Anemia in Inflammatory Bowel Disease

Summary

Anemia is a clinical manifestation, which is commonly observed in patients with inflammatory bowel disease, and it accounts for significant loss in the quality of life of these patients. The aim of the current study is to assess the effect of orally administered iron treatment, as well as its response predictors in patients with inflammatory bowel disease who are in remission and present anemia. The study will recruit 100 patients with Crohn's disease (CD) and 100 patients with ulcerative colitis (UC) diagnosed and regularly monitored in the Inflammatory Bowel Disease Center at the University Hospital of the Federal University of Juiz de Fora, for clinical, hematological, biochemical and immunological assessment. Blood samples will be collected (10 ml) and the following tests will be performed in all the anemia patients (in remission) at the beginning of the treatment and 8 weeks later: complete blood count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), erythrocyte sedimentation rate (ESR) , transferrin saturation index, ferritin, serum iron, hepcidin, quantitative C-reactive protein (CRP), interleukin-6 (IL-6)) and fecal calprotectin. In addition, quality of life, anxiety and depression and fatigue questionnaires will be applied to the patients (IBDQ, HAD and Chalder). The World Health Organization (WHO) criteria will be used to diagnose anemia, therefore, hemoglobin lower than 12 g/dl for women and 13g/dl for men will be considered anemia; hemoglobin lower than 10 g/dl will be considered severe anemia. Patients with mild and moderate anemia in remission will be initially treated with oral iron (oral liposomal iron) and the occurrence of possible symptoms related to oral iron intolerance will be assessed, as well as the patients' disease activity level and quality of life. The patients in follow-up will be subjected to new laboratory tests after the eighth oral iron treatment week. The results of the current study are expected to help assessing the oral iron efficacy and response predictors, as well as the side effects of the treatment and its impact on the quality of life of patients.

Timeline

Start

2016-08

Primary completion

2017-08

Completion

2018-08

Publications

• Background Bager P, Befrits R, Wikman O, Lindgren S, Moum B, Hjortswang H, Dahlerup JF. The prevalence of anemia and iron deficiency in IBD outpatients in Scandinavia. Scand J Gastroenterol. 2011 Mar;46(3):304-9. doi: 10.3109/00365521.2010.533382. Epub 2010 Nov 15.
• Background Befrits R, Wikman O, Blomquist L, Hjortswang H, Hammarlund P, Bajor A, Klintman D, Blom H. Anemia and iron deficiency in inflammatory bowel disease: an open, prospective, observational study on diagnosis, treatment with ferric carboxymaltose and quality of life. Scand J Gastroenterol. 2013 Sep;48(9):1027-32. doi: 10.3109/00365521.2013.819442. Epub 2013 Jul 29.
• Background Bergamaschi G, Di Sabatino A, Albertini R, Ardizzone S, Biancheri P, Bonetti E, Cassinotti A, Cazzola P, Markopoulos K, Massari A, Rosti V, Porro GB, Corazza GR. Prevalence and pathogenesis of anemia in inflammatory bowel disease. Influence of anti-tumor necrosis factor-alpha treatment. Haematologica. 2010 Feb;95(2):199-205. doi: 10.3324/haematol.2009.009985. Epub 2009 Oct 8.
• Background Gasche C, Ahmad T, Tulassay Z, Baumgart DC, Bokemeyer B, Buning C, Howaldt S, Stallmach A; AEGIS Study Group. Ferric maltol is effective in correcting iron deficiency anemia in patients with inflammatory bowel disease: results from a phase-3 clinical trial program. Inflamm Bowel Dis. 2015 Mar;21(3):579-88. doi: 10.1097/MIB.0000000000000314.
• Background Iqbal T, Stein J, Sharma N, Kulnigg-Dabsch S, Vel S, Gasche C. Clinical significance of C-reactive protein levels in predicting responsiveness to iron therapy in patients with inflammatory bowel disease and iron deficiency anemia. Dig Dis Sci. 2015 May;60(5):1375-81. doi: 10.1007/s10620-014-3460-4. Epub 2014 Dec 12.
• Background Kaitha S, Bashir M, Ali T. Iron deficiency anemia in inflammatory bowel disease. World J Gastrointest Pathophysiol. 2015 Aug 15;6(3):62-72. doi: 10.4291/wjgp.v6.i3.62.
• Background Nemeth E, Rivera S, Gabayan V, Keller C, Taudorf S, Pedersen BK, Ganz T. IL-6 mediates hypoferremia of inflammation by inducing the synthesis of the iron regulatory hormone hepcidin. J Clin Invest. 2004 May;113(9):1271-6. doi: 10.1172/JCI20945.
• Background Nielsen OH, Ainsworth M, Coskun M, Weiss G. Management of Iron-Deficiency Anemia in Inflammatory Bowel Disease: A Systematic Review. Medicine (Baltimore). 2015 Jun;94(23):e963. doi: 10.1097/MD.0000000000000963.
• Background Nielsen OH, Coskun M, Weiss G. Iron replacement therapy: do we need new guidelines? Curr Opin Gastroenterol. 2016 Mar;32(2):128-35. doi: 10.1097/MOG.0000000000000247.
• Background Pisani A, Riccio E, Sabbatini M, Andreucci M, Del Rio A, Visciano B. Effect of oral liposomal iron versus intravenous iron for treatment of iron deficiency anaemia in CKD patients: a randomized trial. Nephrol Dial Transplant. 2015 Apr;30(4):645-52. doi: 10.1093/ndt/gfu357. Epub 2014 Nov 13.
• Results Antunes CV, Hallack Neto AE, Nascimento CR, Chebli LA, Moutinho IL, Pinheiro Bdo V, Reboredo MM, Malaguti C, Castro AC, Chebli JM. Anemia in inflammatory bowel disease outpatients: prevalence, risk factors, and etiology. Biomed Res Int. 2015;2015:728925. doi: 10.1155/2015/728925. Epub 2015 Feb 1.
• Results Filmann N, Rey J, Schneeweiss S, Ardizzone S, Bager P, Bergamaschi G, Koutroubakis I, Lindgren S, Morena Fde L, Moum B, Vavricka SR, Schroder O, Herrmann E, Blumenstein I. Prevalence of anemia in inflammatory bowel diseases in european countries: a systematic review and individual patient data meta-analysis. Inflamm Bowel Dis. 2014 May;20(5):936-45. doi: 10.1097/01.MIB.0000442728.74340.fd.
• Results Bonovas S, Fiorino G, Allocca M, Lytras T, Tsantes A, Peyrin-Biroulet L, Danese S. Intravenous Versus Oral Iron for the Treatment of Anemia in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Medicine (Baltimore). 2016 Jan;95(2):e2308. doi: 10.1097/MD.0000000000002308.

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