Fenofibrate improves GLOBE and UK-PBC scores and histological features in primary biliary cholangitis

Wang, Lu; Sun, Keshuai; Tian, Ai; Liu, Yansheng; Zhang, Miao; Zhou, Xinmin; Han, Ying

doi:10.23736/s0026-4806.21.07316-x

Cited by 13 publications

(9 citation statements)

References 29 publications

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“…Chinese PBC cohort study [7,8] . Although more studies are needed to con rm these survival bene ts, the favorable impact on the long-term prognosis makes adding brates (FF or BZF) a reasonable option for PBC patients with suboptimal biochemical responses to UDCA.…”

Section: Discussionmentioning

confidence: 99%

“…Furthermore, a real-world study demonstrated that BZF could improve the survival of PBC patients with suboptimal response to UDCA [6] . Recent studies have also shown that adding FF could improve GLOBE and UK-PBC scores [7,8] . However, the impact of FF add-on therapy on the long-term survival of PBC patients remains unclear, although it is reported that a median of 11 months of FF add-on therapy could improve the transplant-free survival [9] .…”

Section: Introductionmentioning

confidence: 99%

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Fenofibrate add-on therapy improves transplant-free survival in patients with primary biliary cholangitis refractory to ursodeoxycholic acid

Chen

et al. 2022

Preprint

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Background Fenofibrate (FF) has shown biochemical benefit in primary biliary cholangitis (PBC) patients with a suboptimal response to ursodeoxycholic acid (UDCA), but the long-term efficacy on survival remains unknown. Methods In this retrospective cohort study, we evaluated the efficacy and safety of the long-term effects of FF add-on therapy in PBC patients with a suboptimal response to UDCA, with special focus on the long-term survivals analyzed by Kaplan-Meier plotting and log-rank test. Results We enrolled 121 PBC patients with a suboptimal response to UDCA, with 57 patients continuing the UDCA monotherapy, and 64 patients receiving FF add-on therapy (200 mg/d). After one year of treatment, the FF add-on group had a more remarkable improvement in the serum levels of alkaline phosphatase (ALP) and gamma-glutamyl transferase (GGT) than the UDCA monotherapy group. Significant improvements in serum alanine aminotransferase (ALT), total bilirubin (TBIL), albumin (ALB), lipid, and immunoglobulins were only found in the FF add-on group, with ALP normalized in 60.9% and both ALP and TBIL normalized in 45.3% of the patients. Importantly, compared with UDCA monotherapy group, FF add-on therapy was associated with a significant improvement in 5- (89.7% vs 75.3%) and 10- (87.0% vs 47.6%) year transplant-free survivals (HR: 0.3282, 95% CI: 0.1334–0.8073, P < 0.05). Twenty-one cases (25.6%) developed adverse events during the follow-up, with liver injury being the most frequent one. Conclusions FF add-on therapy improves not only biochemical responses but also long-term transplant-free survival in PBC patients with suboptimal response to UDCA. However, liver and renal injuries need to be closely monitored and properly managed.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Fenofibrate add-on therapy improves transplant-free survival in patients with primary biliary cholangitis refractory to ursodeoxycholic acid

Chen

et al. 2022

Preprint

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“…A study by Wang et al reported that the addition of fenofibrate to UDCA resulted in an improvement in the GLOBE and UK-PBC scores. 90 On the contrary, Duan et al in their study of 39 patients with PBC, refractory to UDCA reported that 2-year combination therapy with UDCA and fenofibrate was not associated with improvement in the UK-PBC risk score and GLOBE score. 91 Further studies are needed to estimate the true effect of fenofibrate on GLOBE scores.…”

Section: Emerging Therapiesmentioning

confidence: 95%

Primary Biliary Cholangitis: Promising Emerging Innovative Therapies and Their Impact on GLOBE Scores

Sohal¹,

Kowdley²

2023

HMER

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Primary biliary cholangitis (PBC), previously referred to as primary biliary cirrhosis, is an autoimmune disorder leading to the destruction of intra-hepatic bile ducts. If untreated, progressive bile duct damage and cholestasis can lead to ductopenia and result in cirrhosis. Ursodiol, the first drug approved for PBC, has changed the natural history of this disease and improved patient outcomes. Subsequently, several new prediction models incorporating a response to ursodiol were developed. These include the GLOBE score, which was shown to predict long-term outcomes in patients with PBC. In 2016, obeticholic acid (OCA) became the second drug to be approved by the FDA, predominantly based on improvement in alkaline phosphatase (ALP) levels. This trial has subsequently influenced the design of clinical trials. Several drugs are currently being evaluated as therapeutic options for PBC, with improvement in ALP being a main endpoint. In this review, we will discuss the impact of new therapies on GLOBE scores in patients with PBC.

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“…46 However, fenofibrate treatment was associated higher rates of side effects and withdrawal events than bezafibrate. 47 Budesonide: Budesonide is a second-generation glucocorticoid with high first-pass elimination in the liver and with relatively few systemic side effects. Budesonide regulates bile acid synthesis, transport, and metabolism through the glucocorticoid receptor/pregnane X receptor pathway.…”

Section: Obeticholic Acid (Oca)mentioning

confidence: 99%

Guidelines on the Diagnosis and Management of Primary Biliary Cholangitis (2021)

You¹,

Duan²,

Li³

et al. 2023

J Clin Transl Hepatol

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In 2015, the Chinese Society of Hepatology and the Chinese Society of Gastroenterology published a consensus on primary biliary cholangitis (PBC). In the past years, numerous clinical studies have been published in the field of PBC. To guide the clinical diagnosis and management of PBC patients, the Chinese Society of Hepatology invited a panel of experts to assess the new clinical evidence and formulate the current guidelines.

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Fenofibrate improves GLOBE and UK-PBC scores and histological features in primary biliary cholangitis

Cited by 13 publications

References 29 publications

Fenofibrate add-on therapy improves transplant-free survival in patients with primary biliary cholangitis refractory to ursodeoxycholic acid

Fenofibrate add-on therapy improves transplant-free survival in patients with primary biliary cholangitis refractory to ursodeoxycholic acid

Primary Biliary Cholangitis: Promising Emerging Innovative Therapies and Their Impact on GLOBE Scores

Guidelines on the Diagnosis and Management of Primary Biliary Cholangitis (2021)

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