Table 1.
Baseline characteristics of 71 patients with entero-Behcet’s disease
| With TNF inhibitors (all: n = 49) | With CS without TNF inhibitors | ||||
|---|---|---|---|---|---|
| With CS (n = 20) | Without CS (n = 29) | P value* | (n = 22) | P value** | |
| Male, n (%) | 5 (25) | 7 (24.1) | 0.6607 | 10 (45.5) | 0.0773 |
| Age | 42.2 ± 13.4 | 40.7 ± 14.7 | 0.6989 | 34.1 ± 11.8 | 0.0349 |
| Clinical manifestations at diagnosis, n (%) | Recurrent aphthae 20 (10), | Recurrent aphthae 29 (100), | Recurrent aphthae 22 (100), | ||
| Skin 20 (100), uveitis 3 (15), genital ulcer 14 (70), arthritis 10 (50), epididymitis 1 (5), digestive tract sores 20 (100), vascular lesion 5 (25), CNS lesion 3 (15) | Skin 26 (89.7), uveitis 3 (10.3), genital ulcer 19 (65.5), arthritis 21 (72.4), digestive tract sores 29 (100), vascular lesion 1 (3.4), CNS lesion 4 (13.8) | Skin 22 (100), uveitis 7 (31.8), genital ulcer 13 (59.1), arthritis 18 (81.8), digestive tract sores 22 (100), vascular lesion 2 (9.1), CNS lesion 3 (13.6) | |||
| Type, n (%) | Complete 3 (15), incomplete 17 (85) | Complete 3 (10.3), incomplete 26 (89.7) | 0.8244 | Complete 2 (9.1), incomplete 20 (90.9) | 0.6975 |
| Vascular-BD, n (%) | 5 (25) | None | 0.0081* | 2 (9.1) | 0.9163 |
| Neuro-BD, n (%) | 2 (10) | 8 (27.6) | 0.1260 | 3 (13.6) | 0.4951 |
| HLA-B51 positive (%) | 4 of 18 (22.2) | 6 of 20 (30) | 0.4323 | 3 of 10 (30) | 0.8156 |
| Disease duration BD (month) | 83.8 ± 73.5 | 86.6 ± 67.0 | 0.6451 | 48.2 ± 30.0 | 0.0552 |
| entero-BD (month) | 55.8 ± 69.3 | 50.1 ± 56.6 | 0.6540 | 28.3 ± 21.2 | 0.5135 |
| Site of ulceration, n (%) (overlapping) | Ileum 4 (20), ileocecum 13 (65), ascending colon 5 (25), transverse colon 2 (10), descending colon 4 (20), sigmoid colon 4 (20) | Ileum 6 (20.7), ileocecum 15 (51.7), ascending colon 8 (27.6), transverse colon 7 (24.1), descending colon 5 (17.2), sigmoid colon 7 (24.1), esophagus 1 (3.4) | Ileum 4 (18.2), ileocecum 17 (77.3), ascending colon 5 (22.7), transverse colon 4 (18.2), descending colon 2 (9.1), sigmoid colon 1 (4.5) | ||
| Cases with multiple ulceration, n (%) | 7 (35) | 10 (34.5) | 0.9072 | 7 (31.8) | 0.8128 |
| Treatment history, n (%) | High-dose CS 9 (45), low-dose CS 9 (45), col 10 (50), MTX 17 (85), SSZ/MS 8 (40), AZ 3 (15), IVCY 2 (10), IFX 3 (15), GLM 3 (15), ETN 1 (5) | High-dose CS 3 (10.3), low-dose CS 3 (10.3), col 19 (65.5), MTX 16 (55.2), SSZ/MS 11 (37.9), AZ 3 (10.3), CsA 1 (34.4), IFX 5 (17.2), GLM 1 (34.5), ETN 3 (10.3), ADA 3 (10.3) | High-dose CS 13 (59.1), col 14 (63.6), MTX 1 (45.5), SSZ/MS 11 (50), AZ 1 (45.5) | ||
| Bio naïve, n (%) | 16 (80) | 21 (69.0) | 0.7605 | NA | |
| History of relapse, n (%) | 13 (65) | 16 (55.2) | 0.3488 | 11 (50) | 0.4076 |
