Table 3.
Safety outcomes reported by baseline age in combined UC and CD populations
| Adverse event | Patients, n (rate per 100 PY) | |||||
|---|---|---|---|---|---|---|
| Age <35 years | Age 35 to <55 years | Age ≥55 years | ||||
| PBO/PBOa (n = 120; TPY = 61.0) | VDZ/VDZb (n = 688; TPY = 505.7) | PBO/PBOa (n = 141; TPY = 86.1) | VDZ/VDZb (n = 599; TPY = 440.4) | PBO/PBOa (n = 36; TPY = 24.3) |
VDZ/VDZb (n = 147; TPY = 112.1) | |
| Any AE | 98 (482.6) | 570 (337.8) | 107 (323.6) | 507 (364.6) | 27 (394.3) | 126 (343.8) |
| Any infection | 44 (99.9) | 301 (87.0) | 45 (67.0) | 260 (84.7) | 14 (85.0) | 61 (77.4) |
| Any investigator-defined infusion-related reaction | 5 (8.6) | 31 (6.4) | 3 (3.5) | 26 (6.1) | 1 (4.2) | 4 (3.7) |
| Any serious AE | 21 (38.6) | 149 (32.1) | 14 (17.2) | 110 (27.5) | 5 (22.0) | 17 (15.9) |
| Any serious infection | 4 (6.7) | 37 (7.5) | 3 (3.5) | 19 (4.4) | 1 (4.2) | 1 (0.9) |
| Hospitalizationsc | 20 (36.5) | 143 (30.7) | 13 (15.9) | 99 (24.4) | 5 (22.0) | 16 (14.8) |
| Malignancy | 0 | 2 (0.4) | 0 | 2 (0.5) | 1 (4.3) | 0 |
| Death | 0 | 3 (0.6) | 0 | 1 (0.2) | 1 (4.2) | 1 (0.9) |
| Common AEs (≥5 per 100 PY in the VDZ treatment group and with higher incidence than in the PBO group in any age group)d | ||||||
| Nasopharyngitis | 9 (15.3) | 91 (19.8) | 9 (10.9) | 72 (18.0) | 3 (13.6) | 17 (16.2) |
| Headache | 11 (19.5) | 88 (19.3) | 17 (21.7) | 70 (17.7) | 4 (18.0) | 19 (18.9) |
| Arthralgia | 7 (11.9) | 74 (15.8) | 17 (21.2) | 74 (18.4) | 5 (22.8) | 18 (17.4) |
| Pyrexia | 12 (20.8) | 69 (14.5) | 9 (10.8) | 48 (11.5) | 1 (4.2) | 10 (9.3) |
| Nausea | 10 (17.6) | 61 (12.8) | 11 (13.4) | 54 (13.1) | 2 (8.8) | 13 (12.2) |
| Upper respiratory tract infection | 7 (12.2) | 42 (8.7) | 10 (12.0) | 52 (12.6) | 2 (8.6) | 12 (11.2) |
| Fatigue | 2 (3.3) | 37 (7.6) | 5 (5.9) | 43 (10.4) | 3 (13.0) | 6 (5.5) |
| Back pain | 5 (8.5) | 28 (5.7) | 4 (4.7) | 28 (6.5) | 1 (4.3) | 6 (5.5) |
| Cough | 3 (5.0) | 28 (5.7) | 3 (3.6) | 35 (8.4) | 4 (18.5) | 7 (6.4) |
| Dizziness | 3 (5.0) | 25 (5.1) | 3 (3.5) | 15 (3.5) | 2 (8.7) | 8 (7.4) |
| Bronchitis | 6 (10.3) | 20 (4.1) | 2 (2.4) | 30 (7.0) | 2 (8.7) | 7 (6.4) |
| Pruritus | 2 (3.4) | 13 (2.6) | 2 (2.4) | 24 (5.6) | 0 | 2 (1.8) |
| Muscle spasms | 1 (1.7) | 11 (2.2) | 1 (1.2) | 11 (2.5) | 0 | 6 (5.5) |
| Muscular weakness | 1 (1.7) | 5 (1.0) | 1 (1.2) | 11 (2.5) | 1 (4.3) | 7 (6.4) |
AE adverse event, CD Crohn’s disease, PBO placebo, PY person–years, TPY total person–years of exposure, UC ulcerative colitis, VDZ vedolizumab
aPatients received PBO during induction and maintenance periods
bPatients received VDZ during induction and maintenance periods
cDefined as a treatment-emergent AE leading to hospitalization
dRanked from highest to lowest incidence per 100 PY in patients aged <35 years treated with VDZ