Table 4

Summary of treatment-emergent adverse events (safety population: all patients who received at least one dose of study drug or placebo)

Placebo (N=223) n (%)ADA 80/40 (N=130) n (%)ADA 160/80 (N=223) n (%)
Any AE108 (48.4)70 (53.8)112 (50.2)
Any severe AE17 (7.6)9 (6.9)19 (8.5)
Any serious AE17 (7.6)5 (3.8)9 (4.0)
AE leading to discontinuation12 (5.4)8 (6.2)12 (5.4)
Infectious AE35 (15.7)26 (20.0)32 (14.3)
 Serious infectious AE3 (1.3)*2 (1.5)*0
Malignancy2 (0.9)†00
Injection-site reaction7 (3.1)7 (5.4)13 (5.8)
Opportunistic infection (excluding TB)001 (0.4)‡
Congestive heart failure000
Demyelinating disease000
Lupus-like syndrome000
Fatal AE000

  • ↵* Placebo: pneumonia (one); sepsis (one); wound infection staphylococcal (one). ADA 80/40: abscess rupture (one); perirectal abscess (one).

  • ↵† Basal cell carcinoma (one); breast cancer (one).

  • ↵‡ Oesophogeal candidiasis.

  • ADA, adalimumab; AE, adverse event; TB, tuberculosis.