Second-generation corticosteroids for the treatment of Crohn's disease and ulcerative colitis: More effective and less side effects?

Digestive Diseases

Volumn 30, Issue 4, 2012, Pages 368-375

  De Cassan, Chiara ^a   Fiorino, Gionata ^a,b   Danese, Silvio ^a,b  

^a IBD Center   (Italy)

^b HUMANITAS CLINICAL AND RESEARCH CENTER   (Italy)

Author keywords

Crohn's disease; Second generation corticosteroids; Ulcerative colitis

Indexed keywords

AMINOSALICYLIC ACID; BECLOMETASONE DIPROPIONATE; BUDENOFALK; BUDESONIDE; BUDESONIDE MMX; DEXAMETHASONE; ENTOCIR; MESALAZINE; PREDNISONE; UNCLASSIFIED DRUG;

ARTICLE; CROHN DISEASE; DISEASE SEVERITY; DRUG DELIVERY SYSTEM; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; ERYTHROCYTE; HEALING; HUMAN; PRIORITY JOURNAL; ULCERATIVE COLITIS; UNSPECIFIED SIDE EFFECT;

ADRENAL CORTEX HORMONES; ANIMALS; COLITIS, ULCERATIVE; CROHN DISEASE; DRUG COMPOUNDING; DRUG DELIVERY SYSTEMS; HUMANS; TREATMENT OUTCOME;

EID: 84863937981     PISSN: 02572753     EISSN: 14219875     Source Type: Journal    
DOI: 10.1159/000338128     Document Type: Article

References (64)

