The problem of adherence to therapy in ulcerative colitis and the potential utility of multi-matrix system (MMX) technology

References

• Danese S, Fiocchi C. Ulcerative colitis. N Engl J Med. 2011;365:1713–1725.
   PubMed Web of Science ®Google Scholar
• Cosnes J, Gower-Rousseau C, Seksik P, et al. Epidemiology and natural history of inflammatory bowel diseases. Gastroenterology. 2011;140:1785–1794.
   PubMed Web of Science ®Google Scholar
• Moum B, Ekbom A, Vatn MH, et al. Change in the extent of colonoscopic and histological involvement in ulcerative colitis over time. Am J Gastroenterol. 1999;94:1564–1569.
   PubMed Web of Science ®Google Scholar
• Langholz E. Current trends in inflammatory bowel disease: the natural history. Therap Adv Gastroenterol. 2010;3:77–86.
   PubMedGoogle Scholar
• Van Der Have M, Fidder HH, Leenders M, et al. Self-reported disability in patients with inflammatory bowel disease largely determined by disease activity and illness perceptions. Inflamm Bowel Dis. 2015;21:369–377.
   PubMed Web of Science ®Google Scholar
• Zhao LN, Li JY, Yu T, et al. 5-aminosalicylates reduce the risk of colorectal neoplasia in patients with ulcerative colitis: an updated meta-analysis. PLoS One. 2014;9:e94208.
   PubMed Web of Science ®Google Scholar
• Gong J, Zhu L, Guo Z, et al. Use of thiopurines and risk of colorectal neoplasia in patients with inflammatory bowel diseases: a meta-analysis. PLoS One. 2013;8:e81487.
   PubMed Web of Science ®Google Scholar
• Furfaro F, Bezzio C, Ardizzone S, et al. Overview of biological therapy in ulcerative colitis: current and future directions. Gastrointestin Liver Dis. 2015;24:203–213.
   PubMed Web of Science ®Google Scholar
• Feagan BG, Rutgeerts P, Sands BE, et al. Vedolizumab as induction and maintenance therapy for ulcerative colitis. GEMINI 1 study group. N Engl J Med. 2013;369:699–710.
   PubMed Web of Science ®Google Scholar
• Øresland T, Bemelman WA, Sampietro GM, et al. European evidence based consensus on surgery for ulcerative colitis. J Crohns Colitis. 2015;9:4–25.
   PubMed Web of Science ®Google Scholar
• Kane S, Huo D, Aikens J, et al. Medication nonadherence and the outcomes of patients with quiescent ulcerative colitis. Am J Med. 2003;114:39–43.
   PubMed Web of Science ®Google Scholar
• Dignass AU, Bokemeyer B, Adamek H, et al. Mesalamine once daily is more effective than twice daily in patients with quiescent ulcerative colitis. Clin Gastroenterol Hepatol. 2009;7:762–769.
   PubMed Web of Science ®Google Scholar
• Lakatos PL, Czegledi Z, David G, et al. Association of adherence to therapy and complementary and alternative medicine use with demographic factors and disease phenotype in patients with inflammatory bowel disease. J Crohns Colitis. 2010;4:283–290.
   PubMed Web of Science ®Google Scholar
• Ediger JP, Walker JR, Graff L, et al. Predictors of medication adherence in inflammatory bowel disease. Am J Gastroenterol. 2007;102:1417–1426.
   PubMed Web of Science ®Google Scholar
• Morisky DE, Ang A, Krousel-Wood M, et al. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich). 2008;10:348–354.
   PubMed Web of Science ®Google Scholar
• Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005;353:487–497.
   PubMed Web of Science ®Google Scholar
• Kane SV, Cohen RD, Aikens JE, et al. Prevalence of nonadherence with maintenance mesalamine in quiescent ulcerative colitis. Am J Gastroenterol. 2001;96:2929–2933.
   PubMed Web of Science ®Google Scholar
• Mitra D, Hodgkins P, Yen L, et al. Association between oral 5-ASA adherence and health care utilization and costs among patients with active ulcerative colitis. BMC Gastroenterol. 2012;12:132.
   PubMed Web of Science ®Google Scholar
• Khan N, Abbas AM, Bazzano LA, et al. Long-term oral mesalazine adherence and the risk of disease flare in ulcerative colitis: nationwide 10-year retrospective cohort from the veterans affairs healthcare system. Aliment Pharmacol Ther. 2012;36:755–764.
   PubMed Web of Science ®Google Scholar
• Robinson A, Hankins M, Wiseman G, et al. Maintaining stable symptom control in inflammatory bowel disease: a retrospective analysis of adherence, medication switches and the risk of relapse. Aliment Pharmacol Ther. 2013;38:531–538.
