P1184 : Age, bilirubin and albumin, regardless of sex, are the strongest independent predictors of biochemical response and transplantation-free survival in patients with primary biliary cirrhosis

Cheung, Angela; Lammers, Wim J. E. P.; Hirschfield, Gideon; Invernizzi, Pietro; Mason, Andrew L.; Ponsioen, Cyriel Y.; Floreani, Annarosa; Corpechot, Christophe; Mayo, Marlyn J.; Pares, A.; Battezzati, P. M.; Nevens, Frederik; Thorburn, Douglas; Kowdley, Kris V.; Trivedi, Paak; Kumagi, Teru; Lleò, Ana; LaRusso, Nicholas F.; Boonstra, Kirsten; Cazzagon, Nora; Franceschet, I.; Poupon, Raoul; Caballería, Llorenç; Lindor, Keith D.; Hansen, Bettina E.; Janssen, Harry L A; Buuren, Henk van

doi:10.1016/s0168-8278(15)31380-5

Cited by 11 publications

(16 citation statements)

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“… This is also in line with two population‐based large cohorts from northern Italy and Denmark, which showed F:M ratios of 2.3:1 and 4.2:1, respectively, indicating there might be an underestimated prevalence of PBC in men . More importantly, our study showed that male sex was associated with much delayed diagnosis and worse liver biochemistries at presentation, which were consistent with previous studies . All of this suggests that male PBC cases maybe underdiagnosed and more attention should be paid to the impact of gender on long‐time survival.…”

Section: Discussionmentioning

confidence: 99%

“…Till now, many risk factors for long‐term outcome in PBC patients have been identified, including older age at diagnosis, elevated bilirubin and alkaline phosphatase (ALP), decreased albumin, cirrhosis, and non‐response to ursodeoxycholic acid (UDCA) therapy . However, the predictive role of male sex remains controversial . Furthermore, whether past hepatitis B virus (HBV) infection, which is common in China and other HBV endemic areas, is associated with a poorer prognosis remains uncertain …”

Section: Introductionmentioning

confidence: 99%

“…1 However, the predictive role of male sex remains controversial. [8][9][10][11] Furthermore, whether past hepatitis B virus (HBV) infection, which is common in China and other HBV endemic areas, 12 is associated with a poorer prognosis remains uncertain. 13,14 Although population-based epidemiological study in mainland China is still lacking, a high prevalence of PBC was reported.…”

Section: Introductionmentioning

confidence: 99%

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Prognosis of 732 ursodeoxycholic acid‐treated patients with primary biliary cholangitis: A single center follow‐up study from China

Chen

Duan

et al. 2018

J of Gastro and Hepatol

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Background and Aim The impact of male sex and past hepatitis B virus (HBV) infection on survival of primary biliary cholangitis (PBC) are issues at discussion. The aim of the present study was to identify risk factors for transplant‐free survival (TRS) in Chinese PBC patients who received ursodeoxycholic acid (UDCA), with special focus on the impact of male sex and past HBV infection. Methods We followed up PBC patients who received UDCA at our institute between January 2000 and December 2017 until their death, liver transplantation, or censored on April 1, 2018, by interview and review of medical records. We used Cox proportional hazards model and Kaplan–Meier method. Results Out of 976 PBC patients, 732 UDCA‐treated patients (female : male = 6.2:1) with required clinical and laboratory data were enrolled in this study. The median follow‐up period were 4.8 years (interquartile range: 2.8–7.1 years). The overall 5‐, 10‐, and 15‐year TRS rates were 86.7% (95% CI: 83.8–88.1), 71.1% (95% CI: 65.0–77.2), and 59.2% (95% CI: 44.5–73.9), respectively. The survival was significantly worse for male patients and older patients (≥ 55 years) (log‐rank test: P < 0.05 for both). On multivariate analysis, male sex, cirrhosis, serum bilirubin, and serum albumin were independent predictors for TRS. There was no significant difference in survivals between patients with (n = 167) and without (n = 219) past HBV infection (log‐rank test: P = 0.293). Conclusions In this large Chinese cohort of UDCA‐treated PBC patients, male sex was associated with shorter survival, whereas past HBV infection was not associated with poorer outcome.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Prognosis of 732 ursodeoxycholic acid‐treated patients with primary biliary cholangitis: A single center follow‐up study from China

