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      EULAR recommendations for women's health and the management of family planning, assisted reproduction, pregnancy and menopause in patients with systemic lupus erythematosus and/or antiphospholipid syndrome

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          Abstract

          Objectives

          Develop recommendations for women's health issues and family planning in systemic lupus erythematosus (SLE) and/or antiphospholipid syndrome (APS).

          Methods

          Systematic review of evidence followed by modified Delphi method to compile questions, elicit expert opinions and reach consensus.

          Results

          Family planning should be discussed as early as possible after diagnosis. Most women can have successful pregnancies and measures can be taken to reduce the risks of adverse maternal or fetal outcomes. Risk stratification includes disease activity, autoantibody profile, previous vascular and pregnancy morbidity, hypertension and the use of drugs (emphasis on benefits from hydroxychloroquine and antiplatelets/anticoagulants). Hormonal contraception and menopause replacement therapy can be used in patients with stable/inactive disease and low risk of thrombosis. Fertility preservation with gonadotropin-releasing hormone analogues should be considered prior to the use of alkylating agents. Assisted reproduction techniques can be safely used in patients with stable/inactive disease; patients with positive antiphospholipid antibodies/APS should receive anticoagulation and/or low-dose aspirin. Assessment of disease activity, renal function and serological markers is important for diagnosing disease flares and monitoring for obstetrical adverse outcomes. Fetal monitoring includes Doppler ultrasonography and fetal biometry, particularly in the third trimester, to screen for placental insufficiency and small for gestational age fetuses. Screening for gynaecological malignancies is similar to the general population, with increased vigilance for cervical premalignant lesions if exposed to immunosuppressive drugs. Human papillomavirus immunisation can be used in women with stable/inactive disease.

          Conclusions

          Recommendations for women's health issues in SLE and/or APS were developed using an evidence-based approach followed by expert consensus.

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          Most cited references 137

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          Antiphospholipid syndrome: clinical and immunologic manifestations and patterns of disease expression in a cohort of 1,000 patients.

          To analyze the clinical and immunologic manifestations of antiphospholipid syndrome (APS) in a large cohort of patients and to define patterns of disease expression. The clinical and serologic features of APS (Sapporo preliminary criteria) in 1,000 patients from 13 European countries were analyzed using a computerized database. The cohort consisted of 820 female patients (82.0%) and 180 male patients (18.0%) with a mean +/- SD age of 42 +/- 14 years at study entry. "Primary" APS was present in 53.1% of the patients; APS was associated with systemic lupus erythematosus (SLE) in 36.2%, with lupus-like syndrome in 5.0%, and with other diseases in 5.9%. A variety of thrombotic manifestations affecting the majority of organs were recorded. A catastrophic APS occurred in 0.8% of the patients. Patients with APS associated with SLE had more episodes of arthritis and livedo reticularis, and more frequently exhibited thrombocytopenia and leukopenia. Female patients had a higher frequency of arthritis, livedo reticularis, and migraine. Male patients had a higher frequency of myocardial infarction, epilepsy, and arterial thrombosis in the lower legs and feet. In 28 patients (2.8%), disease onset occurred before age 15; these patients had more episodes of chorea and jugular vein thrombosis than the remaining patients. In 127 patients (12.7%), disease onset occurred after age 50; most of these patients were men. These patients had a higher frequency of stroke and angina pectoris, but a lower frequency of livedo reticularis, than the remaining patients. APS may affect any organ of the body and display a broad spectrum of manifestations. An association with SLE, the patient's sex, and the patient's age at disease onset can modify the disease expression and define specific subsets of APS.
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            Combined oral contraceptives in women with systemic lupus erythematosus.

            Oral contraceptives are rarely prescribed for women with systemic lupus erythematosus, because of concern about potential negative side effects. In this double-blind, randomized, noninferiority trial, we prospectively evaluated the effect of oral contraceptives on lupus activity in premenopausal women with systemic lupus erythematosus. A total of 183 women with inactive (76 percent) or stable active (24 percent) systemic lupus erythematosus at 15 U.S. sites were randomly assigned to receive either oral contraceptives (triphasic ethinyl estradiol at a dose of 35 microg plus norethindrone at a dose of 0.5 to 1 mg for 12 cycles of 28 days each; 91 women) or placebo (92 women) and were evaluated at months 1, 2, 3, 6, 9, and 12. Subjects were excluded if they had moderate or high levels of anticardiolipin antibodies, lupus anticoagulant, or a history of thrombosis. The primary end point, a severe lupus flare, occurred in 7 of 91 subjects receiving oral contraceptives (7.7 percent) as compared with 7 of 92 subjects receiving placebo (7.6 percent). The 12-month rates of severe flare were similar: 0.084 for the group receiving oral contraceptives and 0.087 for the placebo group (P=0.95; upper limit of the one-sided 95 percent confidence interval for this difference, 0.069, which is within the prespecified 9 percent margin for noninferiority). Rates of mild or moderate flares were 1.40 flares per person-year for subjects receiving oral contraceptives and 1.44 flares per person-year for subjects receiving placebo (relative risk, 0.98; P=0.86). In the group that was randomized to receive oral contraceptives, there was one deep venous thrombosis and one clotted graft; in the placebo group, there was one deep venous thrombosis, one ocular thrombosis, one superficial thrombophlebitis, and one death (after cessation of the trial). Our study indicates that oral contraceptives do not increase the risk of flare among women with systemic lupus erythematosus whose disease is stable. Copyright 2005 Massachusetts Medical Society.
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              A systematic review and meta-analysis of pregnancy outcomes in patients with systemic lupus erythematosus and lupus nephritis.

