Pregnancy outcomes in multiple sclerosis following subcutaneous interferon beta-1a Therapy.
(2011) In Multiple Sclerosis Journal 17(4). p.423-430- Abstract
- Background: Women with multiple sclerosis (MS) are advised to discontinue interferon-beta therapy before trying to conceive. Unplanned pregnancies occur and risks related to exposure remain unclear. Methods: To determine pregnancy outcomes following interferon-beta therapy, we examined pregnancies from a global drug safety database containing individual case safety reports received in the post-marketing setting and safety data from clinical trials of subcutaneous interferon beta-1a in MS. Results: One thousand and twenty-two cases of exposure to subcutaneous interferon beta-1a during pregnancy were retrieved; 679 had a documented outcome. In cases for which exposure duration was available (n = 231), mean time of foetal exposure to... (More)
- Background: Women with multiple sclerosis (MS) are advised to discontinue interferon-beta therapy before trying to conceive. Unplanned pregnancies occur and risks related to exposure remain unclear. Methods: To determine pregnancy outcomes following interferon-beta therapy, we examined pregnancies from a global drug safety database containing individual case safety reports received in the post-marketing setting and safety data from clinical trials of subcutaneous interferon beta-1a in MS. Results: One thousand and twenty-two cases of exposure to subcutaneous interferon beta-1a during pregnancy were retrieved; 679 had a documented outcome. In cases for which exposure duration was available (n = 231), mean time of foetal exposure to subcutaneous interferon beta-1a before treatment discontinuation was 28 days; most pregnancies (199/231; 86.1%) were exposed for ≤45 days. To avoid bias, only outcomes for prospective data (n = 425) in pregnancies exposed to interferon beta-1a in utero were analysed further. Of these, 324 (76.2%) resulted in normal live births and four (0.9%) in live births with congenital anomalies (3 [0.7%] were 'major'). Four (0.9%) pregnancies resulted in stillbirths (1 [0.2%] with foetal defects). There were 5 (1.2%) ectopic pregnancies, 49 (11.5%) spontaneous abortions and 39 (9.2%) elective terminations. Most pregnancies exposed to subcutaneous interferon beta-1a in utero were associated with normal live births. The rates of spontaneous abortion and major congenital anomalies in live births were in line with those observed in the general population. Conclusions: These data should be taken into account when considering options for women with MS who become pregnant or who are planning pregnancy while on treatment with subcutaneous interferon beta-1a. (Less)
Please use this url to cite or link to this publication:
https://lup.lub.lu.se/record/1777642
- author
- Sandberg Wollheim, Magnhild LU ; Alteri, Enrica ; Stam Moraga, Margaretha and Kornmann, Gabrielle
- organization
- publishing date
- 2011
- type
- Contribution to journal
- publication status
- published
- subject
- in
- Multiple Sclerosis Journal
- volume
- 17
- issue
- 4
- pages
- 423 - 430
- publisher
- SAGE Publications
- external identifiers
-
- wos:000290969600007
- pmid:21220368
- scopus:79954602080
- pmid:21220368
- ISSN
- 1477-0970
- DOI
- 10.1177/1352458510394610
- language
- English
- LU publication?
- yes
- id
- 2297c860-0af2-423f-8e01-29f796734482 (old id 1777642)
- alternative location
- http://www.ncbi.nlm.nih.gov/pubmed/21220368?dopt=Abstract
- date added to LUP
- 2016-04-01 10:11:17
- date last changed
- 2022-04-04 03:14:22
@article{2297c860-0af2-423f-8e01-29f796734482,
abstract = {{Background: Women with multiple sclerosis (MS) are advised to discontinue interferon-beta therapy before trying to conceive. Unplanned pregnancies occur and risks related to exposure remain unclear. Methods: To determine pregnancy outcomes following interferon-beta therapy, we examined pregnancies from a global drug safety database containing individual case safety reports received in the post-marketing setting and safety data from clinical trials of subcutaneous interferon beta-1a in MS. Results: One thousand and twenty-two cases of exposure to subcutaneous interferon beta-1a during pregnancy were retrieved; 679 had a documented outcome. In cases for which exposure duration was available (n = 231), mean time of foetal exposure to subcutaneous interferon beta-1a before treatment discontinuation was 28 days; most pregnancies (199/231; 86.1%) were exposed for ≤45 days. To avoid bias, only outcomes for prospective data (n = 425) in pregnancies exposed to interferon beta-1a in utero were analysed further. Of these, 324 (76.2%) resulted in normal live births and four (0.9%) in live births with congenital anomalies (3 [0.7%] were 'major'). Four (0.9%) pregnancies resulted in stillbirths (1 [0.2%] with foetal defects). There were 5 (1.2%) ectopic pregnancies, 49 (11.5%) spontaneous abortions and 39 (9.2%) elective terminations. Most pregnancies exposed to subcutaneous interferon beta-1a in utero were associated with normal live births. The rates of spontaneous abortion and major congenital anomalies in live births were in line with those observed in the general population. Conclusions: These data should be taken into account when considering options for women with MS who become pregnant or who are planning pregnancy while on treatment with subcutaneous interferon beta-1a.}},
author = {{Sandberg Wollheim, Magnhild and Alteri, Enrica and Stam Moraga, Margaretha and Kornmann, Gabrielle}},
issn = {{1477-0970}},
language = {{eng}},
number = {{4}},
pages = {{423--430}},
publisher = {{SAGE Publications}},
series = {{Multiple Sclerosis Journal}},
title = {{Pregnancy outcomes in multiple sclerosis following subcutaneous interferon beta-1a Therapy.}},
url = {{https://lup.lub.lu.se/search/files/1636000/1971390.pdf}},
doi = {{10.1177/1352458510394610}},
volume = {{17}},
year = {{2011}},
}