Table 1.
Patient characteristics
| CD (n = 50) | UC (n = 140) | IBD-U (n = 12) | Total (N = 202) | |
|---|---|---|---|---|
| Age, y | 35 (25-46) | 46 (37-56) | 47 (43-53) | 43 (34-54) |
| Sex | ||||
| Male | 33 (66.0) | 67 (47.9) | 6 (50.0) | 106 (52.5) |
| Female | 17 (34.0) | 73 (52.1) | 6 (50.0) | 96 (47.5) |
| Smoking status | ||||
| Never smoking | 36 (72.0) | 97 (69.3) | 9 (75.0) | 142 (70.3) |
| Smoking | 5 (10.0) | 7 (5.0) | 3 (25.0) | 15 (7.4) |
| Given up smoking | 9 (18.0) | 36 (25.7) | 0 (0) | 45 (22.3) |
| Disease course | ||||
| ≤2 y | 19 (38.0) | 39 (27.9) | 8 (66.7) | 66 (32.7) |
| 2~5 y (>2 y, ≤5 y) | 18 (36.0) | 50 (35.7) | 3 (25.0) | 71 (35.1) |
| 5~10 y (>5 y, ≤10 y) | 6 (12.0) | 22 (15.7) | 1 (8.3) | 29 (14.4) |
| >10 y | 7 (14.0) | 29 (20.7) | 0 (0) | 36 (17.8) |
| Drugs | ||||
| 5-ASA | 17 (34.0) | 128 (91.4) | 10 (83.3) | 155 (76.7) |
| Mesalazine | 10 (20.0) | 94 (67.1) | 4 (33.3) | 108 (53.5) |
| Azathioprine | 5 (10.0) | 4 (2.9) | 0 (0) | 9 (4.5) |
| Thalidomide | 1 (2.0) | 0 (0) | 0 (0) | 1 (0.5) |
| Infliximab | 24 (48.0) | 7 (5.0) | 0 (0) | 31 (15.3) |
| Adalimumab | 4 (8.0) | 2 (1.4) | 1 (8.3) | 7 (3.5) |
| Vedolizumab | 8 (16.0) | 9 (6.4) | 1 (8.3) | 18 (8.9) |
| Ustekinumab | 5 (10.0) | 0 (0) | 0 (0) | 5 (2.5) |
| Steroids | 4 (8.0) | 6 (4.3) | 0 (0) | 10 (5.0) |
| Enteral nutrition | 10 (20.0) | 24 (17.1) | 3 (25.0) | 37 (18.3) |
| Disease stage | ||||
| Active | 5 (10.0) | 18 (12.9) | 0 (0) | 23 (11.4) |
| Remission | 32 (64.0) | 93 (66.4) | 6 (50.0) | 131 (64.9) |
| Unknown | 13 (26.0) | 29 (20.7) | 6 (50.0) | 48 (23.8) |
| Times vaccinated | ||||
| 1 | 8 (16.0) | 11 (7.9) | 1 (8.3) | 20 (9.9) |
| 2 | 41 (82.0) | 124 (88.6) | 11 (91.7) | 176 (87.1) |
| 3 | 1 (2.0) | 5 (3.6) | 0 (0) | 6 (3.0) |
| AE after vaccination | ||||
| Yes | 10 (20.0) | 21 (15.0) | 3 (25.0) | 34 (16.8) |
| No | 40 (80.0) | 119 (85.0) | 9 (75.0) | 168 (83.2) |
| Which time did AE occur after vaccination? | ||||
| D1 | 9 (90.0) | 14 (66.7) | 0 (0) | 23 (67.6) |
| D2 | 1 (10.0) | 7 (33.3) | 3 (100.0) | 11 (32.4) |
| D3 | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| How long after vaccination did AE occur? | ||||
| <1 d | 5 (50.0) | 3 (14.3) | 0 (0) | 8 (23.5) |
| 2~7 d (>2 d, ≤5 d) | 3 (30.0) | 10 (47.6) | 1 (33.3) | 14 (41.2) |
| 5~14 d (>5 d, ≤14 d) | 0 (0) | 3 (14.3) | 0 (0) | 3 (8.8) |
| >14 d | 1 (10.0) | 5 (23.8) | 1 (33.3) | 7 (20.6) |
| AE after vaccination | ||||
| Headache | 0 (0) | 2 (9.5) | 0 (0) | 2 (5.9) |
| Fatigue | 4 (40.0) | 11 (52.4) | 3 (100.0) | 18 (52.9) |
| Fever | 5 (50.0) | 2 (9.5) | 1 (33.3) | 8 (23.5) |
| Chill | 2 (20.0) | 0 (0) | 0 (0) | 2 (5.9) |
| Dizzy | 2 (20.0) | 2 (9.5) | 0 (0) | 4 (11.8) |
| Vomit | 2 (20.0) | 0 (0) | 0 (0) | 2 (5.9) |
| Local pain of injection | 5 (50.0) | 7 (33.3) | 0 (0) | 12 (35.3) |
| Limb pain | 0 (0) | 5 (23.8) | 0 (0) | 5 (14.7) |
| Somnolence | 3 (30.0) | 3 (14.3) | 1 (33.3) | 7 (20.6) |
| Dyspnea | 0 (0) | 1 (4.8) | 0 (0) | 1 (2.9) |
| Others | 3 (30.0) | 10 (47.6) | 0 (0) | 13 (38.2) |
| Was there exacerbation of IBD-related symptoms after vaccination? | ||||
| Yes | 7 (14.0) | 21 (15.0) | 2 (16.7) | 30 (14.9) |
| No | 43 (86.0) | 119 (85.0) | 10 (83.3) | 172 (85.1) |
| What IBD-related symptoms were exacerbated after vaccination? | ||||
| Abdominal pain | 4 (57.1) | 9 (42.8) | 1 (50.0) | 14 (46.7) |
| Diarrhea | 5 (71.4) | 13 (61.9) | 1 (50.0) | 19 (63.3) |
| Hematochezia | 0 (0) | 15 (71.4) | 1 (50.0) | 16 (53.3) |
| Fever | 3 (42.9) | 3 (14.3) | 0 (0) | 6 (20.0) |
| Others | 2 (28.8) | 0 (0) | 0 (0) | 2 (6.7) |
| Did the symptoms require hospitalization? | ||||
| Yes | 3 (42.9) | 4 (19.0) | 1 (50.0) | 8 (26.7) |
| No | 4 (57.1) | 17 (81.0) | 1 (50.0) | 22 (73.3) |
| Were CRP and fecal calprotectin elevated? | ||||
| Yes | 2 (28.6) | 6 (28.6) | 0 (0) | 8 (26.7) |
| No | 3 (42.9) | 2 (9.5) | 1 (50.0) | 6 (20.0) |
| Did endoscopic outcomes worsen after vaccination? | ||||
| Yes | 2 (28.6) | 9 (42.9) | 1 (50.0) | 12 (40.0) |
| No | 2 (28.6) | 0 (0) | 1 (50.0) | 3 (10.0) |
| Did CTE or MRE worsen after vaccination? | ||||
| Yes | 1 (14.3) | 4 (19.0) | 0 (0) | 5 (16.7) |
| No | 4 (57.1) | 1 (4.8) | 1 (50.0) | 6 (20.0) |
Values are mean (interquartile range) or n (%).
Abbreviations: 5-aminosalicylic acid; AE, adverse event; CD, Crohn's disease; CRP, C-reactive protein; CTE, computed tomography enterography; D, dose; IBD-U, inflammatory bowel disease–unclassified; MRE, magnetic resonance enterography; UC, ulcerative colitis.