Mesalamine with MMX™ technology for the treatment of ulcerative colitis

Expert Review of Gastroenterology and Hepatology

Volumn 2, Issue 3, 2008, Pages 299-314

  Schreiber, Stefan ^a   Kamm, Michael A ^b,c   Lichtenstein, Gary R ^d  

^a UNIVERSITY HOSPITAL SCHLESWIG HOLSTEIN   (Germany)

^b ST VINCENT S HOSPITAL   (Australia)

^c IMPERIAL COLLEGE LONDON   (United Kingdom)

^d UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

5 aminosalicylic acid; Adherence; Induction; Maintenance; Mesalamine; MMX Multi Matrix System; Mucosal healing; Remission; Ulcerative colitis

Indexed keywords

BALSALAZIDE; DIVISTYRAMINE; MASASAL; MESALAZINE; MESREN; MEZAVANT; OLSALAZINE; PLACEBO; SALAZOSULFAPYRIDINE; SALOFALK GRANU STIX; UNCLASSIFIED DRUG; NONSTEROID ANTIINFLAMMATORY AGENT;

ABDOMINAL PAIN; ANOREXIA; AREA UNDER THE CURVE; CLINICAL PRACTICE; CLINICAL TRIAL; COLON HEMORRHAGE; DELAYED DRUG RELEASE; DIARRHEA; DISEASE SEVERITY; DOSAGE SCHEDULE COMPARISON; DRUG ABSORPTION; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG FORMULATION; DRUG HYPERSENSITIVITY; DRUG INDUCED HEADACHE; DRUG MEGADOSE; DRUG PENETRATION; DRUG SAFETY; DRUG STRUCTURE; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPEPSIA; EVIDENCE BASED MEDICINE; FLATULENCE; FOOD DRUG INTERACTION; GASTROINTESTINAL SYMPTOM; HUMAN; LIPID DIET; LOW DRUG DOSE; MAXIMUM PLASMA CONCENTRATION; MEDICAL DECISION MAKING; NAUSEA; PANCREATITIS; PATENT; PATIENT COMPLIANCE; PERIANAL ABSCESS; PHARMACODYNAMICS; RECOMMENDED DRUG DOSE; REMISSION; REPEATED DRUG DOSE; REVIEW; SINGLE DRUG DOSE; STOMACH PH; TREATMENT DURATION; ULCERATIVE COLITIS; UNSPECIFIED SIDE EFFECT; URINE RETENTION; VIRAL GASTROENTERITIS; VOMITING; CHEMISTRY;

ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; COLITIS, ULCERATIVE; HUMANS; MESALAMINE; REMISSION INDUCTION;

EID: 55349084377     PISSN: 17474124     EISSN: None     Source Type: Journal    
DOI: 10.1586/17474124.2.3.299     Document Type: Review

References (90)

