Evidence map›Paper›PMID 40783513›Full record

ArticleBMC gastroenterology2025

Early assessment of treatment response in primary biliary cholangitis: key to timely management.

Tomas Koky, Sylvia Drazilova, Martin Janicko, Dominika Toporcerova, Jakub Gazda, Peter Jarcuska

Abstract readMulticenter Study
In one paragraph

Article in BMC gastroenterology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
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

6 authors.

Tomas KokyDepartment of Internal Medicine, Faculty of Medicine, PJ Safarik University, L Pasteur University Hospital, Kosice, Slovakia.
Sylvia DrazilovaDepartment of Internal Medicine, Faculty of Medicine, PJ Safarik University, L Pasteur University Hospital, Kosice, Slovakia. sylvia.drazilova@upjs.sk.
Martin JanickoDepartment of Internal Medicine, Faculty of Medicine, PJ Safarik University, L Pasteur University Hospital, Kosice, Slovakia.
Dominika ToporcerovaDepartment of Internal Medicine, Faculty of Medicine, PJ Safarik University, L Pasteur University Hospital, Kosice, Slovakia.
Jakub GazdaDepartment of Internal Medicine, Faculty of Medicine, PJ Safarik University, L Pasteur University Hospital, Kosice, Slovakia.
Peter JarcuskaDepartment of Internal Medicine, Faculty of Medicine, PJ Safarik University, L Pasteur University Hospital, Kosice, Slovakia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimThe aim of our study was to explore predictive factors associated with compete biochemical response (CBR) in primary biliary cholangitis (PBC) patients treated with ursodeoxycholic acid (UDCA) at month 12 and at last check-up; CBR was defined as both normal bilirubin and ALP levels. We also evaluated hepatic decompensation and prognosis during UDCA treatment.

methodsWe conducted a multicenter retrospective study of PBC patients. We enrolled patients with PBC before the beginning of UDCA treatment (13-15 mg/kg body weight per day) between 1999 and 2024 in 2 hepatology centers in Eastern Slovakia.

resultsWe enrolled 155 patients in the final analysis, 147 women and 8 men, mean age at diagnosis 57 ± 15 years, the median follow-up was 10 ± 8 years. 29 patients (18.7%) had cirrhosis at diagnosis. Hepatic decompensation occurred in 12 patients during follow-up (7.7%; 95%CI 4-13%). 114 patients (73.5%; 95% CI 66-80%) achieved response to treatment according to Toronto criteria at month 6; CBR after 12 months of treatment was achieved by 41.3% (95% CI 33-50%) of patients; 51 patients (32.9%; 95% CI 26-41%) achieved CBR at last check-up. The OR for achieving CBR at month 12 in Toronto responders at month 6 was 46.36 (95%CI 6.147-349.646); p < 0.001. Of the patients who achieved a response defined by Toronto criteria at month 6, 44.7% of patients achieved CBR at last check-up and 55.3% did not. Out of the patients who did not achieve Toronto at month 6, none achieved CBR at last check-up (0%). Treatment response by Toronto criteria at month 6, CBR at month 12 and absence of liver cirrhosis predicted CBR at last check-up. The odds of decompensation were about 90% lower in patients who achieved treatment response. No case of hepatic decompensation or liver-related mortality during follow-up was observed in patients with CBR at last check-up.

conclusionThe assessment of treatment response at month 6 is very accurate predictor of complete biochemical response throughout the course of the disease. For non-responders to UDCA treatment, the addition of second line PBC treatment is indicated. For patients who have not met Toronto criteria at month 6 of UDCA treatment, the addition of second line PBC therapy should be considered.

Indexed as

Cholagogues and CholereticsLiver Cirrhosis, BiliaryUrsodeoxycholic AcidAdultAgedAlkaline PhosphataseBilirubinFemaleHumansMaleMiddle AgedPrognosisRetrospective StudiesTreatment OutcomeAlkaline PhosphataseBilirubinCholagogues and CholereticsUrsodeoxycholic AcidLiver decompensationPrimary biliary cholangitisPrognosisSecond line treatmentTreatment responseUrsodeoxycholic acid

Identifiers

PMID40783513
PMCPMC12335757

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Registered trials

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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.