#PAGE_PARAMS# #ADS_HEAD_SCRIPTS# #MICRODATA#

Role of biological therapy in early Crohn’s disease: mini-review


Authors: L. Bajer
Authors‘ workplace: Klinika hepatogastroenterologie, IKEM, Praha
Published in: Gastroent Hepatol 2022; 76(4): 296-301
Category: Clinical and Experimental Gastroenterology: Review Article
doi: https://doi.org/10.48095/ccgh2022296

Overview

Crohn’s disease (CD) is a multifactorial disease that (along with ulcerative colitis) represents a phenotype of inflammatory bowel disease (IBD). CD has progressive character and is associated with the development of various complications leading to potentially serious bowel damage (BD). Early stage of Crohn’s disease (eCD) is characterized by a specific immune response and represents an attractive target for specific agressive therapy. The use of bio­logics (BL) in eCD may help to prevent BD and allow early dose reduction or even discontinuation of BL. Wide scientific evidence supports the importance of BL in eCD based on studies with anti-TNF bio­logics (being part of clinical practice for relatively long time now). However, studies on novel bio­logics with low rate of the adverse events (vedolizumab, ustekinumab) also show promising results. Defining high-risk groups and suitable bio­markers would help to select those eCD patients who would benefit the most from early bio­logical therapy.

Keywords:

inflammatory bowel disease – bio­logical therapy – Crohn’s disease


Sources

1. Torres J, Bonovas S, Doherty G et al. ECCO Guidelines on Therapeutics in Crohn‘s Disease: Medical Treatment. J Crohns Colitis 2020; 14 (1): 4–22. doi: 10.1093/ecco-jcc/jjz180.

2. Raine T, Bonovas S, Burisch J et al. ECCO Guidelines on Therapeutics in Ulcerative Colitis: Medical Treatment. J Crohns Colitis 2022; 16 (1): 2–17. doi: 10.1093/ecco-jcc/jjab178.

3. Turpin W, Goethel A, Bedrani L et al. Determinants of IBD Heritability: Genes, Bugs, and More. Inflamm Bowel Dis 2018; 24 (6): 1133–1148. doi: 10.1093/ibd/izy085.

4. Torres J, Mehandru S, Colombel JF et al. Crohn‘s disease. Lancet 2017; 389 (10080): 1741–1755. doi: 10.1016/S0140-6736 (16) 31711-1.

5. Ungaro R, Mehandru S, Allen PB et al. Ulcerative colitis. Lancet 2017; 389 (10080): 1756–1770. doi: 10.1016/S0140-6736 (16) 32126-2.

6. Molodecky NA, Soon IS, Rabi DM et al. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology 2012; 142 (1): 46–54.e42; quiz e30. doi: 10.1053/ j.gastro.2011.10.001.

7. Colombel JF, Panaccione R, Bossuyt P et al. Effect of tight control management on Crohn‘s disease (CALM): a multicentre, randomised, controlled phase 3 trial. Lancet 2017; 390 (10114): 2779–2789. doi: 10.1016/S0140-6736 (17) 32641-7.

8. Verstockt B, Ferrante M, Vermeire S et al. New treatment options for inflammatory bowel diseases. J Gastroenterol 2018; 53 (55): 585–590. doi: 10.1007/s00535-018-1449-z.

9. Fiorino G, Morin M, Bonovas S et al. Prevalence of Bowel Damage Assessed by Cross-Sectional Imaging in Early Crohn‘s Disease and its Impact on Disease Outcome. J Crohns Colitis 2017; 11 (3): 274–280. doi: 10.1093/ecco-jcc/jjw185.

10. Danese S, Fiorino G, Peyrin-Biroulet L. Early intervention in Crohn‘s disease: towards disease modification trials. Gut 2017; 66 (12): 2179–2187. doi: 10.1136/gutjnl-2017-314519.

11. Thia KT, Sandborn WJ, Harmsen WS et al. Risk factors associated with progression to intestinal complications of Crohn‘s disease in a population-based cohort. Gastroenterology 2010; 139 (4): 1147–1155. doi: 10.1053/j.gastro.2010.06.070.

12. Peyrin-Biroulet L. Disease-modifying anti-inflammatory bowel disease drugs (DMAIDs): the missing term in the literature. Am J Gastroenterol 2013; 108 (5): 859–860. doi: 10.1038/ajg.2013.53.

13. Peyrin-Biroulet L, Billioud V, D‘Haens G et al. Development of the Paris definition of early Crohn‘s disease for disease-modification trials: results of an international expert opinion process. Am J Gastroenterol 2012; 107 (12): 1770–1776. doi: 10.1038/ajg.2012.117.

