Development and validation of a scoring system to predict outcomes of patients with primary biliary cirrhosis receiving ursodeoxycholic acid therapy
Open accessAbstract
Background & aims Approaches to risk stratification for patients with primary biliary cirrhosis (PBC) are limited, single-center based, and often dichotomous. We aimed to develop and validate a better model for determining prognoses of patients with PBC.Methods We performed an international, multicenter meta-analysis of 4119 patients with PBC treated with ursodeoxycholic acid at liver centers in 8 European and North American countries. Patients were randomly assigned to derivation (n = 2488 [60%]) and validation cohorts (n = 1631 [40%]). A risk score (GLOBE score) to predict transplantation-free survival was developed and validated with univariate and multivariable Cox regression analyses using clinical and biochemical variables obtained after 1 year of ursodeoxycholic acid therapy. Risk score outcomes were compared with the survival of age-, sex-, and calendar time-matched members of the general population. The prognostic ability of the GLOBE score was evaluated alongside those of the Barcelona, Paris-1, Rotterdam, Toronto, and Paris-2 criteria.Results Age (hazard ratio = 1.05; 95% confidence interval [CI]: 1.04-1.06; P < .0001); levels of bilirubin (hazard ratio = 2.56; 95% CI: 2.22-2.95; P < .0001), albumin (hazard ratio = 0.10; 95% CI: 0.05-0.24; P < .0001), and alkaline phosphatase (hazard ratio = 1.40; 95% CI: 1.18-1.67; P = .0002); and platelet count (hazard ratio/10 units decrease = 0.97; 95% CI: 0.96-0.99; P < .0001) were all independently associated with death or liver transplantation (C-statistic derivation, 0.81; 95% CI: 0.79-0.83, and validation cohort, 0.82; 95% CI: 0.79-0.84). Patients with risk scores >0.30 had significantly shorter times of transplant-free survival than matched healthy individuals (P < .0001). The GLOBE score identified patients who would survive for 5 years and 10 years (responders) with positive predictive values of 98% and 88%, respectively. Up to 22% and 21% of events and nonevents, respectively, 10 years after initiation of treatment were correctly reclassified in comparison with earlier proposed criteria. In subgroups of patients aged <45, 45-52, 52-58, 58-66, and ≥66 years, age-specific GLOBE-score thresholds beyond which survival significantly deviated from matched healthy individuals were -0.52, 0.01, 0.60, 1.01 and 1.69, respectively. Transplant-free survival could still be accurately calculated by the GLOBE score with laboratory values collected at 2-5 years after treatment.Conclusions We developed and validated scoring system (the GLOBE score) to predict transplant-free survival of ursodeoxycholic acid-treated patients with PBC. This score might be used to select strategies for treatment and care.
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The GLOBE and UK-PBC scores predict death or liver transplantation better than the Paris-I criteria, which perform best among binary models.
“continuous scoring systems incorporating both measures of treatment response and parameters of disease severity [106,107].Thus, both the GLOBE score and the UK-PBC score have shown better performance for the prediction of death or liver transplantation than the Paris-I criteria, which have the best performance among binary models.”
From EASL Clinical Practice Guidelines: The diagnosis and management of patients with primary biliary cholangitis. (2017) · cites this paper as [106]
The Performance of the GLOBE Score Compared With Other Criteria section says GLOBE discriminated outcomes better than the earlier criteria; Table 3 reports higher C-statistics for GLOBE than Paris-1 and the other binary criteria. The paper also describes Paris-1 as generally having the best predictability among those criteria. It does not evaluate the UK-PBC score, so it cannot support that score’s claimed superiority to Paris-1; its mention of the UK-PBC consortium is not a comparison of scores. (LLM, conf=0.88)
Experimental — accuracy not yet measuredThe Global PBC score and the UK-PBC risk score derive from large multicentre cohorts and convey probability of survival on a continuous scale (area under the receiver operator curve >0.9).
“These scoring systems derive from large multicentre cohorts and convey probability of survival on a continuous, as opposed to dichotomous, scale (area under the receiver operator curve >0.9).”
From The British Society of Gastroenterology/UK-PBC primary biliary cholangitis treatment and management guidelines (2018) · cites this paper as [109]
The Methods (page not provided) describe the GLOBE score’s development from a 4,119-patient international multicentre cohort, and Construction of the GLOBE Score shows that it calculates survival probability for an individual patient. But this paper does not establish the corresponding claims about the UK-PBC score. It also reports GLOBE C-statistics of 0.81 and 0.82 in the derivation and validation cohorts, respectively, not a value above 0.9. (LLM, conf=0.90)
Experimental — accuracy not yet measuredThe GLOBE score improves risk classification by nearly 10% versus Paris-I, and about 40% of UDCA-treated patients are expected to have shorter transplant-free survival than matched healthy people.
“Compared to the Paris-I criteria, the GLOBE score improves the global classification of patients into low-and high-risk groups by nearly 10% [106].According to the GLOBE score, approximately 40% of patients under UDCA are expected to have shorter transplant-free survival times than matched healthy individuals [106].”
