Cholangitis

Study findings highlight regional variability in the prevalence of PBC in the US in 2021, additionally suggesting potential barriers to specialist care.

An analysis of data from 2 PBC and PSC cohorts suggests fatigue is common, especially in females with PBC, and may be influenced by pruritus.

Study findings suggest use and monitoring of commonly evaluated hepatic biomarkers and fibrosis scores may provide additional prognostic value in PBC.

Our Q1 recap for hepatology spotlights regulatory updates, clinical trial data, 2 new guidance documents, and the anniversary of a historic FDA approval.

PBC patients with increased serum IgG levels at initial evaluation experienced faster disease progression and a greater probability of liver-related death.

Goel describes the clinical impact of having 2 newly approved second-line PBC therapies and looks ahead to what’s next and where more research is needed.

Goel explains the importance of second-line therapies and describes the role PPARs play in PBC treatment, including 2 newly approved therapies.

Patients with PBC and cirrhosis had a higher comorbidity burden and more acute-care events than those without cirrhosis.

Patients with PBC and severe pruritus had worse HRQoL, greater rates of depression, and more sleep interference than those with mild/moderate pruritus.

Chemomab completed an end-of-phase 2 meeting with the FDA and has aligned on the design of a phase 3 registration study for nebokitug (CM-101) in PSC.

This month in review spotlights HCPLive’s coverage of hepatic pipeline news and recent research about MASLD, liver transplant, and alcohol in liver disease.

The designation follows positive topline data from the phase 2a trial of CNP-104 in PBC, which were presented at AASLD’s The Liver Meeting

Patients with PSC had worse death, transplant, liver-related mortality, and liver-related decompensation outcomes than PBC and autoimmune hepatitis.

Retransplantation outcomes were similar or better in patients with PSC compared with patients with other liver disease etiologies.

An FDA review of postmarket clinical trial data revealed an increased risk of liver injury with obeticholic acid in patients with PBC without cirrhosis.

Andreas Kremer, MD, PhD, MHBA, describes the burden of pruritus in PBC and the toll it can take on patients’ quality of life.

Trivedi and Lawitz review long-term data from the phase 3 open-label ASSURE study and explain what they add to our understanding of seladelpar for PBC.

Trivedi and Lawitz discuss what sets seladelpar apart from other PBC therapies in the rapidly evolving treatment landscape.

Trivedi and Lawitz discuss the clinical impact of having seladelpar as a second-line treatment option for patients with PBC.

Trivedi and Lawitz discuss seladelpar’s mechanism of action and its use as a second-line therapy in PBC.

Hirschfield describes the need for therapies that address itch in PBC and explains what linerixibat, an IBAT inhibitor, may offer for pruritus.

Kugelmas reviews findings from a secondary analysis of the phase 3 ELATIVE trial suggesting elafibranor is associated with stable kidney function.

Kowdley reviews open-label extension data for biochemical response, ALP normalization, and pruritus improvement from the phase 3 ELATIVE study.

Findings from the open-label extension of the ELATIVE study suggest sustained safety and efficacy for up to 3 years, with improvements in itch and sleep.

Diabetes was associated with an increased risk of liver transplant or death and with liver-specific events in patients with PBC.