High mucosal healing rates in 5-ASA-treated ulcerative colitis patients: Results of a meta-analysis of clinical trials

Inflammatory Bowel Diseases

Volumn 18, Issue 11, 2012, Pages 2190-2198

  Römkens, Tessa E H ^a,b   Kampschreur, Milou T ^a,b   Drenth, Joost P H ^a   Van Oijen, Martijn G H ^a,c   De Jong, Dirk J ^a  

^a RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^b JEROEN BOSCH HOSPITAL   (Netherlands)

^c UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

Author keywords

5 ASA; clinical trials; mucosal healing; systematic review; ulcerative colitis

Indexed keywords

5 ACETAMIDOSALICYLIC ACID; ENEMA;

COLON MUCOSA; DRUG DOSAGE FORM COMPARISON; DRUG EFFICACY; DRUG FORMULATION; DRUG GRANULE; FOAM; HUMAN; META ANALYSIS; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SUPPOSITORY; SYSTEMATIC REVIEW; TREATMENT OUTCOME; ULCERATIVE COLITIS;

CLINICAL TRIALS AS TOPIC; COLITIS, ULCERATIVE; HUMANS; INTESTINAL MUCOSA; MESALAMINE; WOUND HEALING;

EID: 84867578354     PISSN: 10780998     EISSN: 15364844     Source Type: Journal    
DOI: 10.1002/ibd.22939     Document Type: Review

References (61)

