scholarly journals Oral versus intravenous iron therapy in patients with inflammatory bowel disease and iron deficiency with and without anemia in Germany – a real-world evidence analysis

2018 ◽  
Vol Volume 10 ◽  
pp. 93-103 ◽  
Author(s):  
Jürgen Stein ◽  
Jennifer Scarlet Haas ◽  
Siew Hwa Ong ◽  
Kathrin Borchert ◽  
Thomas Hardt ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Iron Deficiency ◽  
Real World ◽  
Bowel Disease ◽  
Intravenous Iron ◽  
Iron Therapy ◽  
Real World Evidence ◽  
Evidence Analysis ◽  
Inflammatory Bowel ◽  
Intravenous Iron Therapy

scholarly journals Utility of routinely collected electronic health records data to support effectiveness evaluations in inflammatory bowel disease: a pilot study of tofacitinib

2021 ◽  
Vol 28 (1) ◽  
pp. e100337
Author(s):  
Vivek Ashok Rudrapatna ◽  
Benjamin Scott Glicksberg ◽  
Atul Janardhan Butte
Keyword(s):  
Inflammatory Bowel Disease ◽  
Pilot Study ◽  
Disease Activity ◽  
Real World ◽  
Bowel Disease ◽  
P Value ◽  
Health Records ◽  
Real World Evidence ◽  
Inflammatory Bowel

ObjectivesElectronic health records (EHR) are receiving growing attention from regulators, biopharmaceuticals and payors as a potential source of real-world evidence. However, their suitability for the study of diseases with complex activity measures is unclear. We sought to evaluate the use of EHR data for estimating treatment effectiveness in inflammatory bowel disease (IBD), using tofacitinib as a use case.MethodsRecords from the University of California, San Francisco (6/2012 to 4/2019) were queried to identify tofacitinib-treated IBD patients. Disease activity variables at baseline and follow-up were manually abstracted according to a preregistered protocol. The proportion of patients meeting the endpoints of recent randomised trials in ulcerative colitis (UC) and Crohn’s disease (CD) was assessed.Results86 patients initiated tofacitinib. Baseline characteristics of the real-world and trial cohorts were similar, except for universal failure of tumour necrosis factor inhibitors in the former. 54% (UC) and 62% (CD) of patients had complete capture of disease activity at baseline (month −6 to 0), while only 32% (UC) and 69% (CD) of patients had complete follow-up data (month 2 to 8). Using data imputation, we estimated the proportion achieving the trial primary endpoints as being similar to the published estimates for both UC (16%, p value=0.5) and CD (38%, p-value=0.8).Discussion/ConclusionThis pilot study reproduced trial-based estimates of tofacitinib efficacy despite its use in a different cohort but revealed substantial missingness in routinely collected data. Future work is needed to strengthen EHR data and enable real-world evidence in complex diseases like IBD.

scholarly journals Dipeptidyl Peptidase 4 Inhibitors and Risk of Inflammatory Bowel Disease: Real-world Evidence in U.S. Adults

Diabetes Care ◽  
2019 ◽  
Vol 42 (11) ◽  
pp. 2065-2074
Author(s):  
Tiansheng Wang ◽  
Jeff Y. Yang ◽  
John B. Buse ◽  
Virginia Pate ◽  
Huilin Tang ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Real World ◽  
Bowel Disease ◽  
Dipeptidyl Peptidase ◽  
Dipeptidyl Peptidase 4 ◽  
Real World Evidence ◽  
Dipeptidyl Peptidase 4 Inhibitors ◽  
Inflammatory Bowel

scholarly journals Safety and Efficacy of Intravenous Iron Sucrose for Iron-Deficiency Anemia in Children and Adolescents With Inflammatory Bowel Disease

2019 ◽  
Vol 6 ◽  
pp. 2333794X1987098
Author(s):  
Ramy Sabe ◽  
Anant Vatsayan ◽  
Amr Mahran ◽  
Ali S. Khalili ◽  
Sanjay Ahuja ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Bowel Disease ◽  
Intravenous Iron ◽  
Iron Sucrose ◽  
Deficiency Anemia ◽  
Safety And Efficacy ◽  
Normal Ranges ◽  
Inflammatory Bowel

Background. Anemia is common in inflammatory bowel disease (IBD). Oral iron is widely used but efficacy can be reduced by poor compliance and insufficient absorption. Intravenous iron is safe and effective in adults but is not well studied in children. Purpose. To assess safety and efficacy of intravenous iron sucrose (IVIS) in children with IBD. Methods. We reviewed medical records of IBD patients <22 years of age who received IVIS at our institution between 2009 and 2014. Anemia was defined as hemoglobin (Hgb) level below normal for age and gender and iron-deficiency anemia as serum iron studies and red cell mean corpuscular volume below normal ranges. Each IVIS infusion was evaluated for safety. Efficacy was defined as ≥2 g/dL increase in Hgb ≤12 weeks from IVIS initiation. Results. We identified 88 patients (Crohn’s disease, n = 52; ulcerative colitis, n = 33; IBD-unclassified, n = 3) who underwent 329 IVIS infusions over 121 courses. No patient developed anaphylaxis. Six patients developed minor adverse reactions. Of the 121 IVIS courses, 80 were included in the efficacy evaluation. There was a significant rise in Hgb (mean 9.1 ±1.4 to 11.9 ± 1.8 g/dL; P < .0001, paired t test). Overall, 58.7% (47/80 courses) resulted in goal Hgb increase. Conclusions. IVIS is safe and effective in treating iron-deficiency anemia in pediatric IBD. There were only minor adverse events, and the observed rise in Hgb was clinically significant, with the majority achieving goal Hgb.

