Mesalamine Once Daily Is More Effective Than Twice Daily in Patients With Quiescent Ulcerative Colitis

Dignaß, Axel; Bokemeyer, Bernd; Adamek, Henning E.; Mroß, Michael; Vinter‐Jensen, Lars; Börner, N; Silvennoinen, Jouni; Tan, Gie; Pool, M. Oudkerk; Stijnen, Theo; Dietel, P.; Klugmann, Tobias; Vermeire, Séverine; Bhatt, Aomesh; Veerman, Henri

doi:10.1016/j.cgh.2009.04.004

Cited by 134 publications

(103 citation statements)

References 24 publications

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“…It showed an 11.9% greater remission rate at one year (73.8% vs 63.6%, respectively) in the single daily dose group [28] . Patient questionnaires showed significantly greater selfreported compliance (P < 0.05) and acceptability (P < 0.001) in the once-daily group.…”

Section: Drug Type and Dosing Regimesmentioning

confidence: 88%

Prevalence, predictors, and clinical consequences of medical adherence in IBD: How to improve it?

Lakatos¹

2009

WJG

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Inflammatory bowel diseases (IBD) are chronic diseases with a relapsing-remitting disease course necessitating lifelong treatment. However, non-adherence has been reported in over 40% of patients, especially those in remission taking maintenance therapies for IBD. The economical impact of non-adherence to medical therapy including absenteeism, hospitalization risk, and the health care costs in chronic conditions, is enormous. The causes of medication non-adherence are complex, where the patient-doctor relationship, treatment regimen, and other disease-related factors play key roles. Moreover, subjective assessment might underestimate adherence. Poor adherence may result in more frequent relapses, a disabling disease course, in ulcerative colitis, and an increased risk for colorectal cancer. Improving medication adherence in patients is an important challenge for physicians. Understanding the different patient types, the reasons given by patients for non-adherence, simpler and more convenient dosage regimens, dynamic communication within the health care team, a self-management package incorporating enhanced patient education and physician-patient interaction, and identifying the predictors of nonadherence will help devise suitable plans to optimize patient adherence. This editorial summarizes the available literature on frequency, predictors, clinical consequences, and strategies for improving medical adherence in patients with IBD.

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Section: Drug Type and Dosing Regimesmentioning

confidence: 88%

Prevalence, predictors, and clinical consequences of medical adherence in IBD: How to improve it?

Lakatos¹

2009

WJG

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“…Effectiveness data were drawn from a number of sources including RCTs and non-randomised studies. 49,[87][88][89][90][91][92][93][94][95][96][97][98][99] The effectiveness of IFX in inducing and maintaining response and remission was based on the results of the ACT1 and ACT2 studies. 49 The rate of developing colorectal cancer was derived from an observational study.…”

Section: Assessment Of Cost-effectivenessmentioning

confidence: 99%

Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy (including a review of TA140 and TA262): clinical effectiveness systematic review and economic model

