Objective Disease Monitoring Strategies from a Tertiary Inflammatory Bowel Disease Center in Hungary.

Background: Emerging data suggest that a treat-to-target approach and early therapeutic intervention using regular objective disease assessment leads to improved outcomes. Our aim was to evaluate the value of objective disease monitoring during regular follow-up in a single tertiary inflammatory bowel disease center.

Methods: Consecutive inflammatory bowel disease patients (n = 161, Crohn's disease: 118/ulcerative colitis: 43; biological therapy: 70%) were included and followed up for 1 year between January and December 2018.

Epidemiology, Treatment Strategy, Natural Disease Course and Surgical Outcomes of Patients with Ulcerative Colitis in Western Hungary - A Population-based Study Between 2007 and 2018: Data from the Veszprem County Cohort.

Background And Aims: The number of population-based studies in ulcerative colitis [UC] from Eastern Europe is limited. Our aim here was to analyse the incidence, prevalence, disease phenotype, treatment strategy, disease course and colectomy rates in a prospective population-based inception cohort including UC patients diagnosed between 2007 and 2018. The present study is a continuation of the Veszprem IBD cohort since 1977.

Incidence, Prevalence, Disease Course, and Treatment Strategy of Crohn's Disease Patients from the Veszprem Cohort, Western Hungary: A Population-based Inception Cohort Study Between 2007 and 2018.

Background And Aims: The number of prospective population-based studies on Crohn's disease[CD] is still limited from Eastern Europe. The present study is a continuation of the Veszprem IBD cohort. Our aim was to analyse incidence, prevalence, disease phenotype, treatment strategy, disease course, and surgical outcomes in a prospective population-based inception cohort including CD patients diagnosed between 2007 and 2018.

The Burden of Anemia Remains Significant over Time in Patients with Inflammatory Bowel Diseases at a Tertiary Referral Center.

Background And Aims: Anemia is a common complication of inflammatory bowel diseases (IBD), as well as a predictor of poor outcomes. The aim of this study was to determine the prevalence of anemia over time and the management of moderate to severe anemia at a tertiary referral IBD center.

Methods: We retrospectively reviewed the occurrence of anemia at the time of referral or diagnosis and during follow-up at the McGill University Health Centre IBD center.

Benefits of implementing a rapid access clinic in a high-volume inflammatory bowel disease center: Access, resource utilization and outcomes.

Background: Emergency situations in inflammatory bowel diseases (IBD) put significant burden on both the patient and the healthcare system.

Aim: To prospectively measure Quality-of-Care indicators and resource utilization after the implementation of the new rapid access clinic service (RAC) at a tertiary IBD center.

Methods: Patient access, resource utilization and outcome parameters were collected from consecutive patients contacting the RAC between July 2017 and March 2019 in this observational study.

High Adherence to Surveillance Guidelines in Inflammatory Bowel Disease Patients Results in Low Colorectal Cancer and Dysplasia Rates, While Rates of Dysplasia are Low Before the Suggested Onset of Surveillance.

Background: Patients with Crohn's disease [CD] and ulcerative colitis [UC] are at increased risk for colorectal dysplasia [CRD] and colorectal cancer [CRC]. Adherence to CRC surveillance guidelines is reportedly low internationally.

Aim: To evaluate surveillance practices at the tertiary IBD Center of the McGill University Health Center [MUHC] and to determine CRD/CRC incidence.

Biosimilars in IBD: Will it Benefit to Patients, Physicians or the Health Care System?

The introduction of biological drugs has revolutionized the management of inflammatory bowel diseases (IBD), however, the increasing financial burden of biologicals on the health care system is alarming. Biosimilars are considered to be equivalent to the reference medicinal product (RMP) in terms of pharmacokinetic properties, clinical effectiveness and safety. CT-P13 infliximab was the first biosimilar to be approved by the regulatory authorities EMA and US FDA, and others are becoming increasingly available as patents expire on the RMP.

[The role of fecal calprotectin in the diagnosis and treatment of gastrointestinal diseases].

The diagnostics of gastrointestinal diseases have evolved significantly in the past few decades. Besides endoscopy and conventional imaging modalities, there is a growing interest for rapid point-of-care laboratory tests to help discriminate between diseases with similar clinical symptoms and/or help the follow-up of chronic conditions, predicting relapses. The fecal calprotectin testing is a routine diagnostic tool in many countries.

