Evidence map›Paper›PMID 33319187›Full record

ArticleJHEP reports : innovation in hepatology2021

Obeticholic acid is associated with improvements in AST-to-platelet ratio index and GLOBE score in patients with primary biliary cholangitis.

Maren H Harms, Gideon M Hirschfield, Annarosa Floreani, Marlyn J Mayo, Albert Parés, Alexander Liberman, Elizabeth Smoot Malecha, Richard Pencek, Leigh MacConell, Bettina E Hansen

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in JHEP reports : innovation in hepatology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01473524 (A Phase 3, Double-Blind, Placebo-Controlled Trial and Long-Term Safety Extension of Obeticholic Acid in Patients With Primary Biliary Cirrhosis), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.5field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01473524 phase3completednot on this map

A Phase 3, Double-Blind, Placebo-Controlled Trial and Long-Term Safety Extension of Obeticholic Acid in Patients With Primary Biliary Cirrhosis

TypeinterventionalSponsorIntercept PharmaceuticalsRan2012 to 2018Enrolled217ConditionsPrimary Biliary CirrhosisArmsObeticholic Acid (OCA), Placebo
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 16 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Review
  5. Review
  6. Celebrating the third year of JHEP Reports in the COVID-19 era.JHEP reports : innovation in hepatology · 2021
    Article
  7. A Current Understanding of Bile Acids in Chronic Liver Disease.Journal of clinical and experimental hepatology
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 6 institutions in 5 countries.

Maren H HarmsDepartment of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, the Netherlands.
Gideon M HirschfieldToronto Centre for Liver Disease, Toronto General Hospital, Toronto, ON, Canada.
Annarosa FloreaniUniversità di Padova, Padova, Italy.
Marlyn J MayoUT Southwestern Medical Center, Dallas, TX, USA.
Albert ParésHospital Clinic, IDIBAPS, CIBERehd, University of Barcelona, Barcelona, Spain.
Alexander LibermanIntercept Pharmaceuticals, Inc., San Diego, CA, USA.
Elizabeth Smoot MalechaIntercept Pharmaceuticals, Inc., San Diego, CA, USA.
Richard PencekIntercept Pharmaceuticals, Inc., San Diego, CA, USA.
Leigh MacConellIntercept Pharmaceuticals, Inc., San Diego, CA, USA.
Bettina E HansenToronto Centre for Liver Disease, Toronto General Hospital, Toronto, ON, Canada.
Intercept Pharmaceuticals (United States) · USToronto General Hospital · CACentro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas · ESErasmus MC · NLSouthwestern Medical CenterUniversity of Padua · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND &

aimsBiochemical markers, including GLOBE score and aspartate aminotransferase-to-platelet ratio index (APRI), are used to stratify risk in patients with primary biliary cholangitis (PBC). This study aimed to evaluate the effects of obeticholic acid (OCA) on categorical shifts in GLOBE score, APRI, and both combined, based on data from POISE, a phase III placebo-controlled trial in patients with PBC who had an incomplete response or were intolerant to ursodeoxycholic acid.

methodsIn a

resultsThe analysis included 215 patients (47 low risk; 79 moderate risk; 89 high risk). Using the combined GLOBE score (threshold of 0.3) and APRI thresholds, there was improvement in ≥1 risk stage in 37% and 35% of patients in the OCA 5-10 mg and 10 mg groups, respectively,

conclusionsBased on change in APRI and GLOBE score at 12 months, OCA treatment is associated with reduction in the predicted risk of liver-related complications in patients with PBC. LAY SUMMARY: Primary biliary cholangitis (PBC) is a chronic disease affecting the liver. People who suffer from PBC are at risk of serious long-term complications. Information from certain blood tests can be used to estimate the likelihood of experiencing long-term complications. The results of this study showed that based on blood test results, people taking obeticholic acid, with or without ursodeoxycholic acid, for PBC were predicted to have a better outcome than those taking placebo. CLINICAL TRIALS REGISTRATION: NCT01473524.

Indexed as

AE, adverse eventALP, alkaline phosphataseAPRIAPRI, aspartate aminotransferase-to-platelet ratio indexAST, aspartate aminotransferaseCholestasisDB, double-blindFXR, farnesoid X receptorIQR, inter-quartile rangeLLN, lower limit of normalLN, natural logarithmLT, liver transplantOCA, obeticholic acidOR, odds ratioPBCPBC, primary biliary cholangitisRisk stratificationUDCA, ursodeoxycholic acidULN, upper limit of normal

Identifiers

PMID33319187
PMCPMC7724188
OpenAlexW3091107552

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.