Stopping 5-aminosalicylates in patients with ulcerative colitis starting biologic therapy does not increase the risk of adverse clinical outcomes: analysis of two nationwide population-based cohorts. Issue 6 (12th November 2018)

• Record Type: Journal Article
• Authors: Ungaro, Ryan C; Limketkai, Berkeley N; Jensen, Camilla Bjørn; Allin, Kristine Højgaard; Agrawal, Manasi; Ullman, Thomas; Colombel, Jean-Frederic; Jess, Tine
• Is Part Of: Gut. Volume 68:Issue 6(2019)
• Page Start: 977
• Page End: 984
• Publication Date: 2018-11-12
• Subjects: ulcerative colitis -- biologic -- mesalamine -- 5-aminosalicylates; Gastroenterology -- Periodicals; 616.33
• DOI: 10.1136/gutjnl-2018-317021
• Languages: English
• ISSNs: 0017-5749

Abstract

Abstract : Objective: The benefit of continuing 5-aminosalicylate (5-ASA) in patients with ulcerative colitis (UC) who initiate anti-tumour necrosis factor-alpha (anti-TNF) biologics is unknown. We aimed to compare clinical outcomes in patients with UC already on 5-ASA who started anti-TNF and then either stopped or continued 5-ASA. Design: Our primary outcome was any adverse clinical event defined as a composite of new corticosteroid use, UC-related hospitalisation or surgery. We used two national databases: the United States (US) Truven MarketScan health claims database and the Danish health registers. Patients with UC 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. We performed multivariable Cox regression models controlling for demographics, clinical factors and healthcare utilisation. Adjusted HRs (aHR) with 95% CI are reported comparing stopping 5-ASA with continuing 5-ASA. Results: A total of 3589 patients with UC were included (2890 US and 699 Denmark). Stopping 5-ASA after initiating anti-TNF was not associated with an increased risk of adverse clinical events in the U.S. cohort (aHR 1.04; 95% CI 0.90 to 1.21, p=0.57) nor in the Danish cohort (aHR 1.09; 95% CI 0.80 to 1.49, p=0.60). 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 patients with UC starting anti-TNF therapy did not increase the risk of adverse clinical events. These results should be validated in a prospective clinical trial.