Evidence map›Paper›PMID 29174792›Full record

Trial reportSeminars in arthritis and rheumatism2018

A randomized, double-blind, placebo-controlled trial of infliximab in refractory polymyositis and dermatomyositis.

Adam Schiffenbauer, Megha Garg, Christine Castro, Angelina Pokrovnichka, Galen Joe, Joseph Shrader, Imelda Victoria Cabalar, Sara Faghihi-Kashani, Michael O Harris-Love, Paul H Plotz and 2 more

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Seminars in arthritis and rheumatism, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 2 pooled it
4.0field-weighted citation impact, top 6% 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

36 citing papers in PubMed, 2 syntheses or guidelines pooled it, 70 citations in OpenAlex.

  1. Pooled it
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  6. Targeted Therapy for Idiopathic Inflammatory Myopathy.Journal of cachexia, sarcopenia and muscle · 2025
    Review
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  8. Paradoxical and bimodal immune-mediated dermatological side effects of TNF-α inhibitors: A comprehensive review.Skin research and technology : official journal of International Society for Bioengineering and the Skin (ISBS) [and] International Society for Digital Imaging of Skin (ISDIS) [and] International Society for Skin Imaging (ISSI) · 2024
    Review
  9. Review
  10. Article
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  14. Antibody Therapies in Autoimmune Inflammatory Myopathies: Promising Treatment Options.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2022
    Review
  15. Idiopathic inflammatory myopathies.Nature reviews. Disease primers · 2021
    Review
  16. Idiopathic inflammatory myopathies.Nature reviews. Disease primers · 2021
    Article
  17. Review
  18. Monoclonal Antibodies as Neurological Therapeutics.Pharmaceuticals (Basel, Switzerland) · 2021
    Review
  19. Article
  20. 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

12 authors at 3 institutions in 1 country.

Adam SchiffenbauerEnvironmental Autoimmunity Group, National Institute of Environmental Health Sciences. Electronic address: adam.schiffenbauer@nih.gov.
Megha GargNational Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health.
Christine CastroNational Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health.
Angelina PokrovnichkaNational Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health.
Galen JoeClinical Center, NIH, Department of Rehabilitation Medicine.
Joseph ShraderClinical Center, NIH, Department of Rehabilitation Medicine.
Imelda Victoria CabalarNational Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health.
Sara Faghihi-KashaniEnvironmental Autoimmunity Group, National Institute of Environmental Health Sciences.
Michael O Harris-LoveClinical Center, NIH, Department of Rehabilitation Medicine.
Paul H PlotzNational Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health.
Frederick W MillerEnvironmental Autoimmunity Group, National Institute of Environmental Health Sciences.
Mark GourleyNational Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health.
National Institute of Arthritis and Musculoskeletal and Skin Diseases · USNational Institute of Environmental Health Sciences · USNational Institutes of Health · US

Funding

Assessment, Therapy and Prevention Of Autoimmune DiseaseZIAES101081 · NIEHS · NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES · PI RIDER, LISA · 2009 to 2025
$17.6M
Intramural NIH HHS Z99 ES999999
6 · The paper itself

Abstract

objectiveTo investigate in a pilot study the safety and efficacy of infliximab in patients with refractory dermatomyositis (DM) and polymyositis (PM).

methodsA randomized, double-blind, placebo-controlled trial including subjects with active DM or PM. Participants had stable doses of immunosuppressive medication and prednisone (≤0.5mg/kg/day), and exhibited clinical signs of muscle weakness for at least 4 weeks prior to study entry. Participants received infusions of either placebo or infliximab 5mg/kg at 0, 2, 6, and 14 weeks in blinded manner. The primary outcome was a ≥15% manual muscle strength (MMT) improvement at week 16 compared to week 0. The secondary outcome measures were improvement defined by the International Myositis Assessment and Clinical Studies Group (IMACS) criteria. At week 16, responders in each arm had the option of either continuing the same treatment or changing to the non-responder treatment for that study arm. Non-responders in the 5mg/kg infliximab arm were increased to infliximab 7.5mg/kg for weeks 22, 30, and 38. Non-responders in the placebo arm at week 16 received infliximab 5mg/kg at weeks 16, 18, 22, 30, and 38. Outcomes were reassessed at week 40.

resultsTwelve subjects completed the study to week 16. Six of the 12 subjects received infliximab treatment at the dose of 5mg/kg with only one subject meeting the responder criteria at that dose. Of the remaining five subjects on infliximab, three crossed over to the infliximab 7.5mg/kg dose. One of those three subjects responded. All six patients in the placebo arm crossed over to the 5mg/kg dosing regimen after week 16, and two of those responded to infliximab.

conclusionsInfliximab therapy for patients with refractory PM and DM was well tolerated and may benefit a subset of patients.

Indexed as

AdultCross-Over StudiesDermatologic AgentsDermatomyositisDouble-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationFemaleHumansImmunosuppressive AgentsInfliximabMaleMiddle AgedPilot ProjectsPrednisoneTreatment OutcomeDermatologic AgentsImmunosuppressive AgentsInfliximabPrednisoneDermatomyositisInfliximabPolymyositisTNF inhibitor

Identifiers

PMID29174792
PMCPMC6208161
OpenAlexW2761661768

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.