TABLE 1.
Incidence of adverse events and local injection reactions during study
| All patients (IBD) | Crohn’s disease | Ulcerative colitis | |
|---|---|---|---|
| Local injection reactions (adapted from Dehoratius et al.),16 n (%) | |||
| Discomfort | |||
| None | 60 (72.3) | 35 (74.5) | 25 (69.4) |
| Mild | 18 (21.7) | 10 (21.3) | 8 (22.2) |
| Moderate | 4 (4.8) | 2 (4.3) | 2 (5.6) |
| Severe | 1 (1.2) | 0 (0.0) | 1 (2.8) |
| Pain | |||
| None | 51 (61.4) | 29 (61.7) | 22 (61.1) |
| Mild | 22 (26.5) | 14 (29.8) | 8 (22.2) |
| Moderate | 9 (10.8) | 3 (6.4) | 6 (16.7) |
| Severe | 1 (1.2) | 1 (2.1) | 0 (0.0) |
| Burning sensation | |||
| None | 40 (48.2) | 22 (46.8) | 18 (50.0) |
| Mild | 35 (42.2) | 20 (42.6) | 15 (41.7) |
| Moderate | 7 (8.4) | 4 (8.5) | 3 (8.3) |
| Severe | 1 (1.2) | 1 (2.1) | 0 (0.0) |
| Erythema | |||
| None | 57 (68.7) | 36 (76.6) | 21 (58.3) |
| Mild | 16 (19.3) | 5 (10.6) | 11 (30.6) |
| Moderate | 9 (10.8) | 6 (12.8) | 3 (8.3) |
| Severe | 1 (1.2) | 0 (0.0) | 1 (2.8) |
| Other adverse events, n (%) | |||
| Fatigue | 8 (9.0) | 6 (12.5) | 2 (4.9) |
| Headache | 3 (3.4) | 1 (2.1) | 1 (2.4) |
| Nausea | 3 (3.4) | 3 (6.3) | 0 (0.0) |
| Rash | 3 (3.4) | 2 (4.2) | 1 (2.4) |
| Arthralgia | 2 (2.2) | 2 (4.2) | 0 (0.0) |
| Clostridium difficile enteritis | 1 (1.1) | 1 (2.1) | 0 (0.0) |
| Early satiety | 1 (1.1) | 1 (2.1) | 0 (0.0) |
| Herpes labialis | 1 (1.1) | 1 (2.1) | 0 (0.0) |
| Hyperhidrosis | 1 (1.1) | 1 (2.1) | 0 (0.0) |
| Muscle weakness/faintness | 1 (1.1) | 0 (0.0) | 1 (2.4) |
| Nasal congestion | 1 (1.1) | 1 (2.1) | 0 (0.0) |
| Nasal ulceration | 1 (1.1) | 0 (0.0) | 1 (2.4) |
| Non‐productive cough | 1 (1.1) | 1 (2.1) | 0 (0.0) |
| Paresthesia | 1 (1.1) | 0 (0.0) | 1 (2.4) |
| Photosensitivity | 1 (1.1) | 0 (0.0) | 1 (2.4) |
| Pruritus | 1 (1.1) | 1 (2.1) | 0 (0.0) |
| Sleep disturbance | 1 (1.1) | 0 (0.0) | 1 (2.4) |
| Weight loss | 1 (1.1) | 1 (2.1) | 0 (0.0) |
| Xerostomia | 1 (1.1) | 0 (0.0) | 1 (2.4) |
Abbreviations: IBD, inflammatory bowel disease; n, number of patients.