title: The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation.
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.
authors.affiliation: 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.
authors.forename: Carina
authors.identifier: http://orcid.org/0000-0003-0000-3124
authors.initials: C
authors.lastname: Götestam Skorpen
authors.affiliation: Berlin Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy, Charité-Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: Maria
authors.initials: M
authors.lastname: Hoeltzenbein
authors.affiliation: Department of Clinical and Experimental Science Rheumatology and Clinical Immunology Unit, Spedali Civili and University of Brescia, Brescia, Italy.
authors.forename: Angela
authors.initials: A
authors.lastname: Tincani
authors.affiliation: Department of Rheumatology, University Hospital of Düsseldorf, Duesseldorf, Germany.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Fischer-Betz
authors.affiliation: Centre de Référence sur les Agents Tératogènes (CRAT), Groupe Hospitalier Universitaire Est, Hôpital Armand Trousseau, Paris, France.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Elefant
authors.affiliation: Department of Pediatrics, University of California San Diego, La Jolla, USA.
authors.forename: Christina
authors.initials: C
authors.lastname: Chambers
authors.affiliation: Department of Rheumatology, University Hospital, Coimbra, Portugal.
authors.forename: Josè
authors.identifier: http://orcid.org/0000-0002-2782-6780
authors.initials: J
authors.lastname: da Silva
authors.affiliation: Women's Health Academic Centre, St Thomas' Hospital, London, UK.
authors.forename: Catherine
authors.initials: C
authors.lastname: Nelson-Piercy
authors.affiliation: Department of Mother and Child, Hospital Luigi Sacco, University of Milano, Milano, Italy.
authors.forename: Irene
authors.initials: I
authors.lastname: Cetin
authors.affiliation: Université Paris-Descartes, Paris, France Service de médecine interne, AP-HP, Hôpital Cochin, Centre de référence maladies auto-immunes et systémiques rares, Paris, France.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Costedoat-Chalumeau
authors.affiliation: Department of Rheumatology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.
authors.forename: Radboud
authors.initials: R
authors.lastname: Dolhain
authors.affiliation: Department of Rheumatology, Immunology and Allergology, University Hospital of Bern, Bern, Switzerland.
authors.forename: Frauke
authors.initials: F
authors.lastname: Förger
authors.affiliation: Graham Hughes Lupus Research Laboratory, Division of Women's Health, King's College London, The Rayne Institute, St Thomas' Hospital, London, UK.
authors.forename: Munther
authors.initials: M
authors.lastname: Khamashta
authors.affiliation: Autoimmune Diseases Research Unit, Department of Internal Medicine, Biocruces Health Research Institute, University Hospital Cruces, University of the Basque Country, Bizkaia, Spain.
authors.forename: Guillermo
authors.identifier: http://orcid.org/0000-0001-7788-1043
authors.initials: G
authors.lastname: Ruiz-Irastorza
authors.affiliation: Epidemiology Unit, and Department for Rheumatology, German Rheumatism Research Centre, Charité University Medicine, Berlin, Germany.
authors.forename: Angela
authors.initials: A
authors.lastname: Zink
authors.affiliation: Institute of Rheumatology, Praha, Czech Republic.
authors.forename: Jiri
authors.initials: J
authors.lastname: Vencovsky
authors.affiliation: Research Laboratories and Academic Division of Clinical Rheumatology, Department of Internal Medicine, University of Genova, Genova, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Cutolo
authors.affiliation: EULAR Social Leagues Patients' representative, Leuven, Belgium.
authors.forename: Nele
authors.initials: N
authors.lastname: Caeyers
authors.affiliation: EULAR Social Leagues Patients' representative, Zürich, Switzerland.
authors.forename: Claudia
authors.initials: C
authors.lastname: Zumbühl
authors.affiliation: 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.
authors.forename: Monika
authors.initials: M
authors.lastname: Østensen
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000517:prevention & control; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001688:Biological Products / Q000009:adverse effects / Q000627:therapeutic use; D003697:Delphi Technique; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007774:Lactation; D008431:Maternal-Fetal Exchange; D016742:Preconception Care / Q000379:methods*; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy*; D011256:Pregnancy Outcome; D011297:Prenatal Exposure Delayed Effects; D012216:Rheumatic Diseases / Q000188:drug therapy*
chemical_list: D018501:Antirheumatic Agents; D001688:Biological Products
keywords: DMARDs (biologic); DMARDs (synthetic); Nursing; Treatment