Budesonide for the treatment of ulcerative colitis

References

• Truelove SC, Witts LJ. Cortisone and corticotrophin in ulcerative colitis. Br Med J. 1959;1(5119):387–394.
   PubMedGoogle Scholar
• Lennard-Jones JE, Longmore AJ, Newell AC, et al. An assessment of prednisone, salazopyrin, and topical hydrocortisone hemisuccinate used as out-patient treatment for ulcerative colitis. Gut. 1960;1:217–222.
   PubMed Web of Science ®Google Scholar
• Truelove SC, Watkinson G, Draper G. Comparison of corticosteroid and sulphasalazine therapy in ulcerative colitis. Br Med J. 1962;2(5321):1708–1711.
   PubMed Web of Science ®Google Scholar
• Faubion WA Jr, Loftus EV Jr, Harmsen WS, et al. The natural history of corticosteroid therapy for inflammatory bowel disease: A population-based study. Gastroenterology. 2001;121(2):255–260.
   PubMed Web of Science ®Google Scholar
• Katz JA. Treatment of inflammatory bowel disease with corticosteroids. Gastroenterol Clin North Am. 2004;33(2):171–189. vii
   PubMed Web of Science ®Google Scholar
• 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(3):501–523. quiz 524
   PubMed Web of Science ®Google Scholar
• Ford AC, Bernstein CN, Khan KJ, et al. Glucocorticosteroid therapy in inflammatory bowel disease: systematic review and meta-analysis. Am J Gastroenterol. 2011;106(4):590–599. quiz 600
   PubMed Web of Science ®Google Scholar
• Brattsand R, Linden M. Cytokine modulation by glucocorticoids: mechanisms and actions in cellular studies. Aliment Pharmacol Ther. 1996;10(Suppl 2):81–90. discussion 91-2
   PubMed Web of Science ®Google Scholar
• Farrell RJ, Kelleher D. Glucocorticoid resistance in inflammatory bowel disease. J Endocrinol. 2003;178(3):339–346.
   PubMed Web of Science ®Google Scholar
• Lennard-Jones JE, Misiewicz JJ, Connell AM, et al. Prednisone as maintenance treatment for ulcerative colitis in remission. Lancet. 1965;1(7378):188–189.
   PubMed Web of Science ®Google Scholar
• Nunes T, Barreiro-de Acosta M, Marin-Jiménez I, et al. Oral locally active steroids in inflammatory bowel disease. J Crohns Colitis. 2013;7(3):183–191.
   PubMed Web of Science ®Google Scholar
• Lichtenstein GR, Hanauer SB, Sandborn WJ. Practice Parameters Committee of American College of Gastroenterology. Management of Crohn’s disease in adults. Am J Gastroenterol. 2009;104(2):465–483. quiz 464, 484
   PubMed Web of Science ®Google Scholar
• Rezaie A, Kuenzig ME, Benchimol EI, et al. Budesonide for induction of remission in Crohn’s disease. Cochrane Database Syst Rev. 2015;6:CD000296.
   PubMed Web of Science ®Google Scholar
• Ye Y, Pang Z, Chen W, et al. The epidemiology and risk factors of inflammatory bowel disease. Int J Clin Exp Med. 2015;8(12):22529–22542.
   PubMed Web of Science ®Google Scholar
• Grinspan A, Kornbluth A. Positioning therapy for ulcerative colitis. Curr Gastroenterol Rep. 2015;17(8):29-015-0454-0.
   PubMedGoogle Scholar
• U.S. Food and Drug Administration. Drug approval package: uceris (budesonide) 9 mg tablets. [Updated 2013; cited 2016 Apr 14]. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203634_uceris_toc.cfm.
   Google Scholar
• U.S. Food and Drug Administration. Uceris (budesonide) rectal foam. [Updated 2015; cited 2016 Apr 14]. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205613Orig1s000TOC.cfm.
   Google Scholar
• Ryrfeldt A, Edsbäcker S, Pauwels R. Kinetics of the epimeric glucocorticoid budesonide. Clin Pharmacol Ther. 1984;35(4):525–530.
   PubMed Web of Science ®Google Scholar
• Dahlberg E, Thalén A, Brattsand R, et al. Correlation between chemical structure, receptor binding, and biological activity of some novel, highly active, 16 alpha, 17 alpha-acetal-substituted glucocorticoids. Mol Pharmacol. 1984;25(1):70–78.
