ArticleDigestive diseases (Basel, Switzerland)2019
Pregnancy Outcomes of Patients Exposed to Adalimumab in Japan.
Article in Digestive diseases (Basel, Switzerland), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 3 of them syntheses that pooled it.
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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.
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Who cites it
9 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- British Society for Rheumatology guideline on prescribing drugs in pregnancy and breastfeeding: immunomodulatory anti-rheumatic drugs and corticosteroids.Rheumatology (Oxford, England) · 2023Guideline
- Fetal and maternal outcomes after maternal biologic use during conception and pregnancy: A systematic review and meta-analysis.BJOG : an international journal of obstetrics and gynaecology · 2022Pooled it
- Intrauterine Exposure to Biologics in Inflammatory Autoimmune Diseases: A Systematic Review.Drugs · 2020Pooled it
- Hidradenitis Suppurativa Treatment During Pregnancy and Lactation: Navigating Challenges.International journal of dermatology · 2025Review
- Ulcerative Colitis in Pregnancy: A Japanese Multicenter Cohort Study Focusing on Their Mutual Influence.Internal medicine (Tokyo, Japan) · 2025Article
- Pharmacovigilance Pregnancy Data in a Population of Japanese Patients With Chronic Inflammatory Disease Exposed to Certolizumab Pegol.International journal of rheumatic diseases · 2025Article
- TNF-Expert reviews in molecular medicine · 2022Review
- Impact of Psoriasis and Hidradenitis Suppurativa in Pregnancy, a Systematic Review.Journal of clinical medicine · 2021Review
- Fertility and infertility implications in rheumatoid arthritis; state of the art.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2020Review
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThis is the first retrospective report of pregnancy outcomes after exposure to adalimumab treatment in Japan.
methodsUsing the AbbVie safety database, we analyzed pregnancy outcome data from patients who received adalimumab treatment from April 16, 2008, to May 15, 2017.
resultsData were extracted retrospectively for 74 pregnancies in 73 patients. More than half of the patients included in the study received adalimumab for the treatment of Crohn's disease (37.8%) or ulcerative colitis (20.3%), while 9.5% received adalimumab for rheumatoid arthritis. Of the 53 pregnancies with available outcome data, 45 newborns (45/53 [84.9%]) were delivered. Of these births, 30 were full-term, 2 were preterm, and 13 were unknown. Apgar scores were available for 11 of the 16 newborns whose mothers were exposed to adalimumab in the third trimester; all scores were within the normal range. Low birth weight was observed in 5 infants out of the 30 full-term deliveries. There were also 5 miscarriages (5/53 [9.4%]), 2 induced abortions (2/53 [3.8%]), and 1 stillbirth (1/53 [1.9%]). Eight maternal adverse events were observed in 5 pregnancies; no serious adverse events occurred.
conclusionAlthough safety concerns were inconclusive, these data do not report additional risk to pregnancy outcomes with adalimumab exposure.
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