scholarly journals P570 The burden of anaemia remains significant over time in patients with inflammatory bowel disease at a tertiary referral centre

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S480-S480
Author(s):  
K Singh Singh ◽  
A Al-Khoury ◽  
Z Kurti ◽  
L Gonczi ◽  
P Golovics ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Intravenous Iron ◽  
Severe Anaemia ◽  
Iron Therapy ◽  
Tertiary Referral ◽  
Inflammatory Bowel ◽  
Intravenous Iron Therapy ◽  
Active Disease ◽  
Over Time

Abstract Background Anaemia is an important complication and/or extra-intestinal manifestation of inflammatory bowel disease (IBD), as well as a predictor of poor outcomes. The aim of this study was to determine the occurrence of anaemia and the frequency of anaemia screening over time, at a tertiary referral IBD centre. Methods We retrospectively reviewed the occurrence of anaemia at the time of referral or diagnosis and during follow-up at the McGill University Health Centre (MUHC) IBD centre. Consecutive patients presenting with an outpatient visit (‘index visit’) between July and December 2016 and between December 2018 and March 2019 were included. Disease characteristics, biochemistry and medical management, including the need for intravenous iron therapy were captured. Results 1356 and 1293 CD and UC patients [disease duration: 12 (IQR:6–22) and 10 (IQR: 5–19) years] were included in the 2 periods. The prevalence of moderate or severe anaemia at referral/diagnosis (15.4% and 8.5%) and during the follow-up (11.1% and 8.1%) was higher in CD than in UC patients, with a decrease of anaemia in CD patients between the 2 periods. The prevalence of any anaemia at follow-up was 22.4% and 18.7% in CD and in UC, while 82.7% of patients were tested at least once for anaemia during a 6-month period. UC patients with more extensive disease, treated with steroids or biologics at the time of referral but not during follow-up, active disease, or an elevated calprotectin at the time of assessment, and CD patients with active disease, elevated CRP or calprotectin at the time of assessment, with complicated disease, perianal involvement, previous respective surgery or colonic disease location, had a higher risk of anaemia. Intravenous iron therapy was prescribed in 46 patients (46.8% patients (37/79) with moderate or severe anaemia) with 72.3% having active disease (CD: 65.2%, steroid 83.3%, biological therapy: 78.6%, CRP: 97.8%, FCAL: 73.9%) in the second cohort. 91.3% of patients receiving intravenous iron had an extensive evaluation of anaemia pre- and post-therapy (CBC, ferritin, transferrin, TSAT, B12, folate). Anaemia improved by &gt;2g/l in 56.5% after 4–6 weeks (intravenous iron dose &gt;1000mg in 87% of patients). Four patients required a blood transfusion. Conclusion Anaemia occurred frequently in this IBD cohort, at referral to the centre and during follow-up, and contributes to the burden of IBD in referral populations. Most patients were assessed for anaemia regularly and with accurate anaemia workup in patients prescribed intravenous iron therapy, yet the targeted management of moderate to severe anaemia was suboptimal.

scholarly journals Management of Iron Deficiency Anaemia in Inflammatory Bowel Disease

2019 ◽  
Vol 142 (1) ◽  
pp. 30-36 ◽  
Author(s):  
Kristine Michelle Jimenez ◽  
Christoph Gasche
Keyword(s):  
Inflammatory Bowel Disease ◽  
Iron Deficiency ◽  
Bowel Disease ◽  
Iron Deficiency Anaemia ◽  
Intravenous Iron ◽  
Extraintestinal Manifestation ◽  
Deficiency Anaemia ◽  
Multiple Parameters ◽  
Inflammatory Bowel ◽  
Selection Of

Inflammatory bowel disease (IBD) is a group of chronic relapsing inflammatory disorders affecting the large and small intestine, with a rising worldwide incidence and prevalence. Anaemia is the most common extraintestinal manifestation of IBD, correlating with disease activity, and tending to relapse even after successful therapy. Iron deficiency is the most common cause; however, it often manifests in combination with anaemia of inflammation. As such, multiple parameters are used for the diagnosis of iron deficiency anaemia in IBD. Timely recognition and selection of appropriate therapy leads to an improvement in the quality of life and prevention of potential sequelae. Oral iron can be effective under specific circumstances; however, as luminal iron changes microbiota and bacterial metabolism, oral administration should be avoided. Intravenous iron is preferred as it bypasses the sites of inflammation. Nevertheless, the optimization of IBD treatment should occur simultaneously, as this improves both patient condition and response to iron therapy. Herein, we discuss the screening, diagnosis, selection of therapy, and follow-up for iron deficiency anaemia in IBD.

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