We thank Adegbenga Bankole, MD, Karen Costenbader, MD, MPH, and Michael Weisman, MD for serving on the Expert Panel. Supplementary Appendix 7, Tables I (conventional rheumatology medications), J (biologic rheumatology medications), and K (glucocorticoids) (http://onlinelibrary.wiley.com/doi/10.1002/art.41191/abstract) present formal best practice statements and recommendations regarding maternal medication use in patients with RMD, with strength of supporting evidence. It is irreversible, and management transfers to pediatric cardiologists. If CHB (without other cardiac inflammation) is present, we conditionally recommend against treating with dexamethasone. These include 3 consecutive losses prior to 10 weeks’ gestation, a fetal loss at or after 10 weeks’ gestation, or delivery at <34 weeks due to preeclampsia, intrauterine growth restriction, or fetal distress. Among aPLs, LAC conveys the greatest risk for adverse pregnancy outcome in women with or without SLE: the RR for adverse pregnancy outcome with LAC was 12.15 (95% CI 2.92–50.54, P = 0.0006) in the PROMISSE (Predictors of Pregnancy Outcome: Biomarkers in APL syndrome and SLE) study 118. While long‐acting reversible contraceptives are encouraged as first‐line contraceptives for all appropriate candidates, including nulliparous women and adolescents 17, lack of data specific to RMD and variability in clinical situations, values, and preferences may affect a patient's choice. We strongly recommend against use of CYC, leflunomide, MMF, and thalidomide while breastfeeding. Mikuls TR, Johnson SR, Fraenkel L, Arasaratnam RJ, Baden LR, Bermas BL, Chatham W, Cohen S, Costenbader K, Gravallese EM, Kalil AC, Weinblatt ME, Winthrop K, Mudano AS, Turner A, Saag KG. Levonorgestrel, the over‐the‐counter option, is widely available and has no medical contraindications to use, including thrombophilia 18. We conditionally recommend continuing treatment with rituximab while a woman is trying to conceive, and we conditionally recommend continuing rituximab during pregnancy if severe life‐ or organ‐threatening maternal disease so warrants. Figure 3 details the HRT decision‐making process. Recommendations and good practice statements (GPS) for use of contraception in women with rheumatic and musculoskeletal disease (RMD). We conditionally recommend against use of MTX while breastfeeding. Reports of thrombosis in aPL‐positive patients undergoing IVF are uncommon, but most reported patients received empiric anticoagulation 41, 42. One such situation that reflects an ongoing research need is the challenge of reproductive health issues specific to transgender individuals, especially regarding hormonal therapies. 2020 Aug 16:1-5. doi: 10.1007/s40267-020-00767-1. Detailed justifications for strong and conditional recommendations are shown in Supplementary Appendix 12 (http://onlinelibrary.wiley.com/doi/10.1002/art.41191/abstract). Objectives American College of Rheumatology Composite Response Index in Systemic Sclerosis (ACR-CRISS) is a composite endpoint to assess the likelihood of improvement in diffuse … Results of the systematic literature review were compiled in an Evidence Report (Supplementary Appendix 6, http://onlinelibrary.wiley.com/doi/10.1002/art.41191/abstract). Abstract Number: 542 ‘BENEFIT’ Pan-European Observational Study to Evaluate the Real-world Effectiveness of SB4 Transition from Originator Etanercept (ETN) in Patients with Rheumatoid Arthritis … In women with asymptomatic aPL, we conditionally recommend against treating with HRT. Population-level interest in anti-rheumatic drugs in the COVID-19 era: insights from Google Trends. Enter your email address below and we will send you your username, If the address matches an existing account you will receive an email with instructions to retrieve your username, This article is published simultaneously in. The American College of Rheumatology’s 2019 Annual Meeting will be in ACR’s home city of Atlanta, Georgia November 8 – 13. Dr. Chakravarty has received consulting fees, speaking fees, and/or honoraria from UCB (less than $10,000). These include use of medications and presence or risk of osteoporosis. Recent small studies of APS pregnancies suggest that HCQ may decrease complications 111. Please check your email for instructions on resetting your password. Most information regarding pregnancy management in RMD comes from observational studies, primarily in patients with SLE and APS. Other independent risk factors in aPL‐positive women were younger age, history of thrombosis, and SLE. Prospective studies of infants born to women with anti‐Ro/SSA and/or anti‐La/SSB antibodies show that ~10% develop an NLE rash, 20% transient cytopenias, and 30% mild transient transaminitis (estimates vary widely between reports). As a result, identifying the appropriate screening and management (including medication use) for RMD patients is challenging for clinicians. The level of evidence