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Colorectal
Original research
Effectiveness of risankizumab induction and maintenance therapy for refractory Crohn’s disease: a real-world experience from a preapproval access programme and early access to medicines scheme
  1. Benjamin Zare1,2,
  2. Beatriz Gros3,4,
  3. Natasha Lal1,
  4. Patrick Dawson1,
  5. Esha Sharma1,
  6. Robin J Dart1,
  7. Samuel Lim1,
  8. Shuvra Ray1,
  9. Simon H C Anderson1,
  10. Joel Mawdsley1,
  11. Peter M Irving1,
  12. Charlie W Lees3,5,
  13. Mark A Samaan1
  1. 1IBD Centre, Guy's and St Thomas' NHS Foundation Trust, London, UK
  2. 2St Mark's Hospital and Academic Institute, London, UK
  3. 3The Edinburgh IBD Unit, Western General Hospital, Edinburgh, UK
  4. 4Reina Sofia University Hospital, Cordoba, Spain
  5. 5Centre for Genomics and Experimental Medicine, Institute of Genetics and Cancer, University of Edinburgh Western General Hospital, Edinburgh, UK
  1. Correspondence to Dr Benjamin Zare; b.zare{at}nhs.net

Abstract

Objective Since approval in Crohn’s disease (CD) of risankizumab, there has been widespread use. Real-world data are, however, limited and our aim is to address that gap.

Design/method We performed a retrospective, observational study of risankizumab use in patients with CD starting treatment between January 2021 and January 2023 at two UK centres. Clinical activity, biochemical and faecal biomarkers were measured at baseline, weeks 4, 12, 28 and 52. The primary outcome was clinical response at weeks 12, 28 and 52.

Results 53 patients (51% women); median (range) age 40 years (20–70); median disease duration 15 years (6–52). Clinical response was observed in 33% (n=14/42), 45% (n=17/38) and 52% (n=13/25), and clinical remission in 31% (n=13/42), 40% (n=15/38) and 44% (n=11/25) at weeks 12, 28 and 52, respectively. Median C reactive protein decreased from 12 mg/L (IQR: 4–30; n=50) at baseline to 6 mg/L (IQR: 2–16; p=0.03 vs baseline; n=49) at week 12, 3 mg/L (IQR: 2–8, p=0.003; n=44) at week 28 and 3 mg/L (IQR 1–4, p=0.007; n=31) at week 52. Median faecal calprotectin concentration was 668 µg/g (IQR: 246–1098; n=32) at baseline, 298 µg/g (IQR: 176–546, p=NS; n=21) at week 12, 358 µg/g (IQR: 133–622, p=0.03; n=14) at week 28 and 63 µg/g (IQR: 38–120, p=0.007; n=12) at week 52.

12 out of 18 patients discontinued corticosteroids at week 12, 16 by week 28 and 18 by week 52. Four major adverse events—three elective and one emergency surgery—were recorded.

Conclusion Risankizumab is effective in a refractory real-world population with CD.

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

Data availability statement

Data are available on reasonable request.

https://doi.org/10.1136/flgastro-2024-102809

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    Data availability statement

    Data are available on reasonable request.

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    Footnotes

    • BZ and BG are joint first authors.

    • CWL and MAS are joint senior authors.

    • X @zare_benjamin, @SamaanMark

    • Contributors Guarantor of the article: MAS. Development of study concept and design: BZ, BG, ES, PD, CWL and MAS. Study supervision: CWL and MAS. Acquisition, analysis and interpretation of the data: BZ, BG, NL, ES, PD and SL. Statistical analysis: BZ and RJD. Drafting of the manuscript: BZ, BG, CWL and MAS. Critical revision of the manuscript for important intellectual content: RJD, SL, SR, SHCA, JM, PMI, CWL and MAS.

    • 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 BZ—education bursary: Dr Falk. BG—advisory fees: Galapagos and Abbvie; lecture fees: Abbvie, Jansen, Takeda, Pfizer and Galapagos. CWL—advisory fees: Abbvie, Janssen, Takeda, Pfizer, Galapagos, Bristol Myers Squibb, B.I., Sandoz, Novartis, GSK, Gilead, Vifor Pharma, Dr Falk, Trellus Health and Iterative Scopes; lecture fees: Pfizer, Janssen, Abbvie, Galapagos, MSD, Takeda, Shire, Ferring, Hospira and Dr Falk. MAS—Advisory fees: Janssen, Takeda, Sandoz, Samsung Bioepis, Galapagos, AbbVie, Bristol-Myers Squibb, Pfizer, Tillotts; lecture fees: Bristol-Myers Squibb, Janssen, Takeda, MSD, Falk, AbbVie, Galapagos.

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