   PubMed Web of Science ®Google Scholar
• Lachaine J, Yen L, Beauchemin C, et al. Medication adherence and persistence in the treatment of Canadian ulcerative colitis patients: analyses with the RAMQ database. BMC Gastroenterol. 2013;13:23.
   PubMed Web of Science ®Google Scholar
• Lopez A, Billioud V, Peyrin-Biroulet C, et al. Adherence to anti-TNF therapy in inflammatory bowel diseases: a systematic review. Inflamm Bowel Dis. 2013;19:1528–1533.
   PubMed Web of Science ®Google Scholar
• Mountifield R, Andrews JM, Mikocka-Walus A, et al. Covert dose reduction is a distinct type of medication non-adherence observed across all care settings in inflammatory bowel disease. J Crohns Colitis. 2014;8:1723–1729.
   PubMed Web of Science ®Google Scholar
• Selinger CP, Eaden J, Jones DB, et al. Modifiable factors associated with nonadherence to maintenance medication for inflammatory bowel disease. Inflamm Bowel Dis. 2013;19:2199–2206.
   PubMed Web of Science ®Google Scholar
• Horváth G, Farkas K, Hollósi R, et al. Is there any association between impaired health-related quality of life and non-adherence to medical therapy in inflammatory bowel disease? Scand J Gastroenterol. 2012;47:1298–1303.
   PubMed Web of Science ®Google Scholar
• Nahon S, Lahmek P, Saas C, et al. Socioeconomic and psychological factors associated with nonadherence to treatment in inflammatory bowel disease patients: results of the ISSEO survey. Inflamm Bowel Dis. 2011;17:1270–1276.
   PubMed Web of Science ®Google Scholar
• Bhatt J, Patil S, Joshi A, et al. Self-reported treatment adherence in inflammatory bowel disease in Indian patients. Indian J Gastroenterol. 2009;28:143–146.
   PubMedGoogle Scholar
• Baars JE, Zelinkova Z, Mensink PB, et al. High therapy adherence but substantial limitations to daily activities amongst members of the Dutch inflammatory bowel disease patients’ organization: a patient empowerment study. Aliment Pharmacol Ther. 2009;30:864–872.
   PubMed Web of Science ®Google Scholar
• Nguyen GC, LaVeist TA, Harris ML, et al. Patient trust-in-physician and race are predictors of adherence to medical management in inflammatory bowel disease. Inflamm Bowel Dis. 2009;15:1233–1239.
   PubMed Web of Science ®Google Scholar
• Horne R, Parham R, Driscoll R, et al. Patients’ attitudes to medicines and adherence to maintenance treatment in inflammatory bowel disease. Inflamm Bowel Dis. 2009;15:837–844.
   PubMed Web of Science ®Google Scholar
• D’Incà R, Bertomoro P, Mazzocco K, et al. Risk factors for non-adherence to medication in inflammatory bowel disease patients. Aliment Pharmacol Ther. 2008;27:166–172.
   PubMed Web of Science ®Google Scholar
• Cerveny P, Bortlik M, Vlcek J, et al. Non-adherence to treatment in inflammatory bowel disease in Czech Republic. J Crohns Colitis. 2007;1:77–81.
   PubMed Web of Science ®Google Scholar
• Cervený P, Bortlík M, Kubena A, et al. Nonadherence in inflammatory bowel disease: results of factor analysis. Inflamm Bowel Dis. 2007;13:1244–1249.
   PubMed Web of Science ®Google Scholar
• Bernal I, Domènech E, Garcia-Planella E, et al. Medication-taking behavior in a cohort of patients with inflammatory bowel disease. Dig Dis Sci. 2006;51:2165–2169.
   PubMed Web of Science ®Google Scholar
• Shale MJ, Riley SA. Studies of compliance with delayed-release mesalazine therapy in patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2003;18:191–198.
   PubMed Web of Science ®Google Scholar
• Coenen S, Weyts E, Ballet V, et al. Identifying predictors of low adherence in patients with inflammatory bowel disease. Eur J Gastroenterol Hepatol. 2016;28:503–507.
   PubMed Web of Science ®Google Scholar
• Devlen J, Beusterien K, Yen L, et al. Barriers to mesalamine adherence in patients with inflammatory bowel disease: a qualitative analysis. J Manag Care Spec Pharm. 2014;20:309–314.
   PubMed Web of Science ®Google Scholar
• Sewitch MJ, Abrahamowicz M, Barkun A, et al. Patient nonadherence to medication in inflammatory bowel disease. Am J Gastroenterol. 2003;98:1535–1544.
   PubMed Web of Science ®Google Scholar
• Jackson CA, Clatworthy J, Robinson A, et al. Factors associated with non-adherence to oral medication for inflammatory bowel disease: a systematic review. Am J Gastroenterol. 2010;105:525–539.
