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Clin Exp Rheumatol. 2015 Sep-Oct;33(5):688-93. Epub 2015 Aug 25.

Prospectively-followed pregnancies in patients with inflammatory arthritis taking biological drugs: an Italian multicentre study.

Author information

1
Rheumatology and Clinical Immunology Unit, Spedali Civili di Brescia, Italy.
2
Department of Internal Medicine and Medical Specialties, Rheumatology Unit, La Sapienza University, Rome, Italy.
3
Rheumatology and Clinical Immunology Unit, Spedali Civili di Brescia; and Department of Clinical and Experimental Sciences, University of Brescia, Italy.
4
Department of Internal Medicine and Clinical Immunology, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.
5
Department of Clinical Sciences and Community Health, University of Milan, Istituto G. Pini and IRCCS Istituto Auxologico Italiano, Milan, Italy.
6
Rheumatology Unit, IRCCS Policlinico S. Matteo Foundation, University of Pavia, Italy.
7
Obstetric and Gynecology Department, IIRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico, Mangiagalli, Regina Elena, Milan, Italy.
8
Obstetric and Gynecology Department, Spedali Civili di Brescia, Italy.
9
Department of Internal Medicine and Public Medicine, Rheumatology Unit, University of Bari, Italy.
10
Department of Clinical and Experimental Sciences, University of Brescia; and Obstetric and Gynecology Department, Spedali Civili di Brescia, Italy.
11
Neonatology and Neonatal Intensive Care Unit, Spedali Civili di Brescia, Italy.

Abstract

OBJECTIVES:

Information on new drugs does not include their possible effects on pregnancy because pregnant women are excluded from clinical trials. Although not classified as teratogenic in animals, limited data is available on biological anti-rheumatic agents and their safety in human pregnancy. The aim of the study is to evaluate the safety of biological drugs in pregnant patients with chronic arthritis.

METHODS:

Pregnancy outcome and maternal disease variations were prospectively followed in six Italian Rheumatology Centres. Patients exposed to biological agents during the periconceptional period or during pregnancy were included in the study. The occurrence of congenital malformations as well as the obstetric and neonatal outcomes were assessed.

RESULTS:

Between 1999 and 2013 we identified 79 exposed pregnancies in 67 women affected by different rheumatic diseases with peripheral chronic arthritis. At the time of the start of pregnancy, 56 patients were taking etanercept, 13 adalimumab, 3 infliximab, 2 each certolizumab-pegol and rituximab, 1 each golimumab, anakinra and abatacept. Biological treatment was stopped after a mean of 41 days since documented pregnancy. Live births were reported in 66% of pregnancies. The rate of spontaneous pregnancy loss was 20%. Only one congenital malformation was reported.

CONCLUSIONS:

TNF-alpha inhibitors can be considered safe in the periconception period, representing a possible therapeutic choice also in young women affected by an aggressive form of chronic arthritis and hoping for a pregnancy. Reports of exposure during 2nd/3rd trimester are still limited and suggest caution. Experience with abatacept, tocilizumab, anakinra and rituximab in pregnancy is insufficient.

PMID:
26311348
[Indexed for MEDLINE]

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