Budesonide Multi-matrix for the Treatment of Patients with Ulcerative Colitis

Digestive Diseases and Sciences

Volumn 61, Issue 2, 2016, Pages 358-370

  Lichtenstein, Gary R ^a  

^a UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

Budesonide MMX; Induction therapy; Remission; Ulcerative colitis

Indexed keywords

BUDESONIDE; CORTICOSTEROID; HYDROCORTISONE; MESALAZINE; PLACEBO; PREDNISOLONE; ANTIINFLAMMATORY AGENT; DELAYED RELEASE FORMULATION; DRUG DOSAGE FORM;

ABDOMINAL PAIN; AREA UNDER THE CURVE; BACKACHE; DIARRHEA; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG EFFICACY; DRUG EXCRETION; DRUG SAFETY; FEVER; FLATULENCE; HEADACHE; HIRSUTISM; HUMAN; HYDROCORTISONE BLOOD LEVEL; HYPOTHALAMUS HYPOPHYSIS ADRENAL SYSTEM; INSOMNIA; MAXIMUM PLASMA CONCENTRATION; MOOD CHANGE; NAUSEA; PLASMA CONCENTRATION-TIME CURVE; PRIORITY JOURNAL; RELAPSE; REMISSION; REVIEW; RHINOPHARYNGITIS; SIDE EFFECT; STRIA; TIME TO MAXIMUM PLASMA CONCENTRATION; ULCERATIVE COLITIS; COLITIS, ULCERATIVE; DELAYED RELEASE FORMULATION; DRUG DOSAGE FORM;

ANTI-INFLAMMATORY AGENTS; BUDESONIDE; COLITIS, ULCERATIVE; DELAYED-ACTION PREPARATIONS; DOSAGE FORMS; HUMANS;

EID: 84946426642     PISSN: 01632116     EISSN: 15732568     Source Type: Journal    
DOI: 10.1007/s10620-015-3897-0     Document Type: Review

References (59)

