Evidence map›Paper›PMID 34195587›Full record

ArticleJournal of translational autoimmunity2021

Baricitinib and primary biliary cholangitis.

Stuart C Gordon, Sheri Trudeau, Arie Regev, Jonathan M Uhas, Sujatro Chakladar, Ana Pinto-Correia, Klaus Gottlieb, Doug Schlichting

Open access · goldAbstract read
In one paragraph

Article in Journal of translational autoimmunity, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 24 citations in OpenAlex.

  1. Article
  2. Liver diseases: epidemiology, causes, trends and predictions.Signal transduction and targeted therapy · 2025
    Review
  3. Article
  4. Article
  5. Review
  6. Article
  7. Review
  8. Review
  9. Review
  10. Review
  11. Review
  12. Current and future opportunities for the management of primary biliary cholangitis.Frontiers in gastroenterology (Lausanne, Switzerland) · 2023
    Review
  13. Article
  14. Review
  15. Article
  16. 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

8 authors at 2 institutions in 1 country.

Stuart C GordonDivision of Gastroenterology and Hepatology, Henry Ford Health System, Detroit, MI, USA.
Sheri TrudeauDepartment of Public Health Sciences, Henry Ford Health System, Detroit, MI, USA.
Arie RegevEli Lilly & Company, Indianapolis, IN, USA.
Jonathan M UhasDivision of Gastroenterology and Hepatology, Henry Ford Health System, Detroit, MI, USA.
Sujatro ChakladarEli Lilly & Company, Indianapolis, IN, USA.
Ana Pinto-CorreiaEli Lilly & Company, Indianapolis, IN, USA.
Klaus GottliebEli Lilly & Company, Indianapolis, IN, USA.
Doug SchlichtingEli Lilly & Company, Indianapolis, IN, USA.
Eli Lilly (United States) · USHenry Ford Health System · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsThere is an unmet need for alternative treatments for patients with primary biliary cholangitis (PBC) who do not respond to treatment with ursodeoxycholic acid (UDCA). A proof-of-concept study of baricitinib, an orally administered Janus kinase 1 and 2 inhibitor, was initiated to evaluate its use in PBC patients. APPROACH AND

resultsPatients with PBC showing inadequate response or intolerance to UDCA were eligible. This was a randomized, double-blinded placebo-controlled trial. Enrollees were assigned 1:1 to baricitinib (2 mg/day) or placebo. Endpoints included change in alkaline phosphatase (ALP), itch Numeric Rating Score (NRS), and fatigue NRS at 12 weeks post-baseline; exploratory markers included high sensitivity C-reactive protein (hs-CRP) and Enhanced Liver Fibrosis (ELF) score.Due to low enrollment, the study was terminated early. Two patients were enrolled and completed the trial; 1 was randomized to receive baricitinib and 1 to placebo. Over the treatment period, the baricitinib-treated patient demonstrated a 30% decrease in ALP and a 7-point improvement in the itch NRS, but a 2-point increase in the Fatigue NRS. Markers of inflammation and liver fibrosis (hs-CRP and ELF score) also improved over the study period. In contrast, the placebo-treated patient showed no improvement in primary or secondary endpoints. A single non-serious treatment-emergent adverse event of moderate sinusitis was reported by the baricitinib-treated patient at day 47.

conclusionsIn a 12-week trial, a patient with PBC showing inadequate response to treatment with UDCA demonstrated a dramatic response to treatment with baricitinib.

Indexed as

12-WeekItchJak1/2 inhibitorsLiver disease

Identifiers

PMID34195587
PMCPMC8240017
OpenAlexW3170630002

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.