14. Bamias G, Cominelli F. Exploring the Early Phase of Crohn‘s Disease. Clin Gastroenterol Hepatol 2021; 19 (12): 2469–2480. doi: 10.1016/ j.cgh.2020.09.023.

15. Spencer DM, Veldman GM, Banerjee S et al. Distinct inflammatory mechanisms mediate early versus late colitis in mice. Gastroenterology 2002; 122 (1): 94–105. doi: 10.1053/gast.2002. 30308.

16. Zorzi F, Monteleone I, Sarra M et al. Distinct profiles of effector cytokines mark the different phases of Crohn‘s disease. PLoS One 2013; 8 (1): e54562. doi: 10.1371/journal.pone.0054562.

17. Kugathasan S, Saubermann LJ, Smith L et al. Mucosal T-cell immunoregulation varies in early and late inflammatory bowel disease. Gut 2007; 56 (12): 1696–1705. doi: 10.1136/gut.2006. 116467.

18. Becker E, Dedden M, Gall C et al. Residual homing of alpha4beta7-expressing beta1 (+) PI16 (+) regulatory T cells with potent suppressive activity correlates with exposure-efficacy of vedolizumab. Gut 2022; 71 (8): 1551–1566. doi: 10.1136/gutjnl-2021-324868.

19. Sandborn WJ, Feagan BG, Rutgeerts P et al. Vedolizumab as induction and maintenance therapy for Crohn‘s disease. N Engl J Med 2013; 369 (8): 711–721. doi: 10.1056/NEJMoa1215739.

20. Sands BE, Feagan BG, Rutgeerts P et al. Effects of vedolizumab induction therapy for patients with Crohn‘s disease in whom tumor necrosis factor antagonist treatment failed. Gastroenterology 2014; 147 (3): 618–627.e3. doi: 10.1053/j.gastro.2014.05.008. Epub 2014 May 21.

21. Berg DR, Colombel JF, Ungaro R. The Role of Early Biologic Therapy in Inflammatory Bowel Disease. Inflamm Bowel Dis 2019; 25 (12): 1896–1905. doi: 10.1093/ibd/izz059.

22. Romberg-Camps MJ, Dagnelie PC, Kester AD et al. Influence of phenotype at dia­gnosis and of other potential prognostic factors on the course of inflammatory bowel disease. Am J Gastroenterol 2009; 104 (2): 371–383. doi: 10.1038/ajg.2008.38.

23. Zallot C, Peyrin-Biroulet L. Clinical risk factors for complicated disease: how reliable are they? Dig Dis 2012; 30 (Suppl 3): 67–72. doi: 10.1159/000342608.

24. Con D, Parthasarathy N, Bishara M et al. Development of a Simple, Serum Biomarker-based Model Predictive of the Need for Early Biologic Therapy in Crohn‘s Disease. J Crohns Colitis 2021; 15 (4): 583–593. doi: 10.1093/ecco-jcc/jjaa194.

25. Olbjorn C, Cvancarova Smastuen M, Thiis-Evensen E et al. Serological markers in dia­gnosis of pediatric inflammatory bowel disease and as predictors for early tumor necrosis factor blocker therapy. Scand J Gastroenterol 2017; 52 (4): 414–419. doi: 10.1080/00365521.2016.1259653.

26. Dubinsky MC, Kugathasan S, Mei L et al. Increased immune reactivity predicts aggressive complicating Crohn‘s disease in children. Clin Gastroenterol Hepatol 2008; 6 (10): 1105–1111. doi: 10.1016/j.cgh.2008.04.032.

27. Maaser C, Sturm A, Vavricka SR et al. ECCO-ESGAR Guideline for Dia­gnostic Assessment in IBD Part 1: Initial dia­gnosis, monitoring of known IBD, detection of complications. J Crohns Colitis 2019; 13 (2): 144–164. doi: 10.1093/ecco-jcc/jjy113.

28. Sturm A, Maaser C, Calabrese E et al. ECCO-ESGAR Guideline for Dia­gnostic Assessment in IBD Part 2: IBD scores and general principles and technical aspects. J Crohns Colitis 2019; 13 (3): 273–284. doi: 10.1093/ecco-jcc/jjy114.

29. Pariente B, Mary JY, Danese S et al. Development of the Lemann index to assess digestive tract damage in patients with Crohn‘s disease. Gastroenterology 2015; 148 (1): 52–63.e3. doi: 10.1053/j.gastro.2014.09.015.