1. Ordás I, Eckmann L, Talamini M, Baumgart DC, Sandborn WJ. Ulcerative colitis. Lancet. 2012;380:1606–1619.
2. 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.
3. Walsh A, Palmer R, Travis S. Mucosal healing as a target of therapy for colonic inflammatory bowel disease and methods to score disease activity. Gastrointest Endosc Clin N Am. 2014;24:367–378.
4. Pagnini C, Menasci F, Festa S, Rizzatti G, Delle FG. “Mucosal healing” in ulcerative colitis: between clinical evidence and market suggestion. World J Gastrointest Pathophysiol. 2014;5:54–62.
5. Kalafateli M, Triantos C, Theocharis G, et al. Health-related quality of life in patients with inflammatory bowel disease: a single-center experience. Ann Gastroenterol. 2013;26:243–248.
6. Loftus EV Jr. A practical perspective on ulcerative colitis: patients’ needs from aminosalicylate therapies. Inflamm Bowel Dis. 2006;12:1107–1113.
7. Nurmi E, Haapamäki J, Paavilainen E, Rantanen A, Hillilä M, Arkkila P. The burden of inflammatory bowel disease on health care utilization and quality of life. Scand J Gastroenterol. 2013;48:51–57.
8. Kornbluth A, Sachar DB, The 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.
9. Dignass A, Lindsay JO, Sturm A, et al. Second European evidence-based consensus on the diagnosis and management of ulcerative colitis part 2: current management. J Crohns Colitis. 2012;6:991–1030.
10. Danese S, Siegel CA, Peyrin-Biroulet L. Review article: integrating budesonide-MMX into treatment algorithms for mild-to-moderate ulcerative colitis. Aliment Pharmacol Ther. 2014;39:1095–1103.
11. Lewis JD, Gelfand JM, Troxel AB, et al. Immunosuppressant medications and mortality in inflammatory bowel disease. Am J Gastroenterol. 2008;103:1428–1435.
12. Lichtenstein GR, Feagan BG, Cohen RD, et al. Serious infections and mortality in association with therapies for Crohn’s disease: TREAT registry. Clin Gastroenterol Hepatol. 2006;4:621–630.
13. Esmailpour N, Högger P, Rohdewald P. Binding kinetics of budesonide to the human glucocorticoid receptor. Eur J Pharm Sci. 1998;6:219–223.
14. Brattsand R. Overview of newer glucocorticosteroid preparations for inflammatory bowel disease. Can J Gastroenterol. 1990;4:407–414.
15. ® extended-release tablets induce remission in patients with mild to moderate ulcerative colitis: results from the CORE I study. Gastroenterology. 2012;143:1218–1226.
16. Travis SP, Danese S, Kupcinskas L, et al. Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: results from the randomised CORE II study. Gut. 2014;63:433–441.
17. ® 6 mg QD for the maintenance of remission in patients with ulcerative colitis: results from a phase III, 12 month safety and extended use study [Abstract Su2080]. Gastroenterology. 2012;142:S-564.
18. Greenberg GR, Feagan BG, Martin F, The Canadian Inflammatory Bowel Disease Study Group, et al. Oral budesonide as maintenance treatment for Crohn’s disease: a placebo-controlled, dose-ranging study. Gastroenterology. 1996;110:45–51.
19. Ferguson A, Campieri M, Doe W, Persson T, Nygard G, The Global Budesonide Study Group. Oral budesonide as maintenance therapy in Crohn’s disease—results of a 12-month study. Aliment Pharmacol Ther. 1998;12:175–183.
20. Gross V, Andus T, Ecker KW, The Budesonide Study Group, et al. Low dose oral pH modified release budesonide for maintenance of steroid induced remission in Crohn’s disease. Gut. 1998;42:493–496.
21. Ewe K, Bottger T, Buhr HJ, Ecker KW, Otto HF, The German Budesonide Study Group. Low-dose budesonide treatment for prevention of postoperative recurrence of Crohn’s disease: a multicentre randomized placebo-controlled trial. Eur J Gastroenterol Hepatol. 1999;11:277–282.
22. Hellers G, Cortot A, Jewell D, The IOIBD Budesonide Study Group, et al. Oral budesonide for prevention of postsurgical recurrence in Crohn’s disease. Gastroenterology. 1999;116:294–300.
23. Hanauer S, Sandborn WJ, Persson A, Persson T. Budesonide as maintenance treatment in Crohn’s disease: a placebo-controlled trial. Aliment Pharmacol Ther. 2005;21:363–371.
24. Mantzaris GJ, Petraki K, Sfakianakis M, et al. Budesonide versus mesalamine for maintaining remission in patients refusing other immunomodulators for steroid-dependent Crohn’s disease. Clin Gastroenterol Hepatol. 2003;1:122–128.
25. Schoon EJ, Bollani S, Mills PR, et al. Bone mineral density in relation to efficacy and side effects of budesonide and prednisolone in Crohn’s disease. Clin Gastroenterol Hepatol. 2005;3:113–121.
26. de Jong DJ, Bac DJ, Tan G, et al. Maintenance treatment with budesonide 6 mg versus 9 mg once daily in patients with Crohn’s disease in remission. Neth J Med. 2007;65:339–345.
27. Cortot A, Colombel JF, Rutgeerts P, et al. Switch from systemic steroids to budesonide in steroid dependent patients with inactive Crohn’s disease. Gut. 2001;48:186–190.
28. Lichtenstein GR, Bengtsson B, Hapten-White L, Rutgeerts P. Oral budesonide for maintenance of remission of Crohn’s disease: a pooled safety analysis. Aliment Pharmacol Ther. 2009;29:643–653.
29. Ryrfeldt Å, Andersson P, Edsbäcker S, Tönnesson M, Davies D, Pauwels R. Pharmacokinetics and metabolism of budesonide, a selective glucocorticoid. Eur J Respir Dis Suppl. 1982;122:86–95.
