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Am J Gastroenterol. 2018 Aug;113(8):1197-1205. doi: 10.1038/s41395-018-0144-2. Epub 2018 Jun 21.

No Benefit of Concomitant 5-Aminosalicylates in Patients With Ulcerative Colitis Escalated to Biologic Therapy: Pooled Analysis of Individual Participant Data From Clinical Trials.

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Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA.
Division of Biomedical Informatics, University of California San Diego, La Jolla, CA, USA.
Biostatistics Unit, Altman Clinical and Translational Research Institute, La Jolla, USA.
Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA.
Division of Epidemiology and Biostatistics, Western University, London, ON, Canada.
Department of Medicine, Division of Gastroenterology, University Hospital, London, ON, Canada.
Gastroenterology Unit, Amiens University and Hospital, Université de Picardie Jules Verne, Amiens, France.
Department of Family Medicine and Public Health and Department of Mathematics, University of California San Diego, La Jolla, CA, USA.



5-aminosalicylates (5-ASA) are frequently continued in patients with moderate-severe ulcerative colitis (UC), even after escalation to biologic agents, without evaluation of the benefit of this approach. We conducted an individual participant data (IPD) pooled analysis of trials of infliximab and golimumab in UC, to evaluate whether concomitant use of 5-ASA modifies clinical outcomes among anti-tumor necrosis factor (TNF)-α-treated patients.


We included IPD from five trials of infliximab and golimumab in patients with moderate-severe UC (ACT-1 and -2, PURSUIT-SC, PURSUIT-M, NCT00336492). Patients treated with infliximab or golimumab were categorized as receiving concomitant 5-ASA or not at time of trial entry. Primary outcome was clinical remission (Mayo Clinic Score < 3) at last follow-up for each trial; secondary outcomes were clinical response and mucosal healing. Using multivariable logistic regression analysis, we evaluated association between concomitant 5-ASA and clinical remission, after adjusting for sex, smoking, baseline disease activity, disease extent, biochemical variables (C-reactive protein, albumin, hemoglobin), and concomitant prednisone and immunomodulators.


We included 2183 infliximab-treated or golimumab-treated patients (1715 [78.6%] on 5-ASA). Concomitant use of 5-ASA was not associated with odds of achieving clinical remission (adjusted OR, 0.67 [95% CI, 0.45-1.01], p = 0.06), clinical response (aOR, 0.89 [0.60-1.33], p = 0.58) or mucosal healing (aOR, 1.12 [0.82-1.51], p = 0.48). These results were consistent in trials of induction and maintenance therapy, and in trials of infliximab and golimumab.


Based on IPD pooled analysis, in patients with moderate-severe UC who are escalated to anti-TNF therapy, continuing 5-ASA does not improve clinical outcomes.


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