Evidence map›Paper›PMID 33538094›Full record

Trial reportArthritis & rheumatology (Hoboken, N.J.)2021

Tocilizumab Prevents Progression of Early Systemic Sclerosis-Associated Interstitial Lung Disease.

David Roofeh, Celia J F Lin, Jonathan Goldin, Grace Hyun Kim, Daniel E Furst, Christopher P Denton, Suiyuan Huang, Dinesh Khanna, focuSSced Investigators

Open access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Arthritis & rheumatology (Hoboken, N.J.), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 103 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
103citing papers in PubMed, 6 pooled it
22.8field-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.

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

103 citing papers in PubMed, 6 syntheses or guidelines pooled it, 181 citations in OpenAlex.

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43 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

9 authors at 3 institutions in 3 countries.

David RoofehUniversity of Michigan, Ann Arbor.ORCID 0000-0002-9750-5771
Celia J F LinGenentech, South San Francisco, California.
Jonathan GoldinUniversity of California, Los Angeles.
Grace Hyun KimUniversity of California, Los Angeles.ORCID 0000-0003-1225-3489
Daniel E FurstUniversity of California, Los Angeles, University of Washington, Seattle, and University of Florence, Florence, Italy.
Christopher P DentonUniversity College London, London, UK.ORCID 0000-0003-3975-8938
Suiyuan HuangUniversity of Michigan, Ann Arbor.
Dinesh KhannaUniversity of Michigan, Ann Arbor.ORCID 0000-0003-1412-4453
focuSSced Investigators
University of California, Los Angeles · USUniversity of Michigan · USUniversity College London · GB

Funding

TRAINING OF ARTHRITIS RESEARCH SCIENTISTST32AR007080 · NIAMS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Jason Knight · 1986 to 2026
$6.3M
Outcomes Research in Rheumatic DiseasesK24AR063120 · NIAMS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI KHANNA, DINESH · 2012 to 2022
$1.6M
Systemic Sclerosis-Associated Interstitial Lung Disease Response IndexR01AR070470 · NIAMS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI KHANNA, DINESH · 2017 to 2019
$642k
Syk blockade in bullous skin diseasesR43AR063129 · NIAMS · PORTOLA PHARMACEUTICALS, INC. · PI SINHA, UMA · 2012 to 2012
$298k
NIAMS NIH HHS K24 AR063120NIAMS NIH HHS R01 AR070470NIAMS NIH HHS R43 AR063129NIAMS NIH HHS T32 AR007080
6 · The paper itself

Abstract

objectiveTocilizumab (TCZ) has demonstrated lung function preservation in 2 randomized controlled trials in early systemic sclerosis (SSc). This effect has yet to be characterized in terms of radiographically evident quantitative lung involvement. We undertook this study to assess the impact of TCZ on lung function preservation in a post hoc analysis, stratifying treatment arms according to the degree of lung involvement.

methodsThe focuSSced trial was a phase III randomized placebo-controlled trial of TCZ in patients with SSc and progressive skin disease. Participants underwent baseline and serial spirometry along with high-resolution chest computed tomography at baseline and at week 48. Quantitative interstitial lung disease (QILD) and fibrosis scores were assessed by computer software. We classified QILD into the following categories of lung involvement: mild (>5-10%), moderate (>10-20%), and severe (>20%).

resultsOf 210 participants recruited for the trial, 136 patients (65%) had ILD. The majority of these patients (77%) had moderate-to-severe involvement (defined as >10% lung involvement). The TCZ arm demonstrated preservation of forced vital capacity percent predicted (FVC%) over 48 weeks (least squares mean change in FVC% = -0.1) compared to placebo (-6.3%). For mild, moderate, and severe QILD, the mean ± SD change in FVC% in the TCZ arm at 48 weeks were -4.1 ± 2.5% (n = 11), 0.7 ± 1.9% (n =19), and 2.1 ± 1.6% (n = 26), respectively, and in the placebo group were -10.0 ± 2.6% (n = 11), -5.7 ± 1.6% (n = 26), and -6.7 ± 2.0% (n = 16), respectively. Similar treatment-related preservation findings were seen independent of fibrosis severity.

conclusionTCZ in early SSc-associated ILD with progressive skin disease stabilized FVC% over 48 weeks, independent of the extent of radiographically evident QILD.

Indexed as

AdultAntibodies, Monoclonal, HumanizedDisease ProgressionFemaleFibrosisHumansImage Processing, Computer-AssistedLungLung Diseases, InterstitialMaleMiddle AgedScleroderma, SystemicSeverity of Illness IndexSpirometryTomography, X-Ray ComputedTreatment OutcomeAntibodies, Monoclonal, Humanizedtocilizumab

Identifiers

PMID33538094
PMCPMC8238790
OpenAlexW3126499013

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.