Pregnancy Experience : Nonclinical Studies and Pregnancy Outcomes in the Daclizumab Clinical Study Program

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064165%3A_____%2F16%3A10332178" target="_blank" >RIV/00064165:_____/16:10332178 - isvavai.cz</a>

Alternative codes found

RIV/00216208:11110/16:10332178

Result on the web

<a href="http://dx.doi.org/10.1007/s40120-016-0048-2" target="_blank" >http://dx.doi.org/10.1007/s40120-016-0048-2</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1007/s40120-016-0048-2" target="_blank" >10.1007/s40120-016-0048-2</a>

Result language

angličtina

Original language name

Pregnancy Experience : Nonclinical Studies and Pregnancy Outcomes in the Daclizumab Clinical Study Program

Original language description

Introduction: Multiple sclerosis (MS) is more common in women and can occur during childbearing years; thus, information on outcomes following exposure to MS therapy during pregnancy is important. No formal studies of daclizumab have been conducted in pregnant women. Here, we report available nonclinical and clinical data on pregnancy outcomes from the daclizumab clinical study program. Methods: Reproductive and developmental toxicity studies were conducted in cynomolgus monkeys. Reports of pregnancies that occurred during the daclizumab clinical study program through March 9, 2015 were collated and summarized. In the event of pregnancy, daclizumab was discontinued and safety monitoring continued. Results: Studies in cynomolgus monkeys showed no daclizumab-related effects on maternal well-being, embryo-fetal development, indirect fertility end points, and pre- and postnatal development and growth. Across the clinical study program, 38 pregnancies were reported in 36 daclizumab-exposed women (on treatment LESS-THAN OR EQUAL TO6 months from last dose); 20 resulted in live births and four (11%) in spontaneous abortions or miscarriages. One congenital heart defect (complex transposition of great vessels) occurred in one live birth (considered unrelated to daclizumab); daclizumab had been discontinued and intramuscular interferon beta-1a and lisinopril were used at conception. Eight women had an elective termination, two had an ectopic pregnancy, and two were lost to follow-up; two pregnancy outcomes are pending. Six additional pregnancies occurred in five women >6 months after their last daclizumab dose; in one additional pregnancy, exposure was unknown. Conclusion: Spontaneous abortion rate in daclizumab-exposed women was consistent with early pregnancy loss in the general population (12%-26%). Data on pregnancies exposed to daclizumab do not suggest an increased risk of adverse fetal or maternal outcomes, although the numbers are too small for definitive conclusions.

Czech name

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Czech description

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Type

J_x - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)

CEP classification

FH - Neurology, neuro-surgery, nuero-sciences

OECD FORD branch

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Project

—

Continuities

V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Publication year

2016

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Neurology and Therapy

ISSN

2193-8253

e-ISSN

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Volume of the periodical

5

Issue of the periodical within the volume

2

Country of publishing house

GB - UNITED KINGDOM

Number of pages

14

Pages from-to

169-182

UT code for WoS article

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EID of the result in the Scopus database

2-s2.0-84999864952