   PubMed Web of Science ®Google Scholar
• Moss AC, Lillis Y, Edwards George JB, et al. Attitudes to mesalamine questionnaire: a novel tool to predict mesalamine nonadherence in patients with IBD. Am J Gastroenterol. 2014;109:1850–1855.
   PubMed Web of Science ®Google Scholar
• Goodhand JR, Kamperidis N, Sirwan B, et al. Factors associated with thiopurine non-adherence in patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2013;38:1097–1108.
   PubMed Web of Science ®Google Scholar
• Kawakami A, Tanaka M, Nishigaki M, et al. Relationship between non-adherence to aminosalicylate medication and the risk of clinical relapse among Japanese patients with ulcerative colitis in clinical remission: a prospective cohort study. J Gastroenterol. 2013;48:1006–1015.
   PubMed Web of Science ®Google Scholar
• Kane S, Shaya F. Medication non-adherence is associated with increased medical health care costs. Dig Dis Sci. 2008;53:1020–1024.
   PubMed Web of Science ®Google Scholar
• Greenley RN, Kunz JH, Walter J, et al. Practical strategies for enhancing adherence to treatment regimen in inflammatory bowel disease. Inflamm Bowel Dis. 2013;19:1534–1545.
   PubMed Web of Science ®Google Scholar
• Van Staa TP, Card T, Logan RF, et al. 5-aminosalicylate use and colorectal cancer risk in inflammatory bowel disease: a large epidemiological study. Gut. 2005;54:1573–1578.
   PubMed Web of Science ®Google Scholar
• Viswanathan M, Golin CE, Jones CD, et al. Interventions to improve adherence to self-administered medications for chronic diseases in the United States: a systematic review. Ann Intern Med. 2012;157:785–795.
   PubMed Web of Science ®Google Scholar
• Linn AJ, Van Dijk L, Smit EG, et al. May you never forget what is worth remembering: the relation between recall of medical information and medication adherence in patients with inflammatory bowel disease. J Crohns Colitis. 2013;7:e543- e50.
   Google Scholar
• Waters BM, Jensen L, Fedorak RN. Effects of formal education for patients with inflammatory bowel disease: a randomized controlled trial. Can J Gastroenterol. 2005;19:235–244.
   PubMed Web of Science ®Google Scholar
• Pedersen N, Thielsen P, Martinsen L, et al. eHealth: individualization of mesalazine treatment through a self-managed web-based solution in mild-to-moderate ulcerative colitis. Inflamm Bowel Dis. 2014;20:2276–2285.
   PubMed Web of Science ®Google Scholar
• Elkjaer M, Shuhaibar M, Burisch J, et al. E-health empowers patients with ulcerative colitis: a randomised controlled trial of the web-guided ‘Constant-care’ approach. Gut. 2010;59:1652–1661.
   PubMed Web of Science ®Google Scholar
• Morningstar BA, Sketris IS, Kephart GC, et al. Variation in pharmacy prescription refill adherence measures by type of oral antihyperglycaemic drug therapy in seniors in Nova Scotia, Canada. J Clin Pharm Ther. 2002;27:213–220.
   PubMed Web of Science ®Google Scholar
• Kane S, Huo D, Magnanti K. A pilot feasibility study of once daily versus conventional dosing mesalamine for maintenance of ulcerative colitis. Clin Gastroenterol Hepatol. 2003;1:170–173.
   PubMed Web of Science ®Google Scholar
• Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther. 2001;23:1296–1310.
   PubMed Web of Science ®Google Scholar
• Gillespie D, Hood K, Farewell D, et al. Electronic monitoring of medication adherence in a 1-year clinical study of 2 dosing regimens of mesalazine for adults in remission with ulcerative colitis. Inflamm Bowel Dis. 2014;20:82–91.
   PubMed Web of Science ®Google Scholar
• Baumgart DC, Vierziger K, Sturm A, et al. Mesalamine promotes intestinal epithelial wound healing in vitro through a TGF-beta-independent mechanism. Scand J Gastroenterol. 2005;40:958–964.
   PubMed Web of Science ®Google Scholar
• Sowmy C, Reddy CS. Colon specific drug delivery systems: a review on pharmaceutical approaches with current trends. J Global Trends Pharmaceut Sci. 2013;4:1174–1183.
   Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Kamm MA, Sandborn WJ, Gassull M, et al. Once-daily high concentration MMX mesalamine in active ulcerative colitis. Gastroenterology. 2007;132:66–75.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Ford AC, Khan KJ, Sandborn WJ, et al. Once-daily dosing vs. conventional dosing schedule of mesalamine and relapse of quiescent ulcerative colitis: systematic review and meta-analysis. Am J Gastroenterol. 2011;106:2070–2077.