   PubMed Web of Science ®Google Scholar
• Hamedani R, Feldman RD, Feagan BG. Review article: drug development in inflammatory bowel disease: budesonide–a model of targeted therapy. Aliment Pharmacol Ther. 1997;11(Suppl 3):98–107. discussion 107-8
   PubMed Web of Science ®Google Scholar
• Kolkman JJ, Möllmann HW, Möllmann AC, et al. Evaluation of oral budesonide in the treatment of active distal ulcerative colitis. Drugs Today (Barc). 2004;40(7):589–601.
   PubMed Web of Science ®Google Scholar
• Nicholls A, Harris-Collazo R, Huang M, et al. Bioavailability profile of uceris MMX extended-release tablets compared with entocort EC capsules in healthy volunteers. J Int Med Res. 2013;41(2):386–394.
   PubMed Web of Science ®Google Scholar
• Edsbäcker S, Andersson T. Pharmacokinetics of budesonide (entocort EC) capsules for crohn’s disease. Clin Pharmacokinet. 2004;43(12):803–821.
   PubMed Web of Science ®Google Scholar
• Medicines & Healthcare products Regulatory Agency, UK. Public assessment report: Budenofalk 9mg gastro-resistant granules (budesonide) - PL 08637/0020; UK/H/2778/001/DC. [Updated 2011; cited 2016 3 Mar]. Available from: http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con111557.pdf.
   Google Scholar
• Nyman-Pantelidis M, Nilsson A, Wagner ZG, et al. Pharmacokinetics and retrograde colonic spread of budesonide enemas in patients with distal ulcerative colitis. Aliment Pharmacol Ther. 1994;8(6):617–622.
   PubMed Web of Science ®Google Scholar
• Danielsson A, Edsbäcker S, Löfberg R, et al. Pharmacokinetics of budesonide enema in patients with distal ulcerative colitis or proctitis. Aliment Pharmacol Ther. 1993;7(4):401–407.
   PubMed Web of Science ®Google Scholar
• Brunner M, Vogelsang H, Greinwald R, et al. Colonic spread and serum pharmacokinetics of budesonide foam in patients with mildly to moderately active ulcerative colitis. Aliment Pharmacol Ther. 2005;22(5):463–470.
   PubMed Web of Science ®Google Scholar
• Rubin DT, Sandborn WJ, Bosworth B, et al. Budesonide foam has a favorable safety profile for inducing remission in mild-to-moderate ulcerative proctitis or proctosigmoiditis. Dig Dis Sci. 2015;60(11):3408–3417.
   PubMed Web of Science ®Google Scholar
• 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(1):31–38.
   PubMed Web of Science ®Google Scholar
• Klein S, Stein J, Dressman J. Site-specific delivery of anti-inflammatory drugs in the gastrointestinal tract: an in-vitro release model. J Pharm Pharmacol. 2005;57(6):709–719.
   PubMed Web of Science ®Google Scholar
• Jönsson G, Aström A, Andersson P. Budesonide is metabolized by cytochrome P450 3A (CYP3A) enzymes in human liver. Drug Metab Dispos. 1995;23(1):137–142.
   PubMed Web of Science ®Google Scholar
• Dilger K, Schwab M, Fromm MF. Identification of budesonide and prednisone as substrates of the intestinal drug efflux pump P-glycoprotein. Inflamm Bowel Dis. 2004;10(5):578–583.
   PubMed Web of Science ®Google Scholar
• Ryrfeldt A, Andersson P, Edsbäcker S, et al. Pharmacokinetics and metabolism of budesonide, a selective glucocorticoid. Eur J Respir Dis Suppl. 1982;122:86–95.
   PubMedGoogle Scholar
• Silverman J, Otley A. Budesonide in the treatment of inflammatory bowel disease. Expert Rev Clin Immunol. 2011;7(4):419–428.
   PubMed Web of Science ®Google Scholar
• Seidegård J. Reduction of the inhibitory effect of ketoconazole on budesonide pharmacokinetics by separation of their time of administration. Clin Pharmacol Ther. 2000;68(1):13–17.
   PubMed Web of Science ®Google Scholar
• Seidegård J, Randvall G, Nyberg L, et al. Grapefruit juice interaction with oral budesonide: equal effect on immediate-release and delayed-release formulations. Pharmazie. 2009;64(7):461–465.
