The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation

Carina Götestam Skorpen¹, Maria Hoeltzenbein², Angela Tincani³, Rebecca Fischer-Betz⁴, Elisabeth Elefant⁵, Christina Chambers⁶, Josè da Silva⁷, Catherine Nelson-Piercy⁸, Irene Cetin⁹, Nathalie Costedoat-Chalumeau¹⁰, Radboud Dolhain¹¹, Frauke Förger¹², Munther Khamashta¹³, Guillermo Ruiz-Irastorza¹⁴, Angela Zink¹⁵, Jiri Vencovsky¹⁶, Maurizio Cutolo¹⁷, Nele Caeyers¹⁸, Claudia Zumbühl¹⁹, Monika Østensen²⁰

Affiliations

¹ National Service for Pregnancy and Rheumatic Diseases, Department of Rheumatology, Trondheim University Hospital, Trondheim, Norway Department of Neuroscience, Norwegian University of Science and Technology (NTNU), Trondheim, Norway Department of Rheumatology, Ålesund Hospital, Ålesund, Norway.
² Berlin Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy, Charité-Universitätsmedizin Berlin, Berlin, Germany.
³ Department of Clinical and Experimental Science Rheumatology and Clinical Immunology Unit, Spedali Civili and University of Brescia, Brescia, Italy.
⁴ Department of Rheumatology, University Hospital of Düsseldorf, Duesseldorf, Germany.
⁵ Centre de Référence sur les Agents Tératogènes (CRAT), Groupe Hospitalier Universitaire Est, Hôpital Armand Trousseau, Paris, France.
⁶ Department of Pediatrics, University of California San Diego, La Jolla, USA.
⁷ Department of Rheumatology, University Hospital, Coimbra, Portugal.
⁸ Women's Health Academic Centre, St Thomas' Hospital, London, UK.
⁹ Department of Mother and Child, Hospital Luigi Sacco, University of Milano, Milano, Italy.
¹⁰ Université Paris-Descartes, Paris, France Service de médecine interne, AP-HP, Hôpital Cochin, Centre de référence maladies auto-immunes et systémiques rares, Paris, France.
¹¹ Department of Rheumatology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.
¹² Department of Rheumatology, Immunology and Allergology, University Hospital of Bern, Bern, Switzerland.
¹³ Graham Hughes Lupus Research Laboratory, Division of Women's Health, King's College London, The Rayne Institute, St Thomas' Hospital, London, UK.
¹⁴ Autoimmune Diseases Research Unit, Department of Internal Medicine, Biocruces Health Research Institute, University Hospital Cruces, University of the Basque Country, Bizkaia, Spain.
¹⁵ Epidemiology Unit, and Department for Rheumatology, German Rheumatism Research Centre, Charité University Medicine, Berlin, Germany.
¹⁶ Institute of Rheumatology, Praha, Czech Republic.
¹⁷ Research Laboratories and Academic Division of Clinical Rheumatology, Department of Internal Medicine, University of Genova, Genova, Italy.
¹⁸ EULAR Social Leagues Patients' representative, Leuven, Belgium.
¹⁹ EULAR Social Leagues Patients' representative, Zürich, Switzerland.
²⁰ National Service for Pregnancy and Rheumatic Diseases, Department of Rheumatology, Trondheim University Hospital, Trondheim, Norway Department of Neuroscience, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.

PMID: 26888948
DOI: 10.1136/annrheumdis-2015-208840

The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation

Carina Götestam Skorpen et al. Ann Rheum Dis. 2016 May.

. 2016 May;75(5):795-810.

doi: 10.1136/annrheumdis-2015-208840. Epub 2016 Feb 17.