              Studies of the impact of systemic lupus erythematosus (SLE) and its pregnancy complications have yielded conflicting results. Major limitations of these studies relate to their small numbers of patients and retrospective designs. The aim of this study was to perform a systematic literature review of pregnancy outcomes in women with SLE and a meta-analysis of the association of lupus nephritis with adverse pregnancy outcomes. We searched electronic databases from 1980 to 2009 and reviewed papers with validity criteria. Random-effects analytical methods were used to evaluate pregnancy complications rates. Thirty-seven studies with 1842 patients and 2751 pregnancies were included. Maternal complications included lupus flare (25.6%), hypertension (16.3%), nephritis (16.1%), pre-eclampsia (7.6%), and eclampsia (0.8%). The induced abortion rate was 5.9%, and when excluded, fetal complications included spontaneous abortion (16.0%), stillbirth (3.6%), neonatal deaths (2.5%), and intrauterine growth retardation (12.7%). The unsuccessful pregnancy rate was 23.4%, and the premature birth rate was 39.4%. Meta-regression analysis showed statistically significant positive associations between premature birth rate and active nephritis and increased hypertension rates in subjects with active nephritis or a history of nephritis. History of nephritis was also associated with pre-eclampsia. Anti-phospholipid antibodies were associated with hypertension, premature birth, and an increased rate of induced abortion. In patients with SLE, both lupus nephritis and anti-phospholipid antibodies increase the risks for maternal hypertension and premature births. The presented evidence further supports timing of pregnancy relative to SLE activity and multispecialty care of these patients.
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                Author and article information

                Journal
                Ann Rheum Dis
                Ann. Rheum. Dis
                annrheumdis
                ard
                Annals of the Rheumatic Diseases
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                0003-4967
                1468-2060
                March 2017
                17 February 2017
                : 76
                : 3
                : 476-485
                Affiliations
                [1 ]Department of Clinical and Experimental Sciences, University of Brescia , Brescia, Italy
                [2 ]Unit of Rheumatology and Clinical Immunology, Spedali Civili , Brescia, Italy
                [3 ]Department of Rheumatology, Clinical Immunology and Allergy, University of Crete Medical School , Heraklion, Greece
                [4 ]The Zabludowicz Center for Autoimmune Diseases , Sheba Medical Center, Tel Hashomer, Israel
                [5 ]The Faculty of Medicine, Tel Aviv University , Israel
                [6 ]Royal National Hospital For Rheumatic Diseases , Bath, UK
                [7 ]Department of Autoimmune Diseases, Hospital Clínic , Barcelona, Catalonia, Spain
                [8 ]AP-HP, Hôpital Cochin, Centre de référence maladies auto-immunes et systémiques rares , Paris, France
                [9 ]Université Paris Descartes-Sorbonne Paris Cité , Paris, France
                [10 ]Rheumatology Unit, Department of Medicine, University of Padua , Italy
                [11 ]Policlinic of Rheumatology, Hiller Research Unit, University Clinic Duesseldorf, Heinrich-Heine-University Duesseldorf , Duesseldorf, Germany
                [12 ]Department of Rheumatology, Immunology and Allergology, University Hospital of Bern , Bern, Switzerland
                [13 ]Unidade de Doenças Auto-imunes—Serviço Medicina Interna 7.2, Hospital Curry Cabral/Centro Hospitalar Lisboa Central, NEDAI/SPMI , Lisboa, Portugal
                [14 ]Lupus Research Unit, The Rayne Institute, St. Thomas Hospital , London, UK
                [15 ]Department of Rheumatology, Dubai Hospital , Dubai, United Arab Emirates
                [16 ]EULAR PARE Patient Research Partner , London, UK
                [17 ]Unit of Obstetrics and Gynaecology , Spedali Civili, Brescia, Italy
                [18 ]EULAR PARE Patient Research Partner , Rome, Italy
                [19 ]Department of Clinical Sciences and Community Health, University of Milan, Istituto Auxologico Italiano , Milan, Italy
                [20 ]Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa , Pisa, Italy
                [21 ]Neonatology and Neonatal Intensive Care Unit, Spedali Civili , Brescia, Italy
                [22 ]Norwegian National Advisory Unit on Pregnancy and Rheumatic Diseases, St. Olavs Hospital, Trondheim University Hospital , Trondheim, Norway
                [23 ]Department of Rheumatology, Iuliu Hatieganu University of Medicine and Pharmacy , Cluj-Napoca, Romania
                [24 ]Department of Obstetrics and Gynaecology, University Hospital of Bern , Inselspital, Switzerland
                [25 ]Rheumatology Unit, Department of Medicine, Solna, Karolinska Institutet , Karolinska University Hospital , Stockholm, Sweden
                [26 ]Rheumatology Unit, Joint Academic Rheumatology Programme, 1st Department of Propaedeutic Internal Medicine Athens, National and Kapodistrian University of Athens , Athens, Greece
                [27 ]Department of Rheumatology, Istanbul Bilim University, Istanbul Florence Nightingale Hospital , Esentepe-Istanbul, Turkey
                [28 ]4th Department of Internal Medicine, ‘Attikon’ University Hospital, Medical School, University of Athens , Athens, Greece
                [29 ]Joint Academic Rheumatology Program, National and Kapodestrian University of Athens , Athens, Greece
                Author notes

                Handling editor Tore K Kvien

                [Correspondence to ] Professor Angela Tincani, Unit of Rheumatology and Clinical Immunology, ASST Spedali Civili, Piazzale Spedali Civili, 1, Brescia 25123, Italy; angela.tincani@ 123456unibs.it

                LA and GKB contributed equally; DB and AT share senior authorship.

                Article
                annrheumdis-2016-209770
                10.1136/annrheumdis-2016-209770
                5446003
                27457513
                Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

                This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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