Table 1.
All patients, n = 154 | Group with adverse event(s), n = 34 | Group without adverse event, n = 120 | P value | |
---|---|---|---|---|
Age in years [mean (SD)] | 41.7 (14.9) | 49.4 (16.1) | 39.6 (13.9) | 0.001a |
>65 years old [n (%)] | 11 (7.1) | 6 (17.6) | 5 (4.2) | 0.007b |
Men [n (%)] | 90 (58.4) | 22 (64.7) | 68 (56.7) | NSb |
Disease [n (%)] | ||||
Crohn’s disease | 99 (64.3) | 22 (64.7) | 77 (64.2) | NSb |
Ulcerative colitis | 48 (31.2) | 11 (32.4) | 37 (30.8) | NSb |
Pouchitis | 6 (3.9) | 1 (2.9) | 5 (4.2) | NSc |
Unclassified | 1 (0.6) | 0 (0) | 1 (0.8) | NSc |
Active disease | 24 (15.6) | 7 (20.6) | 17 (14.2) | NSb |
Smoking status | NSb | |||
Active | 35 (22.7) | 7 (20.6) | 28 (23.3) | |
Former | 42 (27.3) | 13 (38.2) | 29 (24.2) | |
Never | 76 (49.4) | 14 (41.2) | 62 (51.7) | |
BMI, kg/m2 [mean (SD)] | 25.8 (4.5) | 27.6 (5.6) | 25.3 (4) | 0.009a |
Obesity [n (%)] | 21 (13.6) | 9 (26.5) | 12 (10) | 0.013b |
Comorbidities | 55 (35.7) | 20 (58.8) | 35 (29.2) | 0.001b |
Coronary heart disease | 4 (2.6) | 2 (5.9) | 2 (1.6) | NSc |
Diabetes | 4 (2.6) | 3 (8.8) | 1 (0.8) | 0.034c |
Asthma | 4 (2.6) | 2 (5.9) | 2 (1.7) | NSc |
COPD | 4 (2.6) | 4 (11.7) | 0 (0) | 0.002c |
Hypertension | 23 (14.9) | 10 (29.4) | 13 (12.5) | 0.007b |
Cerebrovascular disease | 2 (1.3) | 1 (2.9) | 1 (0.8) | NSc |
Renal disease | 2 (1.3) | 1 (2.9) | 1 (0.8) | NSc |
Liver disease | 8 (5.2) | 4 (11.7) | 4 (3.3) | NSc |
Malignancy | 5 (3.2) | 2 (12.5) | 3 (2.5) | NSc |
Other | 36 (23.4) | 12 (35.3) | 24 (20) | NSb |
IBD treatment | ||||
Biologic | 112 (72.7) | 20 (58.8) | 92 (76.7) | 0.039b |
Infliximab | 56 (36.4) | 11 (32.4) | 45 (37.5) | NSb |
Adalimumab | 34 (22.1) | 3 (8.8) | 31 (25.8) | 0.036c |
Golimumab | 6 (3.9) | 2 (5.9) | 4 (3.3) | NSc |
Vedolizumab | 12 (7.8) | 3 (8.8) | 9 (7.5) | NSc |
Ustekinumab | 4 (2.6) | 1 (2.9) | 3 (2.5) | NSc |
Tofacitinib | 2 (1.3) | 0 (0) | 2 (1.7) | NSc |
Azathioprine | 18 (11.7) | 6 (17.6) | 12 (10) | NSc |
Methotrexate | 11 (7.1) | 3 (8.8) | 8 (6.7) | NSc |
5-asa | 56 (36.4) | 14 (41.2) | 42 (35) | NSb |
Corticosteroids | 8 (5.2) | 2 (5.9) | 6 (5) | NSc |
No treatment | 6 (3.9) | 3 (8.8) | 3 (2.5) | NSc |
Symptoms | ||||
Fever | 113 (73.4) | 30 (88.2) | 83 (69.2) | 0.026b |
Cough | 71 (46.1) | 19 (55.9) | 52 (43.3) | NSb |
Dyspnea | 16 (10.4) | 10 (29.4) | 6 (5) | <0.001c |
Fatigue | 97 (63) | 25 (73.5) | 72 (60) | NSb |
Sore throat | 42 (27.3) | 8 (23.5) | 34 (28.3) | NSb |
Headache | 72 (46.8) | 17 (50) | 55 (45.8) | NSc |
Diarrhea | 30 (19.5) | 7 (20.6) | 23 (19.2) | NSc |
Abdominal pain | 14 (9.1) | 6 (17.6) | 8 (6.7) | 0.049b |
Nausea-vomiting | 6 (3.9) | 2 (5.9) | 4 (3.3) | NSc |
Asymptomatic | 17 (11) | 0 (0) | 17 (14.2) | 0.025c |
Obesity, BMI >30 kg/m2. P values refer to comparisons between cases that developed and that did not develop any adverse event.
Independent-samples t test.
χ2.
Fischer’s exact.