EC Gastroenterology and Digestive System

Mini Review Volume 11 Issue 8 - 2024

Discrepancies Between Real World Clinical Practice and Clinical Trials in IBD

Milan Lukas*, Dana Duricova and Martin Kolar

IBD Clinical and Research Centre, Clinical Centre ISCARE a.s. and 1st Medical Faculty, Charles University, Prague, Czech Republic
*Corresponding Author: Milan Lukas, Professor, IBD Clinical and Research Centre, Clinical Centre ISCARE a.s. and 1st Medical Faculty, Charles University, Prague, Czech Republic.
Received: May 08, 2024; Published: May 17, 2024



Randomized, placebo controlled trials (RCTs) are considered to be the most appropriate study design to provide reliable evidence of efficacy and safety of different drugs used in therapeutic armamentarium for treatment of ulcerative colitis (UC) and Crohn‘s disease (CD). Despite that, gaps in knowledge and significant discrepancies still exist in how to use some drugs in clinical practice in comparison with results of RCTs and international guidelines. In this paper we would like to describe probably the most discussed issues including usage of azathioprine/6-mercaptopurine in clinical practice, new “biobetter” concept of subcutaneous infliximab CT-P13 and position of mesalazine in Crohn‘s disease patients.

 Keywords: Inflammatory Bowel Disease; Crohn´s Disease; Ulcerative Colitis; Mesalazine; Azathioprine

  1. Prefontaine E., et al. “Azathioprine or 6-mercaptopurine for maintenance of remission in Crohn’s disease”. Cochrane Database of Systematic Reviews 1 (2009): CD000067.
  2. Raine T., et al. “ECCO guidelines on therapeutic in ulcerative colitis: Medical treatment”. Journal of Crohn's and Colitis 1 (2022): 2-17.
  3. Markowitz J., et al. “A multicenter trial of 6-mercaptopurine and prednisone in children with newly diagnosed Crohn’s disease”. Gastroenterology 4 (2000): 895-902.
  4. Lakatos PL., et al. “Has there been a change in the natural history of Crohn´s disease? Surgical rates and medical management in a population-based inception cohort from western Hungary between 1977-2009”. American Journal of Gastroenterology 4 (2012): 579-588.
  5. Cosnes J., et al. “Impact of the increasing use of immunosuppressants in Crohn’s disease on the need for intestinal surgery”. Gut 2 (2005): 237-241.
  6. Cosnes J., et al. “Early administration of azathioprine vs conventional management of Crohn´s disease: A randomized controlled trial”. Gastroenterology 4 (2013): 758-765.
  7. Panés J., et al. “Early azathioprine therapy is no more effective than placebo for newly diagnosed Crohn’s disease”. Gastroenterology 4 (2013): 766-774.
  8. Campos S., et al. “Inflammatory bowel disease: adherence to immunomodulators in a biological therapy era”. European Journal of Gastroenterology and Hepatology 11 (2016): 1313-1319.
  9. Annese V., et al. “European evidence-based consensus: inflammatory bowel disease and malignancies”. Journal of Crohn's and Colitis 11 (2015): 945-965.
  10. Torres J., et al. “ECCO guidelines on therapeutics in Crohn’s disease: medical treatment”. Journal of Crohn's and Colitis 2 (2020): 4-22.
  11. Scott FI., et al. “The benefit to risk balance of combining infliximab with azathioprine varies with age: A Markov model”. Clinical Gastroenterology and Hepatology 2 (2015): 302-309.
  12. Kotlyar DS., et al. “Risk of lymphoma in patients with inflammatory bowel disease treated with azathioprine and 6-mercaptopurine: A meta-analysis”. Clinical Gastroenterology and Hepatology 5 (2015): 847-858.
  13. Beaugerie L., et al. “Lymphoproliferative disorders in patients receiving thiopurines for inflammatory bowel disease: a prospective observational cohort study”. Lancet 9701 (2009): 1617-1625.
  14. Turner D., et al. “STRIDE-II: an update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) initiative of the International Organization for the Study of IBD (IOIBD): determining therapeutic goals for treat-to-target strategies in IBD”. Gastroenterology5 (2021): 1570-1583.
  15. Schreiber S., et al. “Randomized controlled trial: subcutaneous vs intravenous infliximab CT-P13 maintenance in inflammatory bowel disease”. Gastroenterology7 (2021): 2340-2353.
  16. Westhovens R., et al. “Efficacy, pharmacokinetics and safety of subcutaneous versus intravenous CT-P13 in rheumatoid arthritis: a randomized phase I/III trial”. Rheumatology (Oxford)5 (2021): 2277-2287.
  17. Schreiber S., et al. “Perspectives on subcutaneous infliximab for rheumatic diseases and inflammatory bowel disease: before, during, and after the covid-19 era”. Advances in Therapy 6 (2022): 2342-2364.
  18. Kennedy NA., et al. “Predictors of anti-TNF treatment failure in anti-TNF-naive patients with active luminal Crohn’s disease: a prospective, multicentre, cohort study”. The Lancet Gastroenterology and Hepatology 5 (2019): 341-353.
  19. Caron B., et al. “Letter: treatment with subcutaneous CT-P13 in Crohn’s disease patients with intravenous infliximab failure”. Alimentary Pharmacology and Therapeutics 4 (2022): 508-509.
  20. East JE., et al. “Controversies in inflammatory bowel disease: Exploring clinical dilemmas using Cochrane reviews”. Inflammatory Bowel Disease 3 (2019): 472-478.
  21. Lim WC., et al. “Aminosalicylates for induction of remission or response in Crohn's disease”. Cochrane Database of Systematic Reviews 7 (2016): CD008870.
  22. Akobeng AK., et al. “Oral 5-aminosalicylic acid for maintenance of medically-induced remission in Crohn's disease”. Cochrane Database of Systematic Reviews (2016).
  23. Torres J., et al. “ECCO guidelines on therapeutics in crohn's disease: medical treatment”. Journal of Crohn's and Colitis 1 (2020): 4-22.
  24. Lamb CA., et al. “British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults”. Gut3 (2019): s1-s106.
  25. Burisch J., et al. “The use of 5-aminosalicylate for patients with Crohn's disease in a prospective European inception cohort with 5 years follow-up - an Epi-IBD study”. United European Gastroenterology Journal 8 (2020): 949-960.
  26. Noureldin M., et al. “Trends of 5-aminosalicylate medication use in patients with crohn´s disease”. Inflammatory Bowel Disease 4 (2021): 516-521.
  27. Charpentier C., et al. “Natural history of elderly-onset inflammatory bowel disease: a population-based cohort study”. Gut3 (2014): 423-432.
  28. Ma C., et al. “Systematic review with meta-analysis: prevalence, risk factors and cost of aminosalicylates in Crohn´s disease”. Alimentary Pharmacology and Therapeutics 2 (2018): 114-126.
  29. Ma C., et al. “Physicians' perspectives on cost, safety, and perceived efficacy determine aminosalicylate use in crohn's disease”. Digestive Diseases and Sciences 10 (2018): 2555-2563.

Milan Lukas., et al. “Discrepancies Between Real World Clinical Practice and Clinical Trials in IBD".  11.8 (2024): 01-07.