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P404 Stopping 5-aminosalicylates in Crohn’s disease patients starting biologic therapy does not increase the risk of adverse clinical outcomes: analysis of two nationwide population-based cohorts

R. Ungaro*1, B. Limketkai2, C. B. Jensen3, C. Yzet4, K. H. Allin3, M. Agrawal5, J. Burisch3, T. Ullman6, T. Jess3, J-F. Colombel1

1Icahn School of Medicine at Mount Sinai, Division of Gastroenterology, New York, USA, 2Division of Gastroenterology and Hepatology, Stanford University School of Medicine, Stanford, USA, 3Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark, 4Amiens University Hospital, Amiens, France, 5Division of Gastroenterology and Hepatology, Lenox Hill Hospital, New York, USA, 6Division of Gastroenterology, Montefiore Medical Center, Albert Einstein College of Medicine, New York, USA

Background

The impact of discontinuing 5-aminosalycilates (5-ASA) in Crohn’s disease (CD) patients who initiate anti-tumour necrosis factor α (anti-TNF) biologics is unknown. We aimed to compare clinical outcomes in CD patients already on 5-ASA who started anti-TNF and then either stopped or continued 5-ASA.

Methods

We analysed two national databases: the USA (U.S.) Truven MarketScan health claims database and the Denmark health registers. CD patients who started anti-TNF after having been on oral 5-ASA for at least 90 days were included. Patients were classified as stopping 5-ASA if therapy was discontinued within 90 days of starting anti-TNF. Our primary outcome was any adverse clinical event defined as a composite of new corticosteroid use, CD-related hospitalisation or surgery. We performed Kaplan–Meier analyses and multivariable Cox regression models controlling for age, gender, duration of 5-ASA treatment before anti-TNF initiation, prior CD-related surgery, disease duration (Danish database only) and healthcare utilisation (corticosteroid use, hospitalisations and emergency department visits in year prior to anti-TNF). Adjusted hazard ratios (aHR) with 95% confidence intervals (95% CI) are reported comparing stopping 5-ASA with continuing 5-ASA.

Results

A total of 3,178 CD patients were included (2,960 USA and 218 Denmark). 1,044 patients in the US cohort and 106 patients in the Danish cohort stopped 5-ASA after starting anti-TNF. In both cohorts, cumulative rates of the adverse clinical events composite primary outcome were similar when comparing those who stopped vs. those who continued 5-ASA (Figures 1 and 2). In multivariable analysis, stopping 5-ASA after initiating anti-TNF was not associated with an increased risk of adverse clinical events in the U.S. cohort (aHR 0.89, 95% CI 0.77–1.03, p = 0.13) nor in the Danish cohort (aHR 1.13, 95% CI 0.68–1.87, p = 0.63). Results were similar in sensitivity analyses investigating concomitant immunomodulator use and duration of 5-ASA treatment before initiating anti-TNF.

Conclusion

In two national databases, stopping 5-ASA in CD patients starting anti-TNF therapy did not increase the risk of adverse clinical events. These results should be validated in a prospective clinical trial.

Figure 1. Cumulative rates of CD patients with adverse clinical events (composite of new corticosteroid use, CD-related hospitalisation or surgery) comparing those who continued or stopped 5-ASA in the USA cohort.

Figure 2. Cumulative rates of CD patients with adverse clinical events (composite of new corticosteroid use, CD-related hospitalisation or surgery) comparing those who continued or stopped 5-ASA in the Danish cohort.