Evidence map›Paper›PMID 26873562›Full record

ArticleModern rheumatology2016

Pregnancy outcomes after exposure to tocilizumab: A retrospective analysis of 61 patients in Japan.

Ken Nakajima, Omi Watanabe, Mayumi Mochizuki, Ayako Nakasone, Nobuhiko Ishizuka, Atsuko Murashima

Open access · hybridAbstract read
In one paragraph

Article in Modern rheumatology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 5 pooled it
6.7field-weighted citation impact, top 3% 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

42 citing papers in PubMed, 5 syntheses or guidelines pooled it, 97 citations in OpenAlex.

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  14. Management of Coronavirus Disease-2019 Infection in Pregnancy.Emergency medicine clinics of North America · 2023
    Review
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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

6 authors at 2 institutions in 1 country.

Ken Nakajimaa Japan Drug Information Institute in Pregnancy , Tokyo , Japan .
Omi Watanabea Japan Drug Information Institute in Pregnancy , Tokyo , Japan .
Mayumi Mochizukic Division for Evaluation and Analysis of Drug Information, Faculty of Pharmacy , Keio University , Tokyo , Japan .
Ayako Nakasonee Chugai Pharmaceutical , Tokyo , Japan.
Nobuhiko Ishizukae Chugai Pharmaceutical , Tokyo , Japan.
Atsuko Murashimaa Japan Drug Information Institute in Pregnancy , Tokyo , Japan .
National Center For Child Health and Development · JPKeio University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo assess the effects of tocilizumab on pregnancy outcomes in Japanese patients with rheumatic disease.

methodsData from Chugai's tocilizumab safety database (April 2005 to October 2014) were retrospectively analyzed to identify pregnancy outcomes in patients exposed to tocilizumab.

resultsData were available for 61 pregnancies exposed to tocilizumab, and outcomes were reported for 50 of those pregnancies. In 36 births, no congenital anomalies were identified; however, six neonatal abnormalities were reported: five cases of low birth weight (<2500 g) and one case of neonatal asphyxia. Of 36 births, tocilizumab was resumed during lactation in two patients, with no subsequent adverse events reported in newborns. The spontaneous abortion rate was 18.0% (9 of 50 pregnancies), which is comparable to the rate in the general population. The five terminated pregnancies included one case of caudal regression syndrome.

conclusionsThe present retrospective study of 61 pregnancies exposed to tocilizumab at conception indicated no increased rates of spontaneous abortion or congenital abnormalities in patients with rheumatic disease. However, further study is necessary to confirm the benefit-risk profile of tocilizumab treatment during pregnancy.

Indexed as

Pregnancy OutcomeAbnormalities, Drug-InducedAbortion, SpontaneousAdultAntibodies, Monoclonal, HumanizedFemaleHumansIncidenceInfant, NewbornJapanMaleMaternal ExposurePregnancyRetrospective StudiesRisk AssessmentAntibodies, Monoclonal, HumanizedtocilizumabAbortionsPregnancy outcomeRheumatoid arthritisTocilizumab

Identifiers

PMID26873562
PMCPMC5020345
OpenAlexW2271701404

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.