Ελληνική Ομάδα Μελέτης

Ιδιοπαθών Φλεγμονωδών Νόσων του Εντέρου

Επιπολασμός, αντιμετώπιση και επίδραση της αναιμίας σε Έλληνες ασθενείς με ΙΦΝΕ" (2019EOMIFNEp8)

EXCEL ΣΥΜΠΛΗΡΩΣΗΣ ΔΕΔΟΜΕΝΩΝ

Title

Prevalence, treatment and impact of anemia in Greek patients with Inflammatory Bowel Disease

Investigators names

Ioannis Koutroubakis, Kalliopi Foteinogiannopoulou

Background & Rationale

Inflammatory bowel diseases (IBD) namely Crohn’s Disease (CD) and Ulcerative Colitis (UC) are chronic disorders that mainly affect the gastrointestinal track. Although the etiology of IBD is not fully understood, it is considered to be the outcome of environmental factors in genetic predisposed patients. The clinical course of these diseases is characterized by periods of exacerbation followed by periods of remission as well. There is a wide range of symptoms not only concerning the gastrointestinal system but many others, in the form of extraintestinal manifestations. The most common complication and/or extraintestinal manifestation is anemia which is present in about 50% of IBD patients. Anemia in IBD is of a great importance not only because of its frequency but because of its significant negative impact on patient‐reported outcomes (PROs) and patients’ quality of life. There are variable causes of anemia in IBD patients, more specifically anemia could be a combination of iron deficiency, anemia of chronic diseases, B12 and folic acid deficiency and less commonly due to certain medications. The most common cause is iron deficiency and as first line treatment has been suggested the intravenous (IV) iron replacement, especially in cases with active disease, severe anemia or intolerance of oral iron. However, recent reports suggest that iron deficiency is underdiagnosed and undertreated in IBD in clinical practice.
There is a lack of reliable and universally accepted biomarkers which predict disease course in IBD. Moreover, the assessment of disease activity in IBD is difficult. Regarding the use of biomarkers in the management and prognosis of IBD, CRP and fecal calprotectin are the most widely used but both have several limitations. Data on the use of anemia and its course over time in the outpatient clinic setting as a potential marker of severe and disabling disease is limited. Moreover, the independent effect of the treatment of anemia and iron deficiency on disease course and severity has not been studied so far. Especially in IBD patients on maintenance treatment with biologics the results of combined management with target to resolve of both disease activity (clinical and endoscopic) and anemia (including iron deficiency without anemia) could be important in terms of disease outcome.

Hypothesis

Persistent/recurrent anemia is a common finding in IBD patients. According to what is known the presence of anemia has been positively correlated with active IBD and plays important role in quality of patients’ life. However, the data on the use of anemia, particularly of the presence of persistent/recurrent anemia as well as it’s treatment as a potential marker of disabling and severe IBD is limited. Moreover, the use of anemia as a predictor of severe and aggressive IBD could offer the option of early and more accurate therapeutic management of IBD. The suitable and timely decision making in the management of IBD including the appropriate treatment of anemia could lead to a better disease course with less complications and surgeries. Having as targets of treatment the clinical/patient‐reported outcome (PRO) remission the endoscopic remission and normalization of hemoglobin level and iron stores could lead to better outcomes for the IBD patients.

Objectives

The aim of this study is first to estimate the prevalence of anemia in Greek IBD patients. Second aim is to investigate the impact of anemia and it’s treatment on the disease course and the overall severity of IBD. The possible positive correlation will render the presence of anemia as a prognostic factor in IBD aiming the proper therapeutic management of these patients.

Design, incl. Treatment

Retrospective analysis of data of the IBD registries. Separate analysis of data of patients with a history of iron supplementation. 

Inclusion Criteria

Subjects must satisfy the following criteria to be enrolled in the study:

  1. Patients with established  diagnosis of Crohn’s Disease or Ulcerative Colitis
  2. Male or female patients aged 18 to 80 years
  3. Only patients with more than two visits to the IBD out clinic
  4. Patients who have provided written informed consent prior to any study-related procedures

Exclusion Criteria

The presence of any of the following will exclude a subject from enrollment:

  1. Patients with uncertain diagnosis of IBD
  2. Comorbidities that are related to anemia such as chirrhosis, chronic kindey failure, heart failure, known neoplasia ect
  3. Patients with limited information (lack of data, only one visit to the IBD out clinic etc)

Endpoints

The healthcare utilization and IBD related surgery will be the primary end points of the study as markers of disease severity. Use of medications (steroids, immunosuppresants and biologics) will be used as a secondary endpoint. In cases with endoscopic data available the mucosal healing will be also evaluated and used as endpoint. Regarding treatment of anemia hematopoetic response (increase of Hb>2gr/dl) or normalization of Hb will be used as endpoints.  

Procedures

Clinical and laboratory data of IBD patients will be collected retrospectively from the IBD registries of the participating centers. Demographic information, clinical, endoscopic, pathological, radiological, and laboratory data, as well as information regarding prescription of medications and healthcare utilization of enrolled patients will be gathered. Analytical patients characteristics will be extracted and recorded in an excel database for the analysis. Furthermore, it will be a focus on the analytical record of the presence of anemia, and its duration or recurrences and its biochemical characteristics (biomarkers of iron deficiency). As result we’ll have an evaluation of anemia and its characteristics over all the period of the follow up in context with the clinical course of IBD. 
More specifically for both UC and CD the Montreal classification for the disease location and phenotype will be used. Furthermore Complete Blood Count (Hb, MCV, RDW), biomarkers of inflammation (CRP, ESR, fecal calprotectin), biomarkers of anemia (ferritin, B12, folic acid, transferrin saturation), clinical indices of disease activity (HBI for CD and SCCAI for UC), questionnaires for quality of life (SIBDQ), endoscopic and histologic data will be included. Analytical information on medications used for IBD treatment as well as on IBD related hospitalizations and IBD related surgeries will also be gathered. Data on the treatment of anemia will be collected as well and in case of iron supplementation the route of administration (per os or intravenous infusion), the dosage, the regimen and the therapeutic result.
Anemia according to WHO is defined as Hb<12 mg/dl in non-pregnant females and Hb<13 mg/dl in males. Persistent anemia is defined as the absence of hematopoetic result after proper treatment whereas and recurrent anemia is considered the drop of Hb anew, after the initially response and resolve of  anemia.

Sample Size

2000 IBD patients followed in the IBD outpatient clinics of Greek IBD referral centers, will be included in this study.

No of Sites

6-8

Statistical Methods

Data will be presented either as mean±SD for continuous, normally distributed variables or as median and range for nonparametric data based on the results of the Kolmogorov-Smirnov test on distribution normality. Differences between groups will be evaluated using Student’s t test for parametric continuous data and Mann–Whitney U test for nonparametric continuous data. Data from contingency tables will be analyzed using chi-squared analysis. Correlation with Spearman’s rho (r) will be used for assessing the relationship between anemia status and biomarkers or disease activity indices.  A logistic regression analysis will be used to adjust for potential confounders.

Planned Timelines

Jan 2019-Dec 2019 collection of data
Jan 2020-Jun 2020 analysis of data
Jun 2020-Dec 2020 writing of the manuscript (s)

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