1. Van Assche G, Dignass A, Panes J, et al: The second European evidence-based consensus on the diagnosis and management of Crohn's disease: definitions and diagnosis. J Crohns Colitis 2010; 4: 7-27.
2. Stange EF, Travis SP, Vermeire S, et al: European evidence-based consensus on the diagnosis and management of ulcerative colitis: definitions and diagnosis. J Crohns Colitis 2008; 2: 1-23.
3. Hayashi R, Wada H, Ito K, et al: Effects of glucocorticoids on gene transcription. Eur J Pharmacol 2004; 500: 51-62.
4. Dignass A, Van Assche G, Lindsay JO, et al: The second European evidence-based consensus on the diagnosis and management of Crohn's disease: current management. J Crohns Colitis 2010; 4: 28-62.
5. Travis SP, Stange EF, Lemann M, et al: European evidence-based consensus on the management of ulcerative colitis: current management. J Crohns Colitis 2008; 2: 24-62.
6. Keenan GF: Management of complications of glucocorticoid therapy. Clin Chest Med 1997; 18: 507-520.
7. Rutgeerts PJ: Review article: the limitations of corticosteroid therapy in Crohn's disease. Aliment Pharmacol Ther 2001; 15: 1515-1525.
8. Lichtenstein GR, Feagan BG, Cohen RD, et al: Serious infections and mortality in association with therapies for Crohn's disease: TREAT registry. Clin Gastroenterol Hepatol 2006; 4: 621-630.
9. Summers RW, Switz DM, Sessions JT Jr., et al: National Cooperative Crohn's Disease study: results of drug treatment. Gastroenterology 1979; 77:847-869.
10. Malchow H, Ewe K, Brandes JW, et al: European Cooperative Crohn's Disease study (ECCDS): results of drug treatment. Gastroenterology 1984; 86: 249-266.
11. Modigliani R, Mary JY, Simon JF, et al: Clinical, biological, and endoscopic picture of attacks of Crohn's disease. Evolution on prednisolone. Groupe d'Etudes Th?apeutiques des Affections Inflammatoires Digestives. Gastroenterology 1990; 98: 811-818.
12. Landi B, Anh TN, Cortot A, et al: Endoscopic monitoring of Crohn's disease treatment: a prospective, randomized clinical trial. Groupe d'Etudes Th?apeutiques des Affections Inflammatoires Digestives. Gastroenterology 1992; 102: 1647-1653.
13. Ho GT, Chiam P, Drummond H, et al: The efficacy of corticosteroid therapy in inflammatory bowel disease: analysis of a 5-year UK inception cohort. Aliment Pharmacol Ther 2006; 24:319-330.
14. Sparberg M, Kirsner JB: Long-term corticosteroid therapy for regional enteritis: an analysis of 58 courses in 54 patients. Am J Dig Dis 1966; 11: 865-880.
15. Jones JH, Lennard-Jones JE: Corticosteroids and corticotrophin in the treatment of Crohn's disease. Gut 1966; 7: 181-187.
16. 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.
17. Truelove SC, Watkinson G, Draper G: Comparison of corticosteroid and sulphasalazine therapy in ulcerative colitis. Br Med J 1962; 2:1708-1711.
18. Regueiro M, Loftus EV Jr., Steinhart AH, et al: Medical management of left-sided ulcerative colitis and ulcerative proctitis: critical evaluation of therapeutic trials. Inflamm Bowel Dis 2006; 12: 979-994.
19. Truelove SC, Jewell DP: Intensive intravenous regimen for severe attacks of ulcerative colitis. Lancet 1974; 1:1067-1070.
20. Ford AC, Bernstein CN, Khan KJ, et al: Glucocorticosteroid therapy in inflammatory bowel disease: systematic review and metaanalysis. Am J Gastroenterol 2011; 106: 590-599; quiz 600.
21. Greenberg GR, Feagan BG, Martin F, et al: Oral budesonide for active Crohn's disease. Canadian Inflammatory Bowel Disease Study Group. N Engl J Med 1994; 331: 836-841.
22. 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: 1748-1754.
23. Bar-Meir S, Chowers Y, Lavy A, et al: Budesonide versus prednisone in the treatment of active Crohn's disease. The Israeli Budesonide Study Group. Gastroenterology 1998; 115: 835-840.
24. Campieri M, Ferguson A, Doe W, et al: Oral budesonide is as effective as oral prednisolone in active Crohn's disease. The Global Budesonide Study Group. Gut 1997; 41: 209-214.
25. Gross V, Andus T, Caesar I, et al: Oral pHmodified release budesonide versus 6-methylprednisolone in active Crohn's disease. German/Austrian Budesonide Study Group. Eur J Gastroenterol Hepatol 1996; 8: 905-909.
26. Rutgeerts P, Lofberg R, Malchow H, et al: A comparison of budesonide with prednisolone for active Crohn's disease. N Engl J Med 1994; 331: 842-845.
27. van Ierssel GJ, van der Sluys Veer A, Verspaget HW, et al: Contribution of plasma cortisol to corticosteroid-suppressed peripheral blood natural killer cell activity in Crohn's disease. Immunopharmacology 1995; 29: 11-17.
28. Escher JC: Budesonide versus prednisolone for the treatment of active Crohn's disease in children: a randomized, double-blind, controlled, multicentre trial. Eur J Gastroenterol Hepatol 2004; 16: 47-54.
29. D'Haens G, Verstraete A, Cheyns K, et al: Bone turnover during short-term therapy with methylprednisolone or budesonide in Crohn's disease. Aliment Pharmacol Ther 1998; 12: 419-424.
30. Tursi A, Giorgetti GM, Brandimarte G, et al: Beclomethasone dipropionate for the treatment of mild-to-moderate Crohn's disease: an open-label, budesonide-controlled, randomized study. Med Sci Monit 2006; 12:I29-I32.
31. Seow CH, Benchimol EI, Griffiths AM, et al: Budesonide for induction of remission in Crohn's disease. Cochrane Database Syst Rev 2008;3:CD000296.
32. Benchimol EI, Seow CH, Otley AR, et al: Budesonide for maintenance of remission in Crohn's disease. Cochrane Database Syst Rev 2009;1:CD002913.
33. Lofberg R, Danielsson A, Suhr O, et al: Oral budesonide versus prednisolone in patients with active extensive and left-sided ulcerative colitis. Gastroenterology 1996; 110: 1713-1718.
34. Ferguson A, Campieri M, Doe W, et al: Oral budesonide as maintenance therapy in Crohn's disease -results of a 12-month study. Global Budesonide Study Group. Aliment Pharmacol Ther 1998; 12: 175-183.
