Publications by authors named "Marlyn Mayo"
Article Synopsis
- The study looked at how patients with a liver disease called primary biliary cholangitis (PBC) respond to a treatment called ursodeoxycholic acid (UDCA).
- It found that many patients (33%) didn’t have a good response after one year, and those who lost their good response had a higher chance of needing a liver transplant or dying.
- The research showed that staying or getting back to a good response is important for improving long-term health.
Background: Cholestatic pruritus and fatigue are debilitating conditions associated with primary biliary cholangitis (PBC) and can significantly impact patients' quality of life. Pruritus in PBC often worsens at night and patients frequently report sleep disturbance, which contributes to cognitive symptoms and fatigue. Linerixibat is an ileal bile acid transporter inhibitor in clinical development for the treatment of pruritus associated with PBC and was recently assessed versus placebo in the Phase 2b GLIMMER trial.
View Article and Find Full Text PDFBackground & Aims: Recurrent primary biliary cholangitis (rPBC) develops in approximately 30% of patients and negatively impacts graft and overall patient survival after liver transplantation (LT). There is a lack of data regarding the response rate to ursodeoxycholic acid (UDCA) in rPBC. We evaluated a large, international, multi-center cohort to assess the performance of PBC scores in predicting the risk of graft and overall survival after LT in patients with rPBC.
View Article and Find Full Text PDFPrimary biliary cholangitis (PBC) is a chronic cholestatic liver disease. The management landscape was transformed 20 years ago with the advent of ursodeoxycholic acid. Up to 40% of patients do not, however, respond adequately to ursodeoxycholic acid and therefore still remain at risk of disease progression to cirrhosis.
View Article and Find Full Text PDFArticle Synopsis
- Seladelpar, a medication aimed at treating primary biliary cholangitis, was tested in a phase 3 trial involving patients who didn't respond well to the standard treatment, ursodeoxycholic acid.
- The trial showed that a significantly higher percentage of patients taking seladelpar achieved a biochemical response and normalized alkaline phosphatase levels compared to those on placebo.
- Additionally, seladelpar was more effective in reducing itchiness, with patients reporting greater relief from pruritus than those receiving placebo, although some adverse events were noted.
Purpose Of Review: The primary therapy of autoimmune hepatitis (AIH) has been established for over three decades. This review focuses on updates in the evaluation and management of patients with AIH.
Recent Findings: The evaluation of patients has recently been updated to include more definitive screening for other autoimmune diseases, including thyroid disease and celiac disease.
Article Synopsis
- Pruritus, a severe itching condition, significantly affects patients with primary biliary cholangitis (PBC), and seladelpar treatment shows promise in alleviating this symptom while also reducing bile acid levels.
- In a study, serum IL-31 levels were measured in patients taking seladelpar or a placebo, revealing a strong correlation between IL-31 levels and the severity of pruritus as well as bile acid levels.
- Results indicated that seladelpar caused significant reductions in both IL-31 and bile acids, supporting the idea that these reductions may explain the medication's effectiveness in relieving itching in PBC patients.
Article Synopsis
- Primary biliary cholangitis (PBC) is a chronic liver disease affecting bile ducts, and the effectiveness of elafibranor, a dual PPAR α and δ agonist, in treating PBC was investigated through a clinical trial.
- In a phase 3, double-blind trial with 161 participants, those treated with elafibranor showed a significant biochemical response (51%) compared to only 4% in the placebo group, indicating substantial improvement in liver function.
- While 15% of elafibranor-treated patients normalized their alkaline phosphatase levels, the results for reducing itching (pruritus) between the elafibranor and placebo groups were not statistically
Chronic cholestasis is the hallmark clinical feature of primary biliary cholangitis. In addition to progressive liver damage, chronic cholestasis can lead to serious complications, many of which occur outside the liver. Bile acids are ligands for nuclear hormone receptors, and alterations in their concentration disrupt normal functioning of numerous different cell types.
View Article and Find Full Text PDFArticle Synopsis
- Seladelpar is a selective drug targeting receptors that help manage conditions like primary biliary cholangitis (PBC) by reducing cholestasis, inflammation, and itching.
- A long-term study evaluated seladelpar's safety and effectiveness in PBC patients, involving 106 individuals treated for up to 2 years.
- Results showed no serious side effects, and an increase in positive treatment responses over two years, indicating that seladelpar significantly improved liver function markers.
Article Synopsis
- The ENHANCE study assessed the efficacy and safety of seladelpar, a PPAR-δ agonist, in patients with primary biliary cholangitis who didn't respond well to or couldn't tolerate traditional treatment with UDCA.
- Participants were divided into three groups receiving either seladelpar (5 mg or 10 mg) or a placebo, with the primary goal of measuring liver function improvements after 12 months.
- Results showed that patients receiving 10 mg of seladelpar had significant liver function improvements and reduced itching compared to placebo, and the treatment was deemed safe with no serious side effects reported.
Background And Aims: Patients with primary biliary cholangitis (PBC) and insufficient response to ursodeoxycholic acid (UDCA), currently assessed after 1 year, are candidates for second-line therapy. The aims of this study are to assess biochemical response pattern and determine the utility of alkaline phosphatase (ALP) at six months as a predictor of insufficient response.
