TABLE 4.
Adverse events reported during vedolizumab treatment
| Adverse event | Whole cohort | Elderly cohort | Nonelderly cohort | OR (95% CI), p | |||
|---|---|---|---|---|---|---|---|
| Occurrence, n (%) | Patients, n | Elderly cohort – Occurrence, n (%) | Elderly cohort – Patients, n | Nonelderly cohort – Occurrence, n (%) | Nonelderly cohort – Patients, n | ||
| Infections, n (%) | 50 (38.5) | 41 | 16 (32.7) | 15 | 34 (42.0) | 26 | 1.21 (0.64–2.3), 0.568 |
| Upper respiratory tract | 17 | 14 | 5 | 4 | 12 | 10 | |
| Lower respiratory tract | 15 | 11 | 5 | 5 | 10 | 6 | |
| Gastrointestinal tract | 7 | 5 | 2 | 2 | 5 | 3 | |
| Skin and mucosa infections | 2 | 2 | 0 | 0 | 2 | 2 | |
| Urinary tract | 2 | 2 | 1 | 1 | 1 | 1 | |
| Others | 7 | 7 | 3 | 3 | 4 | 4 | |
| Cancer or dysplasia, n (%) | 16 (12.3) | 16 | 11 (22.4) | 11 | 5 (6.2) | 5 | 4.62 (1.56–12.13), 0.002 |
| Arthralgia or arthritis, n (%) | 21 (16.2) | 21 | 5 (10.2) | 5 | 16 (19.8) | 16 | 0.66 (0.26–1.80), 0.417 |
| Skin reaction, n (%) | 8 (6.15) | 8 | 2 (4.1) | 2 | 6 (7.4) | 6 | 0.70 (0.14–2.91), 0.663 |
| Cholestatic hepatitis, n (%) | 6 (4.6) | 6 | 4 (8.2) | 4 | 2 (2.5) | 2 | 4.2 (0.97–22.22), 0.074 |
| Infusion reactions, n (%) | 3 (2.3) | 3 | 0 (0.0) | 0 | 3 (3.7) | 3 | 0.00 (0.00–2.45), 0.233 |
| Other, n (%) | 26 (20.0) | 21 | 11 (22.4) | 8 | 15 (18.5) | 13 | 1.12 (0.49–2.61), 0.799 |
| CD | |||||||
| Infections, n (%) | 31 (36.5) | 26 | 11 (32.4) | 10 | 20 (39.2) | 16 | 1.49 (0.65–3.3), 0.353 |
| Upper respiratory tract | 9 | 7 | 3 | 2 | 6 | 5 | |
| Lower respiratory tract | 9 | 8 | 4 | 4 | 5 | 4 | |
| Gastrointestinal tract | 5 | 3 | 1 | 1 | 4 | 2 | |
| Skin and mucosa infections | 2 | 2 | 0 | 0 | 2 | 2 | |
| Urinary tract | 1 | 1 | 0 | 0 | 1 | 1 | |
| Others | 5 | 5 | 3 | 3 | 2 | 2 | |
| Cancer or dysplasia, n (%) | 7 (8.2) | 7 | 5 (14.7) | 5 | 2 (3.9) | 2 | 5.95 (1.22–30.29), 0.018 |
| Arthralgia or arthritis, n (%) | 17 (20.0) | 17 | 5 (14.7) | 5 | 12 (23.5) | 12 | 0.99 (0.37–2.93), 0.989 |
| Skin reaction, n (%) | 5 (5.9) | 5 | 2 (5.9) | 2 | 3 (5.9) | 3 | 1.59 (0.28–7.91), 0.615 |
| Cholestatic hepatitis, n (%) | 3 (3.5) | 3 | 1 (2.9) | 1 | 2 (3.9) | 2 | 1.19 (0.08–10.37), 0.888 |
| Infusion reactions, n (%) | 2 (2.4) | 2 | 0 (0.0) | 0 | 2 (3.9) | 2 |
0.00 (0.00–5.22), 0.360 |
| Other, n (%) | 20 (23.5) | 15 | 10 (29.4) | 7 | 10 (19.6) | 8 | 2.08 (0.78–6.10), 0.166 |
| UC | |||||||
| Infections, n (%) | 19 (42.2) | 15 | 5 (33.3) | 5 | 14 (46.7) | 10 | 0.96 (0.36–2.65), 0.938 |
| Upper respiratory tract | 8 | 7 | 2 | 2 | 6 | 5 | |
| Lower respiratory tract | 6 | 3 | 1 | 1 | 5 | 2 | |
| Gastrointestinal tract | 2 | 2 | 1 | 1 | 1 | 1 | |
| Skin and mucosa infections | 0 | 0 | 0 | 0 | 0 | 0 | |
| Urinary tract | 1 | 1 | 1 | 1 | 0 | 0 | |
| Others | 2 | 2 | 0 | 0 | 2 | 2 | |
| Cancer or dysplasia, n (%) | 9 (20.0) | 9 | 6 (40.0) | 6 | 3 (10.0) | 3 | 3.83 (0.99–14.16), 0.046 |
| Arthralgia or arthritis, n (%) | 4 (8.9) | 4 | 0 (0.0) | 0 | 4 (13.3) | 4 | 0.00 (0.00–1.97), 0.150 |
| Skin reaction, n (%) | 3 (6.7) | 3 | 0 (0.0) | 0 | 3 (10.0) | 3 | 0.00 (0.00–2.24), 0.212 |
| Cholestatic hepatitis, n (%) | 3 (6.7) | 3 | 3 (20.0) | 3 | 0 (0.0) | 0 | ∞ (1.63‐∞), 0.018 a |
| Infusion reactions, n (%) | 1 (2.2) | 1 | 0 (0.0) | 0 | 1 (3.3) | 1 | 0.00 (0.00 to 17.33), 0.470 |
| Other, n (%) | 6 (13.3) | 6 | 1 (6.7) | 1 | 5 (16.7) | 5 | 0.38 (0.03–2.85), 0.367 |
Notes: Table summarising AEs. For each cohort considered (whole cohort, elderly and nonelderly), it is reported the number of AEs occurred (left column, expressed as percentage of the total number of AEs in the reference cohort) and the number of patients experiencing an AE (right column). Odds ratio is expressed as the odds of elderly patients experiencing an AE during observation compared to nonelderly patients; statistical significance is set at p < 0.05.
Abbreviations: CD, Crohn’s disease; CI, Confidence Interval; OR, Odds Ratio; UC, ulcerative colitis.
a
Infinity value due to 0 as denominator in the OR, unlikely to be clinically meaningful.