Induction of clinical and colonoscopic remission of mild-to-moderate ulcerative colitis with budesonide MMX 9 mg: Pooled analysis of two phase 3 studies

Alimentary Pharmacology and Therapeutics

Volumn 41, Issue 5, 2015, Pages 409-418

  Sandborn, W J ^a   Danese, S ^b   D'Haens, G ^c   Moro, L ^d   Jones, R ^d   Bagin, R ^e   Huang, M ^e   David Ballard, E ^e   Masure, J ^f   Travis, S ^g  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b HUMANITAS CLINICAL AND RESEARCH CENTER   (Italy)

^c ACADEMIC MEDICAL CENTER   (Netherlands)

^d Cosmo Technologies Ltd ^*  (Ireland)

^e Santarus Inc ^*  (United States)

^f Ferring Pharmaceuticals AS   (Denmark)

^g OXFORD UNIVERSITY HOSPITALS NHS FOUNDATION TRUST   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

BUDESONIDE; HYDROCORTISONE; MESALAZINE; PLACEBO; DELAYED RELEASE FORMULATION; GASTROINTESTINAL AGENT;

ABDOMINAL PAIN; ACNE; ADULT; AGED; ARTICLE; COLONOSCOPY; CONTROLLED CLINICAL TRIAL; CONTROLLED RELEASE FORMULATION; CONTROLLED STUDY; DISEASE EXACERBATION; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; FEMALE; FLUID RETENTION; FLUSHING; HEADACHE; HISTOPATHOLOGY; HUMAN; HUMAN TISSUE; INSOMNIA; KIDNEY DISEASE; MAJOR CLINICAL STUDY; MALE; MOOD DISORDER; MOON FACE; MULTICENTER STUDY; NAUSEA; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; RELAPSE; REMISSION; RHINOPHARYNGITIS; SLEEP DISORDER; STRIA; ULCERATIVE COLITIS; UNSPECIFIED SIDE EFFECT; ADOLESCENT; COLITIS, ULCERATIVE; DELAYED RELEASE FORMULATION; DOSE RESPONSE; MIDDLE AGED; PHASE 3 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); SOCIOECONOMICS; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; BUDESONIDE; CLINICAL TRIALS, PHASE III AS TOPIC; COLITIS, ULCERATIVE; COLONOSCOPY; DELAYED-ACTION PREPARATIONS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; GASTROINTESTINAL AGENTS; HUMANS; MALE; MESALAMINE; MIDDLE AGED; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REMISSION INDUCTION; SOCIOECONOMIC FACTORS; YOUNG ADULT;

EID: 84921893654     PISSN: 02692813     EISSN: 13652036     Source Type: Journal    
DOI: 10.1111/apt.13076     Document Type: Article

References (23)

1. Knights D, Lassen KG, Xavier RJ,. Advances in inflammatory bowel disease pathogenesis: linking host genetics and the microbiome. Gut 2013; 62: 1505-10.
2. Ordás I, Eckmann L, Talamini M, Baumgart DC, Sandborn WJ,. Ulcerative colitis. Lancet 2012; 380: 1606-19.
3. Iborra M, Álvarez-Sotomayor D, Nos P,. Long-term safety and efficacy of budesonide in the treatment of ulcerative colitis. Clin Exp Gastroenterol 2014; 7: 39-46.
4. 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: 501-23.
5. 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.
6. 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.
7. 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: 1851-7.
8. 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: 31-8.
9. D'Haens GR, Kovacs 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: 153-60.
10. 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: 1218-26.
11. 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: 433-41.
12. Saverymuttu SH, Camilleri M, Rees H, Lavender JP, Hodgson HJ, Chadwick VS,. Indium 111-granulocyte scanning in the assessment of disease extent and disease activity in inflammatory bowel disease. A comparison with colonoscopy, histology, and fecal indium 111-granulocyte excretion. Gastroenterology 1986; 90: 1121-8.
13. Gross V, Bunganic I, Belousova EA, et al,. 3 g mesalazine granules are superior to 9 mg budesonide for achieving remission in active ulcerative colitis: a double-blind, double-dummy, randomised trial. J Crohns Colitis 2011; 5: 129-38.
14. 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.
15. Kamm MA, Lichtenstein GR, Sandborn WJ, et al,. Effect of extended MMX mesalamine therapy for acute, mild-to-moderate ulcerative colitis. Inflamm Bowel Dis 2009; 15: 1-8.
16. Kamm MA, Sandborn WJ, Gassull M, et al,. Once-daily, high-concentration MMX mesalamine in active ulcerative colitis. Gastroenterology 2007; 132: 66-75.
17. Lichtenstein GR, Rutgeerts P,. Importance of mucosal healing in ulcerative colitis. Inflamm Bowel Dis 2010; 16: 338-46.
18. Seidelin JB, Coskun M, Nielsen OH,. Mucosal healing in ulcerative colitis: pathophysiology and pharmacology. Adv Clin Chem 2013; 59: 101-23.
19. Campieri M, Ferguson A, Doe W, Persson T, Nilsson LG,. Oral budesonide is as effective as oral prednisolone in active Crohn's disease. The Global Budesonide Study Group. Gut 1997; 41: 209-14.
20. Tremaine WJ, Hanauer SB, Katz S, et al,. Budesonide CIR capsules (once or twice daily divided-dose) in active Crohn's disease: a randomized placebo-controlled study in the United States. Am J Gastroenterol 2002; 97: 1748-54.
21. Bar-Meir S, Chowers Y, Lavy A, et al,.; Israeli Budesonide Study Group. Budesonide versus prednisone in the treatment of active Crohn's disease. Gastroenterology 1998; 115: 835-40.
22. Gray JR, Leung E, Scales J,. Treatment of ulcerative colitis from the patient's perspective: a survey of preferences and satisfaction with therapy. Aliment Pharmacol Ther 2009; 29: 1114-20.
23. 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: 1095-103.