Evidence map›Paper›PMID 26929219›Full record

Trial reportAnnals of the rheumatic diseases2016

Efficacy of first-line tocilizumab therapy in early polymyalgia rheumatica: a prospective longitudinal study.

Valérie Devauchelle-Pensec, Jean Marie Berthelot, Divi Cornec, Yves Renaudineau, Thierry Marhadour, Sandrine Jousse-Joulin, Solène Querellou, Florent Garrigues, Michel De Bandt, Maelenn Gouillou and 1 more

3 registry-linked trialsOpen access · hybridAbstract readClinical TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 52 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed, 2 pooled it
10.9field-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.

NCT01713842 phase2completednot on this map

Phase II Open 24 Weeks Study to Evaluate Effect and Safety of Tocilizumab as the First Line Therapy in Subjects With Polymyalgia Rheumatica (PMR)

TypeinterventionalSponsorUniversity Hospital, BrestRan2012 to 2014Enrolled21ConditionsPolymyalgia RheumaticaArmsTCZ
NCT02888496 completednot on this map

Caractérisation Des Anomalies Immunologiques au Cours de la Pseudopolyarthrite rhizomélique et Effets du Traitement Par Tocilizumab

TypeobservationalSponsorUniversity Hospital, BrestRan2015 to 2015Enrolled40ConditionsPolymyalgia RheumaticaArmstocilizumab
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

52 citing papers in PubMed, 2 syntheses or guidelines pooled it, 160 citations in OpenAlex.

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  19. [European journal of nuclear medicine and molecular imaging · 2024
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 7 institutions in 3 countries.

Valérie Devauchelle-PensecRheumatology Department, Cavale Blanche Hospital and Brest Occidentale University, Brest, France EA 2216, ERI 29, Brest University, Brest, France.
Jean Marie BerthelotRheumatology Department, Hôtel Dieu University Hospital, Nantes, France.
Divi CornecRheumatology Department, Cavale Blanche Hospital and Brest Occidentale University, Brest, France EA 2216, ERI 29, Brest University, Brest, France.
Yves RenaudineauEA 2216, ERI 29, Brest University, Brest, France.ORCID http://orcid.org/0000-0001-5098-5002
Thierry MarhadourRheumatology Department, Cavale Blanche Hospital and Brest Occidentale University, Brest, France.
Sandrine Jousse-JoulinRheumatology Department, Cavale Blanche Hospital and Brest Occidentale University, Brest, France EA 2216, ERI 29, Brest University, Brest, France.
Solène QuerellouNuclear Medicine Department, Morvan University Hospital, Brest, France.
Florent GarriguesRadiology Department, Cavale Blanche Hospital and Brest Occidentale University, Brest, France.
Michel De BandtRheumatology Department, Fort de France, Martinique, France.
Maelenn GouillouClinical Investigation Centre[CIC] 1412, Institut National de la Santé et de la Recherche Médicale[INSERM], Brest, France.
Alain SarauxRheumatology Department, Cavale Blanche Hospital and Brest Occidentale University, Brest, France EA 2216, ERI 29, Brest University, Brest, France.
Université de Bretagne Occidentale · FRCentre Hospitalier Régional Universitaire de Brest · FRCentre Hospitalier Universitaire de Martinique · MQÉcole nationale d'ingénieurs de Brest · FRHôpital Maison Blanche · FRHotel Dieu Hospital · CAInserm · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGlucocorticoids are the cornerstone treatment of polymyalgia rheumatica (PMR) but induce adverse events.

objectivesTo evaluate the efficacy and safety of first-line tocilizumab in PMR.

methodsIn a prospective open-label study (ClinicalTrials.gov: NCT01713842), 20 glucocorticoid-free patients fulfilling Chuang's PMR criteria, with symptom onset within the last 12 months and a PMR activity score (PMR-AS) >10, each received three tocilizumab infusions at 4-week intervals, without glucocorticoids, followed by oral prednisone from weeks 12 to 24 (0.15 mg/kg if PMR-AS ≤10 and 0.30 mg/kg otherwise). The primary end point was the proportion of patients with PMR-AS≤10 at week 12.

resultsBaseline median PMR-AS was 36.6 (IQR 30.4-43.8). At week 12, all patients had PMR-AS≤10 and received the low prednisone dosage. Median PMR-AS at weeks 12 and 24 was 4.5 (3.2-6.8) and 0.95 (IQR 0.4-2), respectively (p<0.001 vs baseline for both time points). No patient required rescue treatment. Positron emission tomography-CT showed significant improvements. The most common adverse events were transient neutropenia (n=3) and leucopenia (n=5); in one patient, the second tocilizumab infusion was omitted due to leucopenia.

conclusionsTocilizumab monotherapy is effective in recent-onset PMR. Randomised controlled trials are warranted. TRIAL REGISTRATION NUMBER: NCT01713842.

Indexed as

AgedAntibodies, Monoclonal, HumanizedAntirheumatic AgentsDrug Administration ScheduleDrug Therapy, CombinationFemaleGlucocorticoidsHumansInfusions, IntravenousLongitudinal StudiesMaleMiddle AgedPolymyalgia RheumaticaPositron Emission Tomography Computed TomographyPrednisoneProspective StudiesAntibodies, Monoclonal, HumanizedAntirheumatic AgentsGlucocorticoidsPrednisonetocilizumabDisease ActivityDMARDs (biologic)Magnetic Resonance ImagingPolymyalgia RheumaticaTreatment

Identifiers

PMID26929219
PMCPMC4975852
OpenAlexW2290444582

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.