Pregnancy outcome following gestational exposure to TNF-alpha-inhibitors: a prospective, comparative, observational
Orna Diav-Citrin1, Anna Otcheretianski-Volodarsky2, Svetlana Shechtman3
1The Israeli Teratology Information Service, Israel Ministry of Health, Jerusalem, Israel; The Hebrew University Hadassah Medical School, Jerusalem, Israel.
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.
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