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

Abstract

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.

Analysis of the Medication Persistence Rate for and Adherence to Oral 5-Aminosalicylic Acid Preparations in Japanese Patients with Ulcerative Colitis: Study Using a Nationwide Claims Database

“…In this study, MPR at day 180 after the index date was 53.9% in the entire population; the result was similar to that of prior studies [ 12 , 13 , 20 , 22 ], despite differences in the analytical methods such as the study period and sample size. In the respect of adherence, the proportion of patient adherence was high in the entire population analyzed from index date.…”

“…The analyses of each oral formulation of 5-ASA suggested that both MPR and medication adherence were higher for the MMX formulation than for time-dependent or pH-dependent formulations, as seen in prior studies [ 12 , 13 , 20 ]. The clinical efficacy of oral 5-ASA preparations is known to be dose-dependent [ 23 ], and the persistence rate has been reported to be higher for patients prescribed high-dose 5-ASA [ 22 ]. Because the MMX formulation was prescribed at the highest dose and the fewest tables among three oral formulations, this might have resulted in a higher MPR for the MMX formulation.…”