Intest Res.  2018 Oct;16(4):522-528. 10.5217/ir.2018.00073.

Consensus recommendations for patient-centered therapy in mild-to-moderate ulcerative colitis: the i Support Therapy–Access to Rapid Treatment (iSTART) approach

• Danese S
• Banerjee R
• Cummings J
• Dotan I
• Kotze PG
• Leong RW
• Paridaens
• Peyrin-Biroulet L
• Scott G
• Assche GV
• Wehkamp J
• Yamamoto-Furusho JK

• KMID: 2434153
• DOI: http://doi.org/10.5217/ir.2018.00073

Abstract

Symptomatic ulcerative colitis (UC) can be a chronic, disabling condition. Flares in disease activity are associated with many of the negative impacts of mild-to-moderate UC. Rapid resolution of flares can provide benefits to patients and healthcare systems. i Support Therapy-Access to Rapid Treatment (iSTART) introduces patient-centered care for mild-to-moderate UC. iSTART provides patients with the ability to self-assess symptomology and self-start a short course of second-line treatment when necessary. An international panel of experts produced consensus statements and recommendations. These were informed by evidence from systematic reviews on the epidemiology, mesalazine (5-ASA) treatment, and patient use criteria for second-line therapy in UC. Optimized 5-ASA is the first-line treatment in all clinical guidelines, but may not be sufficient to induce remission in all patients. Corticosteroids should be prescribed as second-line therapy when needed, with budesonide MMX® being a preferred steroid option. Active involvement of suitable patients in management of UC flares has the potential to improve therapy, with patients able to show good accuracy for flare self-assessment using validated tools. There is a place in the UC treatment pathway for an approach such as iSTART, which has the potential to provide patient, clinical and economic benefits.

Keyword

Colitis, ulcerative; Consensus guidelines; Mesalazine; Corticosteroids; Patient reported outcome measures

MeSH Terms

Adrenal Cortex Hormones
Budesonide
Colitis, Ulcerative*
Consensus*
Delivery of Health Care
Epidemiology
Humans
Mesalamine
Patient-Centered Care
Self-Assessment
Ulcer*
Adrenal Cortex Hormones
Budesonide
Mesalamine

Reference

1. 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; 142:46–54. e42.

2. M’Koma AE. Inflammatory bowel disease: an expanding global health problem. Clin Med Insights Gastroenterol. 2013; 6:33–47.

3. Prideaux L, Kamm MA, De Cruz PP, Chan FK, Ng SC. Inflammatory bowel disease in Asia: a systematic review. J Gastroenterol Hepatol. 2012; 27:1266–1280.

4. Lok KH, Hung HG, Ng CH, et al. Epidemiology and clinical characteristics of ulcerative colitis in Chinese population: experience from a single center in Hong Kong. J Gastroenterol Hepatol. 2008; 23:406–410.

5. Nuij VJ, Zelinkova Z, Rijk MC, et al. Phenotype of inflammatory bowel disease at diagnosis in the Netherlands: a population-based inception cohort study (the Delta Cohort). Inflamm Bowel Dis. 2013; 19:2215–2222.

6. Yazdanbod A, Farzaneh E, Pourfarzi F, et al. Epidemiologic profile and clinical characteristics of ulcerative colitis in northwest of Iran: a 10-year review. Trop Gastroenterol. 2010; 31:308–311.

7. Gheorghe C, Pascu O, Gheorghe L, et al. Epidemiology of inflammatory bowel disease in adults who refer to gastroenterology care in Romania: a multicenter study. Eur J Gastroenterol Hepatol. 2004; 16:1153–1159.

8. Ling KL, Ooi CJ, Luman W, Cheong WK, Choen FS, Ng HS. Clinical characteristics of ulcerative colitis in Singapore, a multiracial city-state. J Clin Gastroenterol. 2002; 35:144–148.

9. Niriella MA, De Silva AP, Dayaratne AH, et al. Prevalence of inflammatory bowel disease in two districts of Sri Lanka: a hospital based survey. BMC Gastroenterol. 2010; 10:32.

10. Bressler B, Marshall JK, Bernstein CN, et al. Clinical practice guidelines for the medical management of nonhospitalized ulcerative colitis: the Toronto consensus. Gastroenterology. 2015; 148:1035–1058. e3.

11. Harbord M, Eliakim R, Bettenworth D, et al. Third European evidence-based consensus on diagnosis and management of ulcerative colitis. Part 2: current management. J Crohns Colitis. 2017; 11:769–784.

12. Kornbluth A, Sachar DB; Practice Parameters Committee of the American College of Gastroenterology. Ulcerative colitis practice guidelines in adults: American College of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol. 2010; 105:501–523.

13. Magro F, Gionchetti P, Eliakim R, et al. Third European evidencebased consensus on diagnosis and management of ulcerative colitis. Part 1: definitions, diagnosis, extra-intestinal manifestations, pregnancy, cancer surveillance, surgery, and ileo-anal pouch disorders. J Crohns Colitis. 2017; 11:649–670.

14. Portela F, Magro F, Lago P, et al. Ulcerative colitis in a Southern European country: a national perspective. Inflamm Bowel Dis. 2010; 16:822–829.

15. Sjöberg D, Holmström T, Larsson M, et al. Incidence and natural history of ulcerative colitis in the Uppsala Region of Sweden 2005-2009: results from the IBD cohort of the Uppsala Region (ICURE). J Crohns Colitis. 2013; 7:e351–e357. doi: 10.1016/j.crohns.2013.02.006.

