| MTX | No MTX | |
| Total treatment time (years) | 319.5 | 209 |
| Serious adverse events (SAE) per 100 treatment years: | ||
| All SAE | 5.32 (17) | 5.74 (12) |
| Infections* | 1.56 (5) | 0.96 (2) |
| Circulatory† events | 0.94 (3) | 0.96 (2) |
| Musculoskeletal‡ | 0.94 (3) | 0.48 (1) |
| Malignancies | 0.31 (1)§ | 0.48 (1)¶ |
| Infusion reactions | 0.63 (2) | 1.44 (3) |
| Other** | 0.94 (3) | 1.44 (3) |
Exposure time, total rates and subtypes of adverse events are shown.
*Mainly respiratory tract infections with no reported events of tuberculosis.
†One transient ischemic attack, two acute coronary syndromes, and two tachyarrhythmias.
‡Three peripheral fractures and one cervical spinal stenosis requiring surgery.
§Fatal non-Hodgkin’s lymphoma (diffuse large B-cell lymphoma).
¶Chronic lymphatic leukaemia (CLL), with probable subclinical debut prior to anti-tumour necrosis factor (TNF) treatment.
**Includes severe vertigo, irritable bowl disease after hospitalisation and endoscopic biopsy, benign stenosis of the esophagus, concrement in the urinary tract, non-infectious pleuritis, severe dysplasia of cevix uteri.