ReviewJournal of clinical medicine2023
Reproductive Safety Issues of Novel Small Molecules for the Treatment of Inflammatory Bowel Disease: A Systematic Review.
Review in Journal of clinical medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis 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
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.
- Second United Arab Emirates consensus guidance on the diagnosis and management of inflammatory bowel disease.World journal of gastroenterology · 2025Pooled it
- Hidradenitis Suppurativa from Preconception to Lactation: Clinical Treatment Decision-Making Review.Dermatology and therapy · 2026Review
- Update on Pregnancy in Inflammatory Bowel Disease.Gastroenterology & hepatology · 2026Article
- Inconsistent medication recommendations for immune-mediated inflammatory diseases across pregnancy, lactation, and paternal preconception: a guideline-based review.Frontiers in pharmacology · 2026Review
- Janus Kinase Inhibitors During Pregnancy and Adverse Drug Reactions: A Pharmacovigilance Disproportionality Analysis in VigiBase.Clinical and translational science · 2025Article
- Effectiveness and safety of upadacitinib in a real-world cohort of patients with Crohn's disease in the UK: a multicentre retrospective cohort study.BMJ open gastroenterology · 2025Article
- The Current Sphingosine 1 Phosphate Receptor Modulators in the Management of Ulcerative Colitis.Journal of clinical medicine · 2025Review
- Modern Advanced Therapies for Inflammatory Bowel Diseases: Practical Considerations and Positioning.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2025Review
- Article
- Disproportionality analysis of upadacitinib-related adverse events in inflammatory bowel disease using the FDA adverse event reporting system.Frontiers in pharmacology · 2025Article
- Intensified and Accelerated Rescue Infliximab Therapy for Acute Severe Ulcerative Colitis in Pregnancy: A Case Report.JGH open : an open access journal of gastroenterology and hepatology · 2025Article
- Navigating Reproductive Care in Patients With Inflammatory Bowel Disease: A Comprehensive Review.Journal of Crohn's & colitis · 2024Review
- Appropriateness of small molecule agents for patients with IBD of childbearing age - a RAND/UCLA appropriateness panel.Therapeutic advances in gastroenterology · 2024Article
- Pregnancy and Preconception Care for Patients with Inflammatory Bowel Disease.Inflammatory intestinal diseasesReview
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 at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Maintenance of remission during pregnancy is vital for women with inflammatory bowel disease (IBD). The antenatal safety of novel small molecules for IBD is yet to be ascertained. We aimed to describe the current evidence on reproductive data regarding small-molecule drugs. We performed a systematic review searching Embase Classic + Embase and Ovid MEDLINE for reproductive outcomes for tofacitinib, filgotinib, upadacitininb, and ozanimod. Additionally, we asked the manufacturers for available data on file regarding reproduction. We analysed data from 10 sources; six studies and four manufacturer reports were identified from our search. Significant malformation risks were reported for tofacitinib, filgotinib, upadacitininb, and ozanimod in animal studies. In 126 tofacitinib-exposed pregnancies, there were 55 live births with 2 congenital malformations and 1 serious infant infection, 14 terminations, 15 miscarriages, and 42 outcomes unknown. In 50 filgotinib-exposed pregnancies, there were 20 healthy babies, 1 congenital malformation, 9 terminations, 10 miscarriages, and 10 outcomes unknown. In 78 upadacitinib-exposed pregnancies, there were 30 healthy babies, 15 terminations, 15 miscarriages, and 18 outcomes unknown. In 60 ozanimod-exposed pregnancies, there were 31 live births with 1 congenital malformation, 1 case of intra-uterine growth restriction, 1 case of neonatal icterus, 13 terminations, 9 miscarriages, and 8 unknown outcomes. Animal data suggest significant risks of malformations for tofacitinib, filgotinib, upadacitininb, and ozanimod. Human data from clinical trials and real-world observations do not show concerning data so far, but these are very limited. Currently, alternative treatments should be used for IBD during pregnancy.
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What OpenQuestion holds
Registered trials
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.