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Concomitant 5-Aminosalicylate Therapy in Moderate-to-Severe Ulcerative Colitis Patients Escalated to Infliximab Is Not Beneficial

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Abstract

Background and Aims

While there is recent literature to support the discontinuation of 5-aminosalicylate (5-ASA) upon the initiation of biologics, continuing 5-ASA after treatment failure is relatively common. We aimed to assess the impact of concomitant 5-ASA therapy on clinical outcomes in ulcerative colitis (UC) patients escalated to infliximab.

Methods

This is a retrospective chart review of patients with moderate-to-severe UC started on infliximab between January 2012 and December 2017 at the University of Alberta. The primary outcome was clinical remission (partial Mayo score < 2) at 6 and 12 months. Secondary outcomes included endoscopic (endoscopic Mayo < 2) and deep remission (combined clinical and endoscopic remission) as well as the need for rescue therapy, hospitalization or colectomy. Univariate and multivariate logistic regression models were used to estimate the odds ratios and 95% CI for the outcomes.

Results

One hundred and twenty-one patients were followed over a period of 47 (SD = 34) months. Patients on 5-ASA had increased concomitant immunomodulator use (73.3% vs. 54.1%, p = 0.03). There was no difference in clinical remission at 6 (aOR 2.59, p = 0.07) or 12 months (aOR 0.43, p = 0.06). At 12 months, patients on concomitant 5-ASA were less likely to achieve endoscopic (aOR 0.08, p = 0.01) and deep remission (aOR 0.07, p = 0.02). Adverse outcomes such as need for rescue therapy, hospitalization, and colectomy did not differ between the groups.

Conclusions

Our data suggest that 5-ASA may be stopped in patients with moderate-to-severe UC who have been escalated to infliximab therapy as it has no additional benefit to control inflammation.

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Acknowledgments

We would like to acknowledge Calypse Agborsangaya for his statistical support. Results from this paper were presented via poster at Digestive Disease Week 2019 in San Diego, California. All authors have made substantial contributions to all of the following: (1) the conception and design of the study, or acquisition of data, or analysis and interpretation of data, (2) drafting the article or revising it critically for important intellectual content, and (3) final approval of the version to be submitted.

Funding

This work was supported by the University of Alberta Faculty of Medicine and Dentistry, the Department of Medicine and the Division of Gastroenterology.

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Authors and Affiliations

  1. Division of Gastroenterology, University of Alberta, 130 University Campus NW, Edmonton, AB, T6G 2X8, Canada

    Bhairavi Balram, Harshad Joshi, Karen Wong, Karen I. Kroeker, Levinus A. Dieleman, Brendan P. Halloran, Daniel C. Baumgart & Farhad Peerani

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  1. Bhairavi Balram
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  2. Harshad Joshi
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  8. Farhad Peerani
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Contributions

BB analyzed and interpreted the data, drafted the article, and revised it for critically important intellectual content. HJ was involved in the conception and design of study, acquisition of data, analysis and interpretation of data, and revision of the article for critically important intellectual content. KW, KIK, LAD, BPH, and DCB were involved in the analysis and interpretation of data and revision of the article for critically important intellectual content. FP was involved in the conception and design of study, acquisition of data, analysis and interpretation of data, drafting of the article, and revision of the article for critically important intellectual content.

Corresponding author

Correspondence to Farhad Peerani.

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Conflict of interest

BB and HJ have no conflicts of interest to disclose. KW has served on the advisory board of Ferring, Pfizer and AbbVie and has served on the speaker's bureau for AbbVie. KIK has received consulting fees from AbbVie, Janssen, Takeda and Ferring and has served on the speaker’s bureau for AbbVie and Janssen. LD has received consulting fees from AbbVie and Janssen and has served on the speaker’s bureau for AbbVie and Janssen. BPH has received consulting fees from AbbVie and Janssen and has served on the speaker’s bureau for AbbVie, Janssen, Shire and Pendopharm. DB has served over the past 15 years on external scientific advisory boards for 4d Pharma, Abbott, AbbVie, Allergan, Amgen, Astra Zeneca, Bayer, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb (BMS), Celgene, Cellerix, Centocor, CSL Behring, Dr. Falk, Elan, Eli Lilly, Ferring, Forward, Genentech, Gilead, Glaxo Smith Kline (GSK), Hitachi, Janssen, Johnson & Johnson, Merck, Merck Serono, Merck Sharp Dohme (MSD), Millenium, Novartis, Novo Nordisk, Ocera, Otsuka, PDL Biopharma, Pfizer, Prometheus, Recordati, Roche, Sandoz, Sanofi Aventis, Schering, Schering-Plough, Shield, Shire, Takeda, Theravance, TiGenix, Tilliotts Pharma AG, UCB Pharma and Vifor. All of his activities and contracts are in conformity with the “FSA-Kodex Fachkreise” (voluntary self-monitoring code for expert consultants to the pharmaceutical industry) and they have been checked and approved by the Faculty of Medicine. FP has received consulting fees from AbbVie, Janssen, Ferring, Takeda, Pfizer and Pharmascience and has served on the speaker’s bureau for AbbVie, Janssen, Takeda and Pfizer.

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Balram, B., Joshi, H., Wong, K. et al. Concomitant 5-Aminosalicylate Therapy in Moderate-to-Severe Ulcerative Colitis Patients Escalated to Infliximab Is Not Beneficial. Dig Dis Sci 66, 3985–3992 (2021). https://doi.org/10.1007/s10620-020-06704-6

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  • DOI: https://doi.org/10.1007/s10620-020-06704-6

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