1. Scherl EJ, Pruitt R, Gordon GL, et al. Safety and efficacy of a new 3.3 g b.i.d. tablet formulation in patients with mild-to-moderately-active ulcerative colitis: a multicenter, randomized, double-blind, placebo-controlled study. Am J Gastroenterol. 2009; 104: 1452-1459.
2. 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.
3. Raedler A, Behrens C, Bias P,. Mesalazine (5-aminosalicylic acid) micropellets show similar efficacy and tolerability to mesalazine tablets in patients with ulcerative colitis-results from a randomized-controlled trial. Aliment Pharmacol Ther. 2004; 20: 1353-1363.
4. 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.
5. Marteau P, Probert CS, Lindgren S, et al. Combined oral and enema treatment with Pentasa (mesalazine) is superior to oral therapy alone in patients with extensive mild/moderate active ulcerative colitis: a randomised, double blind, placebo controlled study. Gut. 2005; 54: 960-965.
6. 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: 1087-1097.
7. Eliakim R, Tulassay Z, Kupcinskas L, et al. Clinical trial: randomized-controlled clinical study comparing the efficacy and safety of a low-volume vs. a high-volume mesalazine foam in active distal ulcerative colitis. Aliment Pharmacol Ther. 2007; 26: 1237-1249.
8. Sninsky CA, Cort DH, Shanahan F, et al. Oral mesalamine (Asacol) for mildly to moderately active ulcerative colitis. A multicenter study. Ann Intern Med. 1991; 115: 350-355.
9. Levine DS, Riff DS, Pruitt R, et al. A randomized, double blind, dose-response comparison of balsalazide (6.75 g), balsalazide (2.25 g), and mesalamine (2.4 g) in the treatment of active, mild-to-moderate ulcerative colitis. Am J Gastroenterol. 2002; 97: 1398-1407.
10. van Dullemen HM, van Deventer SJ, Hommes DW, et al. Treatment of Crohn's disease with anti-tumor necrosis factor chimeric monoclonal antibody (cA2). Gastroenterology. 1995; 109: 129-135.
11. Rutgeerts P, D'Haens G, Targan S, et al. Efficacy and safety of retreatment with anti-tumor necrosis factor antibody (infliximab) to maintain remission in Crohn's disease. Gastroenterology. 1999; 117: 761-769.
12. Hanauer SB, Feagan BG, Lichtenstein GR, et al. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet. 2002; 359: 1541-1549.
13. Sands BE, Anderson FH, Bernstein CN, et al. Infliximab maintenance therapy for fistulizing Crohn's disease. N Engl J Med. 2004; 350: 876-885.
14. Rutgeerts P, Vermeire S, Van Assche G,. Mucosal healing in inflammatory bowel disease: impossible ideal or therapeutic target? Gut. 2007; 56: 453-455.
15. Froslie KF, Jahnsen J, Moum BA, et al. Mucosal healing in inflammatory bowel disease: results from a Norwegian population-based cohort. Gastroenterology. 2007; 133: 412-422.
16. [No authors listed.] Topical 5-aminosalicylic acid versus prednisolone in ulcerative proctosigmoiditis. A randomized, double-blind multicenter trial. Danish 5-ASA Group. Dig Dis Sci. 1987; 32: 598-602.
17. Farup PG, Hovde O, Halvorsen FA, et al. Mesalazine suppositories versus hydrocortisone foam in patients with distal ulcerative colitis. A comparison of the efficacy and practicality of two topical treatment regimens. Scand J Gastroenterol. 1995; 30: 164-170.
18. Fleig WE, Laudage G, Sommer H, et al. Prospective, randomized, double-blind comparison of benzalazine and sulfasalazine in the treatment of active ulcerative colitis. Digestion. 1988; 40: 173-180.
19. Prantera C, Viscido A, Biancone L, et al. A new oral delivery system for 5-ASA: preliminary clinical findings for MMx. Inflamm Bowel Dis. 2005; 11: 421-427.
20. Gibson PR, Fixa B, Pekarkova B, et al. Comparison of the efficacy and safety of Eudragit-L-coated mesalazine tablets with ethylcellulose-coated mesalazine tablets in patients with mild to moderately active ulcerative colitis. Aliment Pharmacol Ther. 2006; 23: 1017-1026.
21. Vecchi M, Meucci G, Gionchetti P, et al. Oral versus combination mesalazine therapy in active ulcerative colitis: a double-blind, double-dummy, randomized multicentre study. Aliment Pharmacol Ther. 2001; 15: 251-256.
