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COVID-19
Effect of IBD medications on COVID-19 outcomes: results from an international registry
  1. Ryan C Ungaro1,
  2. Erica J Brenner2,
  3. Richard B Gearry3,
  4. Gilaad G Kaplan4,
  5. Michele Kissous-Hunt1,5,
  6. James D Lewis6,
  7. Siew C Ng7,
  8. Jean-Francois Rahier8,
  9. Walter Reinisch9,
  10. Flávio Steinwurz10,
  11. Fox E Underwood4,
  12. Xian Zhang2,
  13. Jean-Frederic Colombel1,
  14. Michael D Kappelman2
  1. 1The Henry D Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York, USA
  2. 2University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
  3. 3Department of Medicine, University of Otago, Christchurch, New Zealand
  4. 4Departments of Medicine and Community Health Sciences, University of Calgary, Calgary, Alberta, Canada
  5. 5Fifth Ave GI, New York, New York, USA
  6. 6Division of Gastroenterology, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA
  7. 7Department of Medicine and Therapeutics, Institute of Digestive Disease, State Key Laboratory of Digestive Disease, Li Ka Shing Institute of Health Science, Chinese University of Hong Kong, Shatin, NT, Hong Kong
  8. 8Department of Gastroenterology, Université Catholique de Louvain, Yvoir, Belgium
  9. 9Department of Medicine IV, Medical University Vienna, Vienna, Austria
  10. 10Department of Gastroenterology, Hospital Israelita Albert Einstein, Sao Paulo, Brazil
  1. Correspondence to Dr Ryan C Ungaro, The Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA; ryan.ungaro{at}mssm.edu

Abstract

Objective We sought to evaluate COVID-19 clinical course in patients with IBD treated with different medication classes and combinations.

Design Surveillance Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) is a large, international registry created to monitor outcomes of IBD patients with confirmed COVID-19. We used multivariable regression with a generalised estimating equation accounting for country as a random effect to analyse the association of different medication classes with severe COVID-19, defined as intensive care unit admission, ventilator use and/or death.

Results 1439 cases from 47 countries were included (mean age 44.1 years, 51.4% men) of whom 112 patients (7.8%) had severe COVID-19. Compared with tumour necrosis factor (TNF) antagonist monotherapy, thiopurine monotherapy (adjusted OR (aOR) 4.08, 95% CI 1.73 to 9.61) and combination therapy with TNF antagonist and thiopurine (aOR 4.01, 95% CI 1.65 to 9.78) were associated with an increased risk of severe COVID-19. Any mesalamine/sulfasalazine compared with no mesalamine/sulfasalazine use was associated with an increased risk (aOR 1.70, 95% CI 1.26 to 2.29). This risk estimate increased when using TNF antagonist monotherapy as a reference group (aOR 3.52, 95% CI 1.93 to 6.45). Interleukin-12/23 and integrin antagonists were not associated with significantly different risk than TNF antagonist monotherapy (aOR 0.98, 95% CI 0.12 to 8.06 and aOR 2.42, 95% CI 0.59 to 9.96, respectively).

Conclusion Combination therapy and thiopurines may be associated with an increased risk of severe COVID-19. No significant differences were observed when comparing classes of biologicals. These findings warrant confirmation in large population-based cohorts.

MKH should be changed to MDK for co-last author line

  • inflammatory bowel disease
  • infectious disease

Data availability statement

Data are available on reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information. All raw data are available at the SECURE-IBD website at covidibd.org.

This article is made freely available for use in accordance with BMJ’s website terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. You may use, download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained.

https://bmj.com/coronavirus/usage

https://doi.org/10.1136/gutjnl-2020-322539

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    Data availability statement

    Data are available on reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information. All raw data are available at the SECURE-IBD website at covidibd.org.

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    Footnotes

    • Twitter @gilkaplan

    • J-FC and MDK contributed equally.

    • Correction notice This article has been corrected since it published Online First. The co-author statement has been corrected.

    • Contributors RCU: conceptualisation, formal analysis, investigation, funding acquisition, methodology and writing original draft. EB: conceptualisation, formal analysis, investigation, methodology and writing – review and editing. RG, GGK, MK-H, JDL, SCN, JFR, WR and FS: formal analysis, writing – review and editing. FEU: visualisation, software, writing – review and editing. XZ: data curation, formal analysis, methodology, writing – review and editing. J-FC and MK: conceptualisation, formal analysis, investigation, methodology, writing original draft and supervision.

    • Funding This work was funded by the Helmsley Charitable Trust (2003-04445), CTSA grant number UL1TR002489 and a K23KD111995-01A1 (RCU). Additional funding provided by Pfizer, Takeda, Janssen, Abbvie, Lilly, Genentech, Boehringer Ingelheim, Bristol Myers Squibb, Celtrion and Arenapharm.