Chen

Duan

et al. 2018

J of Gastro and Hepatol

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“…This is noteworthy given that the degree of interface activity is recognized to influence disease progression in PBC . The impact of presenting age was less apparent in men, who, despite being older at diagnosis, exhibited greater frequency of nonresponse overall, possibly reflecting more advanced baseline fibrosis at presentation …”

Section: Biochemical Response Criteria In Pbcmentioning

confidence: 94%

Risk stratification in autoimmune cholestatic liver diseases: Opportunities for clinicians and trialists

et al. 2015

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Primary biliary cirrhosis (PBC) and primary sclerosing cholangitis (PSC) are infrequent autoimmune cholestatic liver diseases, that disproportionate to their incidence and prevalence, remain very important causes of morbidity and mortality for patients with liver disease. Mechanistic insights spanning genetic risks and biological pathways to liver injury and fibrosis have led to a renewed interest in developing therapies beyond ursodeoxycholic acid that are aimed at both slowing disease course and improving quality of life. International cohort studies have facilitated a much greater understanding of disease heterogeneity, and in so doing highlight the opportunity to provide patients with a more individualized assessment of their risk of progressive liver disease, based on clinical, laboratory, or imaging findings. This has led to a new approach to patient care that focuses on risk stratification (both high and low risk); and furthermore allows such stratification tools to help identify patient subgroups at greatest potential benefit from inclusion in clinical trials. In this article, we review the applicability and validity of risk stratification in autoimmune cholestatic liver disease, highlighting strengths and weaknesses of current and emergent approaches. (Hepatology 2016;63:644–659)

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“…Males were also more likely not to respond [25] . Another recent cohort study, however, concluded that after adjusting for severity of disease, males and females had comparable treatment responses and prognosis [26] .…”

Section: Prognosis In Pbcmentioning

confidence: 99%

Surrogate Endpoints for Optimal Therapeutic Response to UDCA in Primary Biliary Cholangitis

Buuren¹,

Lammers²,

Harms³

et al. 2015

Dig Dis

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Background: Ursodeoxycholic acid (UDCA) is the standard treatment for primary biliary cholangitis (PBC), as it can delay histological progression, improve long-term outcome and is extremely safe and well tolerated. However, UDCA is not always sufficient and the prognosis of patients inadequately responding to treatment is worse compared with the general population. Reliable identification of so-called non-responders is of key importance, not only for selecting patients who could benefit from additional, second-line therapy, but also for identifying those individuals who are at low risk of developing end-stage disease and in whom UDCA mono-therapy can be safely continued. Several laboratory surrogate endpoints for the long-term response to UDCA have been proposed, including the Barcelona, Paris, Toronto and Rotterdam criteria. All these criteria have limitations and the superiority of one over the other has not been firmly established. Key Messages: Recently the Global PBC Study Group developed a new prognostic tool by studying a large, representative and multinational cohort of 4,119 UDCA-treated patients. In a random sample of 2,488 cases, a risk score - the GLOBE score - was developed, predictive of transplantation-free survival. This risk score comprises age, and bilirubin, albumin, alkaline phosphatase and platelet count obtained after 1 year therapy, and has a performance (C statistic 0.81, 95% CI 0.79-0.83) that is markedly better than that of previously proposed response criteria. Comparable performance was found in an independent validation cohort of 1,631 cases (C statistic 0.82, 95% CI 0.79-0.84). A web app will allow the easy use of the score in clinical practice.

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P1184 : Age, bilirubin and albumin, regardless of sex, are the strongest independent predictors of biochemical response and transplantation-free survival in patients with primary biliary cirrhosis

Cited by 11 publications

References 0 publications

Prognosis of 732 ursodeoxycholic acid‐treated patients with primary biliary cholangitis: A single center follow‐up study from China

Prognosis of 732 ursodeoxycholic acid‐treated patients with primary biliary cholangitis: A single center follow‐up study from China

Risk stratification in autoimmune cholestatic liver diseases: Opportunities for clinicians and trialists

Surrogate Endpoints for Optimal Therapeutic Response to UDCA in Primary Biliary Cholangitis

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