Archer

Tappenden

Ren

et al. 2016

Health Technol Assess

143

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BackgroundUlcerative colitis (UC) is the most common form of inflammatory bowel disease in the UK. UC can have a considerable impact on patients’ quality of life. The burden for the NHS is substantial.ObjectivesTo evaluate the clinical effectiveness and safety of interventions, to evaluate the incremental cost-effectiveness of all interventions and comparators (including medical and surgical options), to estimate the expected net budget impact of each intervention, and to identify key research priorities.Data sourcesPeer-reviewed publications, European Public Assessment Reports and manufacturers’ submissions. The following databases were searched from inception to December 2013 for clinical effectiveness searches and from inception to January 2014 for cost-effectiveness searches for published and unpublished research evidence: MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature, The Cochrane Library including the Cochrane Systematic Reviews Database, Cochrane Controlled Trials Register, Database of Abstracts of Reviews of Effects, the Health Technology Assessment database and NHS Economic Evaluation Database; ISI Web of Science, including Science Citation Index, and the Conference Proceedings Citation Index-Science and Bioscience Information Service Previews. The US Food and Drug Administration website and the European Medicines Agency website were also searched, as were research registers, conference proceedings and key journals.Review methodsA systematic review [including network meta-analysis (NMA)] was conducted to evaluate the clinical effectiveness and safety of named interventions. The health economic analysis included a review of published economic evaluations and the development of a de novo model.ResultsTen randomised controlled trials were included in the systematic review. The trials suggest that adult patients receiving infliximab (IFX) [Remicade®, Merck Sharp & Dohme Ltd (MSD)], adalimumab (ADA) (Humira®, AbbVie) or golimumab (GOL) (Simponi®, MSD) were more likely to achieve clinical response and remission than those receiving placebo (PBO). Hospitalisation data were limited, but suggested more favourable outcomes for ADA- and IFX-treated patients. Data on the use of surgical intervention were sparse, with a potential benefit for intervention-treated patients. Data were available from one trial to support the use of IFX in paediatric patients. Safety issues identified included serious infections, malignancies and administration site reactions. Based on the NMA, in the induction phase, all biological treatments were associated with statistically significant beneficial effects relative to PBO, with the greatest effect associated with IFX. For patients in response following induction, all treatments except ADA and GOL 100 mg at 32–52 weeks were associated with beneficial effects when compared with PBO, although these were not significant. The greatest effects at 8–32 and 32–52 weeks were associated with 100 mg of GOL and 5 mg/kg of IFX, respectively. For patients in remission following induction, all treatments except ADA at 8–32 weeks and GOL 50 mg at 32–52 weeks were associated with beneficial effects when compared with PBO, although only the effect of ADA at 32–52 weeks was significant. The greatest effects were associated with GOL (at 8–32 weeks) and ADA (at 32–52 weeks). The economic analysis suggests that colectomy is expected to dominate drug therapies, but for some patients, colectomy may not be considered acceptable. In circumstances in which only drug options are considered, IFX and GOL are expected to be ruled out because of dominance, while the incremental cost-effectiveness ratio for ADA versus conventional treatment is approximately £50,300 per QALY gained.LimitationsThe health economic model is subject to several limitations: uncertainty associated with extrapolating trial data over a lifetime horizon, the model does not consider explicit sequential pathways of non-biological treatments, and evidence relating to complications of colectomy was identified through consideration of approaches used within previous models rather than a full systematic review.ConclusionsAdult patients receiving IFX, ADA or GOL were more likely to achieve clinical response and remission than those receiving PBO. Further data are required to conclusively demonstrate the effect of interventions on hospitalisation and surgical outcomes. The economic analysis indicates that colectomy is expected to dominate medical treatments for moderate to severe UC.Study registrationThis study is registered as PROSPERO CRD42013006883.FundingThe National Institute for Health Research Health Technology Assessment programme.

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“…By comparison, others showed that a 2.0 g once daily dosage of oral ethylcellulosecoated 5-ASA (Pentasa Õ ) was statistically superior to the 1.0 g twice daily format in maintenance of clinical remission in UC [Dignass et al 2009]. Approximately three quarters of the patients in the study of Dignass and colleagues had left-sided colitis.…”

Section: Maintenance Of Remission In Ulcerative Colitismentioning

confidence: 99%

Optimizing clinical use of mesalazine (5-aminosalicylic acid) in inflammatory bowel disease

Panaccione

Ghosh

et al. 2011

Therap Adv Gastroenterol

115

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Mesalamine Once Daily Is More Effective Than Twice Daily in Patients With Quiescent Ulcerative Colitis

Cited by 134 publications

References 24 publications

Prevalence, predictors, and clinical consequences of medical adherence in IBD: How to improve it?

Prevalence, predictors, and clinical consequences of medical adherence in IBD: How to improve it?

Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy (including a review of TA140 and TA262): clinical effectiveness systematic review and economic model

Optimizing clinical use of mesalazine (5-aminosalicylic acid) in inflammatory bowel disease

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