Table 2

Display of adverse events

SB2 (N=290)INF (N=293)
n (%)n (%)
Any TEAEs, patients (%)167 (57.6)170 (58.0)
 Latent tuberculosis17 (5.9)20 (6.8)
 Alanine aminotransferase increased23 (7.9)8 (2.7)
 Headache16 (5.5)13 (4.4)
 Nasopharyngitis14 (4.8)15 (5.1)
 Rheumatoid arthritis16 (5.5)9 (3.1)
 Aspartate aminotransferase increased12 (4.1)8 (2.7)
 Bronchitis9 (3.1)11 (3.8)
 Upper respiratory tract infection10 (3.4)9 (3.1)
 Back pain7 (2.4)9 (3.1)
 Arthralgia8 (2.8)7 (2.4)
 Pneumonia7 (2.4)7 (2.4)
 Hypertension6 (2.1)8 (2.7)
 Urinary tract infection7 (2.4)5 (1.7)
 Cough6 (2.1)6 (2.0)
 Rash6 (2.1)5 (1.7)
 Pharyngitis4 (1.4)6 (2.0)
 Pyrexia2 (0.7)7 (2.4)
 Dyspepsia1 (0.3)6 (2.0)
Any SAEs26 (9.0)26 (8.9)
 Serious infections or tuberculosis9 (3.1)6 (2.0)
 Pneumonia3 (1.0)2 (0.7)
 Pneumonia bacterial1 (0.3)0 (0.0)
 Pyelonephritis1 (0.3)0 (0.0)
 Soft tissue infection1 (0.3)0 (0.0)
 Tuberculous pleurisy1 (0.3)0 (0.0)
 Urinary tract infection1 (0.3)0 (0.0)
 Enteritis1 (0.3)0 (0.0)
 Cellulitis0 (0.0)1 (0.3)
 Erysipelas0 (0.0)1 (0.3)
 Pulmonary tuberculosis0 (0.0)1 (0.3)
 Wound infection0 (0.0)1 (0.3)
Infusion related reactions15 (5.2)13 (4.4)
  • TEAEs are listed for reported events of at least a frequency ≥2% in either study group in the safety population (SAF). Latent tuberculosis was reported when a positive Quantiferon test seroconversion occurred after randomisation. The incidence rate for any infections was 47 cases/100-person years for SB2 and 64 cases/100 person-years for INF.

  • INF, infliximab reference product; SAE, serious adverse event; TEAE, treatment-emergent adverse event.