30. Pariente B, Torres J, Burisch J et al. Validation and Update of the Lemann Index to Measure Cumulative Structural Bowel Damage in Crohn‘s Disease. Gastroenterology 2021; 161 (3): 853–864.e13. doi: 10.1053/j.gastro.2021.05.049.

31. Zhu M, Feng Q, Xu X et al. Efficacy of early intervention on the bowel damage and intestinal surgery of Crohn‘s disease, based on the Lemann index. BMC Gastroenterol 2020; 20 (1): 421. doi: 10.1186/s12876-020-01575-7.

32. Lichtenstein GR, Loftus EV, Isaacs KL et al. ACG Clinical Guideline: Management of Crohn‘s Disease in Adults. Am J Gastroenterol 2018; 113 (4): 481–517. doi: 10.1038/ajg.2018.27.

33. Mao EJ, Hazlewood GS, Kaplan GG et al. Systematic review with meta-analysis: comparative efficacy of immunosuppressants and bio­logics for reducing hospitalisation and surgery in Crohn‘s disease and ulcerative colitis. Aliment Pharmacol Ther 2017; 45 (1): 3–13. doi: 10.1111/apt.13847.

34. D‘Haens G, Baert F, van Assche G et al. Early combined immunosuppression or conventional management in patients with newly dia­g­­- nosed Crohn‘s disease: an open randomised trial. Lancet 2008; 371 (9613): 660–667. doi: 10.1016/S0140-6736 (08) 60304-9.

35. Colombel JF, Sandborn WJ, Reinisch W et al. Infliximab, azathioprine, or combination therapy for Crohn‘s disease. N Engl J Med 2010; 362 (15): 1383–1395. doi: 10.1056/NEJMoa0904492.

36. Colombel JF, Reinisch W, Mantzaris GJ et al. Randomised clinical trial: deep remission in bio­logic and immunomodulator naive patients with Crohn‘s disease – a SONIC post hoc analysis. Aliment Pharmacol Ther 2015; 41 (8): 734–746. doi: 10.1111/apt.13139.

37. Colombel JF, Sandborn WJ, Rutgeerts P et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn‘s disease: the CHARM trial. Gastroenterology 2007; 132 (1): 52–65. doi: 10.1053/j.gastro.2006.11.041.

38. Kamm MA, Hanauer SB, Panaccione R et al. Adalimumab sustains steroid-free remission after 3 years of therapy for Crohn‘s disease. Aliment Pharmacol Ther 2011; 34 (3): 306–317. doi: 10.1111/j.1365-2036.2011.04717.x.

39. Schreiber S, Reinisch W, Colombel JF et al. Subgroup analysis of the placebo-controlled CHARM trial: increased remission rates through 3 years for adalimumab-treated patients with early Crohn‘s disease. J Crohns Colitis 2013; 7 (3): 213–221. doi: 10.1016/j.crohns.2012.05.015.

40. Colombel JF, Rutgeerts PJ, Sandborn WJ et al. Adalimumab induces deep remission in patients with Crohn‘s disease. Clin Gastroenterol Hepatol 2014; 12 (3): 414–422.e5. doi: 10.1016/ j.cgh.2013.06.019.

41. Schreiber S, Khaliq-Kareemi M, Lawrance IC et al. Maintenance therapy with certolizumab pegol for Crohn‘s disease. N Engl J Med 2007; 357 (3): 239–250. doi: 10.1056/NEJMoa062897.

42. Schreiber S, Colombel JF, Bloomfield R et al. Increased response and remission rates in short-duration Crohn‘s disease with subcutaneous certolizumab pegol: an analysis of PRECiSE 2 randomized maintenance trial data. Am J Gastroenterol 2010; 105 (7): 1574–1582. doi: 10.1038/ajg.2010.78.

43. Chudy-Onwugaje KO, Christian KE, Farraye FA et al. A State-of-the-Art Review of New and Emerging Therapies for the Treatment of IBD. Inflamm Bowel Dis 2019; 25 (5): 820–830. doi: 10.1093/ibd/izy327.

44. Lichtenstein GR, Feagan BG, Cohen RD et al. Serious infection and mortality in patients with Crohn‘s disease: more than 5 years of follow-up in the TREAT registry. Am J Gastroenterol 2012; 107 (9): 1409–1422. doi: 10.1038/ajg.2012.218.

45. Yanai H, Hanauer SB. Assessing response and loss of response to bio­logical therapies in IBD. Am J Gastroenterol 2011; 106 (4): 685–698. doi: 10.1038/ajg.2011.103.