specific to RMD patients is very low 41, 42, but evidence supports the safety of ART in a general population 43, 44. HELLP syndrome (hemolysis, elevated liver enzymes, and low platelets) or eclampsia may resemble severe disease flare. American College of Rheumatology Guidance for the Management of Rheumatic Disease in Adult Patients During the COVID-19 Pandemic: Version 1. Figure 1 details the contraception decision‐making process, and Table 1 provides efficacy data and comments on available contraceptives. The ACR considers adherence to the recommendations within this guideline to be voluntary, with the ultimate determination regarding their application to be made by the clinician in light of each patient’s individual circumstances. “Positive aPL” throughout this guideline refers to laboratory criteria only 10: persistent (2 positive test results at least 12 weeks apart) moderate‐high–titer anticardiolipin antibody (aCL) (≥40 units or ≥99th percentile), moderate‐high–titer anti–β2‐glycoprotein I (anti‐β2GPI) (≥40 units or ≥99th percentile), or positive lupus anticoagulant (LAC). 196: thromboembolism in pregnancy, The clinical spectrum of autoimmune congenital heart block, Dubois’ lupus erythematosus and related syndromes, Serial echocardiography for immune‐mediated heart disease in the fetus: results of a risk‐based prospective surveillance strategy, Maternal use of hydroxychloroquine is associated with a reduced risk of recurrent anti‐SSA/Ro‐antibody–associated cardiac manifestations of neonatal lupus, A management strategy for fetal immune‐mediated atrioventricular block, Prospective evaluation of fetuses with autoimmune‐associated congenital heart block followed in the PR Interval and Dexamethasone Evaluation (PRIDE) study, Assessment of fluorinated steroids to avert progression and mortality in anti‐SSA/Ro‐associated cardiac injury limited to the fetal conduction system, Cyclophosphamide: review of its mutagenicity for an assessment of potential germ cell risks, Effectiveness of risk evaluation and mitigation strategies (REMS) for lenalidomide and thalidomide: patient comprehension and knowledge retention, Thalidomide is distributed into human semen after oral dosing, Birth outcomes in children fathered by men treated with anti‐TNF‐α agents before conception, Reassuring results on birth outcomes in children fathered by men treated with azathioprine/6‐mercaptopurine within 3 months before conception: a nationwide cohort study, The outcome of pregnancy in the wives of men with familial Mediterranean fever treated with colchicine, No evidence for an increased risk of adverse pregnancy outcome after paternal low‐dose methotrexate: an observational cohort study, Risk of adverse pregnancy outcome after paternal exposure to methotrexate within 90 days before pregnancy, Birth outcomes after preconception paternal exposure to methotrexate: a nationwide cohort study, No excess risks in offspring with paternal preconception exposure to disease‐modifying antirheumatic drugs, Pregnancy outcomes following maternal and paternal exposure to teriflunomide during treatment for relapsing‐remitting multiple sclerosis, Outcomes of pregnancies fathered by solid‐organ transplant recipients exposed to mycophenolic acid products, The safety of therapeutic drugs in male inflammatory bowel disease patients wishing to conceive [review], International multi‐centre study of pregnancy outcomes with interleukin‐1 inhibitors, Recommendations for the use of rituximab in neuromyelitis optica spectrum disorders, Clinical teratology counseling and consultation case report: low dose methotrexate exposure in the early weeks of pregnancy, Review of the course and outcome of 100 pregnancies in 84 women treated with tacrolimus, Pregnancy outcomes in solid organ transplant recipients with exposure to mycophenolate mofetil or sirolimus, Thalidomide‐induced teratogenesis: history and mechanisms, Leflunomide use during pregnancy and the risk of adverse pregnancy outcomes, Leflunomide—a human teratogen? Since IUDs are the most effective contraceptive options, we strongly recommend the IUD (copper or progestin) for women with RMD who are receiving immunosuppressive therapy, despite hypothetical infection risk. 2020 Oct 31:1-9. doi: 10.1007/s10067-020-05490-w. Online ahead of print. Patients receiving regular anticoagulation therapy with vitamin K antagonists for thrombotic APS should transition to therapeutic‐dose LMWH for ART (usually enoxaparin 1 mg/kg subcutaneously every 12 hours), with this treatment withheld for retrieval and resumed subsequently, to continue throughout pregnancy. 