   PubMed Web of Science ®Google Scholar
• Feagan BG, MacDonald JK. Once daily oral mesalamine compared to conventional dosing for induction and maintenance of remission in ulcerative colitis: a systematic review and meta-analysis. Inflamm Bowel Dis. 2012;18:1785–1794.
   PubMed Web of Science ®Google Scholar
• Wang Y, Parker CE, Bhanji T, et al. Oral 5-aminosalicylic acid for induction of remission in ulcerative colitis. Cochrane Database Syst Rev. 2016 Apr;21(4):CD000543.
   Google Scholar
• Wang Y, Parker CE, Feagan BG, et al. Oral 5-aminosalicylic acid for maintenance of remission in ulcerative colitis. Cochrane Database Syst Rev. 2016 May;9(5):CD000544.
   Google Scholar
• Kane SV. Overcoming adherence issues in ulcerative colitis. Gastroenterol Hepatol. 2007;3:795–799.
   Google Scholar
• Higgins PDR, Rubin DT, Kaulback K, et al. Systematic review: impact of non-adherence to 5-aminosalicylic acid products on the frequency and cost of ulcerative colitis flares. Aliment Pharmacol Ther. 2009;29:247–257.
   PubMed Web of Science ®Google Scholar
• Kane S, Katz S, Mazen Jamal M, et al. Strategies in Maintenance for Patients Receiving Long-term Therapy (SIMPLE): a Study of MMX Mesalamine for the long- term maintenance of quiescent ulcerative colitis. Inflamm Bowel Dis. 2012;18:1026–1033.
   PubMed Web of Science ®Google Scholar
• Saibeni S, Meucci G, Papi C, et al. Low bioavailability steroids in inflammatory bowel disease: an old chestnut or a whole new ballgame? Expert Rev Gastroenterol Hepatol. 2014;8:949–962.
   PubMed Web of Science ®Google Scholar
• Edsbäcker S, Bengtsson B, Larsson P, et al. A pharmacoscintigraphic evaluation of oral budesonide given as controlled-release (Entocort) capsules. Aliment Pharmacol Ther. 2003;17:525–536.
   PubMed Web of Science ®Google Scholar
• Pena AS, Kolkman JJ, Greinwald R, et al. Pharmacokinetics after single and multiple oral dosing of budesonide pH-modified-release capsule in patients with distal ulcerative colitis. Proceedings of falk workshop on topical steroids in gastroenterology and hepatology; Berlin, Germany. 2003 Jun 14. Dignass A, Gross V, Buhr HJ, et al., editors. Dordrecht, The Netherlands: Kluwer Academic Publishers; p. 30–36.
   Google Scholar
• Gomollón F, Dignass A, Annese V, et al. 3. EUROPEAN Evidence-based consensus on the diagnosis and management of Crohn’s disease 2016: Part 1: diagnosis and medical management. J Crohns Colitis. 2016 Sep 22; pii: jjw168. [Epub ahead of print].
   Web of Science ®Google Scholar
• Sherlock ME, Seow CH, Steinhart AH, et al. Oral budesonide for induction of remission in ulcerative colitis. Cochrane Database Syst Rev. 2010;10:CD007698.
   PubMed Web of Science ®Google Scholar
• Marshall JK, Irvine EJ. Rectal corticosteroids versus alternative treatments in ulcerative colitis: a meta-analysis. Gut. 1997;40:775–781.
   PubMed Web of Science ®Google Scholar
• D’Haens GR, Kovács 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;4:153–160.
   PubMed Web of Science ®Google Scholar
• 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;143:1218–1226.
   PubMed Web of Science ®Google Scholar
• Travis SP, Danese S, Kupcinskas L, et al. Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: results from the randomised CORE II study. Gut. 2014;63:433–441.
   PubMed Web of Science ®Google Scholar
• Sandborn WJ, Danese S, Ballard DE, et al. Efficacy of budesonide MMx® 6 mg QD 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(5 Suppl 1):S–564.
   Web of Science ®Google Scholar
• Kane SV. Systematic review: adherence issues in the treatment of ulcerative colitis. Aliment Pharmacol Ther. 2006;23:577–585.
   PubMed Web of Science ®Google Scholar
• Lichtenstein GR. Budesonide multi-matrix for the treatment of patients with ulcerative colitis. Dig Dis Sci. 2016;61:358–370.
   PubMed Web of Science ®Google Scholar
• Loftus EV Jr. A practical perspective on ulcerative colitis: patients’ needs from aminosalicylate therapies. Inflamm Bowel Dis. 2006;12:1107–1113.
   PubMed Web of Science ®Google Scholar