30. Jönsson G, Åström A, Andersson P. Budesonide is metabolized by cytochrome P450 3A (CYP3A) enzymes in human liver. Drug Metab Dispos. 1995;23:137–142.
31. Prantera C, Viscido A, Biancone L, Francavilla A, Giglio L, Campieri M. A new oral delivery system for 5-ASA: preliminary clinical findings for MMx. Inflamm Bowel Dis. 2005;11:421–427.
32. Fiorino G, Fries W, De La Rue SA, Malesci AC, Repici A, Danese S. New drug delivery systems in inflammatory bowel disease: MMX™ and tailored delivery to the gut. Curr Med Chem. 2010;17:1851–1857.
33. D’Haens G, Hommes D, Engels L, et al. Once daily MMX mesalazine for the treatment of mild-to-moderate ulcerative colitis: a phase II, dose-ranging study. Aliment Pharmacol Ther. 2006;24:1087–1097.
34. Lichtenstein GR, Kamm MA, Boddu P, et al. Effect of once- or twice-daily MMX mesalamine (SPD476) for the induction of remission of mild to moderately active ulcerative colitis. Clin Gastroenterol Hepatol. 2007;5:95–102.
35. Kamm MA, Sandborn WJ, Gassull M, et al. Once-daily, high-concentration MMX mesalamine in active ulcerative colitis. Gastroenterology. 2007;132:66–75.
36. Kamm MA, Lichtenstein GR, Sandborn WJ, et al. Randomised trial of once- or twice-daily MMX mesalazine for maintenance of remission in ulcerative colitis. Gut. 2008;57:893–902.
37. ® mesalamine for endoscopic maintenance of remission of ulcerative colitis. Am J Gastroenterol. 2012;107:1064–1077.
38. Brunner M, Ziegler S, Di Stefano AF, et al. Gastrointestinal transit, release and plasma pharmacokinetics of a new oral budesonide formulation. Br J Clin Pharmacol. 2006;61:31–38.
39. Edsbäcker S, Bengtsson B, Larsson P, et al. A pharmacoscintigraphic evaluation of oral budesonide given as controlled-release (Entocort) capsules. Aliment Pharmacol Ther. 2003;17:525–536.
40. Lundin P, Naber T, Nilsson M, Edsbäcker S. Effect of food on the pharmacokinetics of budesonide controlled ileal release capsules in patients with active Crohn’s disease. Aliment Pharmacol Ther. 2001;15:45–51.
41. Kolkman JJ, Mollmann HW, Mollmann AC, et al. Evaluation of oral budesonide in the treatment of active distal ulcerative colitis. Drugs Today (Barc). 2004;40:589–601.
42. Salix Pharmaceuticals, Inc. Uceris (budesonide) extended release tablets, for oral use [package insert]. Raleigh, NC: Salix Pharmaceuticals, Inc. 2014.
43. Nicholls A, Harris-Collazo R, Huang M, Hardiman Y, Jones R, Moro L. Bioavailability profile of Uceris MMX extended-release tablets compared with Entocort EC capsules in healthy volunteers. J Int Med Res. 2013;41:386–394.
44. Hempfling W, Grunhage F, Dilger K, Reichel C, Beuers U, Sauerbruch T. Pharmacokinetics and pharmacodynamic action of budesonide in early- and late-stage primary biliary cirrhosis. Hepatology. 2003;38:196–202.
45. Dilger K, Cascorbi I, Grunhage F, Hohenester S, Sauerbruch T, Beuers U. Multidrug resistance 1 genotype and disposition of budesonide in early primary biliary cirrhosis. Liver Int. 2006;26:285–290.
46. Farrell RJ, Kelleher D. Glucocorticoid resistance in inflammatory bowel disease. J Endocrinol. 2003;178:339–346.
47. 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.
48. Travis S, Ballard ED. Induction of remission with oral budesonide MMXVR (9 mg) tablets in patients with mild to moderate, active ulcerative colitis: a multicenter, open-label efficacy and safety study [Abstract]. Inflamm Bowel Dis. 2011;17:S20.
49. Rutgeerts P, Löfberg R, Malchow H, et al. A comparison of budesonide with prednisolone for active Crohn’s disease. N Engl J Med. 1994;331:842–845.
50. Kappelman MD, Rifas-Shiman SL, Porter CQ, et al. Direct health care costs of Crohn’s disease and ulcerative colitis in United States children and adults. Gastroenterology. 2008;135:1907–1913.
51. Gunnarsson C, Chen J, Rizzo JA, Ladapo JA, Lofland JH. Direct health care insurer and out-of-pocket expenditures of inflammatory bowel disease: evidence from a US national survey. Dig Dis Sci. 2012;57:3080–3091.
52. Bodger K. Cost effectiveness of treatments for inflammatory bowel disease. Pharmacoeconomics. 2011;29:387–401.
53. Feagins LA, Iqbal R, Spechler SJ. Case-control study of factors that trigger inflammatory bowel disease flares. World J Gastroenterol. 2014;20:4329–4334.
54. Kane SV, Cohen RD, Aikens JE, Hanauer SB. Prevalence of nonadherence with maintenance mesalamine in quiescent ulcerative colitis. Am J Gastroenterol. 2001;96:2929–2933.
55. Kane SV, Brixner D, Rubin DT, Sewitch MJ. The challenge of compliance and persistence: focus on ulcerative colitis. J Manag Care Pharm. 2008;14:s2–s12.
56. Kane SV. Systematic review: adherence issues in the treatment of ulcerative colitis. Aliment Pharmacol Ther. 2006;23:577–585.
57. Mitra D, Hodgkins P, Yen L, Davis KL, Cohen RD. Association between oral 5-ASA adherence and health care utilization and costs among patients with active ulcerative colitis. BMC Gastroenterol. 2012;12:132.
58. AstraZeneca LP. Entocort EC (budesonide) capsules [package insert]. Wilmington, DE: AstraZeneca LP. 2012.
59. Kane S, Huo D, Magnanti K. A pilot feasibility study of once daily versus conventional dosing mesalamine for maintenance of ulcerative colitis. Clin Gastroenterol Hepatol. 2003;1:170–173.