Evidence map›Paper›PMID 38206197›Full record

SynthesisHepatology communications2024

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 and 4 more

Open access · goldAbstract readMeta-AnalysisSystematic Review
In one paragraph

Synthesis in Hepatology communications, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
8.1field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 9 institutions in 4 countries.

Ayesha ShahThe University of Queensland, Faculty of Medicine, Australia.ORCID 0000-0003-0710-1691
Michael P JonesAGIRA (Australian Gastrointestinal Research Alliance) and the NHMRC Centre of Research Excellence in Digestive Health.
Gavin CallaghanThe University of Queensland, Faculty of Medicine, Australia.
Thomas FairlieThe University of Queensland, Faculty of Medicine, Australia.
Xiaomin MaThe University of Queensland, Faculty of Medicine, Australia.
Emma L CulverTranslational Gastroenterology Unit, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom.
Katherine StuartThe University of Queensland, Faculty of Medicine, Australia.
Peter De CruzDepartment of Gastroenterology, Austin Health, Melbourne, Australia.
James O'BeirneUniversity of the Sunshine Coast, Sunshine Coast, Queensland, Australia.
James H TabibianDavid Geffen School of Medicine at UCLA, Los Angeles, California, USA.
Axel DignassDepartment of Medicine I, Agaplesion Markus Hospital, Frankfurt, Germany.
Ali CanbayDepartment of Medicine, University Hospital of the Ruhr-University Bochum, Germany.
Gregory J GoresDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
Gerald J HoltmannThe University of Queensland, Faculty of Medicine, Australia.ORCID 0000-0002-0206-2358
Translational Research Institute · AUThe University of Queensland · AUAustralasian Gastro Intestinal Research Foundation · AUMayo Clinic · USThe University of Melbourne · AUUniversity Hospitals of the Ruhr-University of Bochum · DEUniversity of California, Los Angeles · USUniversity of Oxford · GBUniversity of the Sunshine Coast · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPrimary 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).

methodsMEDLINE, 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.

resultsSix 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.

conclusionsTreatment 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.

Indexed as

Biological ProductsCholangitis, SclerosingCholestasisColitis, UlcerativeInflammatory Bowel DiseasesAlkaline PhosphataseBilirubinHumansAlkaline PhosphataseBilirubinBiological Products

Identifiers

PMID38206197
PMCPMC10786591
OpenAlexW4390753759

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.