Evidence map›Paper›PMID 27159185›Full record

Trial reportArthritis & rheumatology (Hoboken, N.J.)2016

Brief Report: A Prospective Open-Label Phase IIa Trial of Tocilizumab in the Treatment of Polymyalgia Rheumatica.

Lindsay Lally, Lindsy Forbess, Christopher Hatzis, Robert Spiera

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Arthritis & rheumatology (Hoboken, N.J.), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03576794 (A Multicenter Randomized Placebo Controlled Treatment Study of Leflunomide in Polymyalgia Rheumatica), which is not on this map. Cited by 45 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 2 pooled it
12.3field-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.

NCT03576794 phase3unknown statusnot on this mapstarted 2019, after this paper: background citation

A Multicenter Randomized Placebo Controlled Treatment Study of Leflunomide in Polymyalgia Rheumatica

TypeinterventionalSponsorElisabeth BrouwerRan2019 to 2022Enrolled94ConditionsPolymyalgia RheumaticaArmsLeflunomide 20 mg, Prednisolone
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 2 syntheses or guidelines pooled it, 124 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Trial
  4. Trial
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  9. Review
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  15. Polymyalgia rheumatica: An update (Review).Experimental and therapeutic medicine · 2023
    Article
  16. Review
  17. Article
  18. Article
  19. Article
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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

4 authors at 2 institutions in 1 country.

Lindsay LallyHospital for Special Surgery, New York, New York. lally1@hss.edu.
Lindsy ForbessCedars-Sinai Medical Center, Los Angeles, California.
Christopher HatzisHospital for Special Surgery, New York, New York.
Robert SpieraHospital for Special Surgery, New York, New York.
Hospital for Special Surgery · USCedars-Sinai Medical Center · US

Funding

Disparities in COVID Disease Severity and Outcomes in New York CityUL1TR002384 · NCATS · WEILL MEDICAL COLL OF CORNELL UNIV · PI JULIANNE L IMPERATO-MCGINLEY · 2017 to 2026
$86.2M
Clinical and Translational Science CenterUL1TR000457 · NCATS · WEILL MEDICAL COLL OF CORNELL UNIV · PI IMPERATO-MCGINLEY, JULIANNE L · 2012 to 2016
$46.0M
NCATS NIH HHS UL1 TR000457NCATS NIH HHS UL1 TR002384
6 · The paper itself

Abstract

objectiveInterleukin-6 (IL-6) is a pivotal cytokine in the pathogenesis of polymyalgia rheumatica (PMR), yet the efficacy of IL-6 blockade with tocilizumab (TCZ) for the treatment of PMR is unknown. The aim of this study was to assess the efficacy and safety of TCZ in newly diagnosed PMR.

methodsIn a single-center open-label study, patients with newly diagnosed PMR who had been treated with glucocorticoids (GCs) for <1 month were treated monthly with intravenous (IV) TCZ 8 mg/kg for 1 year, with a rapid tapering of GCs according to standardized protocol. The primary end point was the proportion of patients in relapse-free remission without GC treatment at 6 months. Secondary outcome measures included duration of GC use and cumulative GC dose. Patients were followed up for 15 months.

resultsTen patients were enrolled in the study. One patient withdrew after 2 months, leaving 9 patients in whom the primary end point was assessed. The primary end point of relapse-free remission without GC treatment at 6 months was achieved by all 9 of these patients. All patients who received TCZ treatment were able to discontinue GCs within 4 months of study entry. The cumulative mean ± SD prednisone dose was 1,085 ± 301 mg and the total duration of GC exposure was 3.9 ± 0.9 months. Remission persisted without relapse, in all 9 patients, throughout the entire 15-month study.

conclusionOur findings suggest that TCZ may be an effective, safe, and well-tolerated treatment for newly diagnosed patients with PMR, with a robust steroid-sparing effect.

Indexed as

AgedAged, 80 and overAntibodies, Monoclonal, HumanizedDeprescriptionsFemaleGlucocorticoidsHumansHypercholesterolemiaImmunologic FactorsMaleMiddle AgedNeutropeniaPolymyalgia RheumaticaPrednisoneProspective StudiesRemission InductionAntibodies, Monoclonal, HumanizedGlucocorticoidsImmunologic FactorsPrednisonetocilizumab

Identifiers

PMID27159185
PMCPMC5837044
OpenAlexW2527887155

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.