Evidence map›Paper›PMID 21547897›Full record

Trial reportArthritis and rheumatism2011

Predicting treatment outcomes and responder subsets in scleroderma-related interstitial lung disease.

Michael D Roth, Chi-Hong Tseng, Philip J Clements, Daniel E Furst, Donald P Tashkin, Jonathan G Goldin, Dinesh Khanna, Eric C Kleerup, Ning Li, David Elashoff and 2 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Arthritis and rheumatism, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00883129 (Mycophenolate vs. Oral Cyclophosphamide in Scleroderma Interstitial Lung Disease), which is not on this map. Cited by 60 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
60citing papers in PubMed, 4 pooled it
5.3field-weighted citation impact, top 4% 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.

NCT00883129 phase2completednot on this map

Mycophenolate vs. Oral Cyclophosphamide in Scleroderma Interstitial Lung Disease (Scleroderma Lung Study II)

TypeinterventionalSponsorMichael RothRan2009 to 2015Enrolled142ConditionsScleroderma, Interstitial Lung DiseaseArmsMycophenolate mofetil, Cyclophosphamide, Placebo
3 · Its place in the literature

Who cites it

60 citing papers in PubMed, 4 syntheses or guidelines pooled it, 116 citations in OpenAlex.

  1. Pooled it
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  3. Pulmonary function tests as outcomes for systemic sclerosis interstitial lung disease.European respiratory review : an official journal of the European Respiratory Society · 2018
    Pooled it
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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

12 authors at 2 institutions in 1 country.

Michael D RothDepartment of Medicine, David Geffen School of Medicine, University of California, Los Angeles, CA 90095-1690, USA. mroth@mednet.ucla.edu
Chi-Hong Tseng
Philip J Clements
Daniel E Furst
Donald P Tashkin
Jonathan G Goldin
Dinesh Khanna
Eric C Kleerup
Ning Li
David Elashoff
Robert M Elashoff
Scleroderma Lung Study Research Group
University of California, Los Angeles · USCedars-Sinai Medical Center · US

Funding

MOCSLID-DCCR01HL089901 · NHLBI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI ELASHOFF, ROBERT M · 2008 to 2012
$9.1M
SCLERODERMA LUNG STUDYU01HL060587 · NHLBI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI TASHKIN, DONALD P · 1999 to 2003
$2.3M
MOCSLID-CCCR01HL089758 · NHLBI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI TASHKIN, DONALD P · 2008 to 2012
$2.0M
CYTOKINES AS PREDICTORS OF DISEASE PROGRESSION IN SCLERODERMA LUNG DISEASER01AR055075 · NIAMS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI ROTH, MICHAEL D · 2006 to 2009
$1.3M
SCLERODERMA LUNG STUDYU01HL060606 · NHLBI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI ELASHOFF, ROBERT M · 1999 to 2006
$1.3M
SCLERODERMA LUNG STUDYU01HL060550 · NHLBI · UNIV OF MED/DENT NJ-R W JOHNSON MED SCH · PI RILEY, DAVID J · 1999 to 2003
$672k
SCLERODERMA LUNG STUDYU01HL060597 · NHLBI · JOHNS HOPKINS UNIVERSITY · PI WISE, ROBERT A. · 1999 to 2003
$499k
SCLERODERMA LUNG STUDYU01HL060895 · NHLBI · UNIVERSITY OF ILLINOIS AT CHICAGO · PI SCHRAUFNAGEL, DEAN E · 1999 to 2003
$422k
SCLERODERMA LUNG STUDYU01HL060750 · NHLBI · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI SILVER, RICHARD M. · 1999 to 2003
$391k
SCLERODERMA LUNG STUDYU01HL060682 · NHLBI · BOSTON UNIVERSITY MEDICAL CAMPUS · PI THEODORE, ARTHUR C · 1999 to 2003
$343k
SCLERODERMA LUNG STUDYU01HL060794 · NHLBI · GEORGETOWN UNIVERSITY · PI READ, CHARLES · 1999 to 2003
$245k
SCLERODERMA LUNG STUDYU01HL060839 · NHLBI · WAYNE STATE UNIVERSITY · PI MAYES, MAUREEN MAUREEN · 1999 to 2003
$226k
NHLBI NIH HHS R01 HL089758NHLBI NIH HHS R01-HL-089758NHLBI NIH HHS R01 HL089901NHLBI NIH HHS R01-HL-089901NHLBI NIH HHS U01 HL060550NHLBI NIH HHS U01 HL060587NHLBI NIH HHS U01 HL060597NHLBI NIH HHS U01 HL060606NHLBI NIH HHS U01 HL060682NHLBI NIH HHS U01 HL060750NHLBI NIH HHS U01 HL060794NHLBI NIH HHS U01 HL060839NHLBI NIH HHS U01 HL060895NHLBI NIH HHS U01-HL-60550NHLBI NIH HHS U01-HL-60587NHLBI NIH HHS U01-HL-60597NHLBI NIH HHS U01-HL-60606NHLBI NIH HHS U01-HL-60682NHLBI NIH HHS U01-HL-60748NHLBI NIH HHS U01-HL-60750NHLBI NIH HHS U01-HL-60794NHLBI NIH HHS U01-HL-60823NHLBI NIH HHS U01-HL-60839NHLBI NIH HHS U01-HL-60895NIAMS NIH HHS R01 AR055075NIAMS NIH HHS R01-AR-055075
6 · The paper itself

Abstract

objectiveTo identify baseline characteristics of patients with scleroderma-related interstitial lung disease (SSc-ILD) that could serve as predictors of the most favorable response to 12-month treatment with oral cyclophosphamide (CYC).

methodsRegression analyses were retrospectively applied to the Scleroderma Lung Study data in order to identify baseline characteristics that correlated with the absolute change in forced vital capacity (FVC) (% predicted values) and the placebo-adjusted change in % predicted FVC over time (the CYC treatment effect).

resultsCompletion of the CYC arm of the Scleroderma Lung Study was associated with a placebo-adjusted improvement in the % predicted FVC of 2.11% at 12 months, which increased to 4.16% when patients were followed up for another 6 months (P=0.014). Multivariate regression analyses identified the maximal severity of reticular infiltrates (assessed as maximum fibrosis scores) on high-resolution computed tomography (HRCT) at baseline, the modified Rodnan skin thickness score (MRSS) at baseline, and the Mahler baseline dyspnea index as independent correlates of treatment response. When patients were stratified on the basis of whether 50% or more of any lung zone was involved by reticular infiltrates on HRCT and/or whether patients exhibited an MRSS of at least 23, a subgroup of patients emerged in whom there was an average CYC treatment effect of 9.81% at 18 months (P<0.001). Conversely, there was no treatment effect (a -0.58% difference) in patients with less severe HRCT findings and a lower MRSS at baseline.

conclusionA retrospective analysis of the Scleroderma Lung Study data identified the severity of reticular infiltrates on baseline HRCT and the baseline MRSS as patient features that might be predictive of responsiveness to CYC therapy.

Indexed as

AdultAntirheumatic AgentsCyclophosphamideDouble-Blind MethodFemaleHumansImmunosuppressive AgentsLung Diseases, InterstitialMaleRespiratory Function TestsScleroderma, SystemicTreatment OutcomeVital CapacityAntirheumatic AgentsCyclophosphamideImmunosuppressive Agents

Identifiers

PMID21547897
PMCPMC3910296
OpenAlexW1971366332

What OpenQuestion holds

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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.