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Original research
Early management of acute severe UC in the biologics era: development and international validation of a prognostic clinical index to predict steroid response
  1. Alex Adams1,
  2. Vipin Gupta1,2,
  3. Waled Mohsen1,3,
  4. Thomas P Chapman1,4,
  5. Deloshaan Subhaharan3,
  6. Pradeep Kakkadasam Ramaswamy3,
  7. Sudheer Kumar5,
  8. Saurabh Kedia5,
  9. Colleen GC McGregor1,
  10. Tim Ambrose1,
  11. Bruce D George1,
  12. Rebecca Palmer1,
  13. Oliver Brain1,
  14. Alissa Walsh1,
  15. Vineet Ahuja5,
  16. Simon P L Travis1,
  17. Jack Satsangi1
  1. 1Translational Gastroenterology Unit, University of Oxford, Oxford, UK
  2. 2Department of Gastroenterology, North Bristol NHS Trust, Bristol, UK
  3. 3Digestive Diseases Unit, Gold Coast University Hospital, Southport, Queensland, Australia
  4. 4Department of Gastroenterology, St Richard's and Worthing Hospitals, University Hospitals Sussex NHS Foundation Trust, West Sussex, UK
  5. 5Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India
  1. Correspondence to Dr Alex Adams, Translational Gastroenterology Unit, University of Oxford, Oxford, UK; Alex.adams{at}ndm.ox.ac.uk; Professor Jack Satsangi; jack.satsangi{at}ndm.ox.ac.uk

Abstract

Objectives We aimed to determine whether changes in acute severe colitis (ASC) management have translated to improved outcomes and to develop a simple model predicting steroid non-response on admission.

Design Outcomes of 131 adult ASC admissions (117 patients) in Oxford, UK between 2015 and 2019 were compared with data from 1992 to 1993. All patients received standard treatment with intravenous corticosteroids and endoscopic disease activity scoring (Ulcerative Colitis Endoscopic Index of Severity (UCEIS)). Steroid non-response was defined as receiving medical rescue therapy or surgery. A predictive model developed in the Oxford cohort was validated in Australia and India (Gold Coast University Hospital 2015–2020, n=110; All India Institute of Medical Sciences, New Delhi 2018–2020, n=62).

Results In the 2015–2019 Oxford cohort, 15% required colectomy during admission vs 29% in 1992–1993 (p=0.033), while 71 (54%) patients received medical rescue therapy (27% ciclosporin, 27% anti-tumour necrosis factor, compared with 27% ciclosporin in 1992–1993 (p=0.0015). Admission C reactive protein (CRP) (false discovery rate, p=0.00066), albumin (0.0066) and UCEIS scores (0.015) predicted steroid non-response. A four-point model was developed involving CRP of ≥100 mg/L (one point), albumin of ≤25 g/L (one point), and UCEIS score of ≥4 (1 point) or ≥7 (2 points). Patients scoring 0, 1, 2, 3 and 4 in the validation cohorts had steroid response rates of 100, 75.0%, 54.9%, 18.2% and 0%, respectively. Scoring of ≥3 was 84% (95% CI 0.70 to 0.98) predictive of steroid failure (OR 11.9, 95% CI 10.8 to 13.0). Colectomy rates in the validation cohorts were were 8%–11%.

Conclusions Emergency colectomy rates for ASC have halved in 25 years to 8%–15% worldwide. Patients who will not respond to corticosteroids are readily identified on admission and may be prioritised for early intensification of therapy.

  • ulcerative colitis
  • clinical decision making

Data availability statement

Data are available upon reasonable request. Please contact the corresponding authors for access to anonymised data.

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Data availability statement

Data are available upon reasonable request. Please contact the corresponding authors for access to anonymised data.

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Footnotes

  • AA, VG and WM are joint first authors.

  • Twitter @ColleenMcGreg15

  • Contributors JS proposed the study and is guarantor. WM, VG, DS, PKR, SKu and SKe collected the clinical data. AA and PKR performed the analysis. AA, JS, VG, WM and TPC contributed to the study design and prepared the first draft, and all authors interpreted the results, and reviewed and contributed to the final manuscript.

  • Funding This work is funded by the Oxford NIHR Biomedical Research Centre, Gastroenterology and Mucosal Immunity Theme.

  • Disclaimer The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.

  • Competing interests AW reported personal fees outside the submitted work from Ferring Pharmaceuticals, Janssen and Takeda. SPLT reported outside the submitted work receipt of grants/research support from AbbVie, Buhlmann, Celgene, IOIBD, Janssen, Lilly, Pfizer, Takeda, UCB, Vifor and Norman Collisson Foundation; consulting fees from AbbVie, Allergan, Amgen, Arena, Asahi, Astellas, Biocare, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Buhlmann, Celgene, Chemocentryx, Cosmo, Enterome, Ferring, Giuliani SpA, GSK, Genentech, Immunocore, Immunometabolism, Indigo, Janssen, Lexicon, Lilly, Merck, MSD, Neovacs, Novartis, NovoNordisk, NPS Pharmaceuticals, Pfizer, Proximagen, Receptos, Roche, Sensyne, Shire, Sigmoid Pharma, SynDermix, Takeda, Theravance, Tillotts, Topivert, UCB, VHsquared, Vifor and Zeria; speaker fees from AbbVie, Amgen, Biogen, Ferring, Janssen, Lilly, Pfizer, Shire and Takeda; and no stocks or share options. JS received lecture fees from Takeda and from the Falk Foundation.

  • Patient and public involvement Patients and/or the public were not involved in the design, conduct, reporting or dissemination plans of this research.

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

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