1. Neuman MG. Immune dysfunction in inflammatory bowel disease. Transl. Res. 149, 173-186 (2007).
2. Carter MJ, Lobo AJ, Travis SP. Guidelines for the management of inflammatory bowel disease in adults. Gut 53, V1-V16 (2004).
3. Ghosh S, Shand A, Ferguson A. Ulcerative colitis. Br. Med. J. 320, 1119-1123 (2000).
4. Bitton A. Medical management of ulcerative proctitis, proctosigmoiditis, and left-sided colitis. Semin. Gastrointest. Dis. 12, 263-274(2001).
5. Ullman TA. Preventing neoplastic progression in ulcerative colitis. J. Clin. Gastroenterol. 39, S66-S69 (2005).
6. Lakatos PL. Recent trends in the epidemiology of inflammatory bowel diseases: up or down? World J. Gastroenterol. 12, 6102-6108 (2006).
7. Loftus EV Jr. Clinical epidemiology of inflammatory bowel disease: incidence, prevalence, and environmental influences. Gastroenterology 126, 1504-1517 (2004).
8. Kornbluth A, Sachar DB. Ulcerative colitis practice guidelines in adults (update): American College of Gastroenterology, practice parameters committee. Am. J. Gastroenterol. 99, 1371-1385 (2004).
9. Sutherland L, MacDonald JK. Oral 5-aminosalicylic acid for maintenance of remission in ulcerative colitis. Cochrane Database Syst. Rev. 2, CD000544 (2006).
10. Sutherland L, MacDonald JK. Oral 5-aminosalicylic acid for induction of remission in ulcerative colitis. Cochrane Database Syst. Rev. CD000543 (2006).
11. Velayos FS, Terdiman JP, Walsh JM. Effect of 5-aminosalicylate use on colorectal cancer and dysplasia risk: a systematic review and metaanalysis of observational studies. Am. J. Gastroenterol. 100, 1345-1353 (2005).
12. Qureshi AL Cohen RD. Mesalamine delivery systems: do they really make much difference? Adv. Drug Deliv. Rev. 57, 281-302 (2005).
13. Stenson WF, Lobos E. Sulfasalazine inhibits the synthesis of chemotactic lipids by neutrophils. J. Clin. Invest. 69, 494-497 (1982).
14. Mahida YR, Lamming CE, Gallagher A, Hawthorne AB, Hawkey CJ. 5-aminosalicylic add is a potent inhibitor of interleukin 1β production in organ culture of colonic biopsy specimens from patients with inflammatory bowel disease. Gut 32, 50-54 (1991).
15. Rachmilewitz D, Karmeli F, Schwartz LW, Simon PL. Effect of aminophenols (5-ASA and 4-ASA) on colonic interleukin-1 generation. Gut 33, 929-932 (1992).
16. Kaiser GC, Yan F, Polk DB. Mesalamine blocks rumor necrosis factor growth inhibition and nuclear factor κβ activation in mouse colonocytes. Gastroenterology 116, 602-609 (1999).
17. Egan LJ, Mays DC, Huntoon CJ et al. Inhibition of interleukin-1-stimulated NF-κB RelA/p65 phosphorylation by mesalamine is accompanied by decreased transcriptional activity. J. Biol. Chem. 274, 26448-26453 (1999).
18. Ahnfelt-Ronne I, Nielsen OH, Christensen A, Langholz E, Binder V, Riis P. Clinical evidence supporting the radical scavenger mechanism of 5-aminosalicylic acid. Gastroenterology 98, 1162-1169 (1990).
19. Rousseaux C, Lefebvre B, Dubuquoy L et al. Intestinal antiinflammatory effect of 5-aminosalicylic acid is dependent on peroxisome proliferator-activated receptor-γ. J. Exp. Med. 201, 1205-1215 (2005).
20. Lewis JD, Lichtenstein GR, Deren JJ et al. A randomized, placebo-controlled trial of the PPAR-γ ligand rosiglitazone for active ulcerative colitis. Gastroenterology 13(24 Suppl. 1), (2007) (Abstract 639A).
21. 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 54, 960-965 (2005).
22. Blonski W, Lichtenstein GR. Complications of biological therapy for inflammatory bowel diseases. Curr. Opin Gastroenterol. 22, 30-43 (2006).
23. Katz JA. Treatment of inflammatory bowel disease with corticosteroids. Gastroenterol. Clin. North Am. 33, 171-189vii (2004).
24. Siegel CA, Sands BE. Review article: practical management of inflammatory bowel disease patients taking immunomodulators. Aliment. Pharmacol. Ther. 22, 1-16 (2005).
25. Cohen RD. Review article: evolutionary advances in the delivery of aminosalicylates for the treatment of ulcerative colitis. Aliment. Pharmacol. Ther. 24, 465-474 (2006).
26. Moshkovska T, Mayberry JF. Duration of treatment with 5-aminosalicylic acid compounds. World J. Gastroenterol. 13, 4310-4315 (2007).
