Oral 5-aminosalicylic acid for maintenance of remission in ulcerative colitis

Murray, Alistair; Nguyen, Tran M; Parker, Claire E; Feagan, Brian G.; MacDonald, John K

doi:10.1002/14651858.cd000544.pub5

Cited by 55 publications

(67 citation statements)

References 136 publications

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“…However, none of the studies included MMX preparations or compared pH-dependent versus time-dependent preparation for doses >2.4 g, and the quality of evidence was considered to be poor. 1 In the current study we found differences in persistence between 5-ASA preparations in univariate analyses, whereas, in a multivariate analysis indicators of disease severity at treatment start and dose of 5-ASA, but not preparation type, was associated with persistence. Patients taking Mezavant used a higher daily dose (⩾0.5 g/day higher than patients using other preparations) and Mezavant and Salofalk users also had indications of milder disease at treatment start, which could explain the observed differences in persistence between preparations.…”

Section: Discussioncontrasting

confidence: 51%

“… 4 However, a therapeutic mucosal concentration range has yet to be identified 19 ; randomized clinical trials (RCTs) aiming to compare oral 5-ASA preparations are scarce and the different 5-ASA formulations are considered clinically equally efficient. 1 The current study was designed to enable assessment of possible differences in persistence between various oral 5-ASA preparations when used in monotherapy.…”

Section: Introductionmentioning

confidence: 99%

“…Meta-analyses of RCTs suggest a threshold for treatment effect at a minimum dose of 2.0 g/day for induction of remission or response, 2 and patients with moderately active UC may benefit from 4.8 g/day rather than 2.4 g/day. 1 , 20 – 22 Dosing of oral 5-ASA once or twice daily does not seem to affect clinical efficacy. 1 However, non-adherence to oral 5-ASA, defined as intake of <80% of the prescribed amount, is common in patients with UC in remission outside clinical trials.…”

Section: Introductionmentioning

confidence: 99%

“… 1 , 20 – 22 Dosing of oral 5-ASA once or twice daily does not seem to affect clinical efficacy. 1 However, non-adherence to oral 5-ASA, defined as intake of <80% of the prescribed amount, is common in patients with UC in remission outside clinical trials. 7 Patients who are non-adherent to 5-ASA maintenance therapy are far more likely to relapse than treatment-compliant patients, 8 , 23 and it is of clinical interest to identify factors associated with intake of a low dose of 5-ASA.…”

Section: Introductionmentioning

confidence: 99%

“…Introduction 5-Aminosalicylic acid (5-ASA) is the first-line therapy for patients with ulcerative colitis (UC) and is effective both for inducing and maintaining remission. 1,2 5-ASA is proposed to act through numerous mechanisms, including inhibition of pro-inflammatory mediators and peroxisome proliferator-activated receptor gamma (PPAR-γ) receptor agonism, 3 as well as altering the intestinal microbiota. 4 Drug persistence has emerged as a relevant parameter reflecting the long-term therapeutic performance of anti-inflammatory drugs in a reallife setting.…”

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confidence: 99%

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Factors associated with the persistence of oral 5-aminosalicylic acid monotherapy in ulcerative colitis: a nationwide Norwegian cohort study

