Efficacy and safety of biologics in primary sclerosing cholangitis with inflammatory bowel disease: A systematic review and meta-analysis

Ayesha Shah; Michael P. Jones; Gavin Callaghan; Thomas Fairlie; Xiaomin Ma; Emma L. Culver; Katherine Stuart; Peter De Cruz; James O'Beirne; James H. Tabibian; Axel Dignass; Ali Canbay; Gregory J. Gores; Gerald J. Holtmann

doi:10.1097/HC9.0000000000000347

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Efficacy and safety of biologics in primary sclerosing cholangitis with inflammatory bowel disease: A systematic review and meta-analysis

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Efficacy and safety of biologics in primary sclerosing cholangitis with inflammatory bowel disease: A systematic review and meta-analysis

Ayesha Shah, Michael P. Jones, Gavin Callaghan, Thomas Fairlie, Xiaomin Ma, Emma L. Culver, Katherine Stuart, Peter De Cruz, James O'Beirne, James H. Tabibian, …

Hepatology Communications, Vol.8, pp.1-14

2024

DOI: https://doi.org/10.1097/HC9.0000000000000347

PMCID: PMC10786591

PMID: 38206197

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Abstract

primary sclerosing cholangitis (PSC)

liver disease

biologics

inflammatory bowel disease

ulcerative colitis

Background: Primary sclerosing cholangitis (PSC) is an immune-mediated, chronic cholestatic liver disease. Currently, liver transplantation is the only established life-saving treatment. Several studies have evaluated the effect of different biologic therapies on PSC with inconclusive findings. We conducted a systematic review and meta-analysis to assess the effects of biologics in PSC and associated inflammatory bowel disease (IBD). Methods: MEDLINE, Scopus, and Embase were searched up to July 31, 2023, for studies reporting the effects of biologics in patients with PSC-IBD. Effects of biologic therapy on alkaline phosphatase, total bilirubin, ulcerative colitis response score, and adverse events were calculated and expressed as standardized difference of means (SMD), proportions, and 95% CI using a random-effects model. Results: Six studies, including 411 PSC-IBD patients who received biologics, were included. Biologic treatment was associated with no change in alkaline phosphatase (SMD: 0.1, 95% CI: −0.07 −0.17, p=0.43), but a small and statistically significant increase in total bilirubin (SMD: 0.2, 95% CI: 0.05–0.35, p<0.01). 31.2% (95% CI: 23.8–39.7) of patients with IBD achieved endoscopic response, and there was a significant improvement in ulcerative colitis response score (SMD: −0.6,95% CI: −0.88 to 0.36, p<0.01). Furthermore, 17.6% (95% CI: 13.0–23.5) of patients experienced adverse events severe enough to discontinue therapy, and 29.9% (95% CI: 25.2–34.8) had a loss of response to biologics. Conclusions: Treatment of patients with PSC-IBD with biologics (vedolizumab, infliximab, and adalimumab) was not associated with improvement of biochemical markers of cholestasis. Biologics are effective in treating the colitis associated with PSC. Vedolizumab was associated with worsening liver enzymes in contrast to other biologics, a finding that warrants further study.

Details

Title: Efficacy and safety of biologics in primary sclerosing cholangitis with inflammatory bowel disease: A systematic review and meta-analysis
Authors: Ayesha Shah (Author) - The University of Queensland
Michael P. Jones (Author) - Australasian Gastro Intestinal Research Foundation
Gavin Callaghan (Author) - The University of Queensland
Thomas Fairlie (Author) - The University of Queensland
Xiaomin Ma (Author) - The University of Queensland
Emma L. Culver (Author) - Oxford University Hospitals NHS Trust
Katherine Stuart (Author) - The University of Queensland
Peter De Cruz (Author) - Austin Health
James O'Beirne (Author) - University of the Sunshine Coast
James H. Tabibian (Author) - David Geffen School of Medicine at UCLA
Axel Dignass (Author) - Agaplesion Markus Hospital
Ali Canbay (Author) - University Hospitals of the Ruhr-University of Bochum
Gregory J. Gores (Author) - Mayo Clinic
Gerald J. Holtmann (Corresponding Author) - The University of Queensland
Publication details: Hepatology Communications, Vol.8, pp.1-14
Publisher: Wolters Kluwer Health
Date published: 2024
DOI: 10.1097/HC9.0000000000000347
ISSN: 2471-254X
PMID: 38206197; PMC10786591
Copyright note: Copyright © 2024 The Author(s). This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Grant note: This study was supported by National Health and Medical Research Council (APP1084544) and Centre for Research Excellence (APP170993).
Organisation Unit: School of Health and Behavioural Sciences - Legacy
Language: English
Record Identifier: 99998997402621
Output Type: Journal article

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