 1 (0.3%) | 1 (0.2%) |
| Respiratory, thoracic and mediastinal disorders | 0 (0.0%) | 0 (0.0%) | 1 (0.3%) | 1 (0.2%) |
| Interstitial lung disease | 0 (0.0%) | 0 (0.0%) | 1 (0.3%) | 1 (0.2%) |
| Infusion reactions | ||||
| Patients with reactions | 1 (0.5%) | 3 (4.4%) | 13 (3.3%) | 16 (3.5%) |
| Infusions with reactions | 2/828 (0.2%) | 3/136 (2.2%) | 15/1528 (1.0%) | 18/1664 (1.1%) |
| ALT abnormalities by TB prophylaxis | ||||
| Patients with baseline ALT ≤ULN and receiving TB prophylaxis | 34 | 16 | 48 | 64 |
| Patients with ALT abnormalities | 7 (20.6%) | 1 (6.3%) | 19 (39.6%) | 20 (31.3%) |
| Patients with baseline ALT ≤ULN and not receiving TB prophylaxis | 148 | 47 | 309 | 356 |
| Patients with ALT abnormalities | 32 (21.6%) | 12 (25.5%) | 88 (28.5%) | 100 (28.1%) |
Data presented are number (%) of patients.
↵* Patients who early escaped at week 16 and started receiving golimumab at week 16.
ALT, alanine aminotransferase; MTX, methotrexate; TB, tuberculosis; ULN, upper limit of the normal range.