Real-world effectiveness and safety of vedolizumab induction therapy for ulcerative colitis: A prospective nationwide Polish observational study.

BACKGROUND: Vedolizumab is recommended as a first-line biological treatment, along with other biological drugs, in ulcerative colitis (UC) patients in whom conventional therapy failed and as a second-line biological treatment following a failure of a tumor necrosis factor alpha (TNF-α) antagonist. OBJECTIVES: We aimed to assess the real-world effectiveness and safety of vedolizumab induction therapy in UC patients treated in the scope of the National Drug Program (NDP) in Poland. MATERIAL AND METHODS: The endpoints were the proportions of patients who reached clinical response, clinical remission and mucosal healing at week 14. Partial Mayo scores, Mayo subscores and C-reactive protein (CRP) levels were also evaluated. RESULTS: Our study population consisted of 100 patients (55 biologic-naïve and 45 biologic-exposed). The median total Mayo score at baseline was 10 (interquartile range (IQR): 9-11), and 52 patients (52%) had extensive colitis. The clinical response at week 14 was achieved in 83 (83%) and clinical remission in 24 (24%) cases. Mucosal healing was observed in 56 (62%) patients at week 14. In patients with prior failure of biologic treatment (n = 25), 17 (68%) responded to vedolizumab treatment. A decrease in the median CRP level (from 3.7 mg/L to 2.6 mg/L) and the median total Mayo score (from 10 to 4) was observed. No new safety concerns were recorded and no patients discontinued the treatment due to adverse events (AEs). CONCLUSIONS: Vedolizumab was effective and safe as induction therapy for UC in a Polish real-world population including patients with severely active UC and a low number of patients with prior biological treatment failures.

Autoimmune Pancreatitis in Patients with Inflammatory Bowel Disease: A Real-World Multicentre Collaborative ECCO CONFER Study.

BACKGROUND: Autoimmune pancreatitis [AIP] is rarely associated with inflammatory bowel disease [IBD]. The long-term outcomes of AIP and IBD in patients with coexisting AIP-IBD and predictors of complicated AIP course have rarely been reported. METHODS: An ECCO COllaborative Network For Exceptionally Rare case reports project [ECCO-CONFER] collected cases of AIP diagnosed in patients with IBD. Complicated AIP was defined as a composite of endocrine and/or exocrine pancreatic insufficiency, and/or pancreatic cancer. We explored factors associated with complicated AIP in IBD. RESULTS: We included 96 patients [53% males, 79% ulcerative colitis, 72% type 2 AIP, age at AIP diagnosis 35 ±â€…16 years]. The majority of Crohn's disease [CD] cases [78%] had colonic/ileocolonic involvement. In 59%, IBD preceded AIP diagnosis, whereas 18% were diagnosed simultaneously. Advanced therapy to control IBD was used in 61% and 17% underwent IBD-related surgery. In total, 82% of patients were treated with steroids for AIP, the majority of whom [91%] responded to a single course of treatment. During a mean follow-up of 7 years, AIP complications occurred in 25/96 [26%] individuals. In a multivariate model, older age at AIP diagnosis was associated with a complicated AIP course (odds ratio [OR] = 1.05, p = 0.008), whereas family history of IBD [OR = 0.1, p = 0.03], and CD diagnosis [OR = 0.2, p = 0.04] decreased the risk of AIP complications. No IBD- or AIP-related deaths occurred. CONCLUSIONS: In this large international cohort of patients with concomitant AIP-IBD, most patients have type 2 AIP and colonic IBD. AIP course is relatively benign and long-term outcomes are favourable, but one-quarter develop pancreatic complications. Age, familial history of IBD, and CD may predict uncomplicated AIP course.

The usefulness of selected sequences of magnetic resonance imaging in a diagnostic model for Crohn's disease.

Introduction: We hypothesized that, based on magnetic resonance enterography (MRE) and the apparent diffusion coefficient (ADC), measured in the affected parts of the intestine, it is possible to effectively differentiate active and chronic phases of Crohn's disease. Aim: To create a multidimensional diagnostic model for differentiating between the phases of Crohn's disease. Material and methods: This study included 125 patients - 55 women (aged 19 to 66 years) and 70 men (aged 12 to 67 years) - who underwent MRE and ADC measurement for the first time. Results: The group of potential explanatory variables comprised 11 variables, including the thickness and length of the occupied section, number of lymph nodes, layered bowel wall enhancement, total transitions on fat tissue, and features of restricted diffusion. The final discrimination model was based on 2 variables: ADC (A) and layered bowel wall enhancement (W). Active Crohn's disease was defined as -6.339 + 4.747 × W + 0.008 × A, while chronic Crohn's disease was defined as -11.365 + 2.812 × W + 0.012 × A. Definitive diagnosis was based on histological examination of material collected during ileocolonoscopy in 96 patients, surgery with subsequent histopathological examination in 17 patients, and capsule endoscopy in 12 patients. Conclusions: The predictive model described here could identify the active form of Crohn's disease with a probability of 93.06% and the chronic form with a probability of 75.57%. The use of classic MRE layered bowel wall enhancement and a DWI-based ADC metric eliminates the main shortcomings of both approaches.