27. Azad Khan AK, Piris J, Truelove SC. An experiment to determine the active therapeutic moiety of sulphasalazine. Lancet 2, 892-895 (1977).
28. Hanauer SB. Review article: aminosalicylates in inflammatory bowel disease. Aliment. Pharmacol. Ther. 20(Suppl. 4), 60-65 (2004).
29. Lim WC, Hanauer SB. Controversies with aminosalicylates in inflammatory bowel disease. Rev. Gastroenterol. Disord. 4, 104-117 (2004).
30. Courtney MG, Nunes DP, Bergin CF et al. Randomised comparison of olsalazine and mesalazine in prevention of relapses in ulcerative colitis. Lancet 339, 1279-1281 (1992).
31. Green JR, Gibson JA, Kerr GD et al. Maintenance of remission of ulcerative colitis: a comparison between balsalazide 3 g daily and mesalazine 1.2 g daily over 12 months. ABACUS Investigator group. Aliment. Pharmacol. Ther. 12, 1207-1216 (1998).
32. 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. 97, 1398-1407 (2002).
33. Pruitt RE, Hanson J, Safdi M et al. Balsalazide is superior to mesalamine in the time to improvment in signs and symptoms of acute mild-to-moderate ulcerative colitis. Am. J. Gastroenterol. 97, 3078-3086 (2002).
34. De Vos M, Verdievel H, Schoonjans R, Praet M, Bogaert M, Barbier F. Concentrations of 5-ASA and Ac-5-ASA in human ileocolonic biopsy homogenates after oral 5-ASA preparations. Gut 33, 1338-1342 (1992).
35. Ewe K, Press AG, Oestreicher M. The effect of food intake on the gastric emptying of gastric juice-resistant tablets and capsules. Dtsch. Med. Wochenschr. 117, 287-290 (1992).
36. Kane SV. Systematic review: adherence issues in the treatment of ulcerative colitis. Aliment. Pharmacol. Ther. 23, 577-585 (2006).
37. Nugent SG, Kumar D, Rampton DS, Evans DF. Intestinal luminal pH in inflammatory bowel disease: possible determinants and implications for therapy with aminosalicytates and other drugs. Gut 48, 571-577 (2001).
38. Rochester J, Abreu MT. Ulcerative colitis therapy: importance of delivery mechanisms. Rev. Gastmenterol. Disord. 5, 215-222 (2005).
39. Kane SV, Cohen RD, Aikens JE, Hanauer SB. Prevalence of nonadherence with maintenance mesalamine in quiescent ulcerative colitis. Am. J. Gastroenterol. 96, 2929-2933 (2001).
40. Kane S, Huo D, Aikens J, Hanauer S. Medication nonadherence and the outcomes of patients with quiescent ulcerative colitis. Am. J. Med. 114, 39-43 (2003).
41. Shale MJ, Riley SA. Studies of compliance with delayed-release mesalazine therapy in patients with inflammatory bowel disease. Aliment. Pharmacol. Ther. 18, 191-198 (2003).
42. van Hees PA, van Tongeren JH. Compliance to therapy in patients on a maintenance dose of sulfasalazine. J. Clin. Gastroenterol. 4, 333-336 (1982).
43. Levy RL, Feld AD. Increasing patient adherence to gastroenterology treatment and prevention regimens. Am. J. Gastroenterol. 94, 1733-1742 (1999).
44. Lofrus EV Jr. A practical perspective on ulcerative colitis: patients' needs from aminosalicylate therapies. Inflamm. Bowel. Dis. 12, 1107-1113 (2006).
45. Bernklev T, Jahnsen J, Aadland E et al. Health-related quality of life in patients with inflammatory bowel disease five years after the initial diagnosis. Scand J. Gastroenterol. 39, 365-373 (2004).
46. Casellas F, Arenas JI, Baudet JS et al. Impairment of health-related quality of life in patients with inflammatory bowel disease: a Spanish multicenter study. Inflamm. Bowel Dis. 11, 488-496 (2005).
47. Han SW, McColl E, Barton JR, James P, Steen IN, Welfare MR. Predictors of quality of life in ulcerative colitis: the importance of symptoms and illness representations. Inflamm. Bowel Dis. 11, 24-34 (2005).
48. Janke KH, Klump B, Gregor M, Meisner C, Haeuser W. Determinants of life satisfaction in inflammatory bowel disease. Inflamm. Bawel Dis. 11, 272-286 (2005).
49. Lialda™ (mesalamine) delayed release tablets, prescribing information. Shire US Inc., Wayne PA USA (2007).
50. Hanauer S, Sandborn W, Kombluth 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. 100, 2478-2485 (2005).
51. Hananuer 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. 21, 827-834 (2007).
