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Reprod Toxicol. 2014 Jan;43:78-84. doi: 10.1016/j.reprotox.2013.11.004. Epub 2013 Nov 24.

Pregnancy outcome following gestational exposure to TNF-alpha-inhibitors: a prospective, comparative, observational study.

Author information

1
The Israeli Teratology Information Service, Israel Ministry of Health, Jerusalem, Israel; The Hebrew University Hadassah Medical School, Jerusalem, Israel. Electronic address: orna.diav-citrin@moh.health.gov.il.
2
The Division of Clinical Pharmacy, the Hebrew University of Jerusalem, Israel.
3
The Israeli Teratology Information Service, Israel Ministry of Health, Jerusalem, Israel.
4
The Israeli Teratology Information Service, Israel Ministry of Health, Jerusalem, Israel; The Hebrew University Hadassah Medical School, Jerusalem, Israel.

Abstract

OBJECTIVE:

To evaluate pregnancy safety of anti-TNF-α medications.

DESIGN:

Prospective, comparative, observational study done at the Israeli Teratology Information Service between 2002 and 2011.

RESULTS:

83 anti-TNF-α-exposed-pregnancies (97.6% in the first trimester, T1) were followed-up and compared with 86 disease-matched (DM) and 341 non-teratogenic-exposed (NTE) pregnancies. The anti-TNF-α group consisted of 35 infliximab-, 25 etanercept-, and 23 adalimumab-exposed pregnancies. The rate of major congenital anomalies did not significantly differ between the three groups [3/65 (4.6%) (anti-TNF-α, T1), 5/79 (6.3%) (DM), 8/336 (2.4%) (NTE)], even after excluding genetic or cytogenetic anomalies [3/65 (4.6%) (anti-TNF-α, T1), 4/79 (5.1%) (DM), 6/336 (1.8%) (NTE)]. There were no cases of VATER/VACTERL association.

CONCLUSION:

The present study suggests that anti-TNF-α treatment does not pose a major teratogenic risk in humans. This conclusion is based on relatively small numbers of exposed pregnancies and should be interpreted with caution. Larger studies are needed to establish anti-TNF-α pregnancy safety.

KEYWORDS:

Adalimumab; Anti-TNF-α; Autoimmune diseases; Congenital anomalies; Etanercept; Infliximab; Pregnancy

PMID:
24284028
DOI:
10.1016/j.reprotox.2013.11.004
[Indexed for MEDLINE]

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