46. Bohm M, Xu R, Zhang Y et al. Comparative safety and effectiveness of vedolizumab to tumour necrosis factor antagonist therapy for Crohn‘s disease. Aliment Pharmacol Ther 2020; 52 (4): 669–681. doi: 10.1111/apt.15921.

47. Fiorino G, Correale C, Fries W et al. Leukocyte traffic control: a novel therapeutic strategy for inflammatory bowel disease. Expert Rev Clin Immunol 2010; 6 (4): 567–572. doi: 10.1586/eci.10.40.

48. Van Assche G, Van Ranst M, Sciot R et al. Progressive multifocal leukoencephalopathy after natalizumab therapy for Crohn‘s disease. N Engl J Med 2005; 353 (4): 362–368. doi: 10.1056/ NEJMoa051586.

49. Dulai PS, Peyrin-Biroulet L, Demuth D et al. Early Intervention With Vedolizumab on Longer Term Surgery Rates in Crohn‘s Disease: Post Hoc Analysis of the GEMINI Phase 3 and Long-term Safety Programs. J Crohns Colitis 2020; 15 (2): 195–202. doi: 10.1093/ecco-jcc/jjaa153.

50. Faleck DM, Winters A, Chablaney S et al. Shorter Disease Duration Is Associated With Higher Rates of Response to Vedolizumab in Patients With Crohn‘s Disease But Not Ulcerative Colitis. Clin Gastroenterol Hepatol 2019; 17 (12): 2497–2505.e1. doi: 10.1016/j.cgh.2018.12.040.

51. Feagan BG, Sandborn WJ, Gasink C et al. Ustekinumab as Induction and Maintenance Therapy for Crohn‘s Disease. N Engl J Med 2016; 375 (20): 1946–1960. doi: 10.1056/NEJMoa1602 773.

52. Meima-van Praag EM, Buskens CJ, Hompes R et al. Surgical management of Crohn‘s disease: a state of the art review. Int J Colorectal Dis 2021; 36 (6): 1133–1145. doi: 10.1007/ s00384-021-03857-2.

53. Adamina M, Bonovas S, Raine T et al. ECCO Guidelines on Therapeutics in Crohn‘s Disease: Surgical Treatment. J Crohns Colitis 2020; 14 (2): 155–168. doi: 10.1093/ecco-jcc/jjz187.

54. Ponsioen CY, de Groof EJ, Eshuis EJ et al. Laparoscopic ileocaecal resection versus infliximab for terminal ileitis in Crohn‘s disease: a randomised controlled, open-label, multicentre trial. Lancet Gastroenterol Hepatol 2017; 2 (11): 785–792. doi: 10.1016/S2468-1253 (17) 30248-0.

55. de Groof EJ, Stevens TW, Eshuis EJ et al. Cost-effectiveness of laparoscopic ileocaecal resection versus infliximab treatment of terminal ileitis in Crohn‘s disease: the LIR!C Trial. Gut 2019; 68 (10) n: 1774–1780. doi: 10.1136/gutjnl-2018-317539.

56. Stevens TW, Haasnoot ML, D‘Haens GR et al. Laparoscopic ileocaecal resection versus infliximab for terminal ileitis in Crohn‘s disease: retrospective long-term follow-up of the LIR!C trial. Lancet Gastroenterol Hepatol 2020; 5 (10): 900–n907. doi: 10.1016/S2468-1253 (20) 30117-5.

57. Aratari A, Papi C, Leandro G et al. Early versus late surgery for ileo-caecal Crohn‘s disease. Aliment Pharmacol Ther 2007; 26 (10): 1303–1312. doi: 10.1111/j.1365-2036.2007.03515.x.

58. Golovics PA, Lakatos L, Nagy A et al. Is early limited surgery associated with a more benign disease course in Crohn‘s disease? World J Gastroenterol 2013; 19 (43): 7701–7710. doi: 10.3748/wjg.v19.i43.7701.

59. Šerclová Z, Ryska O, Bortlík M et al. Doporučené postupy chirurgické léčby pacientů s idiopatickými střevními záněty – 2. část: Crohno­va nemoc. Gastroent Hepatol 2015; 69 (3): 223–238. doi: 10.14735/amgh2015223.

Labels
Paediatric gastroenterology Gastroenterology and hepatology Surgery

Article was published in

Gastroenterology and Hepatology

Issue 4

2022 Issue 4

Most read in this issue
Topics Journals
Login
Forgotten password

Enter the email address that you registered with. We will send you instructions on how to set a new password.

Login

Don‘t have an account?  Create new account

#ADS_BOTTOM_SCRIPTS#