Table 6 Summary of safety in adalimumab and placebo-treated patients with fistulas to 56 weeks in CHARM
EventPlacebo (n  =  47)All adalimumab (n  =  70)
No (%)No (%)
Adverse event38 (80.9)59 (84.3)
Serious adverse event5 (10.6)9 (12.9)
Adverse event leading to discontinuation of study medication3 (6.4)4 (5.7)
Infectious adverse event16 (34.0)31 (44.3)
Serious infectious adverse event*2 (4.3)5 (7.1)
Abscess (all)5 (10.6)8 (11.4)
Malignant neoplasm00
Injection-site reaction (all)2 (4.3)3 (4.3)
Opportunistic infection†1 (2.1)0
Congestive heart failure00
Demyelinating disorder00
Death00
  • *Both of the placebo-treated patients had an abdominal abscess. The serious infectious adverse events for the five adalimumab-treated patients were a pulmonary embolus with pneumonia (n  =  1); intra-abdominal abscess (n  =  1); perianal abscess (n  =  2) and scrotal abscess (n  =  1). †Oral candidiasis. CHARM, Crohn’s Trial of the fully Human Antibody Adalimumab for Remission Maintenance.