35. Gross V, Andus T, Ecker KW, et al: Low dose oral pH modified release budesonide for maintenance of steroid induced remission in Crohn's disease. Budesonide Study Group. Gut 1998; 42: 493-496.
36. Ewe K, Bottger T, Buhr HJ, et al: Low-dose budesonide treatment for prevention of postoperative recurrence of Crohn's disease: a multicentre randomized placebo-controlled trial. German Budesonide Study Group. Eur J Gastroenterol Hepatol 1999; 11: 277-282.
37. Hellers G, Cortot A, Jewell D, et al: Oral budesonide for prevention of postsurgical recurrence in Crohn's disease. IOIBD Budesonide Study Group. Gastroenterology 1999; 116: 294-300.
38. Cortot A, Colombel JF, Rutgeerts P, et al: Switch from systemic steroids to budesonide in steroid dependent patients with inactive Crohn's disease. Gut 2001; 48: 186-190.
39. 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.
40. Schoon EJ, Bollani S, Mills PR, et al: 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.
41. Mantzaris GJ, Christidou A, Sfakianakis M, et al: Azathioprine is superior to budesonide in achieving and maintaining mucosal healing and histologic remission in steroid-dependent Crohn's disease. Inflamm Bowel Dis 2009; 15: 375-382.
42. Sherlock ME, Seow CH, Steinhart AH, et al: Oral budesonide for induction of remission in ulcerative colitis. Cochrane Database Syst Rev 2010;10:CD007698.
43. 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, doubledummy, randomised trial. J Crohns Colitis 2011; 5: 129-138.
44. Hammond A, Andus T, Gierend M, et al: Controlled, open, randomized multicenter trial comparing the effects of treatment on quality of life, safety and efficacy of bude sonide foam and betamethasone enemas in patients with active distal ulcerative colitis. Hepatogastroenterology 2004; 51:1345-1349.
45. Fiorino G, Fries W, De La Rue SA, et al: New drug delivery systems in inflammatory bowel disease: MMX and tailored delivery to the gut. Curr Med Chem 2010; 17: 1851-1857.
46. 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: 31-38.
47. 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: 153-160.
48. Foe K, Cutler DJ, Brown KF, et al: Metabolism kinetics of beclomethasone propionate esters in human lung homogenates. Pharm Res 2000; 17: 1007-1012.
49. Kumana CR, Seaton T, Meghji M, et al: Beclomethasone dipropionate enemas for treating inflammatory bowel disease without producing Cushing's syndrome or hypothalamic pituitary adrenal suppression. Lancet 1982; 1:579-583.
50. Bansky G, Buhler H, Stamm B, et al: Treatment of distal ulcerative colitis with beclomethasone enemas: high therapeutic efficacy without endocrine side effects. A prospective, randomized, double-blind trial. Dis Colon Rectum 1987; 30: 288-292.
51. Mulder CJ, Endert E, van der Heide H, et al: Comparison of beclomethasone dipropionate (2 and 3 mg) and prednisolone sodium phosphate enemas (30 mg) in the treatment of ulcerative proctitis. An adrenocortical approach. Neth J Med 1989; 35: 18-24.
52. Halpern Z, Sold O, Baratz M, et al: A controlled trial of beclomethasone versus betamethasone enemas in distal ulcerative colitis. J Clin Gastroenterol 1991; 13: 38-41.
53. van der Heide H, van den Brandt-Gradel V, Tytgat GN, et al: Comparison of beclomethasone dipropionate and prednisolone 21-phosphate enemas in the treatment of ulcerative proctitis. J Clin Gastroenterol 1988; 10: 169-172.
54. Campieri M, Cottone M, Miglio F, et al: Beclomethasone dipropionate enemas versus prednisolone sodium phosphate enemas in the treatment of distal ulcerative colitis. Aliment Pharmacol Ther 1998; 12: 361-366.
55. Gionchetti P, D'Arienzo A, Rizzello F, et al: Topical treatment of distal active ulcerative colitis with beclomethasone dipropionate or mesalamine: a single-blind randomized controlled trial. J Clin Gastroenterol 2005; 39: 291-297.
56. Biancone L, Gionchetti P, Blanco Gdel V, et al: Beclomethasone dipropionate versus mesalazine in distal ulcerative colitis: a multicenter, randomized, double-blind study. Dig Liver Dis 2007; 39: 329-337.
57. Mulder CJ, Fockens P, Meijer JW, et al: Beclomethasone dipropionate (3 mg) versus 5-aminosalicylic acid (2 g) versus the combination of both (3 mg/2 g) as retention enemas in active ulcerative proctitis. Eur J Gastroenterol Hepatol 1996; 8: 549-553.
58. Rizzello F, Gionchetti P, Galeazzi R, et al: Oral beclomethasone dipropionate in patients with mild to moderate ulcerative colitis: a dose-finding study. Adv Ther 2001; 18: 261-271.
59. Rizzello F, Gionchetti P, D'Arienzo A, et al: Oral beclometasone dipropionate in the treatment of active ulcerative colitis: a double-blind placebo-controlled study. Aliment Pharmacol Ther 2002; 16: 1109-1116.
60. Campieri M, Adamo S, Valpiani D, et al: Oral beclometasone dipropionate in the treatment of extensive and left-sided active ulcerative colitis: a multicentre randomised study. Aliment Pharmacol Ther 2003; 17: 1471-1480.
61. Papi C, Aratari A, Moretti A, et al: Oral beclomethasone dipropionate as an alternative to systemic steroids in mild to moderate ulcerative colitis not responding to aminosalicylates. Dig Dis Sci 2010; 55: 2002-2007.
62. Nunes T, Barreiro-de Acosta M, Nos P, et al: Usefulness of oral beclometasone dipropionate in the treatment of active ulcerative colitis in clinical practice: the RECLICU study. J Crohns Colitis 2010; 4: 629-636.
63. Bossa F, Latiano A, Rossi L, et al: Erythrocyte-mediated delivery of dexamethasone in patients with mild-to-moderate ulcerative colitis, refractory to mesalamine: a randomized, controlled study. Am J Gastroenterol 2008; 103: 2509-2516.
64. Annese V, Latiano A, Rossi L, et al: Erythrocytes-mediated delivery of dexamethasone in steroid-dependent IBD patients -a pilot uncontrolled study. Am J Gastroenterol 2005; 100: 1370-1375.