ArticleNeurology2014
Pregnancy outcomes in the clinical development program of fingolimod in multiple sclerosis.
Article in Neurology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 54 papers, 3 of them syntheses that pooled it.
What it found
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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
54 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Higher disease reactivation risk in women after fingolimod withdrawal.Acta neuropathologica communications · 2026Pooled it
- Potential Protective Role of Pregnancy and Breastfeeding in Delaying Onset Symptoms Related to Multiple Sclerosis.Medicina (Kaunas, Lithuania) · 2023Pooled it
- Fingolimod for relapsing-remitting multiple sclerosis.The Cochrane database of systematic reviews · 2016Pooled it
- Association of Neurodevelopmental Disorders and Congenital Anomalies With Prenatal Multiple Sclerosis Treatment-Real-World Historical Cohort Study.Clinical pharmacology and therapeutics · 2026Article
- Multiple Sclerosis in Women: Impact of Different Life Stages on Treatment Decisions.CNS drugs · 2026Review
- Associations of maternal and paternal characteristics with cardiac malformations using real-world data and machine learning.Communications medicine · 2025Article
- Sex-Related Differences in Lifestyle Factors Affecting Multiple Sclerosis Susceptibility and Disease Progression.Brain sciences · 2025Review
- A Real-World Prospective Multiple Sclerosis Pregnancy Registry in the United States: PREG-MS.Neurology. Clinical practice · 2025Article
- Fingolimod, a sphingosine-1-phosphate receptor modulator, prevents neonatal bronchopulmonary dysplasia and subsequent airway remodeling in a murine model.Journal of applied physiology (Bethesda, Md. : 1985) · 2024Article
- Sphingosine 1-phosphate receptor modulators in multiple sclerosis treatment: A practical review.Annals of clinical and translational neurology · 2024Review
- Treatment algorithms of relapsing multiple sclerosis: an exploration based on the available disease-modifying therapies in China.Therapeutic advances in neurological disorders · 2024Review
- An update on the use of sphingosine 1-phosphate receptor modulators for the treatment of relapsing multiple sclerosis.Expert opinion on pharmacotherapy · 2023Review
- Effect of fingolimod therapy on quantitative macular changes among patients with relapsing-remitting multiple sclerosis: a four-year follow-up study from Oman.BMC ophthalmology · 2022Article
- Multiple Sclerosis Impact on Pregnancy: An Update on Management Issues : Management of MS During Pregnancy.Galen medical journal · 2022Review
- Effect of Multiple Sclerosis and Its Treatments on Male Fertility: Cues for Future Research.Journal of clinical medicine · 2021Review
- Pregnancy-Related and Perinatal Outcomes in Women With Multiple Sclerosis: A Nationwide Danish Cross-sectional Study.Neurology. Clinical practice · 2021Article
- Natalizumab, Fingolimod and Dimethyl Fumarate Use and Pregnancy-Related Relapse and Disability in Women With Multiple Sclerosis.Neurology · 2021Article
- The emerging role of FTY720 as a sphingosine 1-phosphate analog for the treatment of ischemic stroke: The cellular and molecular mechanisms.Brain and behavior · 2021Review
- Review
- Safety and efficacy of fingolimod in Iranian patients with relapsing-remitting multiple sclerosis: An open-label study.Caspian journal of internal medicine · 2021Article
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo report outcomes of pregnancies that occurred during the fingolimod clinical development program.
methodsPregnancy outcomes from phase II, phase III, and phase IV clinical studies (with optional extensions) were reported by clinical trial investigators. Fingolimod exposure in utero was defined as fingolimod treatment at the time of conception or in the 6 weeks before conception.
resultsAs of October 31, 2011, 89 pregnancies were reported in completed or ongoing clinical studies, with 74 in fingolimod treatment arms. Of 66 pregnancies with in utero exposure to fingolimod, there were 28 live births, 9 spontaneous abortions, 24 elective abortions, 4 ongoing pregnancies, and 1 pregnancy with an unknown outcome (patient lost to follow-up). Two infants were born with malformations: 1 with congenital unilateral posteromedial bowing of the tibia and 1 with acrania. Elective abortions were performed for 1 case each of tetralogy of Fallot, spontaneous intrauterine death, and failure of fetal development. There were 5 cases (7.6%; 95% confidence interval 3%-17%) of abnormal fetal development in the 66 pregnancies that had in utero exposure to fingolimod. In all 5 cases, fetal exposure to the drug took place in the first trimester of pregnancy.
conclusionsThe number of patients becoming pregnant during fingolimod therapy remains small and does not permit firm conclusions to be drawn about fetal safety of fingolimod in humans. Given the known risks of teratogenicity in animals and the present data, women of childbearing potential should use effective contraception during fingolimod therapy and for 2 months after discontinuation.
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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.