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.
Berlin Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Ann Rheum Dis. 2016 May;75(5):795-810. doi: 10.1136/annrheumdis-2015-208840. Epub 2016 Feb 17.
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.
一个欧洲抗风湿病联盟(EULAR)工作组成立,以确定在妊娠前、妊娠期间和哺乳期使用抗风湿药物时需要考虑的要点。基于系统的文献回顾和来自多个登记处的妊娠暴露数据,制定了关于妊娠和哺乳期使用抗风湿药物相容性的声明。通过 Delphi 投票确定了专家对临床实践中使用的声明和建议的一致性程度。工作组确定了 4 个总体原则和 11 个在妊娠和哺乳期使用抗风湿药物时需要考虑的要点。抗疟药、柳氮磺胺吡啶、硫唑嘌呤、环孢素、他克莫司、秋水仙碱、静脉注射免疫球蛋白和糖皮质激素与妊娠和哺乳期兼容。由于已证实有致畸性,甲氨蝶呤、霉酚酸酯和环磷酰胺在受孕前需要停药。关于胎儿安全性的文件不足意味着在计划怀孕前,应停止使用来氟米特、托法替尼以及阿巴西普、利妥昔单抗、贝利木单抗、托珠单抗、乌司奴单抗和阿那白滞素。在生物制剂中,肿瘤坏死因子抑制剂研究得最多,在妊娠第一和第二孕期使用似乎相对安全。只有少数已证实致畸性的药物和大量药物因胎儿/儿童的安全性数据不足而受到使用限制。在妊娠和哺乳期,通过合理的胎儿安全性,积极的炎症性风湿病患者可以接受有效的药物治疗。向卫生专业人员和患者传播这些数据,并将其纳入临床实践,可能有助于改善妊娠和哺乳期风湿病患者的管理。