Twice-daily budesonide 2-mg foam induces complete mucosal healing in patients with distal ulcerative colitis

Journal of Crohn's and Colitis

Volumn 10, Issue 7, 2016, Pages 828-836

  Naganuma, Makoto ^a   Aoyama, Nobuo ^b   Suzuki, Yasuo ^c   Nishino, Haruo ^d   Kobayashi, Kiyonori ^e   Hirai, Fumihito ^f   Watanabe, Kenji ^g   Hibi, Toshifumi ^e  

^a KEIO UNIVERSITY   (Japan)

^b Aoyama Medical Clinic   (Japan)

^c TOHO UNIVERSITY   (Japan)

^d Matsushima Clinic ^*  (Japan)

^e KITASATO UNIVERSITY   (Japan)

^f Fukuoka University Chikushi Hospital   (Japan)

^g OSAKA CITY GENERAL HOSPITAL   (Japan)

Author keywords

Budesonide foam; Mucosal healing; Ulcerative colitis

Indexed keywords

BUDESONIDE; CORTICOTROPIN; CREATINE KINASE; HYDROCORTISONE; MESALAZINE; PLACEBO; SALAZOSULFAPYRIDINE; ANTIINFLAMMATORY AGENT;

ADOLESCENT; ADULT; AGED; ARTICLE; COLON MUCOSA; CONTROLLED STUDY; DOSAGE SCHEDULE COMPARISON; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; ENDOSCOPY; FEMALE; FEVER; FOAM; HEADACHE; HUMAN; JAPANESE (PEOPLE); MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REMISSION; SIDE EFFECT; TREATMENT OUTCOME; ULCER HEALING; ULCERATIVE COLITIS; VOMITING; CLINICAL TRIAL; COLITIS, ULCERATIVE; COLON; COLONOSCOPY; DIAGNOSTIC IMAGING; DRUG ADMINISTRATION; FOLLOW UP; INDUCTION CHEMOTHERAPY; INTESTINE MUCOSA; MIDDLE AGED; PATHOLOGY; PROCEDURES; RECTAL DRUG ADMINISTRATION; WOUND HEALING; YOUNG ADULT;

ADMINISTRATION, RECTAL; ADOLESCENT; ADULT; AGED; ANTI-INFLAMMATORY AGENTS; BUDESONIDE; COLITIS, ULCERATIVE; COLON; COLONOSCOPY; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; FOLLOW-UP STUDIES; HUMANS; INDUCTION CHEMOTHERAPY; INTESTINAL MUCOSA; MALE; MIDDLE AGED; TREATMENT OUTCOME; WOUND HEALING; YOUNG ADULT;

EID: 85012113480     PISSN: 18739946     EISSN: 18764479     Source Type: Journal    
DOI: 10.1093/ecco-jcc/jjv208     Document Type: Article

References (21)

1. 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;24:367-78.
2. 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.
3. Mazzooli A, Guglielmi FW, Antonelli E, Salemme M, Bassotti G, Villanacci V. Definition and evaluation of mucosal healing in clinical practice. Dig Liver Dis 2013;45:969-77.
4. Nakarai A, Kato J, Hiraoka S, et al. Prognosis of ulcerative colitis differs between patients with complete and partial mucosal healing, which can be predicted from the platelet count. World J Gastroenterol 2014;20:18367-74.
5. Yokoyama K, Kobayashi K, Mukae M, Sada M, Koizumi W. Clinical study of the relation between mucosal healing and long-term outcomes in ulcerative colitis. Gastroenterol Res Pract 2013;2013:192794.
6. Prantera C. Glucocorticosteroids in the treatment of inflammatory bowel disease and approaches to minimizing systemic activity. Ther Adv Gastroenterol 2013;6:137-56.
7. Iborrra M, Alvarez-Sotomayor D, Nos P. Long-term safety and efficacy of budesonide in the treatment of ulcerative colitis. Clin Exp Gastroenterol 2014;7:39-46.
8. 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.
9. Sandborn WJ, Kamm MA, Lichtenstein GR, Lyne A, Butler T, Joseph RE. MMX mesalazine for the induction of remission in patients with mild to moderate ulcerative colitis: a combined analysis of two randomized, double blind, placebo controlled trails. Aliment Pharmacol Ther 2007;26:205-15.
10. Gross V, Bar-Meir S, Lavy A, et al.; International Budesonide Foam Study Group. Budesonide foam vs. budesonide enema in active ulcerative proctitis and proctosigmoiditis. Aliment Pharmacol Ther 2006;23:303-12.
11. 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;148:740-50.
12. Lindgren S, Lofberg R, Bergholm L, et al. Effect of budesonide enema on remission and relapse rate in distal ulcerative colitis and proctitis. Scand J Gastroenterol 2002;37:705-10.
13. Hanauer SB, Robinson M, Pruitt R, et al. Budesonide enema for the treatment of active, distal ulcerative colitis and proctitis: a dose-ranging study. Gastroenterology 1998;155:525-32.
14. 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;22:463-70.
15. Kobayashi K, Hirai F, Naganuma M, et al. A randomized clinical trial of mesalazine suppository: the usefulness and problems of central review of evaluations of colonic mucosal finding. J Crohns Colitis 2014;8:1444-53.
16. Langholz E, Munkholm P, Davidsen M, Nielsen OH, Binder V. Changes in extent of ulcerative colitis: a study on the course and prognostic factors. Scand J Gastroenterol 1996;31:260-6.
17. Ayres RC, Gillen CD, Walmsley RS, Allan RN. Progression of ulcerative proctosigmoiditis: incidence and factors influencing progression. Eur J Gastroenterol Hepatol 1996;8:555-8.
18. Henriksen M, Jahnsen J, Lygren I, et al.; IBSEN Study Group. UC and clinical course: results of a 5-year population-based follow-up study [the IBSEN study]. Inflamm Bowel Dis 2006;12:543-50.
19. Dignass A, Lindsay JO, Sturm A, et al. Second European evidence-based consensus on the diagnosis and management of ulcerative colitis: current management Part 2. J Crohns Colitis 2012;6:991-1030.
20. 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;143:1218-26.
21. Travis S, Danese S, Kupcinskas L, et al. Once-daily budesonide MMX in active, mild to moderate ulcerative colitis: results from the randomized CORE II study. Gut 2014;63:433-41.