Background
Endoscopic-post-operative-recurrence (ePOR) in Crohn’s disease (CD) after ileocecal resection (ICR) is a major concern. We aimed to evaluate the effectiveness of early prophylaxis with biologics and to compare anti-TNF therapy to vedolizumab (VDZ) and ustekinumab (UST) in a real-world setting.
Methods
A retrospective multicenter study of CD-adults after curative ICR on early prophylaxis. ePOR was defined as a Rutgeerts score [RS]≥i2 or colonic-segmental-SES-CD≥6. Multivariable logistic regression was used to evaluate risk factors, and inverse probability treatment weighting (IPTW) was applied to compare the effectiveness between agents.
Results
Included 297 patients (53.9% males, age at diagnosis 24y[19-32], age at ICR-34y[26-43], 18.5% smokers, 27.6% biologic-naïve, 65.7% anti-TNF experienced, 28.6%≥2 biologics, and 17.2% previous surgery). Overall, 224, 39 and 34 patients received anti-TNF, VDZ or UST, respectively. Patients treated with VDZ and UST were more biologic experienced with higher rates of previous surgery. ePOR rates within 1-year were: 41.8%. ePOR rates by treatment groups: anti-TNF 40.2%, VDZ 33% and UST 61.8%. Risk factors for ePOR at 1-year: past-infliximab (adj.OR=1.73[95%CI:1.01-2.97]), past-adalimumab (adj.OR=2.32[95% CI:1.35-4.01) and surgical aspects. After IPTW, the risk of ePOR within 1-year of VDZ vs. anti-TNF or UST vs. anti-TNF was comparable (OR=0.55[95%CI:0.25-1.19], OR=1.86[95%CI:0.79-4.38]), respectively.
Conclusion
Prevention of ePOR within 1-year after surgery was successful in ~60% of patients. Patients treated with VDZ or UST consisted of a more refractory group. After controlling for confounders, no differences in ePOR risk were seen between anti-TNF prophylaxis and other groups.
Background
Tofacitinib is a selective immunosuppressant, the first representative of the Janus kinase family inhibitors, which has a high selectivity against other kinases of the human genome. According to the results of the study, tofacitinib inhibits JAK-1, JAK-2 and in high concentrations-JAK-3 and tyrosine kinase-2. The drug is registered in Russia for the treatment of patients with ulcerative colitis. According to the instructions for medical use, in patients with incomplete response to the induction course, it is possible to conduct an additional 8 weeks of therapy at an induction dose of 10 mg 2 times a day. The objective of the study was to identify the frequency and reasons for the need to prolong the induction course of tofacitinib in patients with ulcerative colitis.
Methods
35 patients with ulcerative colitis (UC) who received tofacitinib were observed in the Department of inflammatory bowel diseases. Patients were divided into two groups. Group 1 (n = 10) of patients were bionaive. The second group of patients (n = 25) had previous experience of treatment with one or more anti-TNF-α drugs. The necessity of prolongation up to 16 weeks of induction course of tofacitinib was assessed in patients with an insufficient clinical response at week 8 of therapy (reduction of partial index of Mayo less than 30%) and lack of normalisation of laboratory parameters (CRP, haemoglobin, FCP). The comparative analysis was carried out by the method of four-field tables using nonparametric statistical criteria.
Results
In the follow-up period among group 1 UC patients (n = 10) who had not previously received anti-TNF-α drugs, the need for a prolonged induction course of tofacitinib was not required in any patient (0%). In the second group of patients (n = 25), previously treated with anti-TNF-α drugs, a prolonged induction course of tofacitinib was required in 9 (36%) patients (x2-4.484; p = 0.028).
Conclusion
The need for prolongation up to 16 weeks of the induction course of tofacitinib in patients with ulcerative colitis b is significantly higher in patients who have previously received one or more anti-TNF-α drugs.
О р и г и н а л ь н а я с т а т ь я Белоусова Елена Александровна -д-р мед. наук, профессор, руководитель отделения гастроэнтерологии и гепатологии, заведующая кафедрой гастроэнтерологии факультета усовершенствования врачей 1
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