Table 7.
Summary of adverse events in open-label studies of adalimumab for adults with Crohn’s disease and ulcerative colitis
| Events (E/100 PY) | Crohn’s disease | Ulcerative colitis | ||
|---|---|---|---|---|
| EOW (n = 660) PY 1259.9 |
EW (n = 638) PY 962.7 |
EOW (n = 460) PY 1332.6 |
EW (n = 440) PY 719.8 |
|
| Any AE | 5730 (454.8) | 5118 (531.6) | 2925 (219.5) | 2248 (312.3) |
| Serious AE | 332 (26.4) | 333 (34.6) | 182 (13.7) | 149 (20.7) |
| AE leading to discontinuation | 170 (13.5) | 137 (14.2) | 96 (7.2) | 84 (11.7) |
| AE leading to death | 2 (0.2) | 0 | 1 (< 0.1) | 1 (0.1) |
| AEs of special interest | ||||
| Infection | 1312 (104.1) | 1060 (110.1) | 674 (50.6) | 505 (70.2) |
| Opportunistic infectiona | 3 (0.2) | 4 (0.4) | 1 (< 0.1) | 2 (0.3) |
| Serious infection | 77 (6.1) | 55 (5.7) | 44 (3.3) | 24 (3.3) |
| Tuberculosis | 2 (0.2) | 1 (0.1) | 1 (< 0.1) | 3 (0.4) |
| Lupus-like syndrome | 3 (0.2) | 3 (0.3) | 0 | 1 (0.1) |
| Injection-site reactions | 111 (8.8) | 41 (4.3) | 79 (5.9) | 39 (5.4) |
| Lymphoma | 2 (0.2) | 0 | 2 (0.2) | 1 (0.1) |
| Malignancyb | 13 (1.0) | 4 (0.4) | 8 (0.6) | 2 (0.3) |
| NMSC | 13 (1.0) | 7 (0.7) | 2 (0.2) | 3 (0.4) |
| Worsening/new-onset psoriasis | 23 (1.8) | 14 (1.5) | 10 (0.8) | 5 (0.7) |
| CHF | 1 (< 0.1) | 0 | 2 (0.2) | 1 (0.1) |
AE adverse event, CHF congestive heart failure, E events, EOW every-other-week dosing of adalimumab, EW every-week dosing of adalimumab, NMSC non-melanoma skin cancer, PY patient-year
aExcluding oral candidiasis and tuberculosis
bExcluding lymphoma, NMSC, melanoma, leukemia, and hepatosplenic T-cell lymphoma