Event | Placebo (n = 47) | All adalimumab (n = 70) |
No (%) | No (%) | |
Adverse event | 38 (80.9) | 59 (84.3) |
Serious adverse event | 5 (10.6) | 9 (12.9) |
Adverse event leading to discontinuation of study medication | 3 (6.4) | 4 (5.7) |
Infectious adverse event | 16 (34.0) | 31 (44.3) |
Serious infectious adverse event* | 2 (4.3) | 5 (7.1) |
Abscess (all) | 5 (10.6) | 8 (11.4) |
Malignant neoplasm | 0 | 0 |
Injection-site reaction (all) | 2 (4.3) | 3 (4.3) |
Opportunistic infection† | 1 (2.1) | 0 |
Congestive heart failure | 0 | 0 |
Demyelinating disorder | 0 | 0 |
Death | 0 | 0 |
*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.