22. Kruis W, Brandes JW, Schreiber S, et al. Olsalazine versus mesalazine in the treatment of mild to moderate ulcerative colitis. Aliment Pharmacol Ther. 1998; 12: 707-715.
23. Gionchetti P, Rizzello F, Venturi A, et al. Comparison of oral with rectal mesalazine in the treatment of ulcerative proctitis. Dis Colon Rectum. 1998; 41: 93-97.
24. Kamm MA, Sandborn WJ, Gassull M, et al. Once-daily, high-concentration MMX mesalamine in active ulcerative colitis. Gastroenterology. 2007; 132: 66-75.
25. Forbes A, Al-Damluji A, Ashworth S, et al. Multicentre randomized-controlled clinical trial of Ipocol, a new enteric-coated form of mesalazine, in comparison with Asacol in the treatment of ulcerative colitis. Aliment Pharmacol Ther. 2005; 21: 1099-1104.
26. Green JR, Mansfield JC, Gibson JA, et al. A double-blind comparison of balsalazide, 6.75 g daily, and sulfasalazine, 3 g daily, in patients with newly diagnosed or relapsed active ulcerative colitis. Aliment Pharmacol Ther. 2002; 16: 61-68.
27. Hanauer S, Schwartz J, Robinson M, et al. Mesalamine capsules for treatment of active ulcerative colitis: results of a controlled trial. Pentasa Study Group. Am J Gastroenterol. 1993; 88: 1188-1197.
28. Mansfield JC, Giaffer MH, Cann PA, et al. A double-blind comparison of balsalazide, 6.75 g, and sulfasalazine, 3 g, as sole therapy in the management of ulcerative colitis. Aliment Pharmacol Ther. 2002; 16: 69-77.
29. Cobden I, al-Mardini H, Zaitoun A, et al. Is topical therapy necessary in acute distal colitis? Double-blind comparison of high-dose oral mesalazine versus steroid enemas in the treatment of active distal ulcerative colitis. Aliment Pharmacol Ther. 1991; 5: 513-522.
30. Hanauer SB, Sandborn WJ, Kornbluth A, et al. Delayed-release oral mesalamine at 4.8 g/day (800 mg tablet) for the treatment of moderately active ulcerative colitis: the ASCEND II trial. Am J Gastroenterol. 2005; 100: 2478-2485.
31. Hanauer SB, Sandborn WJ, Dallaire C, et al. Delayed-release oral mesalamine 4.8 g/day (800 mg tablets) compared to 2.4 g/day (400 mg tablets) for the treatment of mildly to moderately active ulcerative colitis: the ASCEND I trial. Can J Gastroenterol. 2007; 21: 827-834.
32. Kam L, Cohen H, Dooley C, et al. A comparison of mesalamine suspension enema and oral sulfasalazine for treatment of active distal ulcerative colitis in adults. Am J Gastroenterol. 1996; 91: 1338-1342.
33. Farup PG, Hinterleitner TA, Lukas M, et al. Mesalazine 4 g daily given as prolonged-release granules twice daily and four times daily is at least as effective as prolonged-release tablets four times daily in patients with ulcerative colitis. Inflamm Bowel Dis. 2001; 7: 237-242.
34. Pruitt R, Hanson J, Safdi M, et al. Balsalazide is superior to mesalamine in the time to improvement of signs and symptoms of acute mild-to-moderate ulcerative colitis. Am J Gastroenterol. 2002; 97: 3078-3086.
35. Vernia P, Monteleone G, Grandinetti G, et al. Combined oral sodium butyrate and mesalazine treatment compared to oral mesalazine alone in ulcerative colitis: randomized, double-blind, placebo-controlled pilot study. Dig Dis Sci. 2000; 45: 976-981.
36. Kruis W, Kiudelis G, Racz I, et al. Once daily versus three times daily mesalazine granules in active ulcerative colitis: a double-blind, double-dummy, randomised, non-inferiority trial. Gut. 2009; 58: 233-240.
37. Marakhouski Y, Fixa B, Holoman J, et al. A double-blind dose-escalating trial comparing novel mesalazine pellets with mesalazine tablets in active ulcerative colitis. Aliment Pharmacol Ther. 2005; 21: 133-140.
38. Campieri M, de Franchis R, Bianchi PG, et al. Mesalazine (5-aminosalicylic acid) suppositories in the treatment of ulcerative proctitis or distal proctosigmoiditis. A randomized controlled trial. Scand J Gastroenterol. 1990; 25: 663-668.
39. Campieri M, Gionchetti P, Belluzzi A, et al. Topical treatment with 5-aminosalicylic in distal ulcerative colitis by using a new suppository preparation. A double-blind placebo controlled trial. Int J Colorectal Dis. 1990; 5: 79-81.
