412
Views
4
CrossRef citations to date
0
Altmetric
Drug Safety Evaluation

A safety evaluation of budesonide MMX for the treatment of ulcerative colitis

, , , , &
Pages 437-444 | Received 15 Jan 2018, Accepted 12 Feb 2018, Published online: 23 Feb 2018

References

  • Ananthakrishnan AN. Epidemiology and risk factors for IBD. Nat Rev Gastroenterol Hepatol. 2015;12:205–217.
  • IBSEN Study Group, Solberg IC, Lygren I, Jahnsen J, et al. Clinical course during the first 10 years of ulcerative colitis: results from a population-based inception cohort (IBSEN Study). Scand J Gastroenterol. 2009; 44(4):431–440.
  • Argollo M, Fiorino G, Hindryckx P, et al. Novel therapeutic targets for inflammatory bowel disease. J Autoimmun. 2017;85:103–116.
  • Harbord M, Eliakim R, Bettenworth D, et al. European Crohn’s and Colitis Organisation [ECCO]. Third European evidence-based consensus on diagnosis and management of ulcerative colitis. Part 2: current management. J Crohns Colitis. 2017;11(7):769–784.
  • 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. 2002;123:393–395.
  • Ho GT, Chiam P, Drummond H, et al. The efficacy of corticosteroid therapy in inflammatory boweldisease: analysis of a 5-year UK inception cohort. Aliment Pharmacol Ther. 2006;24:319–330.
  • Saibeni S, Meucci G, Papi C, et al. Low bioavailability steroids in inflammatory bowel disease: an old chestnut or a whole new ballgame? Expert Rev Gastroenterol Hepatol. 2014;8(8):949–962.
  • Gomollón F, Dignass A, Annese V, et al. ECCO. 3rd European evidence-based consensus on the diagnosis and management of Crohn’s disease 2016: part 1: diagnosisand medical management. J Crohns Colitis. 2017 Jan;11(1):3–25.
  • Papi C, Luchetti R, Gili L, et al. Budesonide in the treatment of Crohn’s disease: a meta-analysis. Aliment Pharmacol Ther. 2000;14(11):1419–1428.
  • Kane SV, Schoenfeld P, Sandborn WJ, et al. The effectiveness of budesonide therapy for Crohn’s disease. Aliment Pharmacol Ther. 2002;16(8):1509–1517.
  • Seow CH, Benchimol EI, Griffiths AM, et al. Budesonide for induction of remission in Crohn’s disease. Cochrane Database Sys Rev. 2008; 3.
  • Sandborn WJ, Lofberg R, Feagan BG, et al. Budesonide for maintenance of remission in patients with Crohn’s disease in medically induced remission: a predetermined pooled analysis of four randomized, double-blind, placebo-controlled trials. Am J Gastroenterol. 2005;100(8):1780–1787.
  • Benchimol EI, Seow CH, Otley AR, et al. Budesonide for maintenance of remission in Crohn’s disease. Cochrane Database Syst Rev. 2009;1:CD002913.
  • Sherlock ME, Seow CH, Steinhart AH, et al. Oral budesonide for induction of remission in ulcerative colitis. Cochrane Database Syst Rev. 2010;10:CD007698.
  • Peña AS, Kolkman JJ, Greinwald R, et al. Pharmacokinetics after single and multiple oral dosing of budesonide pH-modified-release capsule in patients with distal ulcerative colitis. Proceedings of Falk Workshop on Topical Steroids in Gastroenterology and Hepatology; Berlin, Germany, 2003 Jun 14. Dignass A, Gross V, Buhr HJ, James OFW, editors. Kluwer Academic Publishers, Dordrecht, The Netherlands: p.30–6.
  • Barnes PJ. Molecular mechanisms and cellular effects of glucocorticosteroids. Immunol Allergy Clin North Am. 2005;25(3):451–468.
  • Stark JG, Werner S, Homrighausen S, et al. Pharmacokinetic/pharmacodynamics modeling of total lymphocytes and selected subtypes after oral budesonide. Pharmacokinet Pharmacodyn. 2006;33(4):441–459.
  • Fedorak RN, Bistritz L. Targeted delivery, safety, and efficacy of oral enteric-coated formulations of budesonide. Adv Drug Deliv Rev. 2005;57:303–316.
  • Bezzio C, Fascì-Spurio F, Viganò C, et al. The problem of adherence to therapy in ulcerative colitis and the potential utility of multi-matrix system (MMX) technology. Expert Rev Gastroenterol Hepatol. 2017;11(1):33–41.
  • 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(7):1087–1097.
