Evidence map›Paper›PMID 39711034›Full record

Trial reportArthritis care & research2025

Treatment Response Biomarkers for Systemic Sclerosis-Associated Interstitial Lung Disease.

Elizabeth R Volkmann, Holly Wilhalme, Donald P Tashkin, Grace Hyun J Kim, Jonathan Goldin, Alana Haussmann, Masataka Kuwana, Michael D Roth, Shervin Assassi

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Arthritis care & research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

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

1 citing paper in PubMed.

  1. Article
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

9 authors.

Elizabeth R VolkmannUniversity of California, Los Angeles.ORCID 0000-0003-3750-6569
Holly WilhalmeUniversity of California, Los Angeles.
Donald P TashkinUniversity of California, Los Angeles.
Grace Hyun J KimUniversity of California, Los Angeles.ORCID 0000-0003-1225-3489
Jonathan GoldinUniversity of California, Los Angeles.
Alana HaussmannUniversity of California, Los Angeles.
Masataka KuwanaNippon Medical School, Tokyo, Japan.ORCID 0000-0001-8352-6136
Michael D RothUniversity of California, Los Angeles.
Shervin AssassiUniversity of Texas Health Science Center at Houston.ORCID 0000-0002-8059-9978

Funding

SCLERODERMA LUNG STUDYU01HL060587 · NHLBI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI TASHKIN, DONALD P · 1999 to 2003
$2.3M
SCLERODERMA LUNG STUDYU01HL060606 · NHLBI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI ELASHOFF, ROBERT M · 1999 to 2006
$1.3M
Identifying predictors of treatment response in systemic sclerosis-related interstitial lung diseaseK23HL150237 · NHLBI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI VOLKMANN, ELIZABETH R · 2020 to 2024
$910k
Hoffmann-La RocheNHLBI NIH HHS K23 HL150237NHLBI NIH HHS U01 HL060587NHLBI NIH HHS U01 HL060606NHLBI NIH HHS U01 HL 60587NHLBI NIH HHS U01 HL 60606U.S. Department of Defense W81XWH-22-1-0162
6 · The paper itself

Abstract

objectiveThis study investigated whether changes in circulating biomarkers predict progressive pulmonary fibrosis (PPF) in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) receiving treatment.

methodsParticipants of the Scleroderma Lung Study II, which compared receiving mycophenolate mofetil (MMF) versus cyclophosphamide (CYC) for treating SSc-ILD, who had blood samples at baseline and 12 months were included. Levels for C-reactive protein (CRP), interleukin-6, C-X-C motif chemokine ligand (CXCL) 4, CCL18, and Krebs von den Lungen (KL)-6 were measured, and a logistic regression model evaluated relationships between changes in these biomarkers and the development of PPF by 24 months.

resultsA total of 92 of the 142 randomized participants had longitudinal biomarker measurements and the required clinical outcome data, with 19 participants (21%) meeting criteria for PPF. In the whole cohort, changes in KL-6 levels were significantly correlated with PPF. KL-6 increased in patients who developed PPF and decreased in patients who did not (mean change ± SD 365.68 ± 434.41 vs -207.45 ± 670.26; P < 0.001). In the arm of participants who received MMF alone, changes in CRP and CXCL4 levels were also significantly correlated with PPF. When added to an existing prediction model based on baseline factors associated with PPF in this cohort (sex, baseline reflux severity, and CXCL4 levels), the change in KL-6 remained significantly associated with PPF (odds ratio 1.4; P = 0.0002).

conclusionChanges in the circulating levels of KL-6 after treatment with MMF or CYC predicted PPF, even after adjusting for baseline factors associated with PPF. Measuring longitudinal KL-6 in patients with SSc-ILD may improve how we personalize therapy in patients with SSc-ILD.

Indexed as

CyclophosphamideImmunosuppressive AgentsLung Diseases, InterstitialMucin-1Mycophenolic AcidScleroderma, SystemicAdultAgedBiomarkersChemokines, CCC-Reactive ProteinFemaleHumansInterleukin-6Longitudinal StudiesMaleBiomarkersCCL18 protein, humanChemokines, CCC-Reactive ProteinCyclophosphamideImmunosuppressive AgentsInterleukin-6MUC1 protein, humanMucin-1Mycophenolic Acid

Identifiers

PMID39711034
PMCPMC12122240

What OpenQuestion holds

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Registered trials

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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.