Authors

Affiliations

¹ National Service for Pregnancy and Rheumatic Diseases, Department of Rheumatology, Trondheim University Hospital, Trondheim, Norway Department of Neuroscience, Norwegian University of Science and Technology (NTNU), Trondheim, Norway Department of Rheumatology, Ålesund Hospital, Ålesund, Norway.
² Berlin Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy, Charité-Universitätsmedizin Berlin, Berlin, Germany.
³ Department of Clinical and Experimental Science Rheumatology and Clinical Immunology Unit, Spedali Civili and University of Brescia, Brescia, Italy.
⁴ Department of Rheumatology, University Hospital of Düsseldorf, Duesseldorf, Germany.
⁵ Centre de Référence sur les Agents Tératogènes (CRAT), Groupe Hospitalier Universitaire Est, Hôpital Armand Trousseau, Paris, France.
⁶ Department of Pediatrics, University of California San Diego, La Jolla, USA.
⁷ Department of Rheumatology, University Hospital, Coimbra, Portugal.
⁸ Women's Health Academic Centre, St Thomas' Hospital, London, UK.
⁹ Department of Mother and Child, Hospital Luigi Sacco, University of Milano, Milano, Italy.
¹⁰ Université Paris-Descartes, Paris, France Service de médecine interne, AP-HP, Hôpital Cochin, Centre de référence maladies auto-immunes et systémiques rares, Paris, France.
¹¹ Department of Rheumatology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.
¹² Department of Rheumatology, Immunology and Allergology, University Hospital of Bern, Bern, Switzerland.
¹³ Graham Hughes Lupus Research Laboratory, Division of Women's Health, King's College London, The Rayne Institute, St Thomas' Hospital, London, UK.
¹⁴ Autoimmune Diseases Research Unit, Department of Internal Medicine, Biocruces Health Research Institute, University Hospital Cruces, University of the Basque Country, Bizkaia, Spain.
¹⁵ Epidemiology Unit, and Department for Rheumatology, German Rheumatism Research Centre, Charité University Medicine, Berlin, Germany.
¹⁶ Institute of Rheumatology, Praha, Czech Republic.
¹⁷ Research Laboratories and Academic Division of Clinical Rheumatology, Department of Internal Medicine, University of Genova, Genova, Italy.
¹⁸ EULAR Social Leagues Patients' representative, Leuven, Belgium.
¹⁹ EULAR Social Leagues Patients' representative, Zürich, Switzerland.
²⁰ National Service for Pregnancy and Rheumatic Diseases, Department of Rheumatology, Trondheim University Hospital, Trondheim, Norway Department of Neuroscience, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.

PMID: 26888948
DOI: 10.1136/annrheumdis-2015-208840

Abstract

A European League Against Rheumatism (EULAR) task force was established to define points to consider on use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Based on a systematic literature review and pregnancy exposure data from several registries, statements on the compatibility of antirheumatic drugs during pregnancy and lactation were developed. The level of agreement among experts in regard to statements and propositions of use in clinical practice was established by Delphi voting. The task force defined 4 overarching principles and 11 points to consider for use of antirheumatic drugs during pregnancy and lactation. Compatibility with pregnancy and lactation was found for antimalarials, sulfasalazine, azathioprine, ciclosporin, tacrolimus, colchicine, intravenous immunoglobulin and glucocorticoids. Methotrexate, mycophenolate mofetil and cyclophosphamide require discontinuation before conception due to proven teratogenicity. Insufficient documentation in regard to fetal safety implies the discontinuation of leflunomide, tofacitinib as well as abatacept, rituximab, belimumab, tocilizumab, ustekinumab and anakinra before a planned pregnancy. Among biologics tumour necrosis factor inhibitors are best studied and appear reasonably safe with first and second trimester use. Restrictions in use apply for the few proven teratogenic drugs and the large proportion of medications for which insufficient safety data for the fetus/child are available. Effective drug treatment of active inflammatory rheumatic disease is possible with reasonable safety for the fetus/child during pregnancy and lactation. The dissemination of the data to health professionals and patients as well as their implementation into clinical practice may help to improve the management of pregnant and lactating patients with rheumatic disease.

Keywords: DMARDs (biologic); DMARDs (synthetic); Nursing; Treatment.

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The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation

Affiliations

The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation

Authors

Affiliations

Abstract

Publication types

MeSH terms

Substances