  • 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.
  • D’Haens GR, Kovács A, Vergauwe P, et al. Clinical trial: preliminary efficacy and safety study of a new Budesonide-MMX® 9 mg extended-release tablets in patients with active left-sided ulcerative colitis. J Crohns Colitis. 2010;4(2):153–160.
  • Sandborn WJ, Travis S, Moro L, et al. Once-daily budesonide MMX® extended-release tablets induce remission in patients with mild to moderate ulcerative colitis: results from the CORE I study. Gastroenterology. 2012;143:1218–1226.
  • 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.
  • 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.
  • Rubin DT, Cohen RD, Sandborn WJ, et al. Budesonide multimatrix is efficacious for mesalamine-refractory, mild to moderate ulcerative colitis: a randomised, placebo-controlled trial. J Crohns Colitis. 2017;11(7):785–791.
  • Sandborn WJ, Danese S, Ballard DE, et al. Efficacy of Budesonide MMx® 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 Suppl 1):S–564.
  • 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;9:738–746.
  • Lichtenstein GR, Danese S, Ballard ED, et al. Effect of budesonide MMX 6 mg on the hypothalamic–pituitary–adrenal (HPA) axis in patients with ulcerative colitis: results from a phase III, 12 month safety and extended use study. Gastroenterology. 2012;142(Suppl1):S785.
  • Landi S, Mezzina N, Carmagnola S, et al. Role, efficacy and safety of budesonide-MMX in ulcerative colitis in real life. A study in three Italian third-level centers. Accepted as Poster Presentation at 13th Congress of European Crohn’s and Colitis Organization (Vienna, 14–17 Feb 2018).
  • Karolewska-Bochenek K, Dziekiewicz M, Banaszkiewicz A. Budesonide MMX in paediatric patients with ulcerative colitis. J Crohns Colitis. 2017;11:1402.
  • Beaulieu DB, Ananthakrishnan AN, Issa M, et al. Budesonide induction and maintenance therapy for Crohn’s disease during pregnancy. Inflamm Bowel Dis. 2009;15:25–28.
  • Magro F, Gionchetti P, Eliakim R, et al. European Crohn’s and Colitis Organisation [ECCO]. Third European evidence-based 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(6):649–670.
  • Bonovas S, Nikolopoulos GK, Lytras T, et al. Comparative safety of systemic and low-bioavailability steroids in inflammatory bowel disease: systematic review and network meta-analysis. Br J Clin Pharmacol. 2017. Epub ahead of print. DOI:10.1111/bcp.13456
  • Ford AC, Bernstein CN, Khan KJ, et al. Glucocorticosteroid therapy in inflammatory bowel disease: systematic review and meta-analysis. Am J Gastroenterol. 2011;106:590–599.
  • Löfberg R, Rutgeerts P, Malchow H, et al. Budesonide prolongs time to relapse in ileal and ileocaecal Crohn’s disease. A placebo controlled one year study. Gut. 1996;39:82–86.
  • Hanauer S, Sandborn WJ, Persson A, et al. Budesonide as maintenance treatment in Crohn’s disease: a placebo-controlled trial. Aliment Pharmacol Ther. 2005;21:363–371.
  • Cino M, Greenberg GR. Bone mineral density in Crohn’s disease: a longitudinal study of budesonide, prednisone, and nonsteroid therapy. Am J Gastroenterol. 2002;97:915–921.
  • Schoon EJ, Bollani S, Mills PR, et al. Matrix Study Group. 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.
  • Schlaghecke R, Kornely E, Santen RT, et al. The effect of long-term glucocorticoid therapy on pituitary-adrenal responses to exogenous corticotropin-releasing hormone. N Engl J Med. 1992;326:226–230.
  • Kuenzig ME, Rezaie A, Seow CH, et al. Budesonide for maintenance of remission in Crohn’s disease. Cochrane Database Syst Rev. 2014;8:CD002913.
  • Biancone L, Annese V, Ardizzone S, et al. Safety of treatments for inflammatory bowel disease: clinical practice guidelines of the Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD). Dig Liver Dis. 2017;49:338–358.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.