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Original research
Real-world clinical effectiveness of ustekinumab in the treatment of Crohn’s disease in the East Midlands UK
  1. Jonathan Richard White1,
  2. Saqib Ahmad2,
  3. Fahad Ashraf2,
  4. Stephen Foley2,
  5. Said Din3,
  6. Ronit Kumar Das4,
  7. Nina Mary Charles4,
  8. João Pinheiro4,
  9. Altaf Palejwala4,
  10. Pamela Wright5,
  11. Manoharan Andiappan6,
  12. Myriam Alexander6,
  13. Burhan Uddin7,
  14. Deloar Hoshen7,
  15. David Elphick7,
  16. Tufail Qamar8,
  17. Nivin Rezwan8,
  18. Mohammad Viquaruddin Hamza8,
  19. John Glover8,
  20. Richard Robinson8,
  21. Veena Gopakumar9,
  22. Aamir Sajjad10,
  23. Muhammad Shahzad10,
  24. Gordon Moran1
  1. 1GI and Liver Theme, NIHR Nottingham Biomedical Research Centre, Nottingham, UK
  2. 2Sherwood Forest Hospitals NHS Foundation Trust, Sutton-In-Ashfield, Nottinghamshire, UK
  3. 3Gastroenterology, Derby Teaching Hospitals, NHS Foundation Trust, Derby, UK
  4. 4University Hospitals of Derby and Burton NHS Foundation Trust, Derby, UK
  5. 5Janssen-Cilag Ltd, High Wycombe, Buckinghamshire, UK
  6. 6OPEN Health Communications LLP London, London, UK
  7. 7Chesterfield Royal Hospital NHS Foundation Trust, Chesterfield, Derbyshire, UK
  8. 8University Hospitals of Leicester NHS Trust, Leicester, UK
  9. 9United Lincolnshire Hospitals NHS Trust, Lincoln, UK
  10. 10Kettering General Hospital NHS Foundation Trust, Kettering, Northamptonshire, UK
  1. Correspondence to Dr Jonathan Richard White, GI and Liver Theme, NIHR Nottingham Biomedical Research Centre, Nottingham NG7 2UH, UK; jonathan.white{at}nottingham.ac.uk

Abstract

Objectives To evaluate the effectiveness of ustekinumab in treating Crohn’s disease (CD) in a UK real-world setting.

Design This was a multicentre, retrospective observational study of patients (aged ≥18 years) with CD or inflammatory bowel disease of unclassified type (IBDU) starting ustekinumab between 11 November 2016 and 1 August 2020 across eight English hospitals. The primary objective was to determine the proportion of patients achieving corticosteroid-free remission at week 52 for patients with CD/IBDU following initiation with ustekinumab. Corticosteroid-free remission was defined as achieving a clinical Harvey-Bradshaw Index (HBI) score of ≤4 and corticosteroid-free status.

Results The analysis included 422 patients with CD/IBDU. Corticosteroid-free remission was 41% (68/166) at week 16, 41% (47/115) at week 30 and 48% (38/80) at week 52. Clinical remission was 51% (85/166) at week 16 and 50% (40/80) at week 52. Clinical response was 34% (43/125) at week 16 and 32% (17/53) at week 52. Objective remission was 40% (4/10) at week 16 and 70% (7/10) at week 52. Corticosteroid-free remission at week 52 was achieved in patients with previous exposure to 1–2 biologics and/or small oral molecules (56%; 35/63), those without surgical history (64%; 16/25), and those without penetrating disease (54%; 29/54). Patients who achieved clinical remission at week 16 were more likely to achieve corticosteroid-free remission at week 52 (70%; 14/20) versus those who did not (20%; 4/20). In total, 37 adverse events occurred in 21 patients.

Conclusion This multicentre study provides real-world experience of ustekinumab in patients with CD/IBDU in England.

  • INFLAMMATORY BOWEL DISEASE
  • CROHN'S DISEASE
  • IBD CLINICAL
  • IMMUNOTHERAPY

Data availability statement

Data are available upon reasonable request.

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Data availability statement

Data are available upon reasonable request.

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Footnotes

  • Contributors JRW, GM: conception/design, collection and/or assembly of data, data analysis and interpretation, manuscript writing, final approval of manuscript. SA, FA, SF, SD, RKD, NMC, JP, AP, BU, DH, DE, TQ, NR, MVH, JG, RR, VG, AS, MS: collection and/or assembly of data, final approval of manuscript; PW: conception/design, data interpretation, manuscript writing, final approval of manuscript. MAn: data analysis and final approval of manuscript; MAl: protocol and statistical analysis plan and final approval of manuscript; JRW is the guarantor.

  • Funding The study was funded by Janssen-Cilag Limited and sponsored by Nottingham University Hospital NHS Trust.

  • Competing interests Janssen-Cilag contributed to interpretation of data; in writing, reviewing, and approval of the final version. JRW is an employee of Nottingham University Hospital NHS Trust. SA, FA and SF are employees of Kings Mill Hospital. SD, RKD and NMC are employees of Royal Derby Hospital. RKD has received educational funding from Takeda. JP and AP are employees of Queens Hospital Burton NHS Trust. PW was an employee of Janssen-Cilag Ltd and may hold shares in Janssen Ltd. MAn and MAl were employees of OPEN Health. BU, DH and DE are employees of Chesterfield Royal Hospital NHS Foundation Trust. TQ, NR, MVH, JG and RR are employees of Leicester General Hospital. VG is an employee of Lincoln County Hospital. AS and MS are employees of Kettering General Hospital NHS Foundation Trust. GM is in receipt of research funding from Alimentiv, Astra Zeneca, Janssen and Bristol Myers Squibb. GW Moran has consulted on advisory boards from Abbvie and Pfizer, and works as a consultant for Alimentiv.

  • 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.