Evidence map›Paper›PMID 32448770›Full record

ArticleEuropean journal of internal medicine2020

Off-label use of tocilizumab for the treatment of SARS-CoV-2 pneumonia in Milan, Italy.

Valentina Morena, Laura Milazzo, Letizia Oreni, Giovanna Bestetti, Tommaso Fossali, Cinzia Bassoli, Alessandro Torre, Maria Vittoria Cossu, Caterina Minari, Elisabetta Ballone and 18 more

Open access · bronzeAbstract read
In one paragraph

Article in European journal of internal medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 117 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
117citing papers in PubMed, 12 pooled it
67.3field-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.

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

117 citing papers in PubMed, 12 syntheses or guidelines pooled it, 207 citations in OpenAlex.

  1. Pooled it
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  5. Guideline
  6. Antibiotic prescribing in patients with COVID-19: rapid review and meta-analysis.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2021
    Pooled it
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  9. Guideline
  10. Tocilizumab for severe COVID-19: a systematic review and meta-analysis.International journal of antimicrobial agents · 2020
    Pooled it
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  13. Efficacy and Safety of Sarilumab in Hospitalized Patients With Coronavirus Disease 2019: A Randomized Clinical Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
    Trial
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  17. Angiotensin-Converting Enzyme-2 (International journal of microbiology · 2023
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57 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

28 authors at 3 institutions in 1 country.

Valentina MorenaLuigi Sacco Department of Biomedical and Clinical Sciences, University of Milan, Italy.
Laura MilazzoDepartment of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy. Electronic address: laura.milazzo@unimi.it.
Letizia OreniDepartment of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy.
Giovanna BestettiDepartment of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy.
Tommaso FossaliDepartment of Anesthesiology and Intensive Care, ASST Fatebenefratelli Sacco, Luigi Sacco Hospital, Milan, Italy.
Cinzia BassoliLuigi Sacco Department of Biomedical and Clinical Sciences, University of Milan, Italy.
Alessandro TorreDepartment of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy.
Maria Vittoria CossuDepartment of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy.
Caterina MinariDepartment of Anesthesiology and Intensive Care, ASST Fatebenefratelli Sacco, Luigi Sacco Hospital, Milan, Italy.
Elisabetta BalloneDepartment of Anesthesiology and Intensive Care, ASST Fatebenefratelli Sacco, Luigi Sacco Hospital, Milan, Italy.
Andrea PerottiDepartment of Anesthesiology and Intensive Care, ASST Fatebenefratelli Sacco, Luigi Sacco Hospital, Milan, Italy.
Davide MiletoMicrobiology, Virology and Bioemergence Diagnostics, ASST Fatebenefratelli Sacco, Milan, Italy.
Fosca NieroDepartment of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy.
Stefania MerliDepartment of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy.
Antonella FoschiDepartment of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy.
Stefania VimercatiClinical Pathology Laboratory, ASST Fatebenefratelli Sacco, Milan, Italy.
Giuliano RizzardiniDepartment of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy.
Salvatore SollimaDepartment of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy.
Lucia BradaniniLuigi Sacco Department of Biomedical and Clinical Sciences, University of Milan, Italy.
Laura GalimbertiDepartment of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy.
Riccardo ColomboDepartment of Anesthesiology and Intensive Care, ASST Fatebenefratelli Sacco, Luigi Sacco Hospital, Milan, Italy.
Valeria MicheliMicrobiology, Virology and Bioemergence Diagnostics, ASST Fatebenefratelli Sacco, Milan, Italy.
Cristina NegriDepartment of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy.
Anna Lisa RidolfoDepartment of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy.
Luca MeroniDepartment of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy.
Massimo GalliDepartment of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy; Luigi Sacco Department of Biomedical and Clinical Sciences, University of Milan, Italy.
Spinello AntinoriDepartment of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy; Luigi Sacco Department of Biomedical and Clinical Sciences, University of Milan, Italy.
Mario CorbellinoDepartment of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy.
ASST Fatebenefratelli Sacco · ITLuigi Sacco Hospital · ITUniversity of Milan · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTocilizumab, a humanized monoclonal antibody, targets IL-6 receptors blocking downstream pro-inflammatory effects of IL-6. In preliminary reports it was suggested to be beneficial in patients with severe COVID-19.

methodsIn this open-label prospective study we describe clinical characteristics and outcome of 51 patients hospitalized with confirmed and severe COVID-19 pneumonia treated with tocilizumab intravenously. All patients had elevated IL-6 plasma level (>40 pg/mL) and oxygen saturation <93% in ambient air. Clinical outcomes, oxygen support, laboratory data and adverse events were collected over a follow-up of 30 days.

resultsForty-five patients (88%) were on high-flow oxygen supplementation, six of whom with invasive ventilation. From baseline to day 7 after tocilizumab we observed a dramatic drop of body temperature and CRP value with a significant increase in lymphocyte count (p<0.001). Over a median follow-up time of 34 days from tocilizumab, 34 patients (67%) showed an improvement in their clinical severity class; 31 were discharged; 17 (33%) showed a worsening of their clinical status, of these 14 died (27%). The mortality rate was significantly associated with mechanical ventilation at baseline (83.3% vs 20% of patients on non-invasive oxygen support; p=0.0001). The most frequent side effects were an increase of hepatic enzymes (29%), thrombocytopenia (14%), and serious bacterial and fungal infections (27%).

conclusionTocilizumab exerts a rapidly beneficial effect on fever and inflammatory markers, although no significant impact on the clinical outcome can be inferred by our results. Critically ill patients seem to have a high risk of serious infections with this drug.

Indexed as

Antibodies, Monoclonal, HumanizedCoronavirus InfectionsPandemicsPneumonia, ViralRespiratory InsufficiencyAntiviral AgentsBetacoronavirusCOVID-19FemaleFeverHumansItalyLymphocyte CountMaleMiddle AgedOutcome and Process Assessment, Health CareAntibodies, Monoclonal, HumanizedAntiviral AgentsReceptors, Interleukin-6tocilizumabCOVID-19IL-6 inhibitorstocilizumab

Identifiers

PMID32448770
PMCPMC7241995
OpenAlexW3027105933

What OpenQuestion holds

Textmetadata
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.