Perceived Quality of Care is Associated with Disease Activity, Quality of Life, Work Productivity, and Gender, but not Disease Phenotype: A Prospective Study in a High-volume IBD Centre.

Background And Aims: Measuring quality of care [QoC] in inflammatory bowel diseases [IBD] has become increasingly important, yet complex assessment of QoC from the patients' perspective is rare. We evaluated perceived QoC using the Quality of Care Through the Patient's Eyes-IBD [QUOTE-IBD] questionnaire, and investigated associations between QoC, disease phenotype, work productivity, and health-related quality of life [HRQoL] in a high-volume IBD centre.

Methods: Consecutive patients attending McGill University Health Centre [MUHC]-IBD Centre completed the QUOTE-IBD, Short Inflammatory Bowel Disease Questionnaire [SIBDQ], IBD-Control, and Work Productivity and Activity Impairment [WPAI] questionnaires.

Outcomes of Patients With Inflammatory Bowel Diseases Switched From Maintenance Therapy With a Biosimilar to Remicade.

Background & Aims: There is evidence that it is safe and effective for patients with inflammatory bowel diseases (IBD) to switch from maintenance therapy with an original infliximab drug to a biosimilar, but little is known about outcomes of reverse switches and/or multiple switches. We aimed to evaluate the effects of a reverse switch (from a biosimilar to Remicade) in a real-life cohort.

Methods: We performed a prospective observational study of 174 unselected and consecutive patients with IBD (136 with Crohn's disease [CD] and 38 with ulcerative colitis [UC]) who received maintenance therapy with the biosimilar in Hungary.

Harmonization of quality of care in an IBD center impacts disease outcomes: Importance of structure, process indicators and rapid access clinic.

Background And Aims: We aimed to evaluate the quality of care at a tertiary inflammatory bowel disease (IBD) center using quality of care indicators (QIs) including patient assessment strategy, monitoring, treatment decisions and outcomes.

Methods: We retrospectively reviewed the quality of care pre- and post-referral and during follow-up at the at the McGill University Health Center (MUHC) IBD center. Consecutive patients were included presenting with an outpatient visit ('index visit') between July and December 2016.

Optimizing Patient Management in Crohn's Disease in a Tertiary Referral Center: the Impact of Fast-Track MRI on Patient Management and Outcomes.

Background And Aims: Rapid optimization of treatment algorithms and disease outcomes requires an objective measurement of disease activity in patients with Crohn's disease (CD). Our aim was to evaluate the impact of rapid-access to magnetic resonance imaging (MRI) on treatment optimization, clinical decision-making and outcomes for CD patients in a specialized tertiary care for inflammatory bowel disease (IBD) patients.

Methods: A cohort of 75 referral CD patients (median age: 34, IQR: 25-43 years) who had underwent 90 fast-track MR enterography (MRE) scans between January 2014 and June 2016 were retrospectively enrolled.

Infliximab biosimilar CT-P13 therapy is effective in maintaining endoscopic remission in ulcerative colitis - results from multicenter observational cohort.

Background: CT-P13, the first biosimilar monoclonal antibody to infliximab (IFX), has previously been confirmed to be efficacious in inducing mucosal healing in ulcerative colitis (UC) patients. The aim of this study was to evaluate the efficacy of CT-P13 therapy in maintaining mucosal healing in UC.

Methods: CT-P13 trough levels, antibody positivity, serum inflammatory markers as CRP level, fecal calprotectin at weeks 14 and 54, concomitant steroid and azathioprine therapy at the time of induction therapy and at weeks 14 and 54, previous use of anti TNF drug and the need of dose intensification as possible predictive factors for mucosal healing at week 54 were evaluated in this prospective study.

Validity of the EQ-5D-5L and EQ-5D-3L in patients with Crohn's disease.

Purpose: The EuroQol five-dimension questionnaire (EQ-5D) is the most commonly used instrument to obtain utility values for cost-effectiveness analyses of treatments for Crohn's disease (CD). We aimed to compare the measurement properties of the two adult versions of EQ-5D (EQ-5D-3L and EQ-5D-5L) in patients with CD.

Methods: Between 2016 and 2017, a multicentre cross-sectional survey was carried out.

Progress with infliximab biosimilars for inflammatory bowel disease.

