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. 2021 Jun 22:2021:9928065.
doi: 10.1155/2021/9928065. eCollection 2021.

External Validation of UDCA Response Score in Slovak and Croatian Patients with Primary Biliary Cholangitis

Affiliations

External Validation of UDCA Response Score in Slovak and Croatian Patients with Primary Biliary Cholangitis

Jakub Gazda et al. Can J Gastroenterol Hepatol. .

Abstract

Background: Ursodeoxycholic acid response score (URS) is a prognostic model that estimates the baseline probability of treatment response after 12 months of ursodeoxycholic acid (UDCA) therapy in patients with primary biliary cholangitis (PBC).

Aim: To independently evaluate the predictive performance of the URS model.

Methods: We used a cohort of Slovak and Croatian treatment-naïve PBC patients to quantify the discrimination ability using the area under receiver operating characteristic curve (AUROC) and its 95% confidence interval (CI). Furthermore, we evaluated the calibration using calibration belts. The primary outcome was treatment response after 12 months of UDCA therapy defined as values of alkaline phosphatase ≤1.67 × upper limit of normal.

Results: One hundred and ninety-four patients were included. Median pretreatment age was 56 years (interquartile range 49-62). Treatment response was achieved in 79.38% of patients. AUROC of the URS was 0.81 (95% CI 0.73-0.88) and the calibration belt revealed that response rates were correctly estimated by predicted probabilities.

Conclusion: Our results confirm that the URS can be used in treatment-naïve PBC patients for estimating the treatment response probability after 12 months of UDCA therapy.

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Conflict of interest statement

The authors declare that they have no conflicts of interest.

Figures

Figure 1
Figure 1
Flowchart of patient recruitment.
Figure 2
Figure 2
Boxplots of the ursodeoxycholic acid response score in Slovak and Croatian patients.
Figure 3
Figure 3
Predictive performance of the URS in Slovak and Croatian PBC patients. (a) AUROC 0.81 (95% CI 0.73−0.88) demonstrates high discrimination ability of the URS model. (b) Calibration belt confirms a well-calibrated URS model.
Figure 4
Figure 4
Predictive performance of the URS in patients with normal and increased baseline AT values. (a) Good discrimination ability in patients with normal baseline AT values. (b) Calibration belt in patients with normal baseline AT values characterized by wide confidence intervals in the lower predicted probabilities range. (c) Good discrimination ability in patients with increased baseline AT values. (d) Calibration belt demonstrating good calibration in patients with increased baseline AT values.

References

    1. Boonstra K., Beuers U., Ponsioen C. Y. Epidemiology of primary sclerosing cholangitis and primary biliary cirrhosis: a systematic review. Journal of Hepatology. 2012;56(5):1181–1188. doi: 10.1016/j.jhep.2011.10.025. - DOI - PubMed
    1. Drazilova S., Babinska I., Babinska I., et al. Epidemiology and clinical course of primary biliary cholangitis in Eastern Slovakia. International Journal of Public Health. 2020;65(5):683–691. doi: 10.1007/s00038-020-01391-6. - DOI - PubMed
    1. Madir A., Božin T., Mikolašević I., et al. Epidemiological and clinical features of primary biliary cholangitis in two Croatian regions: a retrospective study. Croatian Medical Journal. 2019;60(6):494–502. doi: 10.3325/cmj.2019.60.494. - DOI - PMC - PubMed
    1. Carbone M., Milani C., Gerussi A., Ronca V., Cristoferi L., Invernizzi P. Primary biliary cholangitis: a multifaceted pathogenesis with potential therapeutic targets. Journal of Hepatology. 2020;73(4):965–966. doi: 10.1016/j.jhep.2020.05.041. - DOI - PubMed
    1. Hirschfield G. M., Beuers U., Corpechot C., et al. EASL Clinical Practice Guidelines: the diagnosis and management of patients with primary biliary cholangitis. Journal of Hepatology. 2017;67(1):145–172. doi: 10.1016/j.jhep.2017.03.022. - DOI - PubMed

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