Observational studyBMC neurology2016
Evaluation of pregnancy outcomes from the Tysabri® (natalizumab) pregnancy exposure registry: a global, observational, follow-up study.
Observational study in BMC neurology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00472992 (TYSABRI® Pregnancy Exposure Registry), which is not on this map. Cited by 54 papers.
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.
TYSABRI® Pregnancy Exposure Registry
Who cites it
54 citing papers in PubMed, 129 citations in OpenAlex.
- UK consensus on pregnancy in multiple sclerosis: An update to 'Association of British Neurologists' guidance.Multiple sclerosis (Houndmills, Basingstoke, England) · 2026Review
- Risk of congenital anomalies among infants of patients with endometriosis: a population-based cohort study.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2026Article
- Long-term safety evaluation of natalizumab during pregnancy and lactation in patients with multiple sclerosis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2025Article
- A Real-World Prospective Multiple Sclerosis Pregnancy Registry in the United States: PREG-MS.Neurology. Clinical practice · 2025Article
- Disease Activity in Pregnant and Postpartum Women With Multiple Sclerosis Receiving Ocrelizumab or Other Disease-Modifying Therapies.Neurology(R) neuroimmunology & neuroinflammation · 2024Article
- Patient-centered pregnancy planning in multiple sclerosis: evidence for a new era.Arquivos de neuro-psiquiatria · 2024Review
- Disease activity and neonatal outcomes after exposure to natalizumab throughout pregnancy.Journal of neurology, neurosurgery, and psychiatry · 2024Observational
- Practical Considerations for Managing Pregnancy in Patients With Multiple Sclerosis: Dispelling the Myths.Neurology. Clinical practice · 2024Review
- Assisted Reproductive Technology and Disease Management in Infertile Women with Multiple Sclerosis.CNS drugs · 2023Review
- Monoclonal Antibodies in Pregnancy and Breastfeeding in Patients with Multiple Sclerosis: A Review and an Updated Clinical Guide.Pharmaceuticals (Basel, Switzerland) · 2023Review
- So You Want to Build Your Disease's First Online Patient Registry: An Educational Guide for Patient Organizations Based on US and European Experience.The patient · 2023Article
- Pregnancy outcomes after early fetal exposure to injectable first-line treatments, dimethyl fumarate, or natalizumab in Danish women with multiple sclerosis.European journal of neurology · 2023Article
- Natalizumab treatment during pregnancy in multiple sclerosis-clinical and bioethical aspects of an ongoing debate.Wiener medizinische Wochenschrift (1946) · 2022Article
- Review
- Use of B-Cell-Depleting Therapy in Women of Childbearing Potential With Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorder.Neurology. Clinical practice · 2022Review
- Monoclonal Antibodies in the Treatment of Relapsing Multiple Sclerosis: an Overview with Emphasis on Pregnancy, Vaccination, and Risk Management.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2022Review
- Prescribed opioid analgesics in early pregnancy and the risk of congenital anomalies: a population-based cohort study.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2022Article
- Updated Perspectives on the Challenges of Managing Multiple Sclerosis During Pregnancy.Degenerative neurological and neuromuscular disease · 2022Review
- Multiple Sclerosis Impact on Pregnancy: An Update on Management Issues : Management of MS During Pregnancy.Galen medical journal · 2022Review
- Experiences in treatment of multiple sclerosis with natalizumab from a real-life cohort over 15 years.Scientific reports · 2021Article
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 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPatients with multiple sclerosis (MS) or Crohn's disease (CD) being treated with natalizumab (Tysabri®, Biogen) who are planning to become pregnant or discover they are pregnant after exposure to natalizumab are currently advised to balance the potential benefits and potential risks of exposure when considering treatment options. This study was undertaken to evaluate pregnancy outcomes of women with MS or CD who were exposed to natalizumab at any time within 3 months prior to conception or during pregnancy. A pregnancy registry was created to better understand the effect of natalizumab exposure on pregnancy outcomes.
methodsThe Tysabri Pregnancy Exposure Registry was a global, observational exposure registration and follow-up study. Evaluations included spontaneous abortions (<22 weeks gestational age), fetal losses (≥22 weeks gestational age), ectopic pregnancies, elective or therapeutic terminations, stillbirths, birth defects, and live births. Birth defects were reviewed and coded in accordance with the Metropolitan Atlanta Congenital Defects Program (MACDP) classification of birth defects.
resultsA total of 369 patients with MS and 7 patients with CD were enrolled prospectively, of whom 355 patients (99.4 %; 349 MS and 6 CD) had known pregnancy outcomes (including 8 twin sets). The spontaneous abortion rate was 9.0 % (n = 32; 95 % confidence interval [C. I.], 6.3-12.5 %). An independent advisory committee review determined the major birth defect rate to be 5.05 % (16 of 316 live births + 1 elective abortion; 95 % C. I., 2.9-8.1 %). The mean gestational age of the live-born infants was 38.3 weeks, and the mean birth weight was 3158.3 g.
conclusionsAlthough the overall rate of birth defects was higher than that observed by the MACDP, these registry outcomes showed no specific pattern of malformations that would suggest a drug effect, and the spontaneous abortion rate was consistent with that of the general population.
trial registrationClinicalTrials.gov NCT00472992 (11 May 2007).
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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.