Diagnostic and therapeutic management in gastroesophageal reflux disease: consensus of the Polish Society of Gastroenterology.

The paper was prepared by an expert group appointed by the Polish Society of Gastroenterology with an aim to update and systematize the knowledge about diagnosis and treatment of gastroesophageal reflux disease (GERD). Based on the previously published guidelines of international societies, expert consensuses, and recently published good quality data, we formulated 74 statements regarding the definition, diagnosis and treatment of GERD and assessed the level of acceptance of these statements and the reliability of the data. We discussed in details the possibilities and limitations of the available diagnostic methods and therapies, with particular emphasis on the diversity of gastroesophageal reflux symptoms and complications including Barrett's esophagus. Practical principles regarding interpretation of the diagnostic tests are presented. In addition, we discussed the indications for surgical treatment as well as the situations in which surgical treatment is not indicated with emphasis on the importance of preoperative diagnostics. The role of add-on therapy and indications for maintenance treatment are defined.

Itopride in treatment of laryngopharyngeal symptoms of gastroesophageal reflux disease.

In everyday otolaryngological and gastroenterological practice, the diagnosis and treatment of extraesophageal forms of gastroesophageal reflux disease are often challenging. It is sometimes the case that treatment ordered by other specialists proves ineffective or even worsens the symptoms. There is no golden standard of diagnosis for otolaryngological forms of GERD, and currently used tools (gastroscopy, laryngoscopy, impedance and pH testing) have low sensitivity and specificity. After finishing a course of successful treatment, the patients often come back to our offices with the very same symptoms. In order to improve the efficacy of treatment, a prokinetic agent can be added to the standard proton pump inhibitor therapy.

Dynamics of quality of life improvement after floppy Nissen fundoplication for gastroesophageal reflux disease.

INTRODUCTION: Gastroesophageal reflux disease (GERD) has a negative impact on global quality of life (QOL) of patients. In patients affected by GERD, laparoscopic Nissen fundoplication is one of the most commonly performed laparoscopic procedures worldwide. AIM: To prospectively analyze the dynamics of QOL as well as severity of pain in patients with GERD, before and after laparoscopic floppy Nissen fundoplication. MATERIAL AND METHODS: The study involved 104 consecutive patients operated on for GERD in whom laparoscopic floppy Nissen fundoplication was performed. QOL was assessed before surgery and 1, 3, 6, 12 and 24 months after. The following instruments were used: FACIT-G, FACIT-TS-G, GIQLI, GERD symptom scale. RESULTS: It was found that symptom relief and quality of life improvement presented different dynamics in the postoperative course. Observations revealed relief of symptoms 1 month after surgery and improvement in QOL related to the gastrointestinal tract and pain 3 months after surgery. Global QOL increased significantly as late as 12 months after surgery. CONCLUSIONS: Gastroesophageal reflux disease is a chronic disease of long duration, leading to impairment of quality of life. Patients, apart from typical symptoms of GERD, suffer from pain of significant severity. QOL improves significantly after surgery. Surgical treatment results in relief of GERD symptoms, which leads to gradual improvement of QOL.

Platelet 12-lipoxygenase and stem cells in Barrett's esophagus.

Esophageal adenocarcinoma has shown a significant increase in incidence in recent years. It is thought that the development of gastroesophageal reflux disease (GERD), followed by columnar-lined esophagus and the development of dysplasia, leads to invasive adenocarcinoma. The exact pathogenesis of this process, the diagnosis and differentiation of the metaplastic and dysplastic esophageal lesions have yet to be determined. The purpose of this immunohistochemical study was to investigate the expression of pro-tumorigenic enzyme platelet 12-lipoxygenase (p12LOX) using two new available antibodies in non-dysplastic and dysplastic Barrett's esophagus. The stem cell markers nestin, CD117 and CD44, were then evaluated. The comparative group included GERD carditis, gastric intestinal metaplasia and colorectal adenoma. The overexpression of p12LOX detected by two specific antibodies in the non-dysplastic and dysplastic Barrett's mucosa clearly demonstrated that this enzyme plays an important role in the development of esophageal adenocarcinoma.