Evidence map›Paper›PMID 36128663›Full record

ArticleACR open rheumatology2022

Randomized Trial of Tocilizumab in the Treatment of Refractory Adult Polymyositis and Dermatomyositis.

Chester V Oddis, Howard E Rockette, Lei Zhu, Diane C Koontz, David Lacomis, Swamy Venturupalli, Siamak Moghadam-Kia, Dana P Ascherman, Leslie Crofford, Mazen M Dimachkie and 4 more

Open access · goldAbstract read
In one paragraph

Article in ACR open rheumatology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
5.1field-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.

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

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 34 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Article
  6. Targeted Therapy for Idiopathic Inflammatory Myopathy.Journal of cachexia, sarcopenia and muscle · 2025
    Review
  7. Review
  8. Review
  9. Article
  10. Article
  11. Pharmacological Strategies in Dermatomyositis: Current Treatments and Future Directions.Medical science monitor : international medical journal of experimental and clinical research · 2024
    Review
  12. Review
  13. Biological Therapies in Inflammatory Myopathies.Rambam Maimonides medical journal · 2023
    Review
  14. Article
  15. Review
  16. Tocilizumab Treatment in a Patient of Refractory Anti-EJ Positive ASyS: A Case Report.Journal of investigative medicine high impact case reports
    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

14 authors at 7 institutions in 1 country.

Chester V OddisUniversity of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.ORCID https://orcid.org/0000-0002-9529-3111
Howard E RocketteUniversity of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.
Lei ZhuUniversity of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.ORCID https://orcid.org/0000-0002-7318-4387
Diane C KoontzUniversity of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.
David LacomisUniversity of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.
Swamy VenturupalliCedars Sinai Medical Center and University of California Los Angeles School of Medicine, Los Angeles, California.
Siamak Moghadam-KiaUniversity of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.
Dana P AschermanUniversity of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.ORCID https://orcid.org/0000-0002-1387-0860
Leslie CroffordVanderbilt University Medical Center, Nashville, Tennessee.
Mazen M DimachkieUniversity of Kansas Medical Center, Kansas City.
Floranne ErnsteMayo Clinic, Rochester, Minnesota.
David GazeleyMedical College of Wisconsin, Milwaukee.
Galina MarderHofstra Northwell School of Medicine, Uniondale, New York.
Rohit AggarwalUniversity of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.
University of Pittsburgh · USCedars-Sinai Medical Center · USHofstra University · USMayo Clinic · USMedical College of Wisconsin · USUniversity of Kansas Medical Center · USVanderbilt University Medical Center · US

Funding

Genentech I#0039599
6 · The paper itself

Abstract

objectiveTo assess the efficacy and tolerability of tocilizumab in a multicenter, randomized, double-blind, placebo-controlled trial in refractory adult patients with dermatomyositis (DM) and polymyositis (PM).

methodsThirty-six subjects with probable or definite DM/PM were enrolled in a 6-month phase 2B clinical trial and randomized 1:1 to receive tocilizumab (8 mg/kg intravenously) or placebo every 4 weeks for 24 weeks. Eligible subjects had either a DM rash, a myositis-associated autoantibody or an adjudicated PM diagnosis. Active disease was defined by at least three of six abnormal core set measures (CSMs), including a manual muscle testing (MMT)-8 score of less than 136/150. If the MMT-8 score was greater than 136, then a cutaneous score of 3 or more (10 cm visual analogue scale) was required along with three additional abnormal CSMs indicating disease activity. The primary endpoint compared the Total Improvement Score (TIS) between both arms from week 4 to 24. Secondary outcomes included time to meeting minimal TIS improvement, changes in CSMs, time to worsening, steroid-sparing effect, proportion of subjects meeting more stringent improvement criteria, and safety outcomes.

resultsThere was no significant difference (P = 0.86) in the TIS over 24 weeks between tocilizumab and placebo arms. The secondary endpoints of time to improvement (minimal, moderate, or major), time to worsening, CSM changes, safety outcomes, and steroid-sparing effect were also not significantly different between arms.

conclusionTocilizumab was safe and well tolerated but did not meet the primary or secondary efficacy outcomes in refractory DM and PM in this 24-week phase 2B study.

Identifiers

PMID36128663
PMCPMC9661830
OpenAlexW4297874902

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.