Most frequently reported adverse events (in ⩾5% of patients)
| Adverse events | Tocilizumab 8 mg/kg(n = 288) | Methotrexate(n = 284) | p Value |
| Patients with at least one adverse event (total) | 230 (79.9) | 220 (77.5) | 0.484 |
| Infections (total) | 99 (34.4) | 106 (37.3) | 0.462 |
| Nasopharyngitis | 20 (6.9) | 17 (6.0) | |
| Upper respiratory tract infection | 21 (7.3) | 15 (5.3) | |
| Gastrointestinal disorders (total) | 86 (29.9) | 89 (31.3) | 0.702 |
| Nausea | 18 (6.3) | 34 (12.0) | |
| Diarrhoea | 15 (5.2) | 15 (5.3) | |
| Investigations (total)* | 48 (16.7) | 43 (15.1) | 0.618 |
| Skin and subcutaneous disorders (total) | 42 (14.6) | 32 (11.3) | 0.237 |
| Musculoskeletal and connective tissue disorders (total) | 33 (11.5) | 32 (11.3) | 0.943 |
| Nervous system disorders (total) | 37 (12.8) | 18 (6.3) | 0.008 |
| Headache | 21 (7.3) | 7 (2.5) | |
| General disorders and administration site conditions (total) | 21 (7.3) | 24 (8.5) | 0.607 |
| Respiratory, thoracic and mediastinal disorders (total) | 26 (9.0) | 19 (6.7) | 0.299 |
| Vascular disorders (total) | 24 (8.3) | 13 (4.6) | 0.068 |
| Hypertension | 16 (5.6) | 6 (2.1) | |
| Psychiatric disorders (total) | 20 (6.9) | 11 (3.9) | 0.105 |
| Injury, poisoning and procedural complications (total) | 14 (4.9) | 15 (5.3) | 0.819 |
| Eye disorders (total) | 15 (5.2) | 9 (3.2) | 0.224 |
| Serious adverse events (in ⩾3 patients) | |||
| Total number of serious adverse events | 12 | 15 | |
| Infections and infestations | 4 (1.4) | 2 (0.7) | |
| Sepsis | – | 1 (0.4) | |
| Pneumonia | 2 (0.7) | 1 (0.4) | |
| Sinusitis | 1 (0.3) | – | |
| Sialoadenitis | 1 (0.3) | – | |
| Injury, poisoning and procedural complications | 1 (0.3) | 3 (1.1) | |
| Neoplasms benign, malignant and unspecified | 1 (0.3) | 3 (1.1) |
Results are shown as n (%).
*Laboratory parameters.