   PubMed Web of Science ®Google Scholar
• Sherlock ME, Seow CH, Steinhart AH, et al. Oral budesonide for induction of remission in ulcerative colitis. Cochrane Database Syst Rev. 2010;10:CD007698.
   PubMed Web of Science ®Google Scholar
• Löfberg R, Danielsson A, Suhr O, et al. Oral budesonide versus prednisolone in patients with active extensive and left-sided ulcerative colitis. Gastroenterology. 1996;110(6):1713–1718.
   PubMed Web of Science ®Google Scholar
• Gross V, Bunganic I, Belousova EA, et al. 3g mesalazine granules are superior to 9mg budesonide for achieving remission in active ulcerative colitis: a double-blind, double-dummy, randomised trial. J Crohns Colitis. 2011;5(2):129–138.
   PubMed Web of Science ®Google Scholar
• D’Haens GR, Kovács A, Vergauwe P, et al. Clinical trial: preliminary efficacy and safety study of a new budesonide-MMX(R) 9 mg extended-release tablets in patients with active left-sided ulcerative colitis. J Crohns Colitis. 2010;4(2):153–160.
   PubMed Web of Science ®Google Scholar
• Sandborn WJ, Travis S, Moro L, et al. Once-daily budesonide MMX(R) extended-release tablets induce remission in patients with mild to moderate ulcerative colitis: Results from the CORE I study. Gastroenterology. 2012;143(5):1218–1226.e1–2.
   Web of Science ®Google Scholar
• 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(3):433–441.
   PubMed Web of Science ®Google Scholar
• Rubin D, Russell C, William S, et al. O-001 budesonide MMX(R) 9 mg for inducing remission in patients with mild-to-moderate ulcerative colitis not adequately controlled with oral 5-ASAs. Inflamm Bowel Dis. 2014;20(Supplement1):S1.
   PubMedGoogle Scholar
• Sandborn WJ, Danese S, Ballard ED, et al. Su2080 efficacy of budesonide MMx(r) 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. Gastroenterology. 2012;142(5,Supplement 1):S–564.
   Web of Science ®Google Scholar
• 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(5):409–418.
   PubMed Web of Science ®Google Scholar
• Sherlock ME, MacDonald JK, Griffiths AM, et al. Oral budesonide for induction of remission in ulcerative colitis. Cochrane Database Syst Rev. 2015;(10). Art. No.: CD007698. DOI:10.1002/14651858.CD007698.pub3
   PubMed Web of Science ®Google Scholar
• Keller R, Stoll R, Foerster EC, et al. Oral budesonide therapy for steroid-dependent ulcerative colitis: A pilot trial. Aliment Pharmacol Ther. 1997;11(6):1047–1052.
   PubMed Web of Science ®Google Scholar
• Danielsson A, Löfberg R, Persson T, et al. A steroid enema, budesonide, lacking systemic effects for the treatment of distal ulcerative colitis or proctitis. Scand J Gastroenterol. 1992;27(1):9–12.
   PubMed Web of Science ®Google Scholar
• Hanauer SB, Robinson M, Pruitt R, et al. Budesonide enema for the treatment of active, distal ulcerative colitis and proctitis: A dose-ranging study. U.S. budesonide enema study group. Gastroenterology. 1998;115(3):525–532.
   PubMed Web of Science ®Google Scholar
• Sandborn WJ, Bosworth B, Zakko S, et al. Budesonide foam induces remission in patients with mild to moderate ulcerative proctitis and ulcerative proctosigmoiditis. Gastroenterology. 2015;148(4):740–750.e2.
   PubMed Web of Science ®Google Scholar
• Naganuma M, Aoyama N, Suzuki Y, et al. Twice-daily budesonide 2-mg foam induces complete mucosal healing in patients with distal ulcerative colitis. J Crohns Colitis. 2015 Nov 16. pii: jjv208. [Epub ahead of print]
   PubMed Web of Science ®Google Scholar
• Lindgren S, Löfberg R, Bergholm L, et al. Effect of budesonide enema on remission and relapse rate in distal ulcerative colitis and proctitis. Scand J Gastroenterol. 2002;37(6):705–710.
   PubMed Web of Science ®Google Scholar
• Gross V, Bar-Meir S, Lavy A, et al. Budesonide foam versus budesonide enema in active ulcerative proctitis and proctosigmoiditis. Aliment Pharmacol Ther. 2006;23(2):303–312.
