Evidence map›Paper›PMID 42667573›Full record

ArticleAdvances in therapy2026

Meaningful Improvement Thresholds for Pruritus and Sleep Disturbance in PBC Using the Worst Itch and Sleep Interference Numerical Rating Scales.

Brooke M Currie, Katelyn Cutts, Ren Yu, Yipin Han, Gideon M Hirschfield, Cynthia Levy, Megan M McLaughlin, Marlyn J Mayo, David E Jones, Heather L Gelhorn

Registry-linked trialAbstract read
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In one paragraph

Article in Advances in therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04950127 (A Two-part, Randomized, Placebo Controlled, Double Blind, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Linerixibat for the Treatment of Cholestatic Pruritus in Participants With Primary Biliary Cholangitis), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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.

NCT04950127 phase3completednot on this map

A Two-part, Randomized, Placebo Controlled, Double Blind, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Linerixibat for the Treatment of Cholestatic Pruritus in Participants With Primary Biliary Cholangitis (PBC)

TypeinterventionalSponsorGlaxoSmithKlineRan2021 to 2024Enrolled238ConditionsPruritusArmsLinerixibat, Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Brooke M CurrieGSK, Collegeville, PA, USA. brooke.m.currie@gsk.com.ORCID http://orcid.org/0000-0002-2343-9476
Katelyn CuttsEvidera | PPD, Wilmington, NC, USA.
Ren YuEvidera | PPD, Wilmington, NC, USA.
Yipin HanEvidera | PPD, Wilmington, NC, USA.ORCID http://orcid.org/0009-0000-8550-6083
Gideon M HirschfieldThe Autoimmune and Rare Liver Disease Programme, Division of Gastroenterology and Hepatology, University Health Network, Toronto General Hospital, Toronto, ON, Canada.
Cynthia LevyDivision of Digestive Health and Liver Diseases, University of Miami Miller School of Medicine, Miami, FL, USA.
Megan M McLaughlinGSK, Collegeville, PA, USA.
Marlyn J MayoUniversity of Texas Southwestern Medical School, Dallas, TX, USA.
David E JonesInstitute of Translational and Clinical Research and NIHR Newcastle Biomedical Research Centre, Newcastle University, Newcastle Upon Tyne, UK.
Heather L GelhornEvidera | PPD, Wilmington, NC, USA.ORCID http://orcid.org/0000-0003-3566-1004

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCholestatic pruritus is common in primary biliary cholangitis (PBC), adversely affecting quality of life. This study aimed to establish the within-patient meaningful change threshold (MCT) for the Worst Itch Numerical Rating Scale (WI-NRS) in patients with PBC and pruritus. Determining MCTs for patient-reported outcomes is crucial for interpreting treatment efficacy in clinical trials. Given the high impact of pruritus on sleep in PBC, an MCT was also estimated for the Sleep Interference NRS (SI-NRS), which assesses pruritus-related sleep interference.

methodsAnalyses were performed on blinded data from the Phase 3 GLISTEN study of linerixibat in patients with PBC and moderate-to-severe pruritus (NCT04950127). Anchor-based methods included the Patient Global Impression of Severity (PGI-S) and Change (PGI-C) as primary and supportive anchors, respectively. Correlations between weekly averages of daily WI-NRS and SI-NRS change scores and the anchors were assessed. A '1-point' improvement in PGI-S and 'moderately improved' on PGI-C were considered key reference groups for MCT determination. MCTs were evaluated in patients who reported changes in their itch and/or sleep were meaningful, as indicated by PGI-C item 2. Cumulative distribution function curves and distribution-based methods provided supporting evidence.

resultsData from 238 patients were included. Among patients reporting meaningful change in itch at Week 24, mean (standard deviation) change in WI-NRS was - 3.0 (1.7) for the '1-point' PGI-S improvers and - 2.9 (2.0) for the 'moderately improved' PGI-C group. Corresponding values for SI-NRS were - 2.6 (2.1) and - 2.4 (2.1). Distribution-based estimates for the change in WI-NRS and SI-NRS each ranged from 0.42 to 0.85.

conclusionThis study demonstrated that a reduction of ≥ 3 points in WI-NRS and ≥ 2.5 points in SI-NRS weekly scores represent clinically meaningful improvement thresholds for patients with PBC and moderate-to-severe pruritus. These results support use of WI-NRS and SI-NRS in future PBC trials evaluating new treatments for pruritus.

Indexed as

Cholestatic pruritusIBATLinerixibatMeaningful change thresholdNumerical rating scalePatient-reported outcomePrimary biliary cholangitisResponder definitionSleep interferenceWorst itch

Identifiers

PMID42667573

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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.