52. Hanauer S, Schwartz J, Robinson M et al.; Pentasa Study Group. Mesalamine capsules for treatment of active ulcerative colitis: results of a controlled trial. Am. J. Gastroenterol. 88, 1188-1197 (1993).
53. 153Sm-labelled mesalazine pellets vs. tablets in male healthy volunteers. Aliment. Pharmacol. Ther. 17, 1163-1169 (2003).
54. Wilding I, Behrens C, Tardif S, Wray H, Bias P, Albrecht W. Combined scintigraphic and pharmacokinetic investigation of enteric-coated mesalazine micropellets in healthy subjects. Aliment. Pharmacol. Ther. 17, 1153-1162 (2003).
55. Farup P, Hinterleitner T, 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. 7, 237-242 (2001).
56. 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. Pharmacal. Ther. 20, 1353-1363 (2004).
57. Prantera C, Viscido A, Biancone L, Francavilla A, Giglio L, Campieri M. A new oral delivery system for 5-ASA: preliminary clinical findings for MMx. Inflamm. Bowel Dis. 11, 421-427 (2005).
58. Tenjarla S, Romasanta V, Zeijdner E, Villa R, Moro L. Release of 5-aminosalicylate from the MMX™ mesalamine tablet during transit through a simulated gastrointestinal tract system. Adv. Ther. 24, 826-840 (2007).
59. Pierce D, Martin P, Kern M, Lees K. MMX™ mesalazine: a pharmacokinetic profile following single and multiple doses. Gut 56, (2007) (Abstract MON-G-348).
60. Pierce D, Martin P, Kern M, Lees K. MMX™ mesalazine: a pharmacokinetic evaluation of dose proportionality and the effect of food. Gut 56, (2007) (Abstract MON-G-349).
61. Sandborn WJ, Hanauer SB. Systematic review: the pharmacokinetic profiles of oral mesalazine formulations and mesalazine pro-drugs used in the management of ulcerative colitis. Aliment. Pharmacol. Ther. 17, 29-42 (2003).
62. Brunner M, Assandri R, Kletter K et al.. Gastrointestinal transit and 5-ASA release from a new mesalazine extended-release formulation. Aliment. Pharmacol. Ther. 17, 395-402 (2003).
63. Rachmilewitz D. Coated mesalazine (5-aminosalicylic acid) versus sulphasalazine in the treatment of active ulcerative colitis: a randomised trial. BMJ 298, 82-86 (1989).
64. 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. 24, 1087-1097 (2006).
65. Sutherland LR, Martin F, Greet S et al. 5-Aminosalicylic acid enema in the treatment of distal ulcerative colitis, proctosigmoiditis, and proctitis. Gastroenterology 92, 1894-1898 (1987).
66. Kamm MA, Sandborn WJ, Gassull M et al. Once-daily high concentration MMX mesalamine in active ulcerative colitis. Gastroenterology 132, 66-75 (2007).
67. 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. 5, 95-102 (2007).
68. Sandborn WJ, Kamm MA, Lichtenstein GR, Lyne A, Butler T, Joseph RE. Multi Matrix System (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 trials. Aliment. Pharmacol. Ther. 26, 205-215 (2007).
69. Sandborn WJ, Karlstadt RG, Barrett K, Joseph RE. Time to intial symptom resolution withh MMX™ mesalamine therapy for active, mild-to-moderate ulcerative colitis. Am. J. Gastroenterol. 102, (2007) (Abstract 619).
70. Froslie KF, Jahnsen J, Moum BA, Vatn MH. Mucosal healing in inflammatory bowel disease: results from a Norwegian population-based cohort. Gastroenterology 133, 412-422 (2007).
71. Meucci G, Fasoli R, Saibeni S et al. Prognostic significance of endoscopy remission in patients with active ulcerative colkis treated with oral and topical mesalazine: preliminary results of a prospective, multicenter study. Gastroenterology 130, A-197 (2006) (Abstract S 1302).
72. Gassull M, Lichtenstein G, Sandborn W, Kamm M, Barrett K, Joseph R. MMX Mesalazine is an effective treatment for men and women with mild-to-moderate, active ulcerative colitis. J. Crohn's Colitis Suppl. 1(18), P057 (2007).
73. Kamm MA, Lichtenstein GR, Sandborn WJ et al. SPD476, a novd formulation of 5-ASA given once or twice daily, is effective for the induction of remission of left-sided and extensive ulcerative colitis: an analysis of combined data from two pivotal, randomized, placebo-controlled Phase III studies. Gastroenterology 130(4 Suppl. 2), A484 (2006) (Abstract T1148).