    • Competing interests RCU has served as an advisory board member or consultant for Eli Lilly, Janssen, Pfizer and Takeda; research support from AbbVie, Boehringer Ingelheim and Pfizer. EB: no conflicts of interest. RG: speaker fees and Scientific Advisory Boards for AbbVie and Janssen. GGK: honoraria for speaking or consultancy from Abbvie, Janssen, Pfizer and Takeda. He has received research support from Ferring, Janssen, Abbvie, GlaxoSmith Kline, Merck and Shire. Ownership of a patent: treatment of inflammatory disorders, autoimmune disease, and PBC. UTI Limited Partnership, assignee. Patent WO2019046959A1. PCT/CA2018/051098. 7 September 2018. MK-H: speaker/consultant for AbbVie, Janssen and Takeda. JDL: personal fees from Johnson & Johnson Consumer Inc; grants, personal fees and other from Takeda Pharmaceuticals; personal fees and non-financial support from AbbVie; grants and personal fees from Janssen Pharmaceuticals; personal fees from Eli Lilly and Company; personal fees from Samsung Bioepis; personal fees from UCB; personal fees from Bristol-Myers Squibb; grants and personal fees from Nestle Health Science; personal fees from Bridge Biotherapeutics; personal fees from Celgene; personal fees from Merck; personal fees and other from Pfizer; personal fees from Gilead; personal fees from Arena Parmaceuticals; and personal fees from Protagonist Therapeutics. SCN: honoraria for speaking or consultancy from Abbvie, Janssen, Ferring, Tillotts and Takeda; research support from Ferring and AbbVie. WR has served as a speaker for Abbott Laboratories, Abbvie, Aesca, Aptalis, Astellas, Centocor, Celltrion, Danone Austria, Elan, Falk Pharma GmbH, Ferring, Immundiagnostik, Mitsubishi Tanabe Pharma Corporation, MSD, Otsuka, PDL, Pharmacosmos, PLS Education, Schering-Plough, Shire, Takeda, Therakos, Vifor and Yakult. He has been a consultant for Abbott Laboratories, Abbvie, Aesca, Algernon, Amgen, AM Pharma, AMT, AOP Orphan, Arena Pharmaceuticals, Astellas, Astra Zeneca, Avaxia, Roland Berger GmBH, Bioclinica, Biogen IDEC, Boehringer-Ingelheim, Bristol-Myers Squibb, Cellerix, Chemocentryx, Celgene, Centocor, Celltrion, Covance, Danone Austria, DSM, Elan, Eli Lilly, Ernest & Young, Falk Pharma GmbH, Ferring, Galapagos, Genentech, Gilead, Grünenthal, ICON, Index Pharma, Inova, Intrinsic Imaging, Janssen, Johnson & Johnson, Kyowa Hakko Kirin Pharma, Lipid Therapeutics, LivaNova, Mallinckrodt, Medahead, MedImmune, Millenium, Mitsubishi Tanabe Pharma Corporation, MSD, Nash Pharmaceuticals, Nestle, Nippon Kayaku, Novartis, Ocera, OMass, Otsuka, Parexel, PDL, Periconsulting, Pharmacosmos, Philip Morris Institute, Pfizer, Procter & Gamble, Prometheus, Protagonist, Provention, Robarts Clinical Trial, Sandoz, Schering-Plough, Second Genome, Seres Therapeutics, Setpointmedical, Sigmoid, Sublimity, Takeda, Therakos, Theravance, Tigenix, UCB, Vifor, Zealand, Zyngenia and 4SC. He has been as an advisory board member for Abbott Laboratories, Abbvie, Aesca, Amgen, AM Pharma, Astellas, Astra Zeneca, Avaxia, Biogen IDEC, Boehringer-Ingelheim, Bristol-Myers Squibb, Cellerix, Chemocentryx, Celgene, Centocor, Celltrion, Danone Austria, DSM, Elan, Ferring, Galapagos, Genentech, Grünenthal, Inova, Janssen, Johnson & Johnson, Kyowa Hakko Kirin Pharma, Lipid Therapeutics, MedImmune, Millenium, Mitsubishi Tanabe Pharma Corporation, MSD, Nestle, Novartis, Ocera, Otsuka, PDL, Pharmacosmos, Pfizer, Procter & Gamble, Prometheus, Sandoz, Schering-Plough, Second Genome, Setpointmedical, Takeda, Therakos, Tigenix, UCB, Zealand, Zyngenia and 4SC. He has received research funding from Abbott Laboratories, Abbvie, Aesca, Centocor, Falk Pharma GmbH, Immundiagnsotik and MSD. FR: consultation fee, research grant or honorarium from Janssen, Pfizer, Abbvie, Takeda, Celgene, Nestlé Health Science and Nestlé Nutrition Institute. FS: speaker and consultant for: AbbVie, Eurofarma, Ferring, Janssen, Pfizer, Sanofi, Takeda and UCB. FEU: no conflicts of interest. XZ: no conflicts of interest. J-FC: research grants from AbbVie, Janssen Pharmaceuticals and Takeda; receiving payment for lectures from AbbVie, Amgen, Allergan, Inc, Ferring Pharmaceuticals, Shire and Takeda; receiving consulting fees from AbbVie, Amgen, Arena Pharmaceuticals, Boehringer Ingelheim, Celgene Corporation, Celltrion, Eli Lilly, Enterome, Ferring Pharmaceuticals, Genentech, Janssen Pharmaceuticals, Landos, Ipsen, Medimmune, Merck, Novartis, Pfizer, Shire, Takeda, Tigenix and Viela bio; and hold stock options in Intestinal Biotech Development and Genfit. MK has consulted for AbbVie, Janssen and Takeda, is a shareholder in Johnson & Johnson and has received research support from AbbVie and Janssen.

    • Provenance and peer review Not commissioned; externally peer reviewed.

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