16. Huppertz-Hauss G, Lie Høivik M, Jelsness-Jørgensen LP, et al. Healthrelated quality of life in patients with inflammatory bowel disease 20 years after diagnosis: results from the IBSEN study. Inflamm Bowel Dis. 2016; 22:1679–1687.

17. Theede K, Kiszka-Kanowitz M, Nordgaard-Lassen I, Mertz Nielsen A. The impact of endoscopic inflammation and mucosal healing on health-related quality of life in ulcerative colitis patients. J Crohns Colitis. 2015; 9:625–632.

18. Alcalá MJ, Casellas F, Fontanet G, Prieto L, Malagelada JR. Shortened questionnaire on quality of life for inflammatory bowel disease. Inflamm Bowel Dis. 2004; 10:383–391.

19. Romberg-Camps MJ, Bol Y, Dagnelie PC, et al. Fatigue and healthrelated quality of life in inflammatory bowel disease: results from a population-based study in the Netherlands: the IBD-South Limburg cohort. Inflamm Bowel Dis. 2010; 16:2137–2147.

20. Bodger K, Yen L, Szende A, et al. Medical resource utilization and associated costs in patients with ulcerative colitis in the UK: a chart review analysis. Eur J Gastroenterol Hepatol. 2014; 26:213–221.

21. de Boer AG, Sprangers MA, Bartelsman JF, de Haes HC. Predictors of health care utilization in patients with inflammatory bowel disease: a longitudinal study. Eur J Gastroenterol Hepatol. 1998; 10:783–789.

22. Sulz MC, Siebert U, Arvandi M, et al. Predictors for hospitalization and outpatient visits in patients with inflammatory bowel disease: results from the Swiss Inflammatory Bowel Disease Cohort Study. Eur J Gastroenterol Hepatol. 2013; 25:790–797.

23. Siebert U, Wurm J, Gothe RM, et al. Predictors of temporary and permanent work disability in patients with inflammatory bowel disease: results of the swiss inflammatory bowel disease cohort study. Inflamm Bowel Dis. 2013; 19:847–855.

24. Ramos A, Calvet X, Sicilia B, et al. IBD-related work disability in the community: prevalence, severity and predictive factors. A crosssectional study. United European Gastroenterol J. 2015; 3:335–342.

25. Wang Y, Parker CE, Bhanji T, Feagan BG, MacDonald JK. Oral 5-aminosalicylic acid for induction of remission in ulcerative colitis. Cochrane Database Syst Rev. 2016; 4:CD000543. doi: 10.1002/14651858.CD000543.pub4.

26. Lichtenstein GR. Budesonide multi-matrix for the treatment of patients with ulcerative colitis. Dig Dis Sci. 2016; 61:358–370.

27. Abdalla MI, Herfarth H. Budesonide for the treatment of ulcerative colitis. Expert Opin Pharmacother. 2016; 17:1549–1559.

28. Sherlock ME, MacDonald JK, Griffiths AM, Steinhart AH, Seow CH. Oral budesonide for induction of remission in ulcerative colitis. Cochrane Database Syst Rev. 2015; (10):CD007698. doi: 10.1002/14651858.CD007698.pub3.

29. Sandborn WJ, Danese S, D’Haens G, et al. Induction of clinical and colonoscopic remission of mild-to-moderate ulcerative colitis with budesonide MMX 9 mg: pooled analysis of two phase 3 studies. Aliment Pharmacol Ther. 2015; 41:409–418.

30. Jairath V, Khanna R, Zou GY, et al. Development of interim patientreported outcome measures for the assessment of ulcerative colitis disease activity in clinical trials. Aliment Pharmacol Ther. 2015; 42:1200–1210.

31. Bewtra M, Brensinger CM, Tomov VT, et al. An optimized patientreported ulcerative colitis disease activity measure derived from the Mayo score and the simple clinical colitis activity index. Inflamm Bowel Dis. 2014; 20:1070–1078.

32. Van Deen WK, van der Meulen-de Jong AE, Parekh NK, et al. Development and validation of an inflammatory bowel diseases monitoring index for use with mobile health technologies. Clin Gastroenterol Hepatol. 2016; 14:1742–1750. e7.

33. Elkjaer M. E-health: web-guided therapy and disease self-management in ulcerative colitis. Impact on disease outcome, quality of life and compliance. Dan Med J. 2012; 59:B4478.

34. Elkjaer M, Burisch J, Avnstrøm S, Lynge E, Munkholm P. Development of a web-based concept for patients with ulcerative colitis and 5-aminosalicylic acid treatment. Eur J Gastroenterol Hepatol. 2010; 22:695–704.

35. Elkjaer M, Shuhaibar M, Burisch J, et al. E-health empowers patients with ulcerative colitis: a randomised controlled trial of the web-guided ‘Constant-care’ approach. Gut. 2010; 59:1652–1661.

36. Cross RK, Cheevers N, Finkelstein J. Home telemanagement for patients with ulcerative colitis (UC HAT). Dig Dis Sci. 2009; 54:2463–2472.

37. Cross RK, Cheevers N, Rustgi A, Langenberg P, Finkelstein J. Randomized, controlled trial of home telemanagement in patients with ulcerative colitis (UC HAT). Inflamm Bowel Dis. 2012; 18:1018–1025.

38. Robinson A, Thompson DG, Wilkin D, Roberts C; Northwest Gastrointestinal Research Group. Guided self-management and patient-directed follow-up of ulcerative colitis: a randomised trial. Lancet. 2001; 358:976–981.