Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: Results from the randomised CORE II study

Gut

Volumn 63, Issue 3, 2014, Pages 433-441

  Travis, Simon P L ^a   Danese, Silvio ^b   Kupcinskas, Limas ^c   Alexeeva, Olga ^d   D'Haens, Geert ^e   Gibson, Peter R ^f   Moro, Luigi ^g   Jones, Richard ^g   Ballard, E David ^h   Masure, Johan ⁱ   Rossini, Matteo ^j   Sandborn, William J ^k  

^a JOHN RADCLIFFE HOSPITAL   (United Kingdom)

^b HUMANITAS CLINICAL AND RESEARCH CENTER   (Italy)

^c LITHUANIAN UNIVERSITY OF HEALTH SCIENCES   (Lithuania)

^d Regional Clinical Hospital Named after NA Semachko   (Russian Federation)

^e ACADEMIC MEDICAL CENTER   (Netherlands)

^f ALFRED HOSPITAL   (Australia)

^g Cosmo Technologies Ltd ^*  (Ireland)

^h Santarus Inc   (United States)

ⁱ Ferring Pharmaceuticals AS   (Denmark)

^j CROSS SA   (Switzerland)

^k UNIVERSITY OF CALIFORNIA   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

BUDESONIDE; PLACEBO;

ARTICLE; CONTROLLED DRUG RELEASE; DISEASE ACTIVITY; DISEASE SEVERITY; DRUG CAPSULE; DRUG DELIVERY SYSTEM; DRUG EFFICACY; MULTI MATRIX SYSTEM TECHNOLOGY; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); TREATMENT DURATION; TREATMENT RESPONSE; ULCERATIVE COLITIS;

IBD; INFLAMMATORY BOWEL DISEASE; ULCERATIVE COLITIS;

ADMINISTRATION, ORAL; ADOLESCENT; ADULT; AGED; ANTI-INFLAMMATORY AGENTS; BUDESONIDE; COLITIS, ULCERATIVE; DELAYED-ACTION PREPARATIONS; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; INDUCTION CHEMOTHERAPY; INTENTION TO TREAT ANALYSIS; MALE; MIDDLE AGED; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84893767519     PISSN: 00175749     EISSN: 14683288     Source Type: Journal    
DOI: 10.1136/gutjnl-2012-304258     Document Type: Article

References (29)

1. Danese S, Fiocchi C. Ulcerative colitis. N Engl J Med 2011;365:1713-25.
2. Sandborn WJ, Kamm MA, Lichtenstein GR, et al. MMX Multi Matrix System mesalazine for the induction of remission in patients with mild-to-moderate ulcerative colitis: a combined analysis of two randomized, double-blind, placebo-controlled trials. Aliment Pharmacol Ther 2007;26:205-15. (Pubitemid 46985493)
3. Dignass A, Lindsay JO, Sturm A, et al. Second European-evidence-based consensus on the management of ulcerative colitis. J Crohns Colitis 2012;6:991-1030.
4. Ford AC, Bernstein CN, Khan KJ, et al. Glucocorticosteroid therapy in inflammatory bowel disease: systematic review and meta-analysis. Am J Gastroentrol 2011;106:590-9.
5. Hvizdos KM, Jarvis B. Budesonide inhalation suspension: a review of its use in infants, children and adults with inflammatory respiratory disorders. Drugs 2000;60:1141-78.
6. Sherlock ME, Seow CH, Steinhart AH, et al. Oral budesonide for induction for remission in ulcerative colitis. Cochrane Database Syst Rev 2010:CD007698.
7. Seow CH, Benchimol EI, Griffiths AM, et al. Budesonide for induction of remission in Crohn's disease. Cochrane Database Syst Rev 2008:CD000296.
8. Kozuch PL, Hanauer SB. Treatment of inflammatory bowel disease: a review of medical therapy. World J Gastroenterol 2008;14:354-77. (Pubitemid 351320845)
9. 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.
10. 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. (Pubitemid 43381235)
11. 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. (Pubitemid 46096842)
12. Kamm MA, Sandborn WJ, Gassull M, et al. Once-daily, high-concentration MMX mesalamine in active ulcerative colitis. Gastroenterology 2007;132:66-75. (Pubitemid 46108735)
13. 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. (Pubitemid 351919522)
14. D'Haens GR, Kovacs 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;4:153-60.
15. Sutherland LR, Martin F, Greer S, et al. 5-Aminosalicylic acid enema in the treatment of distal ulcerative colitis, proctosigmoiditis, and proctitis. Gastroenterology 1987;92:1894-8. (Pubitemid 17072238)
16. D'Haens G, Sandborn WJ, Feagan BG, et al. A review of activity indices and efficacy end points for clinical trials of medical therapy in adults with ulcerative colitis. Gastroenterology 2007;132:763-86.
17. Rachmilewitz D. Coated mesalazine (5-aminosalicylic acid) versus sulphasalazine in the treatment of active ulcerative colitis: a randomised trial. BMJ 1989;298:82-6. (Pubitemid 19032930)
18. Saverymuttu SH, Camilleri M, Rees H, et al. 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. (Pubitemid 16145475)
19. Kraemer HC, Morgan GA, Leech NL, et al. Measures of clinical significance. J Am Acad Child Adolesc Psychiatry 2003;42:1524-9. (Pubitemid 39585985)
20. Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c332.
21. Travis SP, Higgins PD, Orchard T, et al. Review article: defining remission in ulcerative colitis. Aliment Pharmacol Ther 2011;34:113-24.
22. Colombel JF, Rutgeerts P, Reinisch W, et al. Early mucosal healing with infliximab is associated with improved long-term clinical outcomes in ulcerative colitis. Gastroenterology 2011;141:1194-201.
23. Roberts Laboratories Inc. Pentasa® prescribing information. Eatontown, New Jersey: Roberts Pharmaceutical Corp., 1999.
24. Reinisch W, Sandborn WJ, Hommes DW, et al. Adalimumab for induction of clinical remission in moderately to severely active ulcerative colitis: results of a randomised controlled trial. Gut 2011;60:780-7.
25. Sandborn W, 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;143:1218-26.
26. Wolff S, Terheggen G, Mueller R, et al. Are endoscopic assessments a reliable measure for trials in ulcerative colitis? Gastroenterology 2011;140(Suppl 1):S389.
27. Travis SP, Schnell D, Krzeski P, et al. Developing an instrument to assess the endoscopic severity of ulcerative colitis: the Ulcerative Colitis Endoscopic Index of Severity (UCEIS). Gut 2012;61:535-42.
28. 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(Suppl 1):S785.
29. Travis S, Danese S, Ballard ED, et al. Safety analysis of budesonide MMX 6 mg used 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 (Suppl 1):S566-7.