Real World Data and Inflammatory Bowel Disease
November 22, 2019

Real-world data could create a better understanding of the burden of disease and improve health outcomes for patients

The rates of inflammatory bowel disease (IBD) in Canada are among the highest in the world, with an estimated 10,200 incident cases per year.1  Patients with IBD experience a high economic burden of illness, as well as low quality of life. The economic costs of IBD in Canada in 2012 were estimated to be approximately $2.8 billion, with direct (medications, hospitalizations and physician visits) and indirect costs exceeding $1.2 billion and $1.6 billion per annum, respectively. Indirect costs of IBD are composed primarily of long-term work losses, estimated to be $979 million. The two main forms1  of IBD are Crohn’s Disease (CD) and ulcerative colitis (UC). Specifically, CD is a chronic inflammatory disease that affects different sites in the gastrointestinal tract, whereas UC is limited to the colon.2,3 In 2012, there were approximately 129,000 Canadians living with CD and 104,000 Canadians living with UC.1 The heterogeneous presentation of CD creates difficulty in understanding the etiologic cause of CD; the disorder affects all ages and sexes, and is thought to have genetic, epigenetic and environmental factors.2,3 Thus, the treatment landscape has been targeted at resolving flare-up symptoms and maintaining a symptom-free state.1 Traditionally, CD treatments have consisted of 5-aminosalicylic acid (ASA) compounds, immunomodulators and steroids, which aim to suppress intestinal inflammation.4 However, recent advances in therapy have enabled achievement of endoscopic or histologic remission, and mucosal healing. Biologic treatments such as infliximab, adalimumab and vedolizumab are monoclonal antibodies specific for targets in pathways implicated in chronic inflammatory diseases.5 These treatments have been shown to be highly effective for patients with CD.6 For example, vedolizumab is a gut-selective antibody to α4β7 integrin that has been shown to have a favourable safety profile compared to other biologics.7 Integrin antagonists such as vedolizumab promote lymphocyte migration to inflamed gut tissue.8 Biologic treatments are becoming the standard of care for patients with moderate to severe CD, which has resulted in increased medication costs.1 Interestingly, potentially due to the increasing use of biologic treatments, surgery rates for patients with CD (e.g. colectomies) are decreasing.9 By utilizing real-world data, the relationship between the use of biologic treatments and clinical outcomes (remission), as well as patient costs (direct and indirect) can be explored. The results of such a study may also inform a better understanding of the burden of disease and ultimately improve health outcomes and patient care for those with CD. REFERENCES:

  1.     Rocchi A, Benchimol EI, Bernstein CN, et al. Inflammatory bowel disease: a Canadian burden of illness review. Can J Gastroenterol 2012; 26(11): 811-7.
  2.     Freeman HJ. Natural history and long-term clinical course of Crohn’s disease. World J Gastroenterol 2014; 20(1): 31-6.
  3.     Waugh N, Cummins E, Royle P, et al. Faecal calprotectin testing for differentiating amongst inflammatory and non-inflammatory bowel diseases: systematic review and economic evaluation. Health Technol Assess 2013; 17(55): xv-xix, 1-211.
  4.     Grevenitis P, Thomas A, Lodhia N. Medical Therapy for Inflammatory Bowel Disease. Surg Clin North Am 2015; 95(6): 1159-82, vi.
  5.     Moss AC. Optimizing the use of biological therapy in patients with inflammatory bowel disease. Gastroenterol Rep (Oxf) 2015; 3(1): 63-8.
  6.     Danese S, Colombel JF, Reinisch W, Rutgeerts PJ. Review article: infliximab for Crohn’s disease treatment–shifting therapeutic strategies after 10 years of clinical experience. Aliment Pharmacol Ther 2011; 33(8): 857-69.
  7.     Colombel JF, Sands BE, Rutgeerts P, et al. The safety of vedolizumab for ulcerative colitis and Crohn’s disease. Gut 2017; 66(5): 839-51.
  8.     Wyant T, Fedyk E, Abhyankar B. An Overview of the Mechanism of Action of the Monoclonal Antibody Vedolizumab. J Crohns Colitis 2016; 10(12): 1437-44.
  9.     Annese V, Duricova D, Gower-Rousseau C, Jess T, Langholz E. Impact of New Treatments on Hospitalisation, Surgery, Infection, and Mortality in IBD: a Focus Paper by the Epidemiology Committee of ECCO. J Crohns Colitis 2016; 10(2): 216-25.
  10.   Panaccione R, Colombel JF, Louis E, Peyrin-Biroulet L, Sandborn WJ. Evolving definitions of remission in Crohn’s disease. Inflamm Bowel Dis 2013; 19(8): 1645-53.

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