   PubMed Web of Science ®Google Scholar
• Danielsson A, Hellers G, Lyrenäs E, et al. A controlled randomized trial of budesonide versus prednisolone retention enemas in active distal ulcerative colitis. Scand J Gastroenterol. 1987;22(8):987–992.
   PubMed Web of Science ®Google Scholar
• Matzen P. Budesonide enema in distal ulcerative colitis. A randomized dose-response trial with prednisolone enema as positive control. The Danish budesonide study group. Scand J Gastroenterol. 1991;26(12):1225–1230.
   PubMed Web of Science ®Google Scholar
• Porro GB, Prantera C, Campierit M, et al. Comparative trial of methylprednisolone and budesonide enemas in active distal ulcerative colitis. Eur J Gastroenterol Hepatol. 1994;6(2):125–130.
   Web of Science ®Google Scholar
• Tarpila S, Turunen U, Seppälä K, et al. Budesonide enema in active haemorrhagic proctitis–a controlled trial against hydrocortisone foam enema. Aliment Pharmacol Ther. 1994;8(6):591–595.
   PubMed Web of Science ®Google Scholar
• Löfberg R, Ostergaard Thomsen O, Langholz E, et al. Budesonide versus prednisolone retention enemas in active distal ulcerative colitis. Aliment Pharmacol Ther. 1994;8(6):623–629.
   PubMed Web of Science ®Google Scholar
• Bar-Meir S, Fidder HH, Faszczyk M, et al. Budesonide foam vs. hydrocortisone acetate foam in the treatment of active ulcerative proctosigmoiditis. Dis Colon Rectum. 2003;46(7):929–936.
   PubMed Web of Science ®Google Scholar
• Lémann M, Galian A, Rutgeerts P, et al. Comparison of budesonide and 5-aminosalicylic acid enemas in active distal ulcerative colitis. Aliment Pharmacol Ther. 1995;9(5):557–562.
   PubMed Web of Science ®Google Scholar
• Hartmann F, Stein J, Group B-S. Clinical trial: Controlled, open, randomized multicentre study comparing the effects of treatment on quality of life, safety and efficacy of budesonide or mesalazine enemas in active left-sided ulcerative colitis. Aliment Pharmacol Ther. 2010;32(3):368–376.
   PubMed Web of Science ®Google Scholar
• Lichtenstein GR, Travis S, Danese S, et al. Budesonide MMX for the induction of remission of mild to moderate ulcerative colitis: A pooled safety analysis. J Crohns Colitis. 2015;9(9):738–746.
   PubMed Web of Science ®Google Scholar
• Lichtenstein GR. Budesonide multi-matrix for the treatment of patients with ulcerative colitis. Dig Dis Sci. 2016;61(2):358–370.
   PubMed Web of Science ®Google Scholar
• 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(10):1095–1103.
   PubMed Web of Science ®Google Scholar
• Gionchetti P, Praticò C, Rizzello F, et al. The role of budesonide-MMX in active ulcerative colitis. Expert Rev Gastroenterol Hepatol. 2014;8(3):215–222.
   PubMed Web of Science ®Google Scholar
• Safdi M, DeMicco M, Sninsky C, et al. A double-blind comparison of oral versus rectal mesalamine versus combination therapy in the treatment of distal ulcerative colitis. Am J Gastroenterol. 1997;92(10):1867–1871.
   PubMed Web of Science ®Google Scholar
• Kuenzig ME, Rezaie A, Seow CH, et al. Budesonide for maintenance of remission in Crohn’s disease. Cochrane Database Syst Rev. 2014;8:CD002913.
   PubMed Web of Science ®Google Scholar
• Herfarth H, Gross V, Andus T, et al. Analysis of the therapeutic efficacy of different doses of budesonide in patients with active crohn’s ileocolitis depending on disease activity and localization. Int J Colorectal Dis. 2004;19(2):147–152.
   PubMed Web of Science ®Google Scholar
• Bebb JR, Scott BB. How effective are the usual treatments for ulcerative colitis? Aliment Pharmacol Ther. 2004;20(2):143–149.
   PubMed Web of Science ®Google Scholar
• GoodRx. http://www.goodrx.com/. [Updated 2016; cited 2016 Mar 3].
   Google Scholar