Real-world outcomes of 54-week vedolizumab therapy and response durability after treatment discontinuation in ulcerative colitis: results from a multicenter prospective POLONEZ study.

Background: Vedolizumab is a gut-selective anti-lymphocyte trafficking agent used to treat ulcerative colitis (UC) and Crohn's disease.

Objectives: We aimed to evaluate the effectiveness, safety, and durability of the therapeutic effect of vedolizumab after treatment discontinuation in a real-world cohort of patients with UC treated in Poland.

Design: This was a multicenter, prospective study involving patients with moderate to severely active UC from 12 centers in Poland who qualified for reimbursed treatment with vedolizumab between February and November 2019.

Levels of Biosimilar Infliximab during and after Induction Treatment in Crohn's Disease and Ulcerative Colitis-A Prospective Polish Population Study.

Background: Primary lack or secondary loss of response to therapy with infliximab is a significant problem. This study aimed to evaluate the response to treatment in patients with Crohn's disease (CD) and ulcerative colitis (UC) achieving therapeutic and sub-therapeutic trough levels of biosimilar infliximab (CT-P13).

Results: A total of 65 patients (32 with CD and 33 with UC) were recruited.

Characteristics of patients with moderate-to-severe ulcerative colitis treated with vedolizumab: results from a Polish multicenter, prospective, observational real-life study (the POLONEZ study).

Background: Vedolizumab, a humanized antibody targeting the αβ integrin, was proven to be effective in the treatment of moderate-to-severe ulcerative colitis (UC) in randomized clinical trials. The aim of the POLONEZ study is to determine the demographic and clinical characteristics of the patients with UC treated with vedolizumab within the scope of the National Drug Program in Poland and to assess the real-world effectiveness and safety of vedolizumab in the study population. Here we report the demographic and clinical characteristics of these patients.

Anti-Drug Antibodies in Patients with Inflammatory Bowel Diseases Treated with Biosimilar Infliximab: A Prospective Cohort Study.

Reports of the prevalence of antibodies to infliximab (anti-drug antibodies, ADA) are inconsistent due in part to the various assay formats used to monitor immunogenicity in the clinic and under clinical trial settings. This study aimed to determine the frequency of ADA in patients with inflammatory bowel disease (IBD) during induction and maintenance therapy with biosimilar infliximab (CT-P13) using the ELISA (enzyme-linked immunosorbent assay) method. In this prospective single-center study, we analyzed the incidence of ADA and the relationship between the presence of ADA and the following variables: gender, type of disease, immunosuppressive therapy used, and duration of treatment.

Impact of gastroesophageal reflux disease on the quality of life of Polish patients.

Background: Gastro-esophageal reflux disease (GERD) is a serious health and social problem leading to a considerable decrease in the quality of life of patients. Among the risk factors associated with reflux symptoms and that decrease the quality of life are stress, overweight and an increase in body weight. The concept of health-related quality of life (HRQL) covers an expanded effect of the disease on a patient's wellbeing and daily activities and is one of the measures of widely understood quality of life.