Key Strategies to Optimize Outcomes in Mild-to-Moderate Ulcerative Colitis

Solitano, Virginia; D’Amico, Ferdinando; Fiorino, Gionata; Paridaens, Kristine; Peyrin–Biroulet, Laurent; Danese, Silvio

doi:10.3390/jcm9092905

Cited by 14 publications

(20 citation statements)

References 95 publications

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“…This comprehensive systematic review and meta-analysis has demonstrated the efficacy and safety of oral Pentasa for the treatment of active mild-to-moderate UC. With therapeutic aims in UC becoming more ambitious, targeting endoscopic and histological remission as well as symptomatic improvement, there is increasing emphasis on optimizing currently available treatments and identifying patients who could benefit from dose escalation 46 . The multiple formulations of Pentasa provide physicians' with the scope for optimizing patients' 5-ASA dosing and thus impact not only the likelihood of symptomatic improvement and remission, but also treatment adherence, quality of life, and longterm outcomes.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of oral Pentasa (prolonged-release mesalazine) in mild-to-moderate ulcerative colitis: a systematic review and meta-analysis

Paridaens

Fullarton²,

Travis

2021

Current Medical Research and Opinion

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Background: Pentasa (prolonged-release mesalazine [5-ASA]) has been available for >30 years as an effective treatment for mild-to-moderate ulcerative colitis (UC). A systematic literature review and meta-analysis was undertaken to provide an up-to-date evaluation of oral Pentasa efficacy and safety for induction and maintenance of remission. Methods: Literature searches were conducted in PubMed, Embase and Cochrane databases, from inception to 02 December 2020. Unpublished studies were also sourced. Meta-analyses using a random-effects model and Bayesian inference compared Pentasa (tablets, granules, capsules) against placebo and other 5-ASAs. Results: Twelve studies involving 3674 patients treated with Pentasa were identified. Pentasa 2-4 g/day was superior to placebo at inducing (absolute risk difference [ARD] at 8 weeks 0.14, 95% CI 0.07-0.21; p < .001) and maintaining (ARD 6-12 months 0.18, 95% CI 0.04-0.33; p < .05) remission (clinical/endoscopic). Against other 5-ASAs, Pentasa had similar efficacy for induction (ARD <0.001, 95% CI À0.05-0.05) and maintenance (ARD 0.01, 95% CI À0.07-0.08) treatment using randomized controlled trial data. Upon inclusion of real-world study data, Pentasa was significantly better at maintaining remission compared both to Eudragit-S mesalazine and sulfasalazine (ARD 0.04, 95% CI 0.02-0.06; p < .001). Pentasa (1-4 g/day) had similar treatment-related adverse event rates to placebo (ARD 0.02, 95% CI À0.03-0.06) and Eudragit-L/S mesalazines (2.25-3 vs 2.4-3 g/day, respectively; ARD À0.03, 95% CI À0.12-0.05), but was better tolerated than sulfasalazine (3 g/day) (ARD 0.07, 95% CI 0.003-0.14; p < .05). Conclusion:This study confirms oral Pentasa is efficacious and well-tolerated in treating active UC and maintaining remission. The availability of multiple forms of Pentasa supports physicians' ability to individualize treatment and optimize dosing to improve outcomes.

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Section: Discussionmentioning

confidence: 99%

Efficacy and safety of oral Pentasa (prolonged-release mesalazine) in mild-to-moderate ulcerative colitis: a systematic review and meta-analysis

Paridaens

Fullarton²,

Travis

2021

Current Medical Research and Opinion

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“…Nonadherence arises from many factors such as a patients' fear of side effects or different drug routes, to name a few. For example, topical therapy with suppositories/enemas used with corticosteroids and 5-ASAs has been associated with increased nonadherence over oral therapies [ 32 ]. Therefore, IBD being complex disease may require diverse and mutually interacting components.…”

