Table 2.
Safety overview
| Parameter | Ulcerative colitis (N = 894) | Crohn's disease (N = 1349) | ||
|---|---|---|---|---|
| n (%) | Incidence/1000 person‐years a | n (%) | Incidence/1000 person‐years a | |
| Any AE | 829 (92.7) | 1220.5 | 1295 (96.0) | 1799.2 |
| Disease exacerbation | 321 (35.9) | 105.2 | 476 (35.3) | 121.4 |
| Nasopharyngitis | 252 (28.2) | 93.9 | 342 (25.4) | 94.1 |
| Arthralgia | 155 (17.3) | 51.6 | 329 (24.4) | 90.2 |
| Abdominal pain | 111 (12.4) | 34.4 | 309 (22.9) | 80.0 |
| Headache | 164 (18.3) | 55.5 | 290 (21.5) | 76.4 |
| Upper respiratory tract infection | 166 (18.6) | 55.7 | 213 (15.8) | 53.2 |
| Nausea | 105 (11.7) | 32.3 | 231 (17.1) | 57.7 |
| Pyrexia | 80 (8.9) | 24.3 | 201 (14.9) | 48.6 |
| Severity of AE | ||||
| Mild | 163 (18.2) | NA | 223 (16.5) | NA |
| Moderate | 451 (50.4) | NA | 656 (48.6) | NA |
| Severe | 215 (24.0) | NA | 415 (30.8) | NA |
| Treatment‐related AEs | 355 (39.7) | NA | 623 (46.2) | NA |
| Treatment withdrawn due to AE | 137 (15.3) | NA | 229 (17.0) | NA |
| SAEs | 277 (31.0) | 90.9 | 548 (40.6) | 146.5 |
| Disease exacerbation | 119 (13.3) | 34.8 | 224 (16.6) | 50.3 |
| Abdominal pain | 9 (1.0) | 2.6 | 41 (3.0) | 9.0 |
| Anal abscess | 0 | 0 | 33 (2.4) | 7.3 |
| Small intestinal obstruction | 4 (<1) | 1.1 | 25 (1.9) | 5.5 |
| Treatment‐related SAEs | 37 (4.1) | NA | 79 (5.9) | NA |
| AESIs | ||||
| Total infections | 591 (66.1) | 388.9 | 937 (69.5) | 492.1 |
| Serious infections | 61 (6.8) | 18.0 | 146 (10.8) | 33.6 |
| Malignancies | 58 (6.5) | 17.2 | 92 (6.8) | 20.8 |
| Infusion reactions | 36 (4.0) | NA | 67 (5.0) | NA |
| Hepatic events | 29 (3.2) | 8.4 | 63 (4.7) | 14.1 |
| PML | 0 | 0 | 0 | 0 |
| Deaths | 4 (<1) b | NA | 6 (<1) c | NA |
| Treatment‐related death | 1 (<1) d | NA | 1 (<1) e | NA |
Abbreviations: AE, adverse event; AESIs, adverse events of special interest; NA, not available; PML, progressive multifocal leukoencephalopathy; SAE, serious adverse event.
Time‐adjusted incidence rate per 1000 patient‐years = (number of patients experiencing an AE of interest/total person time in years) × 1000.
Respiratory failure, acute stroke, West Nile virus encephalitis, pulmonary embolism.
Traumatic intracranial haemorrhage, hepatocellular carcinoma, suicide, pneumonia, septicaemia, leiomyosarcoma.
One patient who received long‐term vedolizumab therapy subsequently died because of West Nile virus encephalitis. However, based on the mechanism of action of vedolizumab and available information, there is no known association between this event and vedolizumab therapy. There are also no other safety signals linking vedolizumab to the West Nile virus. Therefore, although this event was recorded by the principal investigator as treatment‐related, there is no evidence to support this association.
Death of 1 patient with Crohn's disease (hepatocellular carcinoma) was considered treatment‐related by the treating physicians.