Orna Diav-Citrin1, Anna Otcheretianski-Volodarsky2, Svetlana Shechtman3, Asher Ornoy4. 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.
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.
Authors: Junie P Warrington; Heather A Drummond; Joey P Granger; Michael J Ryan Journal: Am J Physiol Regul Integr Comp Physiol Date: 2015-09-23 Impact factor: 3.619