| History of perforation, n (%) | 5 (25) | 4 (13.8) | 0.2654 | 1 (4.5) | 0.1216 |
| History of surgery, n (%) | 5 (25) | 1 (3.4) | 0.0595 | 2 (9.1) | 0.6975 |
| Concomitant CS dose (mg/day) | 18.7 ± 20.4 median 10, range 2–62.5 | NA | 32.3 ± 16.4 median 30, range 6–60 | 0.0069** | |
| Concomitant drugs | MTX 17 (85), col 4 (20), MS/SSZ: 3 (15), AZ 1 (5) | MTX 23 (79.3), col 14 (48.3), MS/SSZ 4 (13.8), AZ 3 (10.3) | MS/SSZ 11 (50), col 14 (63.6), AZ 1 (4.5), MTX 1 (4.5) | ||
| Introduced TNF-i | IFX 15 (75), ETN 4 (20), ADA 1 (5) | IFX 17 (58.6), ETN 1 (3.4), ADA 9 (31.0), GLM 2 (6.9) | NA | ||
| DAIBD | 70.7 ± 38.4, median 62.5, range 50–93 | 60.5 ± 32.2, median 60.0, range 37.5–80 | 0.3045 | 85.2 ± 29.6, median 87.5, range 35–135 | 0.0139** |
| General well-being, n (%) | Fair 10 (50), poor 3 (15), very poor 1 (5) | Fair 19 (65.5) | Fair 18 (81.8) | ||
| Fever (≧ 38 °C), n (%) | 6 (30) | 3 (10.3) | 11 (50) | ||
| Extra-intestinal manifestation, n (%) | Oral 12 (60), genital ulcer 7 (35), eye 0, skin 9 (45), arthralgia 5 (25), vascular 5 (25), CNS 1 (5) | Oral 10 (34.5), genital ulcer 7 (24.1), eye 0, skin 7 (24.1), arthralgia 8 (27.6), vascular 0, CNS 7 (24.1) | Oral 15 (68.2), genital ulcer 5 (22.7), eye 0, skin 16 (72.7), arthralgia 6 (27.2), vascular 2 (9.1), CNS 1 (4.5) | ||
| Abdominal pain, n (%) | Mild 8 (40), moderate 6 (30), severe 1 (5) | Mild 11 (37.9), moderate 4 (13.8) | Moderate 18 (81.8), severe 2 (9.1) | ||
| Abdominal mass, n (%) | 1 (5) | None | None | ||
| Abdominal tenderness, n (%) | Mildly 7 (35), moderately or severely 10 (50) | Mildly 14 (48.3), moderately or severely 4 (13.8) | Mildly 3 (13.6), moderately or severely 17 (77.3) | ||
| Intestinal complication, n (%) | Perforation 4 (20), abscess 1 (5), obstruction 3 (15) | Perforation 1 (3.4) | None | ||
| No of liquid stool in 1 week, n (%) | 1–7 times: 6 (30), 8–21 times: 3 (15), 22–35 times: 3 (15) | 1–7 times: 7 (24.1), 8–21 times: 2 (6.9), 22–35 times: 3 (10.3) | 1–7 times: 2 (9.1), 8–21 times: 7 (31.8), ≧ 36 times: 4 (18.2) | ||
Data are shown by means ± SD or n (%). P value *< 0.05: TNF inhibitors with CS group (n = 20) vs. TNF inhibitors without CS group (n = 29), P value **< 0.05: TNF inhibitors group (all; n = 49) vs. CS without TNF inhibitors group (n = 22). BD Behcet’s disease, CS corticosteroid (prednisolone or equivalent), HLA human leukocyte antigen, IVCY cyclophosphamide pulse therapy i.v, MS mesalazine, SSZ sulfasalazine, MTX methotrexate, AZ azathioprine, CsA cyclosporine, col colchicine, IFX infliximab, ADA adalimumab, GLM golimumab, ETN etanercept, DAIBD disease activity index for intestinal Behcet’s disease, NA not applicable