Evidence map›Paper›PMID 28376288›Full record

ArticleArthritis & rheumatology (Hoboken, N.J.)2017

Mycophenolate Mofetil Versus Placebo for Systemic Sclerosis-Related Interstitial Lung Disease: An Analysis of Scleroderma Lung Studies I and II.

Elizabeth R Volkmann, Donald P Tashkin, Ning Li, Michael D Roth, Dinesh Khanna, Anna-Maria Hoffmann-Vold, Grace Kim, Jonathan Goldin, Philip J Clements, Daniel E Furst and 1 more

2 registry-linked trialsAbstract readComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Arthritis & rheumatology (Hoboken, N.J.), 2017. 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 81 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
81citing papers in PubMed, 10 pooled it
10.4field-weighted citation impact, top 1% 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.

NCT03221257 phase2completednot on this map

Scleroderma Lung Study III (SLS III): Combining the Anti-fibrotic Effects of Pirfenidone (PFD) With Mycophenolate (MMF) for Treating Scleroderma-related Interstitial Lung Disease

TypeinterventionalSponsorMichael RothRan2017 to 2022Enrolled51ConditionsScleroderma, Systemic, Interstitial Lung DiseaseArmsPirfenidone (PFD), Placebo (Plac), Mycophenolate Mofetil (MMF)
NCT03678987 completednot on this mapstarted 2018, after this paper: background citation

Mycophenolate Mofetil in Systemic Sclerosis: A Phase 1 Pharmacokinetic Study of Orally Ingested Mycophenolate Mofetil Tablets in Patients Suffering From Systemic Sclerosis

TypeobservationalSponsorRegion SkaneRan2018 to 2020Enrolled35ConditionsSystemic Sclerosis, Gastrointestinal ComplicationArmsP-MPA concentration, mycophenolic acid
3 · Its place in the literature

Who cites it

81 citing papers in PubMed, 10 syntheses or guidelines pooled it, 159 citations in OpenAlex.

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21 more citing papers are in PubMed but not listed here.

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

11 authors at 3 institutions in 2 countries.

Elizabeth R VolkmannUniversity of California, Los Angeles.
Donald P TashkinUniversity of California, Los Angeles.
Ning LiUniversity of California, Los Angeles.
Michael D RothUniversity of California, Los Angeles.
Dinesh KhannaUniversity of Michigan Medical School, Ann Arbor.
Anna-Maria Hoffmann-VoldOslo University Hospital, Oslo, Norway.
Grace KimUniversity of California, Los Angeles.
Jonathan GoldinUniversity of California, Los Angeles.
Philip J ClementsUniversity of California, Los Angeles.
Daniel E FurstUniversity of California, Los Angeles.
Robert M ElashoffUniversity of California, Los Angeles.
University of California, Los Angeles · USOslo University Hospital · NOUniversity of Michigan–Ann Arbor · US

Funding

UCLA Clinical and Translational Science InstituteUL1TR000124 · NCATS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI DUBINETT, STEVEN M. · 2012 to 2015
$57.0M
MOCSLID-DCCR01HL089901 · NHLBI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI ELASHOFF, ROBERT M · 2008 to 2012
$9.1M
MOCSLID-CCCR01HL089758 · NHLBI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI TASHKIN, DONALD P · 2008 to 2012
$2.0M
SCLERODERMA LUNG STUDYU01HL060606 · NHLBI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI ELASHOFF, ROBERT M · 1999 to 2006
$1.3M
NCATS NIH HHS UL1 TR000124NHLBI NIH HHS R01 HL089758NHLBI NIH HHS R01 HL089901NHLBI NIH HHS U01 HL060606
6 · The paper itself

Abstract

objectiveTo compare mycophenolate mofetil (MMF) with placebo for the treatment of systemic sclerosis (SSc)-related interstitial lung disease (ILD).

methodsWe included participants enrolled in the placebo arm of Scleroderma Lung Study (SLS) I and the MMF arm of SLS II. SLS I randomized participants to receive either oral cyclophosphamide (CYC) or placebo for 1 year, while SLS II randomized participants to receive either MMF for 2 years or oral CYC for 1 year followed by 1 year of placebo. Eligibility criteria for SLS I and SLS II were nearly identical. The primary outcome was % predicted forced vital capacity (FVC), and key secondary outcomes included % predicted diffusing capacity for carbon monoxide (DLco), the modified Rodnan skin thickness score (MRSS), and dyspnea. Joint models were created to evaluate the treatment effect on the course of these outcomes over 2 years.

resultsAt baseline, the MMF-treated group in SLS II (n = 69) and the placebo-treated group in SLS I (n = 79) had similar percentages of men and women and similar disease duration, SSc subtype, extent of skin disease, and % predicted FVC. MMF-treated patients in SLS II were slightly older (mean ± SD age 52.6 ± 9.7 years versus 48.1 ± 12.4 years; P = 0.0152) and had higher % predicted DLco (mean ± SD 54.0 ± 11.1 versus 46.2 ± 13.3; P = 0.0002) than placebo-treated patients in SLS I. After adjustment for baseline disease severity, treatment with MMF in comparison with placebo was associated with improved % predicted FVC (P < 0.0001), % predicted DLco (P < 0.0001), MRSS (P < 0.0001), and dyspnea (P = 0.0112) over 2 years.

conclusionAlthough there are inherent limitations in comparing participants from different trials, treatment with MMF was associated with improvements in physiologic outcomes and dyspnea compared with placebo, even after accounting for baseline disease severity. These results further substantiate the use of MMF for the treatment of SSc-related ILD.

Indexed as

AdultAgedAged, 80 and overCyclophosphamideDyspneaFemaleHumansImmunosuppressive AgentsLung Diseases, InterstitialMaleMiddle AgedMycophenolic AcidPulmonary Diffusing CapacityRandomized Controlled Trials as TopicScleroderma, SystemicSkinCyclophosphamideImmunosuppressive AgentsMycophenolic Acid

Identifiers

PMID28376288
PMCPMC5560126
OpenAlexW2604976853

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.