40. Campieri M, Gionchetti P, Belluzzi A, et al. 5-Aminosalicylic acid as enemas or suppositories in distal ulcerative colitis? J Clin Gastroenterol. 1988; 10: 406-409.
41. Gionchetti P, Ardizzone S, Benvenuti ME, et al. A new mesalazine gel enema in the treatment of left-sided ulcerative colitis: a randomized controlled multicentre trial. Aliment Pharmacol Ther. 1999; 13: 381-388.
42. Campieri M, Paoluzi P, D'Albasio G, et al. Better quality of therapy with 5-ASA colonic foam in active ulcerative colitis. A multicenter comparative trial with 5-ASA enema. Dig Dis Sci. 1993; 38: 1843-1850.
43. Pullan RD, Ganesh S, Mani V, et al. Comparison of bismuth citrate and 5-aminosalicylic acid enemas in distal ulcerative colitis: a controlled trial. Gut. 1993; 34: 676-679.
44. Cortot A, Maetz D, Degoutte E, et al. Mesalamine foam enema versus mesalamine liquid enema in active left-sided ulcerative colitis. Am J Gastroenterol. 2008; 103: 3106-3114.
45. Malchow H, Gertz B,. A new mesalazine foam enema (Claversal Foam) compared with a standard liquid enema in patients with active distal ulcerative colitis. Aliment Pharmacol Ther. 2002; 16: 415-423.
46. Miner PB Jr, Wedel MK, Xia S, et al. Safety and efficacy of two dose formulations of alicaforsen enema compared with mesalazine enema for treatment of mild to moderate left-sided ulcerative colitis: a randomized, double-blind, active-controlled trial. Aliment Pharmacol Ther. 2006; 23: 1403-1413.
47. 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.
48. Lemann M, Galian A, Rutgeerts P, et al. Comparison of budesonide and 5-aminosalicylic acid enemas in active distal ulcerative colitis. Aliment Pharmacol Ther. 1995; 9: 557-562.
49. Hanauer SB,. Dose-ranging study of mesalamine (PENTASA) enemas in the treatment of acute ulcerative proctosigmoiditis: results of a multicentered placebo-controlled trial. The U.S. PENTASA Enema Study Group. Inflamm Bowel Dis. 1998; 4: 79-83.
50. Campieri M, Lanfranchi GA, Bazzocchi G, et al. Treatment of ulcerative colitis with high-dose 5-aminosalicylic acid enemas. Lancet. 1981; 2: 270-271.
51. Campieri M, Gionchetti P, Belluzzi A, et al. Optimum dosage of 5-aminosalicylic acid as rectal enemas in patients with active ulcerative colitis. Gut. 1991; 32: 929-931.
52. Pokrotnieks J, Marlicz K, Paradowski L, et al. Efficacy and tolerability of mesalazine foam enema (Salofalk foam) for distal ulcerative colitis: a double-blind, randomized, placebo-controlled study. Aliment Pharmacol Ther. 2000; 14: 1191-1198.
53. Lee FI, Jewell DP, Mani V, et al. A randomised trial comparing mesalazine and prednisolone foam enemas in patients with acute distal ulcerative colitis. Gut. 1996; 38: 229-233.
54. Gionchetti P, Rizzello F, Venturi A, et al. Comparison of mesalazine suppositories in proctitis and distal proctosigmoiditis. Aliment Pharmacol Ther. 1997; 11: 1053-1057.
55. Basilisco G, Ranzi T, Campanini M, et al. 5-Aminosalicylic acid or sulfasalazine retention enemas in distal ulcerative colitis. A randomized therapeutic trial. Current Therapeutic research, vol 42, no 5; 1987.
56. Marshall JK, Thabane M, Steinhart AH, et al. Rectal 5-aminosalicylic acid for induction of remission in ulcerative colitis. Cochrane Database Syst Rev. 2010; CD004115.
57. Mowat C, Cole A, Windsor A, et al. Guidelines for the management of inflammatory bowel disease in adults. Gut. 2011; 60: 571-607.
58. Sandborn WJ, Regula J, Feagan BG, et al. Delayed-release oral mesalamine 4.8 g/day (800-mg tablet) is effective for patients with moderately active ulcerative colitis. Gastroenterology. 2009; 137: 1934-1943.
59. Sutherland L, Macdonald JK,. Oral 5-aminosalicylic acid for induction of remission in ulcerative colitis. Cochrane Database Syst Rev. 2006; CD000543.
60. 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: 763-786.
61. Ngô Y, Gélinet JM, Ivanovic A, et al. Efficacy of a daily application of mesalazine (Pentasa) suppository with progressive release, in the treatment of ulcerative proctitis. A double-blind versus placebo randomized trial. Gastroenterol Clin Biol. 1992; 16: 782-786 (abstract only).