74. Lichtenstein GR, Kamm MA, Sandborn WJ et al. Once- and twice-daily SPD476, a novel, high-strength formulation of 5-ASA, induces remission of both mild and moderate ulcerative colitis: a prespecified analysis of combined data from two pivotal, randomized, placebo-controlled, Phase III studies. Gastroenterology 130(4 Suppl. 2), A-484 (2006) (Abstract T1147).
75. Sandborn WJ, Kamm MA, Lichtenstein GR et al. SPD476, a novel, high-strength 5-ASA formulation induces remission of active, mild-to-moderate ulcerative colitis in subjects that are switched from low-dose oral 5-ASA therapy or are 5-ASA naive: an analysis of pooled data from two Phase III studies. Gastroenterology 130(4 Suppl. 2), A482 (2006) (Abstract T1139).
76. Kamm MA, Lichtenstein GR, Sandborn WJ et al.. Randomized trial of once- or twice-daily MMX™ mesalamine for maintenance of remission in ulcerative colitis. Gut (2008) (In Press).
77. Kamm MA, Culombel J.-F, Kornbluth A et al. A randomized comparison of once versus twice-daily MMX mesalamine for the maintenance of remission in mild-to-moderate ulceratice colitis. Gastroenterology 132, A510 (2007) (Abstract T1296).
78. Lichtenstein GR, Kamm MA, Panaccione R, Barrett K, Lees K, Joseph R, The effect of prolonged therapy with MMX™ mesalamine in patients with acute, mild-to-moderate ulcerative colitis. Am. J. Gastroenterol. 102, S2 (2007) (Abstract 953).
79. Kruis W, Bar-Meir S, Feher J et al. The optimal dose of 5-aminosalicylic acid in active ulcerative colitis: a dose-finding study with newly developed mesalamine. Clin. Gastroenterol. Hepatol. 1, 36-43 (2003).
80. Panaccione R, Kamm M, Karlstadt RG, Diebold R, Barrett K, Joseph RE. Once- or twice-daily MMX™ mesalamine for the maintenance of remission of mild or moderate ulcerative colitis. Am. J. Gastroenterol. 102, (2007) (Abstract 950).
81. Lichtenstein G, Kamm MA, Karlstadt RG, Diebold R, Barrett K, Joseph R. MMX™ mesalamine is effective for the maintenance of ulcerative colitis remission in both left sided and extensive disease. Am. J. Gastroenterol. 102(Suppl. 2), 1049-1058 (2007) (Abstract 949).
82. Hanauer SB, Kamm MA, Diebold R, Barrett K, Joseph RE. Long-term remission rates in patients with mild-to-moderate ulcerative colitis who require an MMX™ mesalamine dose increase to induce initial remission. Am. J. Gastroenterol. 102, (2007) (Abstract 614).
83. Sandborn WJ, Karlstadt RG, Barrett K, Joseph RE. MMX™ mesalamine is effective for the maintenance of remission of mild-to-moderate ulcerative colitis irrespective of patients' previous relapse history. Am. J. Gastroenterol. 102, (2007) (Abstract 283).
84. Lichtenstein GR, Diebold R, Karlstadt RG, Barrett K, Joseph RE. Patients with quiescent mild-to-moderate ulcerative colitis receiving a multiple-daily dose 5-aminosalicylic acid formulation can maintain remission with once- or twice-daily MMX® mesalamine. Gastroenterology 132, A-510 (2007) (Abstract T1295).
85. Lichtenstein G, Katz S, Christenson A, Lees K, Barrett K, Joseph R. Safety of MMX mesalamine, a novel, once-daily 5-aminosalicylic acid (5-ASA) formulation for the treatment of ulcerative colitis, following 8 weeks' treatment: data from three Phase III studies. J. Am. Pharm. Assoc. 47, 210-211 (2007).
86. Adachi E, Okazaki K, Matsushima Y et al. Acute pancreatitis secondary to 5-aminosalicylic acid therapy in a patient with ulcerative colitis. Int. J. Pancreatol. 25, 217-221 (1999).
87. Decocq G, Gras-Champel V, Vrolant-Mille C et al.. Acute pancreatitis induced by drugs derived from 5-aminosalicylic acid: case report and review of the literature. Therapie 54, 41-48 (1999).
88. Lankisch PG, Droge M, Gottesleben F. Drug induced acute pancreatitis: incidence and severity. Gut 37, 565-567 (1995).
89. Marteau P, Nelet F, Le Lu M, Devaux C. Adverse events in patients treated with 5-aminosalicyclic acid: 1993-1994 pharmacovigilance report for Pentasa in France. Aliment. Pharmacol. Ther. 10, 949-956 (1996).
90. Kamm MA, Lichtenstein GR, Sandborn WJ, Barrett K, Joseph R. MMX™ mesalazine is well tolerated dttring 12 months' maintenance treatment of mild-to-moderate ulcerative colitis. Gut 56, A113 (2007).