Introduction: Biological therapies have revolutionized the treatment of inflammatory bowel diseases (IBD) in the last two decades. Though biological drugs are effective, their use is associated with high costs and access to biological agents varies among countries. As the patent for the reference products expired, the advent of biosimilar monoclonal antibodies has been expected.

Therapeutic preferences and outcomes in newly diagnosed patients with Crohn's diseases in the biological era in Hungary: a nationwide study based on the National Health Insurance Fund database.

Background: Accelerated treatment strategy, including tight disease control and early aggressive therapy with immunosuppressives (IS) and biological agents have become increasingly common in inflammatory bowel disease (IBD). The aim of the present study was to estimate the early treatment strategy and outcomes in newly diagnosed patients with Crohn's disease (CD) between 2004 and 2008 and 2009-2015 in the whole IBD population in Hungary based on the administrative database of the National Health Insurance Fund (OEP).

Methods: We used the administrative database of the OEP, the only nationwide state-owned health insurance provider in Hungary.

Quality of care indicators in inflammatory bowel disease in a tertiary referral center with open access and objective assessment policies.

Background: In the management of inflammatory bowel diseases, there is considerable variation in quality of care.

Aims: The aim of this study was to evaluate structural, access/process components and outcome quality indicators in our tertiary referral IBD center.

Methods: In the first phase, structural/process components were assessed, followed by the second phase of formal evaluation of access and management on a set of consecutive IBD patients with and without active disease (248CD/125UC patients, median age 35/39 years).

Long-term Efficacy, Safety, and Immunogenicity of Biosimilar Infliximab After One Year in a Prospective Nationwide Cohort.

Background: It has been previously shown that biosimilar infliximab CT-P13 is effective and safe in inducing remission in inflammatory bowel diseases. We report here the 1-year outcomes from a prospective nationwide inflammatory bowel disease cohort.

Methods: A prospective, nationwide, multicenter, observational cohort was designed to examine the efficacy and safety of CT-P13 in the induction and maintenance treatment of Crohn's disease (CD) and ulcerative colitis (UC).

Infliximab biosimilar CT-P13 therapy is effective and safe in maintaining remission in Crohn's disease and ulcerative colitis - experiences from a single center.

Background: CT-P13, the first biosimilar monoclonal antibody to infliximab (IFX), has been confirmed to be efficacious in inducing remission in inflammatory bowel diseases (IBD). The aim of this study was to evaluate the long-term efficacy and safety of CT-P13 therapy in Crohn's disease (CD) and ulcerative colitis (UC), and to identify predictors of sustained clinical response during a 54-week CT-P13 treatment period.

Patients And Methods: Patients with CD and UC, who were administered CT-P13, were prospectively enrolled.

Drug persistence and need for dose intensification to adalimumab therapy; the importance of therapeutic drug monitoring in inflammatory bowel diseases.

Background: Therapeutic drug monitoring (TDM) aid therapeutic decision making in patients with inflammatory bowel disease (IBD) who lose response to anti-TNF therapy. Our aim was to evaluate the frequency and predictive factors of loss of response (LOR) to adalimumab using TDM in IBD patients.

Methods: One hundred twelve IBD patients (with 214 TDM measurements, CD/UC 84/28, male/female 50/62, mean age CD/UC: 36/35 years) were enrolled in this consecutive cohort from two referral centres in Hungary.

Frequency and characteristics of infusion reactions during biosimilar infliximab treatment in inflammatory bowel diseases: results from Central European nationwide cohort.

Background: Safety data of the 'real life' use of an infliximab biosimilar, CT-P13 in inflammatory bowel disease (IBD) are still lacking. Our aim was to assess the frequency and characteristics of infusion reactions during CT-P13 therapy in 13 Hungarian and 1 Czech IBD centres.

Methods: Clinical and safety data was registered at fixed appointments.

Can we Predict Disease Course with Clinical Factors?

Background: The disease phenotype at diagnosis and the disease course of Crohn's disease (CD) and ulcerative colitis (UC) show remarkable heterogeneity across patients.

Objective: This review aims to summarize the currently available evidence on clinical and some environmental predictive factors, which clinicians should evaluate in the everyday practice together with other laboratory and imaging data to prevent disease progression, enable a more personalized therapy, and avoid negative disease outcomes.

Results: In recent population-based epidemiological and referral cohort studies, the evolution of disease phenotype of CD and UC varied significantly.