Table 1.
Patient characteristics
| Entire patients n = 49 |
Continuing natalizumaba n = 24 |
Discontinuing natalizumabb n = 25 |
p value between a and b |
|
|---|---|---|---|---|
| Gender (male : female) | 21 : 28 | 10 : 14 | 11 : 14 | 0.87† |
| Age (years), median (range) | 33 (20–62) | 34.5 (20–62) | 32 (22–57) | 0.38 |
| Weight (kg), median (IQR) | 68.1 (61.1–85.9) | 68.1 (63.6–86.5) | 68.4 (59.9–85.7) | 0.66 |
| BMI, median (IQR) | 24.9 (20.6–28.4) | 23.2 (20.6–27.1) | 25.89 (20.9–29.8) | 0.42 |
| Age at diagnosis, median (range) | 18 (8–48) | 17 (11–40) | 18 (8–48) | 0.60 |
| Disease duration (months), median (range) | 180 (36–576) | 180 (67–576) | 144 (36–264) | 0.14 |
| Disease location (ileum: colon: ileocolonic) | 1 : 8 : 40 | 1 : 5 : 18 | 0 : 3 : 22 | 0.40† |
| Upper intestinal involvement, n (%) | 5 (10.2) | 2 (8.3) | 3 (12.0) | 0.67† |
| Perianal disease, n (%) | 10 (20.4) | 5 (20.8) | 5 (20.0) | 0.94† |
| Disease behavior (fistulizing : non- fistulizing) | 21 : 27 | 8 : 15 | 13 : 12 | 0.23† |
| Extraintestinal manifestation, n (%) | 21 (42.3) | 8 (33.3) | 12 (48.0) | 0.30† |
| Previous surgery for Crohn’s disease, n (%) | 29 (59.2) | 14 (58.3) | 15 (60.0) | 0.68† |
| Smoker, n (%) | 4 (8.2) | 1 (4.2) | 3 (12.0) | 0.32† |
| Past treatment | ||||
| Corticosteroids, n (%) | 47 (95.9) | 23 (95.8) | 24 (96.0) | 0.98† |
| 5-Aminosalicylates, n (%) | 44 (89.8) | 21 (87.5) | 23 (92.0) | 0.60† |
| Thiopurines, n (%) | 47 (95.9) | 24 (100) | 23 (92.0) | 0.16† |
| Methotrexate, n (%) | 30 (61.2) | 12 (50.0) | 18 (72.0) | 0.11† |
| Anti-TNF, n (%) | 47 (95.9) | 23 (95.8) | 24 (96.0) | 0.98† |
| (3 : 2 : 1 : 0) | (14 : 26 : 7 :2) | (9 : 11 : 3 :1) | (5 : 15 : 4 :1) | 0.60† |
| Concomitant medications | ||||
| Corticosteroids, n (%) | 25 (51.0) | 11 (45.8) | 14 (64.0) | 0.48† |
| 5-Aminosalicylates, n (%) | 3 (6.1) | 2 (8.3) | 1 (4.0) | 0.53† |
| Immunomodulators, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1.00 |
| Harvey-Bradshaw Index, median (IQR) | 12 (9–15.5) | 11 (7.5–13.5) | 13 (10–18.5) | 0.065 |
| C-reactive protein (mg/dl), median (IQR) | 18.5 (7–46.25) | 15 (5.5–26.8) | 34.5 (8–55.5) | 0.066 |
| Albumin (g/dL), median (IQR) | 3.8 (3.4–4.1) | 3.95 (3.6–4.2) | 3.7 (3.2–4) | 0.21 |
| White blood cell count (mg/dL), median (IQR) | 8.3 (6.7–11.2) | 8.3 (6.8–11.4) | 8.3 (6.7–10.8) | 0.96 |
| Hemoglobin (mg/dL), median (IQR) | 11.95 (9.9–13.0) | 11.95 (10.2–13.0) | 12.0 (9.8–13.0) | 0.96 |
| Duration of natalizumab treatment (months), median (IQR) | 7 (3–21.5) | 20 (6–32.5) | 4 (2–8) | 0.0004 |
| Adverse effects, n (%) | 9 (18.4) | 3 (12.5) | 6 (24.0) | 0.46† |
†
Fisher's exact test, all others Mann–Whitney U test.
*
indicates p value of <0.05.
IQR: interquartile range