Table 4.
Overview of adverse events occurring during double-blind therapy
| AE, n (%) | Week 8, n (%) | Week 52, E (E/100 PY) | ||||
|---|---|---|---|---|---|---|
| Placebo (N = 96) | ADA 80/40 mg (N = 87) | ADA 160/80 mg (N = 90) | Placebo (N = 96) PY = 44.8 | ADA 40 mg EOW (N = 177) PY = 98.2 | ADA week 8 responders per full Mayo score (N = 82) PY = 68.7 | |
| Any AE | 45 (46.9) | 49 (56.3) | 40 (44.4) | 273 (609.4) | 538 (547.9) | 343 (499.3) |
| At least possibly drug-related | 10 (10.4) | 14 (16.1) | 12 (13.3) | 34 (75.9) | 91 (92.7) | 64 (93.2) |
| Serious | 7 (7.3) | 2 (2.3) | 4 (4.4) | 14 (31.3) | 33 (33.6) | 20 (29.1) |
| Leading to early discontinuation | 4 (4.2) | 0 | 6 (6.7) | 6 (13.4) | 22 (22.4) | 11 (16.0) |
| AE of interest | ||||||
| Infection | 15 (15.6) | 11 (12.6) | 17 (18.9) | 70 (156.3) | 134 (136.5) | 90 (131.0) |
| Serious infection | 0 | 0 | 3 (3.3) | 2 (4.5) | 8 (8.1) | 6 (8.7) |
| Malignancya | 0 | 0 | 1 (1.1) | 0 | 2 (2.0) | 1 (1.5) |
| Injection site reaction | 2 (2.1) | 5 (5.7) | 7 (7.8) | 4 (8.9) | 20 (20.4) | 9 (13.1) |
| Opportunistic infection (excluding tuberculosis)b | 0 | 0 | 1 (1.1) | 0 | 2 (2.0) | 2 (2.9) |
| Tuberculosis | 0 | 0 | 1 (1.1) | 0 | 1 (1.0) | 0 |
| Hepatic event | 1 (1.0) | 0 | 1 (1.1) | 3 (6.7) | 5 (5.1) | 3 (4.4) |
| Allergic reaction | 0 | 1 (1.1) | 0 | 2 (4.5) | 6 (6.1) | 5 (7.3) |
| Hematologic event | 1 (1.0) | 3 (3.4) | 1 (1.1) | 4 (8.9) | 6 (6.1) | 4 (5.8) |
| UC worsening/flare | 8 (8.3) | 2 (2.3) | 2 (2.2) | 15 (33.5) | 18 (18.3) | 7 (10.2) |
ADA adalimumab, AE adverse event, E event, EOW every other week, PY patient-year, UC ulcerative colitis
aOne pancreatic carcinoma and one parathyroid tumor, which was determined to be benign but was conservatively classified as a malignancy
bOne Mycobacterium avium complex infection and one cytomegalovirus infection