Evidence map›Paper›PMID 34162299›Full record

ArticleExpert opinion on drug safety2021

Tocilizumab in COVID-19: a study of adverse drug events reported in the WHO database.

Jaykaran Charan, Siddhartha Dutta, Rimplejeet Kaur, Pankaj Bhardwaj, Praveen Sharma, Sneha Ambwani, Iffat Jahan, Abdullahi Rabiu Abubakar, Salequl Islam, Timothy Craig Hardcastle and 3 more

Open access · greenAbstract read
In one paragraph

Article in Expert opinion on drug safety, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
2.9field-weighted citation impact, top 7% 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

23 citing papers in PubMed, 47 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Association of COVID with Mycosis in General.Infectious disorders drug targets · 2024
    Review
  5. Article
  6. Article
  7. Review
  8. Article
  9. Review
  10. Article
  11. Article
  12. Review
  13. Article
  14. Review
  15. Article
  16. Review
  17. Review
  18. Article
  19. Review
  20. Observational
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

13 authors at 7 institutions in 5 countries.

Jaykaran CharanDepartment of Pharmacology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.ORCID 0000-0002-4857-6725
Siddhartha DuttaDepartment of Pharmacology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.ORCID 0000-0001-6525-5950
Rimplejeet KaurDepartment of Pharmacology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.
Pankaj BhardwajDepartment of Community and Family Medicine, All India Institute of Medical Sciences (AIIMS), Jodhpur, Rajasthan, India.
Praveen SharmaDepartment of Biochemistry, All India Institute of Medical Sciences (AIIMS), Jodhpur, Rajasthan, India.ORCID 0000-0002-8324-737X
Sneha AmbwaniDepartment of Pharmacology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.
Iffat JahanDepartment of Physiology, Eastern Medical College, Cumilla, Bangladesh.ORCID 0000-0003-0551-3609
Abdullahi Rabiu AbubakarDepartment of Pharmacology and Therapeutics, Faculty of Pharmaceutical Sciences, Bayero University, Kano, Nigeria.
Salequl IslamDepartment of Microbiology, Jahangirnagar University, Savar, Dhaka, Bangladesh.ORCID 0000-0001-6131-4132
Timothy Craig HardcastleDepartment of Surgery, Nelson R Mandela School of Clinical Medicine, University of KwaZulu-Natal, Umbel, Berea, South Africa.ORCID 0000-0002-3967-0234
Nor Azlina A RahmanDepartment of Physical Rehabilitation Sciences, Kulliyyah of Allied Health Sciences, International Islamic University Malaysia, Kuantan, Malaysia.ORCID 0000-0002-9046-6183
Halyna LugovaUnit of Community Medicine. Faculty of Medicine and Defence Health, Universiti Pertahanan Nasional Malaysia (National Defence University of Malaysia), Kem Perdana Sungai Besi, Kuala Lumpur, Malaysia.
Mainul HaqueUnit of Pharmacology, Faculty of Medicine and Defence Health, Universiti Pertahanan Nasional Malaysia (National Defence University of Malaysia), Kem Perdana Sungai Besi, Kuala Lumpur, Malaysia.ORCID 0000-0002-6124-7993
All India Institute of Medical Sciences Jodhpur · INNational Defence University of Malaysia · MYBayero University Kano · NGEastern Medical College and Hospital · BDInternational Islamic University Malaysia · MYJahangirnagar University · BDUniversity of KwaZulu-Natal · ZA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundElevated inflammatory cytokines in Coronavirus disease 2019 (COVID-19) affect the lungs leading to pneumonitis with a poor prognosis. Tocilizumab, a type of humanized monoclonal antibody antagonizing interleukin-6 receptors, is currently utilized to treat COVID-19. The present study reviews tocilizumab adverse drug events (ADEs) reported in the World Health Organization (WHO) pharmacovigilance database. RESEARCH DESIGN AND

methodsAll suspected ADEs associated with tocilizumab between April to August 2020 were analyzed based on COVID-19 patients' demographic and clinical variables, and severity of involvement of organ system.

resultsA total of 1005 ADEs were reported among 513 recipients. The majority of the ADEs (46.26%) were reported from 18-64 years, were males and reported spontaneously. Around 80%, 20%, and 64% were serious, fatal, and administered intravenously, respectively. 'Injury, Poisoning, and Procedural Complications' remain as highest (35%) among categorized ADEs. Neutropenia, hypofibrinogenemia were common hematological ADEs. The above 64 years was found to have significantly lower odds than of below 45 years. In comparison, those in the European Region have substantially higher odds compared to the Region of Americas.

conclusionNeutropenia, superinfections, reactivation of latent infections, hepatitis, and cardiac abnormalities were common ADEs observed that necessitate proper monitoring and reporting.

Indexed as

COVID-19 Drug TreatmentPharmacovigilanceAdolescentAdultAdverse Drug Reaction Reporting SystemsAgedAge DistributionAntibodies, Monoclonal, HumanizedDatabases, FactualFemaleHumansMaleMiddle AgedSex DistributionWorld Health OrganizationYoung AdultAntibodies, Monoclonal, Humanizedtocilizumabadverse drug eventCOVID-19interleukin-6monoclonal antibodypharmacovigilanceTocilizumabWHO

Identifiers

PMID34162299
PMCPMC8290369
OpenAlexW3173171655

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.