Delivery of healthy babies after natalizumab use for multiple sclerosis: a report of two cases

Hoevenaren, Inge A.; Vries, Loes C. de; Rijnders, Robert; Lotgering, F.K.

doi:10.1111/j.1600-0404.2010.01426.x

Cited by 40 publications

(23 citation statements)

References 15 publications

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“…The average birth weight in the natalizumab group (3159 g) was within normal range for full-term infants (i.e., 2500–4000 g [36]), although slightly lower than that in the group of pregnant patients with MS who had not been exposed to disease modifying therapies (3406 g). Additional case reports by Mattioda et al [19], Totaro et al [20], and Hoevenaren et al [18] did not show any abnormalities in infants at birth and at a 6-week follow-up.…”

Section: Discussionmentioning

confidence: 87%

Evaluation of pregnancy outcomes from the Tysabri® (natalizumab) pregnancy exposure registry: a global, observational, follow-up study

et al. 2016

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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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Section: Discussionmentioning

confidence: 87%

Evaluation of pregnancy outcomes from the Tysabri® (natalizumab) pregnancy exposure registry: a global, observational, follow-up study

et al. 2016

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“…However, it is commonly agreed to discontinue IFN- β or GA treatment when pregnancy is detected. Limited data concerning pregnancy is available for the monoclonal antibody natalizumab and the sphingosine receptor modulator fingolimod [18], [19]. Mitoxantrone is known for teratogenic effects, and its withdrawal is recommended in female as well as in male patients at least six months before pregnancy.…”

Section: Introductionmentioning

confidence: 99%

Pregnancy in Multiple Sclerosis: A Questionnaire Study

et al. 2014

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BackgroundMultiple sclerosis (MS) preferentially affects females at childbearing age. For this reason patients and treating physicians were frequently confronted with questions concerning family planning, pregnancy and birth.ObjectiveThe aim of this study was to evaluate the expertise about pregnancy related topics in multiple sclerosis of neurologists in private practice.MethodsWe developed a survey with 16 multiple choice questions about pregnancy related topics and sent it to neurologists in private practice in Berlin, Germany.Results56 completed questionnaires were sent back. 54% of all questions were answered correctly, 21% of the questions were answered with “I don’t know”. Correct answers were more often given by physicians who treat more than 400 MS patients per year (p = 0.001). Further positive associations were found for assumed relevance of the topic (p = 0.002) and the degree of counseling (p<0.001).ConclusionTo provide a comprehensive counseling, MS patients with desire for children should be counseled by physicians with a lot of experience in MS treatment.

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“…There is one recent report on two successful pregnancies on natalizumab, and in one report on the use of mitoxantrone, the pregnancy resulted in the delivery of a growth-restricted baby. 33,34 Taken together, the information on pregnancy outcomes for babies exposed to DMTs is increasing, but the study samples are still small. Even though these drugs do not appear to cause any major fetal malformations it is uncertain how they might affect the developing immune system of the fetus.…”

Section: Treatment During Pregnancymentioning

confidence: 99%

Pregnancy and multiple sclerosis

Airas

Kaaja

2012

Obstet Med

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Summary:The relapse rate of multiple sclerosis (MS) is typically reduced during late pregnancy but increases in the postpartum period. The reasons for the increased postpartum activity are not entirely clear, but factors such as the abrupt decrease in oestrogen levels immediately after the delivery and the loss of the immunosuppressive state of pregnancy are likely of importance. There is a general view that MS does not affect the course or outcome of pregnancy.

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Delivery of healthy babies after natalizumab use for multiple sclerosis: a report of two cases

Cited by 40 publications

References 15 publications

Evaluation of pregnancy outcomes from the Tysabri® (natalizumab) pregnancy exposure registry: a global, observational, follow-up study

Evaluation of pregnancy outcomes from the Tysabri® (natalizumab) pregnancy exposure registry: a global, observational, follow-up study

Pregnancy in Multiple Sclerosis: A Questionnaire Study

Pregnancy and multiple sclerosis

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