Fossmark

Olaisen

Martinsen

et al. 2021

Therap Adv Gastroenterol

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Background: Oral 5-aminosalicylic acid (5-ASA) is the mainstay treatment of ulcerative colitis (UC) and therapy with oral 5-ASA is associated with beneficial outcomes. We have examined factors associated with the persistence of oral 5-ASA treatment in a national cohort of UC patients. Methods: Patients with newly diagnosed UC from 2010 to 2014 using oral 5-ASA monotherapy were identified by combining data from the Norwegian Patient Registry and the Norwegian Prescription Database. The median follow-up time was 1029 days. Drug persistence was defined as duration of oral 5-ASA preparation as monotherapy. Non-persistence of a oral 5-ASA preparation as monotherapy was defined as stopping oral 5-ASA, initiation of any further anti-inflammatory treatment including a course of glucocorticoids and a change to another oral 5-ASA preparation. Drug persistence was analyzed using the Kaplan–Meier method and influence of covariates on drug persistence was analyzed with the Cox proportional hazard model. Results: A total of 3421 patients were identified. The overall median 5-ASA drug persistence was 179 days. In univariate analyses, persistence was associated with preparation type and high-dose treatment, while oral glucocorticoid use or hospitalization around the start of oral 5-ASA were associated with shorter 5-ASA persistence. In multivariate analyses, oral glucocorticoids [HR 1.67 (1.54–1.80), p < 0.005] and hospitalization around start of 5-ASA [HR 1.23 (1.14–1.34), p < 0.005] were associated with non-persistence, whereas high dose (⩾3 g/day) 5-ASA was associated with longer persistence [HR 0.68 (0.65–0.71), p < 0.005]. Conclusion: High-dose treatment with oral 5-ASA was associated with longer persistence of oral 5-ASA monotherapy, whereas the presence of factors indicating more severe disease around initiation of 5-ASA monotherapy was associated with a shorter persistence.

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Section: Discussioncontrasting

confidence: 51%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

mentioning

confidence: 99%

See 3 more Smart Citations

Factors associated with the persistence of oral 5-aminosalicylic acid monotherapy in ulcerative colitis: a nationwide Norwegian cohort study

Fossmark

Olaisen

Martinsen

et al. 2021

Therap Adv Gastroenterol

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Ulcerative Colitis in Adults

Gros,

Kaplan

2023

JAMA

144

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ImportanceUlcerative colitis (UC) is a chronic inflammatory condition of the colon, with a prevalence exceeding 400 per 100 000 in North America. Individuals with UC have a lower life expectancy and are at increased risk for colectomy and colorectal cancer.ObservationsUC impairs quality of life secondary to inflammation of the colon causing chronic diarrhea and rectal bleeding. Extraintestinal manifestations, such as primary sclerosing cholangitis, occur in approximately 27% of patients with UC. People with UC require monitoring of symptoms and biomarkers of inflammation (eg, fecal calprotectin), and require colonoscopy at 8 years from diagnosis for surveillance of dysplasia. Risk stratification by disease location (eg, Montreal Classification) and disease activity (eg, Mayo Score) can guide management of UC. First-line therapy for induction and maintenance of remission of mild to moderate UC is 5-aminosalicylic acid. Moderate to severe UC may require oral corticosteroids for induction of remission as a bridge to medications that sustain remission (biologic monoclonal antibodies against tumor necrosis factor [eg, infliximab], α4β7 integrins [vedolizumab], and interleukin [IL] 12 and IL-23 [ustekinumab]) and oral small molecules that inhibit janus kinase (eg, tofacitinib) or modulate sphingosine-1-phosphate (ozanimod). Despite advances in medical therapies, the highest response to these treatments ranges from 30% to 60% in clinical trials. Within 5 years of diagnosis, approximately 20% of patients with UC are hospitalized and approximately 7% undergo colectomy. The risk of colorectal cancer after 20 years of disease duration is 4.5%, and people with UC have a 1.7-fold higher risk for colorectal cancer compared with the general population. Life expectancy in people with UC is approximately 80.5 years for females and 76.7 years for males, which is approximately 5 years shorter than people without UC.Conclusions and RelevanceUC affects approximately 400 of every 100 000 people in North America. An effective treatment for mild to moderate UC is 5-aminosalicylic acid, whereas moderate to severe UC can be treated with advanced therapies that target specific inflammation pathways, including monoclonal antibodies to tumor necrosis factor, α4β7 integrins, and IL-12 and IL-23 cytokines, as well as oral small molecule therapies targeting janus kinase or sphingosine-1-phosphate.

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