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.
Introduction
Anti-SARS-CoV-2 vaccines clinical trials did not include patients with immune-mediated conditions such as inflammatory bowel disease (IBD). We aimed to describe the implementation of anti-SARS-CoV-2 vaccination among IBD patients, patients’ concerns and side-effect profile of the anti-SARS-CoV-2 vaccines using real-world data.
Methods
An anonymous web-based self-completed survey was distributed in 36 European countries between June and July 2021. The results of the patient characteristics, concerns, vaccination status and side-effect profile were analysed.
Results
3272 IBD patients completed the survey, 79.6% had received at least one dose of anti-SARS-CoV-2 vaccine, and 71.7% had completed the vaccination process. Patients over 60 years old had a significantly higher rate of vaccination (p<0.001). Patients’ main concerns before vaccination were the possibility of having worse vaccine-related adverse events due to their IBD (24.6%), an IBD flare after vaccination (21.1%) and reduced vaccine efficacy due to IBD or associated immunosuppression (17.6%). After the first dose of the vaccine, 72.4% had local symptoms and 51.4% had systemic symptoms (5 patients had non-specified thrombosis). Adverse events were less frequent after the second dose of the vaccine and in older patients. Only a minority of the patients were hospitalized (0.3%), needed a consultation (3.6%) or had to change IBD therapy (13.4%) after anti-SARS-CoV-2 vaccination.
Conclusion
Although IBD patients raised concerns about the safety and efficacy of anti-SARS-CoV-2 vaccines, the implementation of vaccination in those responding to our survey was high and the adverse events were comparable to the general population, with minimal impact on their IBD.
Despite the recent developments in the diagnosis and management of inflammatory bowel diseases (IBD), patients still suffer from disabling bowel symptoms and significant disease complications and many questions remain to improve their care. IBD is a chronic disease, whose management could be divided into the five different stages of chronic diseases, ranging from the pre-treatment evaluation phase to the induction therapy, maintenance therapy, monitor and re-establishment of control and the cessation of the disease. Reconciling these phases with the current unmet needs in IBD could help tailor priorities for research. In this review, some of the unanswered questions in the management of both Crohn’s Disease and Ulcerative Colitis will be addressed, by following this paradigm of chronic diseases’ management.
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