Evidence map›Paper›PMID 33638257›Full record

ArticleJournal of clinical pharmacy and therapeutics2021

Safety of tocilizumab in COVID-19 pregnant women and their newborn: A retrospective study.

Inés Jiménez-Lozano, José Manuel Caro-Teller, Nuria Fernández-Hidalgo, Marta Miarons, Marie Antoinette Frick, Emma Batllori Badia, Berta Serrano, Carlos Javier Parramon-Teixidó, Fátima Camba-Longueira, Maria Teresa Moral-Pumarega and 4 more

Open access · greenAbstract readMulticenter Study
In one paragraph

Article in Journal of clinical pharmacy and therapeutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
4.4field-weighted citation impact, top 5% 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, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Review
  5. Article
  6. Article
  7. Review
  8. Article
  9. Management of Coronavirus Disease-2019 Infection in Pregnancy.Emergency medicine clinics of North America · 2023
    Review
  10. Review
  11. Review
  12. Review
  13. Viral pulmonary infection in pregnancy - Including COVID-19, SARS, influenza A, and varicella.Best practice & research. Clinical obstetrics & gynaecology · 2022
    Review
  14. Article
  15. Tocilizumab for coronavirus disease 2019 in pregnancy and lactation: a narrative review.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2022
    Review
  16. Review
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 2 institutions in 1 country.

Inés Jiménez-LozanoPharmacy Department, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.ORCID https://orcid.org/0000-0003-4473-6768
José Manuel Caro-TellerPharmacy Department. Hospital, Universitario "12 de Octubre", Research Institute 12 de Octubre (i+12, Madrid, Spain.
Nuria Fernández-HidalgoPediatric Infectious Diseases and Primary Immunodeficiencies Unit, Pediatrics Department, Vall d´hebron Hospital, Barcelona, Spain.
Marta MiaronsPharmacy Department, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.ORCID https://orcid.org/0000-0001-7847-1580
Marie Antoinette FrickPediatric Infectious Diseases and Primary Immunodeficiencies Unit, Pediatrics Department, Vall d´hebron Hospital, Barcelona, Spain.
Emma Batllori BadiaUnit of perinatal medicine, Obstetric and Gynaecology Department, Hospital Universitario "12 de Octubre", Research Institute 12 de Octubre (i+12, Madrid, Spain.
Berta SerranoDepartment of Obstetrics and Gynecology, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.
Carlos Javier Parramon-TeixidóPharmacy Department, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.ORCID https://orcid.org/0000-0001-8023-3979
Fátima Camba-LongueiraDepartment of Neonatology, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.
Maria Teresa Moral-PumaregaUnit of perinatal medicine, Obstetric and Gynaecology Department, Hospital Universitario "12 de Octubre", Research Institute 12 de Octubre (i+12, Madrid, Spain.
Rafael San Juan-GarridoUnit of Infectious Diseases, Hospital Universitario "12 de Octubre", Research Institute 12 de Octubre (i+12, Madrid, Spain.
Maria Josep Cabañas PoyPharmacy Department, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.
Anna SuyDepartment of Obstetrics and Gynecology, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.
Maria Queralt Gorgas TornerPharmacy Department, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.
Vall d'Hebron Hospital Universitari · ESResearch Institute Hospital 12 de Octubre · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

WHAT IS KNOWN AND

objectiveTocilizumab is an IL-6 receptor inhibitor agent which has been proposed as a candidate to stop the inflammatory phase of infection by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). However, safety data of tocilizumab in pregnant women and their newborn are scarce. We aimed to describe maternal and neonatal safety outcomes associated with tocilizumab treatment in pregnant women with severe COVID-19.

methodsThis is a retrospective study of severe COVID-19 pregnant women, treated with tocilizumab in two Spanish hospitals between 1 March and 31 April 2020. Demographics, medical history, clinical and radiologic findings, treatment information and laboratory data of mothers and their newborns were collected from electronic medical records. RESULTS AND DISCUSSION: A total of 12 pregnant women were identified to have received tocilizumab during pregnancy in the two hospitals. Median gestational age at admission was 27.7 weeks (interquartile range, 18.0-36.4). Most of them received lopinavir/ritonavir, azithromycin and hydroxychloroquine, two patients received corticosteroids and one received interferon beta 1B. All 12 pregnancies resulted in live births. Somatometric values were normal for all newborns, and evolution at 14 and 28 days was favourable for all of them. Hepatotoxicity was observed in 2 patients, which improved or resolved at discharge. Cytomegalovirus reactivation was detected in another patient who had also received corticosteroids for 15 days, causing a congenital infection in her newborn. Both hepatotoxicity and viral reactivation adverse events were classified as possibly related to tocilizumab administration according to Naranjo's causality algorithm. WHAT IS NEW AND

conclusionsIt does not appear that tocilizumab has detrimental effects for the mother and newborn. Close monitoring of infections should be considered, especially if other immunosuppressive agents are used.

Indexed as

COVID-19 Drug TreatmentAdultAntibodies, Monoclonal, HumanizedFemaleHumansInfant, NewbornPregnancyPregnancy Complications, InfectiousRetrospective StudiesSARS-CoV-2Severity of Illness IndexSpainTreatment OutcomeAntibodies, Monoclonal, Humanizedtocilizumabadverse eventsCOVID-19maternal safetynewborn safetytocilizumab

Identifiers

PMID33638257
PMCPMC8014796
OpenAlexW3131941153

What OpenQuestion holds

Textmetadata
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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.