ArticleDrug safety2020
Exposure to Infliximab During Pregnancy: Post-Marketing Experience.
Article in Drug safety, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 3 of them syntheses that pooled 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.
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.
Who cites it
16 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- British Society of Gastroenterology guidelines for diagnosis and management of autoimmune hepatitis.Gut · 2025Guideline
- 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
- The Impact of Disease Activity and Medications on Pregnancy and Fetal Outcomes in Women With Inflammatory Bowel Disease: A Cohort Study From the IBD-ME Group.Journal of gastroenterology and hepatology · 2026Article
- Hidradenitis Suppurativa Treatment During Pregnancy and Lactation: Navigating Challenges.International journal of dermatology · 2025Review
- Long-term Safety Monitoring and Efficacy Status of Infliximab and its Biosimilars in Psoriasis Management.Current drug safety · 2025Review
- Advancements in dual biologic therapy for inflammatory bowel diseases: efficacy, safety, and future directions.Therapeutic advances in gastroenterology · 2025Review
- Elevated cord levels of ustekinumab following its use in the treatment of Crohn's disease in pregnancy.Obstetric medicine · 2024Article
- TNF-Expert reviews in molecular medicine · 2022Review
- Observational data from the adalimumab post-marketing PYRAMID registry of patients with Crohn's disease who became pregnant: A post hoc analysis.United European gastroenterology journal · 2022Article
- Pregnancy and Crohn's disease: concerns and assurance of medical therapy.Gastroenterology report · 2022Review
- Review
- The use and impact of monoclonal antibody biologics during pregnancy.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2021Review
- Biologic Treatment Algorithms for Moderate-to-Severe Psoriasis with Comorbid Conditions and Special Populations: A Review.American journal of clinical dermatology · 2021Review
- Maternal and Fetal-Placental Effects of Etanercept Treatment During Rats' Pregnancy.Frontiers in physiology · 2021Article
- Biologics During Pregnancy and Breastfeeding Among Women With Rheumatic Diseases: Safety Clinical Evidence on the Road.Frontiers in pharmacology · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWomen of childbearing potential are often treated with monoclonal antibodies to control chronic and debilitating inflammatory diseases. Remicade
methodsProspective and medically confirmed safety data on IFX-exposed pregnancies from Janssen's global safety surveillance database since authorization in 1998 are summarized. Descriptive statistics were used to summarize pregnancy and infant outcomes overall, by disease and timing of exposure.
resultsAs of 23 August 2018, 1850 maternally IFX-exposed pregnancies with known outcomes were identified from the safety database. Of the 1850 pregnancies (mean age 29.7 years), 1526 (82.5%) resulted in live births. When reported, most women had Crohn's disease (67.7%) or ulcerative colitis (18.4%), and 82.8% of live births were exposed to IFX in the first trimester. Spontaneous abortion/intrauterine death/ectopic pregnancy/molar pregnancy (12.1%), preterm births (9.2%), low birth weight infants (3.6%), congenital anomalies (2.0%), and infant infections (1.2%) were documented. The type of congenital anomalies and frequency of serious infant infections observed were consistent with the general population. Frequencies of congenital anomalies and other adverse outcomes were similar in women exposed to IFX in the first trimester and those exposed in the third trimester. More preterm births (13-18.8%) and infant complications (8.7-12.5%) were reported with concomitant immunosuppressant use.
conclusionsThe observed prevalence of adverse pregnancy and infant outcomes including congenital anomalies following exposure to IFX did not exceed estimates reported for the general population and no unexpected patterns were observed.
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