Section: Current Interventions To Ibdmentioning

confidence: 99%

Inflammatory Bowel Disease Therapeutics: A Focus on Probiotic Engineering

Mishra

Stubbs

Kuang

et al. 2022

Mediators of Inflammation

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Inflammatory bowel disease (IBD) is a chronic inflammatory condition of gastrointestinal (GI) tract with dysregulated mucosal immune functions and disturbed commensal ecosystem of the intestinal lumen. IBD is categorized into two major subsets: Crohn’s disease (CD) and ulcerative colitis (UC). Though advent of biologics has shifted the treatment with relatively longer remission compared to small molecule pharmaceuticals, patients still suffer from long-term complications. Since gut-microbiome is now accepted as another human organ holding potential for long-lasting human health, probiotics, and its engineering hold great promises to treat several previously untreatable chronic inflammatory conditions including IBD. Several emerging biological engineering tools have unlimited potential to manipulate probiotic bacterial system. These can produce useful therapeutic biologics with a goal to either ameliorate and/or treat previously untreatable chronic inflammatory conditions. As gut-microbiome is diverse and vary in different ethnic, geographic, and cultural human population, it will be important to develop vision for personalized probiotic treatment and develop the technology thereof to make personalized probiotic options a reality. The aim of this review paper is to present an overview of the current knowledge on both pharmacological and nonpharmacological IBD treatment modalities with a special emphasis on probiotic strains that are developed through the probiotic engineering. These engineered probiotics contain the most anti-inflammatory cytokines found within the human immune response and are currently being used to treat the intestinal inflammation in IBD for the IBD treatment.

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“…10 The main approaches used for optimisation of 5-ASA are the use of combined oral plus rectal therapy and maximising oral doses. 10 A number of studies have shown that these approaches can increase the effectiveness of 5-ASA therapy. [11][12][13] A further step in 5-ASA optimisation has been the use of once daily dosing, which has demonstrated equivalent efficacy to divided dosing regimens and can improve patient adherence to treatment.…”

Section: What Are the New Findings?mentioning

confidence: 99%

Modelling the benefits of an optimised treatment strategy for 5-ASA in mild-to-moderate ulcerative colitis

Louis

Paridaens

Awadhi

et al. 2022

BMJ Open Gastroenterol

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Objectives5-aminosalicylate (mesalazine; 5-ASA) is an established first-line treatment for mild-to-moderate ulcerative colitis (UC). This study aimed to model the benefits of optimising 5-ASA therapy.MethodsA decision tree model followed 10 000 newly diagnosed patients with mild-to-moderately active UC through induction and 1 year of maintenance treatment. Optimised treatment (maximising dose of 5-ASA and use of combined oral and rectal therapy before treatment escalation) was compared with standard treatment (standard doses of 5-ASA without optimisation). Modelled data were derived from published meta-analyses. The primary outcomes were patient numbers achieving and maintaining remission, with an analysis of treatment costs for each strategy conducted as a secondary outcome (using UK reference costs).ResultsDuring induction, there was a 39% increase in patients achieving remission through the optimised pathway without requiring systemic steroids and/or biologics (6565 vs 4725 for standard). Potential steroidal/biological adverse events avoided included: seven venous thromboembolisms and eight serious infections. Out of the 6565 patients entering maintenance following successful induction on 5-ASA, there was a 21% reduction in relapses when optimised (1830 vs 2311 for standard). This translated into 297 patients avoiding further systemic steroids and 214 biologics. Optimisation led to an average net saving of £272 per patient entering the model for the induction and maintenance of remission over 1 year.ConclusionModelling suggests that optimising 5-ASA therapy (both the inclusion of rectal 5-ASA into a combined oral and rectal regimen and maximisation of 5-ASA dose) has clinical and cost benefits that supports wider adoption in clinical practice.

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Key Strategies to Optimize Outcomes in Mild-to-Moderate Ulcerative Colitis

Cited by 14 publications

References 95 publications

Efficacy and safety of oral Pentasa (prolonged-release mesalazine) in mild-to-moderate ulcerative colitis: a systematic review and meta-analysis

Efficacy and safety of oral Pentasa (prolonged-release mesalazine) in mild-to-moderate ulcerative colitis: a systematic review and meta-analysis

Inflammatory Bowel Disease Therapeutics: A Focus on Probiotic Engineering

Modelling the benefits of an optimised treatment strategy for 5-ASA in mild-to-moderate ulcerative colitis

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