Table 3 Serious adverse events during the observational period graded according to World Health Organization (WHO) terminology
Total treatment time (years)319.5209
Serious adverse events (SAE) per 100 treatment years:
All SAE5.32 (17)5.74 (12)
Infections*1.56 (5)0.96 (2)
Circulatory† events0.94 (3)0.96 (2)
Musculoskeletal‡0.94 (3)0.48 (1)
Malignancies0.31 (1)§0.48 (1)¶
Infusion reactions0.63 (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.