Evidence map›Paper›PMID 40355288›Full record

Trial reportBMJ open2025

Minimum clinically important difference in Quantitative Lung Fibrosis score associated with all-cause mortality in idiopathic pulmonary fibrosis: subanalysis from two phase II trials of pamrevlumab.

Grace Hyun Kim, Xueping Zhang, Matthew S Brown, Lona Poole, Jonathan Goldin

2 registry-linked trialsAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT01262001 phase2completednot on this map

A Phase 2, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Efficacy of FG-3019 in Subjects With Idiopathic Pulmonary Fibrosis

TypeinterventionalSponsorKyntra BioRan2011 to 2017Enrolled90ConditionsIdiopathic Pulmonary FibrosisArmsFG-3019
NCT01890265 phase2completednot on this map

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of FG-3019 in Patients With Idiopathic Pulmonary Fibrosis

TypeinterventionalSponsorKyntra BioRan2013 to 2017Enrolled160ConditionsIdiopathic Pulmonary FibrosisArmsPamrevlumab, Placebo, Sub-Study: Pirfenidone, Sub-Study: Nintedanib
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
  4. The importance of mechanical forces in chronic respiratory diseases.European respiratory review : an official journal of the European Respiratory Society · 2026
    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

5 authors.

Grace Hyun KimUniversity of California Los Angeles David Geffen School of Medicine, Los Angeles, California, USA GraceKim@mednet.ucla.edu.ORCID http://orcid.org/0000-0003-1225-3489
Xueping ZhangFibroGen Inc, San Francisco, California, USA.
Matthew S BrownUniversity of California Los Angeles David Geffen School of Medicine, Los Angeles, California, USA.
Lona PooleFibroGen Inc, San Francisco, California, USA.
Jonathan GoldinUniversity of California Los Angeles David Geffen School of Medicine, Los Angeles, California, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesIdiopathic pulmonary fibrosis (IPF) is a progressive interstitial lung disease. Chest high-resolution CT (HRCT) is instrumental in IPF management, and the Quantitative Lung Fibrosis (QLF) score is a computer-assisted metric for quantifying lung disease using HRCT. This study aimed to assess the change in QLF score associated with a minimum clinically important difference (MCID) of IPF symptoms and physiological lung function, and also determine the MCID of QLF change associated with all-cause mortality to serve as an imaging biomarker to confirm disease progression and response to therapy. DESIGN AND STUDY

settingWe conducted post hoc analyses of prospective data from two IPF phase II studies of pamrevlumab, a fully human monoclonal antibody that binds to and inhibits connective tissue growth factor activity.

participantsOverall, 152 patients with follow-up visits after week 24.

methodsWe used the anchor-based Jaeschke's method to estimate the MCID of the QLF score that corresponded with the already established MCID of St. George's Respiratory Questionnaire (SGRQ) and percent-predicted forced vital capacity (ppFVC). We also conducted a Cox regression analysis to establish a sensitive and robust MCID of the QLF score in predicting all-cause mortality.

resultsQLF changes of 4.4% and 3.6% corresponded to the established MCID of a 5-point increase in SGRQ and a 3.4% reduction in ppFVC, respectively. QLF changes of 1% (HR=4.98, p=0.05), 2% (HR=4.04, p=0.041), 20 mL (HR=6.37, p=0.024) and 22 mL (HR=6.38, p=0.024) predicted mortality.

conclusionA conservative metric of 2% can be used as the MCID of QLF for predicting all-cause mortality. This may be considered in IPF trials in which the degree of structural fibrosis assessed via HRCT is an endpoint. The MCID of SGRQ and FVC corresponds with a greater amount of QLF and may reflect that a greater amount of change in fibrosis is required before there is functional change. TRIAL REGISTRATION NUMBER: NCT01262001, NCT01890265.

Indexed as

Antibodies, MonoclonalAntibodies, Monoclonal, HumanizedIdiopathic Pulmonary FibrosisMinimal Clinically Important DifferenceAgedDisease ProgressionFemaleHumansLungMaleMiddle AgedProspective StudiesTomography, X-Ray ComputedVital CapacityAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedChest imagingComputed tomographyInterstitial lung diseasePatient Reported Outcome MeasuresPulmonary DiseaseQUALITATIVE RESEARCH

Identifiers

PMID40355288
PMCPMC12083266

What OpenQuestion holds

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LicenceCC BY-NC
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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.