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. 2024 Jul;15(4):297-304.
doi: 10.1136/flgastro-2024-102668. Epub 2024 Apr 3.

Real-world effectiveness of upadacitinib in Crohn's disease: a UK multicentre retrospective cohort study

Alexander Thomas Elford  1   2 , Maria Bishara  3 , Nikolas Plevris  1 , Beatriz Gros  1   4 , Nathan Constantine-Cooke  5   6 , James Goodhand  3 , Nicholas A Kennedy  3   7 , Tariq Ahmad  3 , Charlie W Lees  1   6
Affiliations

Real-world effectiveness of upadacitinib in Crohn's disease: a UK multicentre retrospective cohort study

Alexander Thomas Elford et al. Frontline Gastroenterol. 2024 Jul.

Abstract

Background: Upadacitinib is a Janus kinase inhibitor, which has recently been approved for treating Crohn's disease. There are limited real-world studies on the outcomes of upadacitinib in Crohn's disease.

Objective: Our aim was to evaluate the outcomes of upadacitinib in a real-world Crohn's disease cohort.

Methods: We conducted a retrospective, multicentre, cohort study over a 2-year period across National Health Service (NHS) Lothian and Royal Devon University Healthcare NHS Foundation Trust. The primary outcome was treatment persistence at week 24. Secondary endpoints were corticosteroid-free clinical remission (Harvey-Bradshaw Index (HBI)<5) and biomarker remission (C-reactive protein (CRP)≤5 mg/L and faecal calprotectin (FCAL)<250 µg/g) at 12, 24 and 52 weeks. We recorded adverse events.

Results: 135 patients commenced upadacitinib as of the 1 January 2024, of which 93 patients with active Crohn's disease were included with a minimum of 12 weeks follow-up. The median follow-up time was 25 weeks (IQR 15-42 weeks). 82% of the cohort had exposure to at least two classes of advanced therapies, and 52% had exposure to at least three classes of advanced therapies. Treatment persistence was 87.1% at week 12, 81.7% at week 24 and 62.8% at week 52. Rates of clinical remission were 64% (42/66), 48% (22/46) and 38% (8/21) at weeks 12, 24 and 52, respectively. Significant reductions in HBI, CRP and FCAL were observed during follow-up. 14% (13/91) had a hospitalisation due to Crohn's disease. Adverse events occurred in 40% (37/93) of the cohort, of which 12% (11/93) were serious.

Conclusion: Upadacitinib was effective in a real-world, highly refractory, Crohn's disease cohort with good persistence.

Keywords: CROHN'S DISEASE; INFLAMMATORY BOWEL DISEASE.

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Conflict of interest statement

Competing interests: BG has served as consultant to Galapagos and Abbvie and as speaker for Abbvie, Janssen, Takeda, Pfizer and Galapagos. NP has served as a speaker for Janssen, Takeda and Pfizer. JG has received grants from F. Hoffmann-La Roche AG, grants from Biogen, grants from Celltrion Healthcare, grants from Galapagos NV, nonfinancial support from Immundiagnostik, outside the submitted work. NAK has acted as a consultant to Amgen, Bristol Myers Squibb, Celltrion, Falk, Janssen, Pfizer, Pharmacosmos, Galapagos, Takeda and Tillotts, received speaking fees from Amgen, Celltrion, Falk, Janssen, Pharmacosmos, Galapagos, Takeda and Tillotts and travel support from AbbVie, Falk, Janssen and Pharmacosmos. His institution has received grants from AbbVie, Biogen, Celgene, Celltrion, Galapagos, MSD, Napp, Pfizer, Pharmacosmos, Roche and Takeda. TA reports grants and non-financial support from F. Hoffmann-La Roche AG, grants from Biogen, grants from Celltrion Healthcare, grants from Galapagos NV, non-financial support from Immundiagnostik, personal fees from Biogen, grants and personal fees from Celltrion Healthcare, personal fees and nonfinancial support from Immundiagnostik, personal fees from Takeda, personal fees from ARENA, personal fees from Gilead, personal fees from Adcock Ingram Healthcare, personal fees from Pfizer, personal fees from Genentech, nonfinancial support from Tillotts, outside the submitted work. CWL has acted as a consultant to Abbvie, Janssen, Takeda, Pfizer, Galapagos, Bristol Myers Squibb, B.I., Sandoz, Novartis, GSK, Gilead, ViforPharma, Dr Falk and Iterative Health; he has received speaking fees and travel support from Pfizer, Janssen, Abbvie, Galapagos, MSD, Takeda, Shire, Ferring, Hospira and Dr Falk.

Figures

Figure 1
Figure 1
UpSet plot demonstrating advanced therapy exposure and combinations of advanced therapies.
Figure 2
Figure 2
(A) Changes in Harvey-Bradshaw Index (HBI) during follow-up; (B) changes in CRP during follow-up; (C) changes in faecal calprotectin during follow-up (graphs are depicted as Tukey plots. Kruskal-Wallis test used to determine significant differences between the three time points). (D) Kaplan-Meier curve showing persistence of upadacitinib therapy. Kaplan-Meier curve showing persistence of upadacitinib therapy (dotted line depicts persistence at weeks 12, 24 and 52, respectively). CRP, C-reactive protein.
See this image and copyright information in PMC

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