From EASL Clinical Practice Guidelines: The diagnosis and management of patients with primary biliary cholangitis. (2017) · cites this paper as [106]
The GLOBE score was developed from a retrospective cohort of 2,488 UDCA-treated patients and validated in 1,631 European and North American patients.
“The GLOBE score was developed from a retrospective cohort of 2,488 UDCA-treated patients and validated by a second cohort of 1,631 European and North American patients.(74)”
From Primary Biliary Cholangitis: 2018 Practice Guidance from the American Association for the Study of Liver Diseases (2019) · cites this paper as [74]
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- Authors
- Lammers, W. J., Hirschfield, G. M., Corpechot, C., Nevens, F., Lindor, K. D., Janssen, H. L. A., Floreani, A., Ponsioen, C. Y., Mayo, M. J., Invernizzi, P., Battezzati, P. M., Parés, A., Burroughs, A. K., Mason, A. L., Kowdley, K. V., Kumagi, T., Harms, M. H., Trivedi, P. J., Poupon, R., Cheung, A., Lleo, A., Caballeria, L., Hansen, B. E., & van Buuren, H. R.
- Affiliations
- Erasmus MC (NL)
- University of Birmingham (GB)
- Hôpital Saint-Antoine (FR)
- Universitair Ziekenhuis Leuven (BE)
- Mayo Clinic (US)
- University Health Network (CA)
- University of Padua (IT)
- Amsterdam UMC Location University of Amsterdam (NL)
- The University of Texas Southwestern Medical Center (US)
- Fondazione Humanitas per la Ricerca (IT)
- University of Milan (IT)
- Hospital Clínic de Barcelona (ES)
- The Royal Free Hospital (GB)
- University of Alberta (CA)
- Swedish Medical Center (US)
- Ehime University (JP)
- ORCID
- Lammers, Willem J.
- Hirschfield, Gideon M.
- Corpechot, Christophe
- Nevens, Frederik
- Lindor, Keith D.
- Janssen, Harry L.A.
- Floreani, Annarosa
- Ponsioen, Cyriel Y.
- Mayo, Marlyn J.
- Invernizzi, Pietro
- Battezzati, Pier M.
- Parés, Albert
- Burroughs, Andrew K.
- Mason, Andrew L.
- Kowdley, Kris V.
- Kumagi, Teru
- Harms, Maren H.
- Trivedi, Palak J.
- Poupon, Raoul
- Cheung, Angela
- Hansen, Bettina E.
- Venue
- Gastroenterology
- Publisher
- Elsevier BV
- Published
- 2015-12
- Volume
- 149
- Issue
- 7
- Pages
- 1804-1812.e4
- ISSN
- 0016-5085 (ISSN-L)
- OpenAlex
- W1071546559
- Cited by
- 441
- References
- 43
- Citations by year
- 2026: 37 · 2025: 37 · 2024: 35 · 2023: 41 · 2022: 43 · 2021: 43 · 2020: 40 · 2019: 58 · 2018: 44 · 2017: 36 · 2016: 20 · 2015: 7
- FWCI
- 21.10
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Gastroenterology (publishedVersion)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (publishedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (publishedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (submittedVersion)
- BOA (University of Milano-Bicocca) (submittedVersion)
- Lirias (submittedVersion)
- University of Birmingham Research Portal (University of Birmingham) (submittedVersion, cc-by-nc-nd)
- Padua Research Archive (University of Padova) (submittedVersion)
- Funders
- Meso Scale Diagnostics
- Ferring Pharmaceuticals
- Abbott Laboratories
- Takeda Pharmaceutical Company
- Innogenetics
- Astellas Pharma US
- Janssen Pharmaceuticals
- Stichting voor Lever- en Maag-Darm Onderzoek
- GlaxoSmithKline
- Wellcome Trust
- Medical Research Council
- Ikaria
- Alberta Heritage Foundation for Medical Research
- Roche
- Alberta Cancer Foundation
- Medtronic
- Canadian Institutes of Health Research
- Gilead Sciences
- Canadian Liver Foundation
- AbbVie
- Cilag
- Novartis
- Intercept Pharmaceuticals
- Merck
- Topics
- Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
- Health Sciences › Medicine › Surgery › Pediatric Hepatobiliary Diseases and Treatments
- Health Sciences › Medicine › Hepatology › Liver Disease and Transplantation
- Keywords
- primary biliary cirrhosis, ursodeoxycholic acid, GLOBE score, risk stratification, prognosis, transplant-free survival, liver transplantation, mortality, prognostic score, serum bilirubin, serum albumin, alkaline phosphatase, platelet count, Paris criteria, Rotterdam criteria
- MeSH terms
- Adult, Age Factors, Aged, Cholagogues and Choleretics, Decision Support Techniques, Europe, Female, Humans, Liver Cirrhosis, Biliary, Male, Middle Aged, North America, Predictive Value of Tests, Risk Factors, Sex Factors, Time Factors, Ursodeoxycholic Acid, Reproducibility of Results, Biomarkers, Multivariate Analysis, Proportional Hazards Models, Liver Transplantation, Treatment Outcome, Disease Progression, Risk Assessment, Disease-Free Survival, Kaplan-Meier Estimate
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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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