Table 3.
Baseline characteristics of the 32 patients with inflammatory bowel diseases treated with integrins antagonists in our cohort. Results of univariate and multivariate analyses investigating the predictors of clinical relapse after therapeutic de-escalation.
| Univariate analysis | Multivariate analysis | ||||
|---|---|---|---|---|---|
| n = 32 patients | HR [95% CI] | p-Value | HR [95% CI] | p-Value | |
| Age at diagnosis mean ± sd | 28.0 ± 14.2 years | 0.99 [0.95–1.02] | 0.48 | ||
| Age at baseline mean ± sd | 40.9 ± 17.9 years | 0.98 [0.96–1.01] | 0.21 | ||
| Male gender n [%] | 16 [50.0%] | 0.59 | |||
| Smoking habits | 0.49 | ||||
| Current smoker | 3 [9.4%] | Reference | |||
| Former smoker | 6 [18.8%] | 1.81 [0.19–17.04] | 0.60 | ||
| Non-smoker | 23 [71.8%] | 2.78 [0.36–21.51] | 0.33 | ||
| Disease duration | 12.4 ± 12.7 years | 0.98 [0.94–1.02] | 0.34 | ||
| IBD subtype | 2.51 [0.87–7.28] | 0.079 | |||
| Crohn’s disease n [%] | 23 [71.8%] | ||||
| Ulcerative colitis n [%] | 9 [28.2%] | ||||
| Montreal classification | |||||
| Location | |||||
| L1 n [%] | 6/23 [26.1%] | Reference | |||
| L2 n [%] | 4/23 [17.4%] | 1.22 [0.20–7.63] | 0.83 | ||
| L3 n [%] | 13/23 [56.5%] | 1.08 [0.28–4.19] | 0.91 | ||
| L4 n [%] | 4/23 [17.4%] | 1.52 [0.32–7.35] | 0.60 | ||
| Behaviour | 0.54 | ||||
| B1 n [%] | 10/23 [43.5%] | Reference | |||
| B2 n [%] | 6/23 [26.1%] | 0.15 [0.02–1.30] | 0.086 | ||
| B3 n [%] | 7/23 [30.4%] | 1.70 [0.48–6.03] | 0.411 | ||
| Extent | 0.61 | ||||
| E1 n [%] | 3/9 [33.3%] | - | |||
| E2 n [%] | 2/9 [22.2%] | - | |||
| vE3 n [%] | 4/9 [45.5%] | - | |||
| Perianal lesions n [%] | 6/23 [26.1%] | 1.26 [0.33–4.90] | 0.73 | ||
| SCCAI>0 or HBI > 2 | 16 [50.0%] | 6.98 [1.95–24.90] | 0.001 | 1.92 [0.42–8.75] | 0.40 |
| Duration of clinical remission at baseline >6 months n, % | 6 [18.8%] | 0.11 [0.01–0.93] | 0.015 | 0.19 [0.02–1.86] | 0.15 |
| CRP > 5.0 g/L n [%] | 4/27 [14.8%] | 2.35 [0.78–7.11] | 0.12 | ||
| Faecal calprotectin > 100 µg/g n [%] | 15 [46.9%] | 19.00 [4.08–88.81] | <0.0001 | 15.68 [2.49–98.54] | 0.003 |
| Medications at baseline | |||||
| Anti-integrins medication | |||||
| Vedolizumab | 31 [96.9%] | - | |||
| Natalizumab | 1 [3.1%] | NA | |||
| Vedolizumab infusion interval | 31[96.9%] | 0.62 | |||
| Every 8 weeks | 26/31 [83.9%] | - | |||
| Every 6 weeks | 1/31 [3.2%] | NA | |||
| Every 4 weeks | 4/31 [12.9%] | NA | |||
| Immunosuppressant therapies | 20 [62.5%] | 0.74 [0.29–1.90] | 0.52 | ||
| Azathioprine | 7 [21.9%] | 0.43 [0.10–1.89] | 0.23 | ||
| 6-mercaptopurin | 2 [6.3%] | 1.14 [0.18–10.78] | 0.74 | ||
| Methotrexate | 10 [31.3%] | 1.04 [0.36–3.02] | 0.93 | ||
| Tacrolimus | 2 [6.3%] | - | 0.28 | ||
| Cyclosporin | 1 [3.1%] | - | NA | ||
| Steroids | 14 [43.7%] | 3.25 [1.19–8.90] | 0.013 | 1.36 [0.35–5.23] | 0.66 |
| 5-ASA | 8 [25.0%] | 2.10 [0.76–5.82] | 0.14 | ||
| Type of therapeutic de-escalation | |||||
| Anti-integrins discontinuation | 3 [9.4%] | 0.48 [0.06–3.69] | 0.47 | ||
| Immunosuppressants discontinuation | 11 [34.4%] | 0.62 [0.20–1.93] | 0.40 | ||
| 5-ASA discontinuation | 4 [12.5%] | 1.09 [0.25–4.83] | 0.90 | ||
| Steroids discontinuation | 8 [25.0%] | 1.55 [0.57–4.19] | 0.37 | ||
| Steroids tapering | 4 [12.5%] | 1.91 [0.61–6.04] | 0.23 | ||
| Budesonide discontinuation | 1 [3.1%] | - | NA | ||
| Decrease of Immunosuppressants dose | 1 [3.1%] | - | NA |
NA: not applicable; sd: standard deviation; n: number; TNF: tumor necrosis factor; IBD: inflammatory bowel disease; HBI: Harvey-Bradshaw index; SCCAI: simple clinical colitis activity index; HR: hazard ratio; CI: confidence interval; CRP: C-reactive protein. Statistically significant values are given in boldface.