Methods: UDCA-treated patients in the GLOBAL PBC database with available liver biochemistries at one year were included.
Primary biliary cholangitis (PBC) is a chronic, cholestatic, autoimmune liver disease that can progress to end-stage liver disease and its complications. A previous expert review panel collaborated on a consensus document for gastroenterologists and other healthcare professionals regarding the care of patients with PBC. Subsequently, there have been several recent important developments in the diagnosis, treatment, and monitoring of patients with PBC.
View Article and Find Full Text PDFIntroduction: Treatment of primary biliary cholangitis (PBC) can improve the GLOBE score. We aimed to assess the association between changes in the GLOBE score (ΔGLOBE) and liver transplantation (LT)-free survival in patients with PBC who were treated with ursodeoxycholic acid (UDCA).
Methods: Among UDCA-treated patients within the Global PBC cohort, the association between ΔGLOBE (ΔGLOBE 0-1 : during the first year of UDCA, ΔGLOBE 1-2 : during the second year) and the risk of LT or death was assessed through Cox regression analyses.
Background And Aims: The are geographic variations in the incidence and prevalence of primary biliary cholangitis (PBC). The aim was to explore whether clinical outcomes of patients within Western Europe differ according to geographical region.
Methods: Ursodeoxycholic acid-treated patients from European centers from the Global PBC database diagnosed from 1990 onwards were included.
Background & Aims: GLIMMER assessed dose-response, efficacy, and safety of linerixibat, an ileal bile acid transporter inhibitor in development for cholestatic pruritus associated with primary biliary cholangitis (PBC).
Methods: GLIMMER was a Phase 2b, multicenter, randomized, parallel-group study in adults with PBC and moderate-to-severe pruritus (≥4 on 0-10 numerical rating scale [NRS]). After 4 weeks of single-blind placebo, patients with NRS ≥3 were randomized (3:1) to double-blind linerixibat/placebo for 12 weeks (to week 16), followed by single-blind placebo (to week 20).
Background & Aims: The Primary Biliary Cholangitis (PBC) Obeticholic Acid (OCA) International Study of Efficacy (POISE) randomized, double-blind, placebo-controlled trial demonstrated that OCA reduced biomarkers associated with adverse clinical outcomes (ie, alkaline phosphatase, bilirubin, aspartate aminotransferase, and alanine aminotransferase) in patients with PBC. The objective of this study was to evaluate time to first occurrence of liver transplantation or death in patients with OCA in the POISE trial and open-label extension vs comparable non-OCA-treated external controls.
Methods: Propensity scores were generated for external control patients meeting POISE eligibility criteria from 2 registry studies (Global PBC and UK-PBC) using an index date selected randomly between the first and last date (inclusive) on which eligibility criteria were met.
Background: After 1 year of ursodeoxycholic acid (UDCA), patients with primary biliary cholangitis (PBC) may have a normal GLOBE score despite high alkaline phosphatase (ALP) levels.
Aim: To assess the association between ALP and liver transplantation (LT)-free survival according to the GLOBE score METHODS: Among patients with a normal or elevated GLOBE score in the Global PBC cohort, the association between ALP after 1 year of UDCA and the risk of LT/death was assessed. The LT-free survival was compared with that of a matched general population.
Background And Aims: Patients with primary biliary cholangitis (PBC) often suffer with pruritus. We describe the impact of pruritus on quality of life and how it is managed in a real-world cohort.
Methods: TARGET-PBC is a longitudinal observational cohort of patients with PBC across the USA.
Article Synopsis
- The study investigated the efficacy and safety of seladelpar, a medication for adults with primary biliary cholangitis (PBC) who are at risk of worsening disease, especially those intolerant to standard medication, ursodeoxycholic acid.
- Over 52 weeks, patients were given varying doses of seladelpar, showing significant reductions in alkaline phosphatase (ALP) levels, a marker of liver disease, particularly at higher doses (10 mg/day). Improvements were maintained over time.
- Results indicated that seladelpar was effective in improving liver function and reducing symptoms like pruritus (itching) without serious side effects, making it a promising option for PBC patients
Treatment of primary biliary cholangitis (PBC) with ursodeoxycholic acid (UDCA) is not always sufficient to prevent progression to hepatic decompensation and/or need for liver transplant. Adjuvant therapy with obeticholic acid may provide additional biochemical improvements in some patients, but it is not well-tolerated by patients with significant itch or advanced cirrhosis. Thus, new and creative approaches to treating patients with PBC are important to identify.
View Article and Find Full Text PDFBackground & Aims: Autoimmune hepatitis can recur after liver transplantation (LT), though the impact of recurrence on patient and graft survival has not been well characterized. We evaluated a large, international, multicenter cohort to identify the probability and risk factors associated with recurrent AIH and the association between recurrent disease and patient and graft survival.
Methods: We included 736 patients (77% female, mean age 42±1 years) with AIH who underwent LT from January 1987 through June 2020, among 33 centers in North America, South America, Europe and Asia.