REVIEW - Can TNF inhibitors be safely used in pregnancy?

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Journal of Rheumatology

Jan 2010

Can Tumor Necrosis Factor Inhibitors Be Safely Used in Pregnancy?

YASER M. ALI, BINDEE KURIYA, CATALINA OROZCO, JOHN J. CUSH and EDWARD

C. KEYSTONE

From the Department of Clinical Immunology and Allergy, and Department

of Rheumatology, University of Toronto, Toronto, Ontario; Presbyterian

Hospital of Dallas; Rheumatology and Clinical Immunology Division,

Arthritis Care and Research Center, Baylor University Medical Center,

Baylor Research Institute, Dallas, Texas, USA; and The

Mac Centre, Mount Sinai Hospital, Toronto, Ontario, Canada.

Y.M. Ali, MD, Department of Clinical Immunology and Allergy; B.

Kuriya, MD, Department of Rheumatology, University of Toronto; C.

Orozco, MD, Presbyterian Hospital of Dallas; J.J. Cush, MD,

Rheumatology and Clinical Immunology Division, Arthritis Care and

Research Center, Baylor University Medical Center, Baylor Research

Institute; E.C. Keystone, MD, The Mac Centre, Mount

Sinai Hospital.

Abstract

Objective. We review available safety data for use of currently

approved tumor necrosis factor (TNF) inhibitors during pregnancy and

lactation and suggest guidelines for use of these agents among women

of reproductive age.

Method. Although regulatory agencies encourage the inclusion of

pregnant women and those of child-bearing age in randomized controlled

trials, pregnant and lactating women have universally been excluded

from studies because of unknown or potential risks to the fetus. Thus,

strong evidence-based treatment recommendations during pregnancy are

usually lacking and safety information is derived from voluntary

reports of adverse events during postmarketing surveillance or via

uncontrolled, observational studies, reviewed here.

Results. Uncommon adverse pregnancy outcomes observed with TNF

inhibitor therapy appear to approximate those seen in women not

receiving such therapy and may include premature birth, miscarriage,

low birthweight, hypertension, and preeclampsia. There are rare

reports of fetal malformations or congenital anomalies in patients

exposed to TNF inhibitors during conception or pregnancy. However, the

incidence of these events appears to be far below the 3% rate of

congenital anomalies in the general population.

Conclusion. If the activity or disease severity precludes the

cessation of a TNF inhibitor and/or DMARD, uncontrolled observations

suggest that conception and early pregnancy are not adversely affected

by use of TNF inhibitors. Nearly 70% of pregnant patients can

discontinue their TNF inhibitor early in the pregnancy (or with

determination of pregnancy) without augmenting maternal or fetal

risks.

http://www.jrheum.org/content/37/1/9.abstract

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