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Original research
Comparative effectiveness of a second-line biologic in patients with ulcerative colitis: vedolizumab followed by an anti-TNF versus anti-TNF followed by vedolizumab
  1. Charles Miller1,
  2. Hanson Kwok1,
  3. Paul Harrow1,
  4. Roser Vega1,
  5. Edward Seward1,
  6. Shameer Mehta1,
  7. Farooq Rahman1,
  8. Sara McCartney1,
  9. Ioanna Parisi1,
  10. Samuel Hsiang Lim2,
  11. Esha Sharma2,
  12. Mark A Samaan2,
  13. Aaron Bancil3,
  14. Klaartje Bel Kok3,
  15. Ahmed Shalabi4,
  16. Emma L Johnston4,
  17. Dev Katarey5,
  18. Nina Taherzadeh5,
  19. Charles Murray5,
  20. Mohammed Tauseef Sharip6,
  21. Martyn J Carter6,
  22. Shiva T Radhakrishnan7,
  23. Simon Peake7,
  24. Imran Khakoo8,
  25. Mahmood Wahed8,
  26. Sebastian Povlsen9,
  27. Mehul Patel9,
  28. Patrick DuBois9,
  29. Jemima Finkel10,
  30. Clive Onnie10,
  31. Stuart Bloom1
  1. 1Department of Gastroenterology, University College Hospital, London, UK
  2. 2Department of Gastroenterology, Guy's and Thomas' Hospital, London, UK
  3. 3Department of Gastroenterology, Royal London Hospital, London, UK
  4. 4Department of Gastroenterology, West Middlesex Hospital, London, UK
  5. 5Department of Gastroenterology, Royal Free Hospital London, London, UK
  6. 6Department of Gastroenterology, Lister Hospital, Stevenage, UK
  7. 7Departments of Gastroenterology and Hepatology, St Mary's Hospital, Imperial College Healthcare NHS Trust, London, UK
  8. 8Departments of Gastroenterology, Chelsea and Westminster Hospital, London, UK
  9. 9Department of Gastroenterology, King's College Hospital, London, UK
  10. 10Department of Gastroenterology, Whittington Hospital, London, UK
  1. Correspondence to Dr Charles Miller, Gastroenterology, University College Hospital London, London, UK; charles.miller{at}nhs.net

Abstract

Background Sequential drug treatment with biological agents in ulcerative colitis (UC) is becoming increasingly complex. There are few studies comparing head-to-head outcomes in second-line treatments. The study assesses whether using anti-tumour necrosis factor (anti-TNF)-α therapy following the α4β7 integrin blocker vedolizumab (VDZ) or VDZ after an anti-TNF has more favourable clinical outcomes in UC in a real-world outpatient setting.

Methods Patients with UC who were exposed to first-line anti-TNF (adalimumab or infliximab) or VDZ who subsequently switched to the alternate class between May 2013 and August 2020 were identified by reviewing patient databases at 10 hospitals. Data were collected retrospectively using patient records. Baseline demographics, disease activity indices, biochemical markers, endoscopic Mayo score, colectomy rates, treatment persistence and urgent hospital utilisation composite endpoint (UHUC) rates were examined over a 52-week period.

Results Second-line week 52 treatment persistence was higher in the VDZ group (71/81, 89%) versus the anti-TNF group (15/34, 44%; p=0.0001), as were week 52 colectomy-free survival (VDZ: 77/80, 96%, vs anti-TNF: 26/32, 81%; p=0.009), week 52 UHUC survival (VDZ: 68/84, 81%, vs anti-TNF: 20/34, 59%; p=0.002) and week 52 corticosteroid-free clinical remission (CFCR) rates (VDZ: 22/34, 65%, vs anti-TNF: 4/20, 20%; p=0.001).

Conclusion Compared with second-line anti TNF usage, the VDZ second-line cohort had significantly higher 52-week treatment persistence, UHUC survival, higher colectomy-free survival rates and higher week 52 CFCR. These data suggest that VDZ is an effective biologic in UC as a second-line therapy after anti-TNF exposure. It highlights the effect of biological order on clinically important outcomes.

  • IBD clinical
  • ulcerative colitis
  • inflammatory bowel disease

Data availability statement

Data are available upon reasonable request. Deidentified participant data are available on reasonable request. This can be requested by email to Dr Charles Miller (charles.miller@nhs.net)

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Data availability statement

Data are available upon reasonable request. Deidentified participant data are available on reasonable request. This can be requested by email to Dr Charles Miller (charles.miller@nhs.net)

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Footnotes

  • Contributors SB, CMi and HK were responsible for the original concept and planning of the study. CMi, HK, SHL, ES, AB, AS, DK, NT, MTS, STR, IK, SPo, MP and JF performed the data collection and analysis. CMi performed the data analysis and drafted the manuscript. PH, RV, ES, SM, FR, SM, IP, MAS, KBK, ELJ, CMu, MJC, SPe, MW, PD, CO and SB critically reviewed and revised the manuscript. SB is the senior author on the paper and is the guarantor of the article.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests SB has acted as an advisor for Takeda, Johnson & Johnson, Sublimity Therapeutics, Tillotts and Janssen. MAS served as a speaker, a consultant and/or advisory board member for Janssen, Sandoz, Takeda, MSD, Falk, Samsung Bioepis, Galapagos and Bristol-Myers Squibb.

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

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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