182-184 Although CYC is used less frequently than in the past due to availability of alternative treatments, it remains a mainstay of therapy for severe or life‐threatening RMD. Pregnancy‐induced hypercoagulability increases RMD‐associated thrombosis risk. Kardeş S, Kuzu AS, Pakhchanian H, Raiker R, Karagülle M. Clin Rheumatol. Recommendations for the management of patients with systemic rheumatic diseases during the coronavirus disease pandemic. There are limited data on the compatibility of other biologics with pregnancy. The Voting Panel agreed that if the patient's disease is under good control, these medications may be discontinued in the third trimester. Available evidence supports the use, when indicated and desired, of HRT in RMD patients without aPL, including those with SLE 65. © 2020, American College of Rheumatology. Patients who are positive for aPL are at increased risk for thrombosis. Although not directly studied in SLE patients, the transdermal estrogen‐progestin patch results in greater estrogen exposure than do oral or transvaginal methods 22, 23, raising concern regarding potential increased risk of flare or thrombosis. ART techniques include ovarian stimulation, which elevates estrogen levels, IVF, and embryo transfer. Options for fertility preservation should be presented to male patients in whom CYC therapy is required. Any queries (other than missing content) should be directed to the corresponding author for the article. We strongly recommend tapering higher doses of nonfluorinated glucocorticoids to <20 mg daily of prednisone, adding a pregnancy‐compatible glucocorticoid‐sparing agent if necessary. Conditional recommendations generally reflect a lack of data, limited data, or conflicting data that lead to uncertainty. Benefit‐risk balance is most favorable for severe vasomotor symptoms in women ≤60 years old or within 10 years of menopause onset 61. As is the case with any underlying significant medical disease, women undertaking ovarian stimulation must be cleared medically by the appropriate specialist. Moderate‐quality direct evidence supports use of oral HRT in aPL‐negative women with SLE who have stable low‐level disease activity and no contraindication to use 65-68, although no studies have directly addressed use of HRT in patients with moderate‐to‐high disease activity. Dr. Sammaritano had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Thrombotic APS refers to patients who meet laboratory criteria for APS and have experienced a prior thrombotic event (arterial or venous), regardless of whether they have had obstetric complications. Estrogen use in aPL‐positive patients should be avoided due to the potential increased risk of thrombosis. In pregnant women with anti‐Ro/SSA and/or anti‐La/SSB antibodies but no history of an infant with CHB or NLE, we conditionally recommend serial fetal echocardiography (less frequent than weekly; interval not determined) starting between 16 and 18 weeks and continuing through week 26. In these and other high‐risk situations, the option of therapeutic termination of pregnancy may be lifesaving and should be discussed with the patient 195. Clipboard, Search History, and several other advanced features are temporarily unavailable. In pregnant women with positive aPL who do not meet criteria for APS and do not have another indication for the drug (such as SLE), we conditionally recommend against treating with prophylactic HCQ. Dr. A novel coronavirus from patients with pneumonia in China, 2019. Dr. White has received consulting fees, speaking fees, and/or honoraria from AbbVie (less than $10,000). Although the drug label suggests discontinuation of MTX before attempting pregnancy, data show no evidence for mutagenesis or teratogenicity 143-145. This guideline was developed, and the literature review conducted, in the adult population. Rheumatologists should collaborate with pediatricians when making recommendations 176. 162 It is difficult to avoid use of medication during pregnancy in patients with RMD. The treatment is often continued until estrogen levels return to near‐physiologic levels if no pregnancy occurs. Thalidomide is detectable in seminal fluid and is strongly teratogenic when given to pregnant women 138, 139, and should be discontinued at least 1 month prior to attempting conception. However, given the low level of available evidence and the rapidly evolving literature, this guidance is presented as a "living document," and future updates are anticipated. We strongly recommend prophylactic anticoagulation with heparin or LMWH in women with OB APS, and we strongly recommend therapeutic anticoagulation in women with thrombotic APS, during ART procedures. Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, et al. Pulmonary arterial hypertension is associated with a particularly high risk of maternal mortality, estimated at up to 20% even with aggressive therapy 191. Fertility and postmenopausal issues are not uncommon in RMD patients. Much in the field of prevention, screening, and management of NLE requires further study. A survey of 9,004 patients with rheumatic disease―both autoimmune-related and non-autoimmune―shows that patients may need continued medication counseling through the duration of the pandemic. In rare situations with significant disease‐related damage, such as pulmonary arterial hypertension, renal dysfunction, heart failure, or other severe organ damage, pregnancy may be contraindicated due to high risk of maternal morbidity and mortality. Risk of VTE may be increased with HRT use in the general population 69, 70. American College of Rheumatology Guidance for the Management of Rheumatic Disease in Adult Patients During the COVID-19 Pandemic: Version 3. The benefits of breastfeeding are numerous 169-175; the American Academy of Pediatrics recommends exclusive breastfeeding for the first 6 months and continued breastfeeding until 1 year 9. Prospective studies (evidence level moderate) in patients with stable SLE showed no increased risk of flare related to estrogen‐progestin pills 19, 20, and there are no data suggesting increased SLE flare risk with progestin‐only pills or copper IUDs 20, 21. Schramm MA, Venhoff N, Wagner D, Thiel J, Huzly D, Craig-Mueller N, Panning M, Hengel H, Kern WV, Voll RE. Guidelines and recommendations are intended to promote beneficial or desirable outcomes, but cannot guarantee any specific outcome. Please enable it to take advantage of the complete set of features! Almost half of pregnancies in the US are unplanned 196. Since ovarian stimulation protocols vary, discussion with the reproductive endocrinology and infertility specialist is appropriate. The strength of evidence on reproductive health topics in RMD patients is moderate at best, and usually low, very low, or nonexistent for many topics of interest. Chambers has received research support from Amgen, AstraZeneca, Bristol‐Myers Squibb, Celgene, GlaxoSmithKline, Janssen, Pfizer, Regeneron, Hoffmann La‐Roche‐Genentech, Genzyme‐Sanofi‐Aventis, Seqirus, Takeda Pharmaceuticals, UCB, Sun Pharma Global FZE, and the Gerber Foundation. ). RMD patients with subfertility value advice from their rheumatologists about oocyte preservation and in vitro fertilization (IVF). In one study 106 SLE patients, regardless of aPL status but excluding those with recent thrombosis, were randomized to receive oral estrogen‐progestin HRT or placebo. One Key Question (www.powertodecide.org) has been suggested in the literature as a simple way of addressing the issue of family planning with patients: “Would you like to become pregnant in the next year?” 14. In fertile women with RMD who have neither SLE nor positive aPL, we strongly recommend use of effective contraceptives (i.e., hormonal contraceptives or IUDs) over less effective options or no contraception; among effective methods, we conditionally recommend the highly effective IUDs or subdermal progestin implant (long‐acting reversible contraceptives) because they have the lowest failure rates. For this reason, we do not include DMPA among the progestin contraceptives recommended for use in patients with positive aPL. We provide data‐derived recommendations for common clinical reproductive health decisions including recent advances in this area and emphasize the need for early involvement of the rheumatologist in reproductive health discussions involving patients with RMD, for instance, the importance of effective contraception. Epub 2020 Sep 15. Supplementary Appendix 7, Table H (http://onlinelibrary.wiley.com/doi/10.1002/art.41191/abstract) presents best practice statements and recommendations regarding paternal medication use in men with RMD, with strength of supporting evidence. During 24 months of follow‐up 3 thrombotic events occurred in the HRT group and 1 in the placebo group, a nonsignificant difference. Methods: Infant serum levels of drugs ingested by the mother depend on multiple variables and are a function of drug concentration in breast milk, quantity of breast milk ingested, and drug absorption through the infant's gastrointestinal tract. Recent data indicate compatibility of many rheumatology medications both with lactation and with paternal use. Effectiveness of reversible forms of contraception varies. Number of times cited according to CrossRef: Impact of a Multifaceted Educational Program to Improve Provider Skills for Lupus Pregnancy Planning and Management: A Mixed‐Methods Approach. We conditionally recommend calcineurin inhibitors (tacrolimus and cyclosporine) and NSAIDs as compatible for use during pregnancy ( We conditionally recommend against testosterone co‐therapy in men with RMD receiving CYC, as it does not preserve fertility in men undergoing chemotherapy for malignancy (57). The American College of Obstetricians and Gynecologists and US Protective Health Task Force recommend aspirin 81 mg daily as prophylaxis in all patients at high risk for preeclampsia 97, 112-117. We do not comment on the relatively new progestin implant due to lack of data. CYC = cyclophosphamide; aPL = antiphospholipid antibody (persistent moderate‐to‐high–titer anticardiolipin or anti–β, Recommendations and good practice statements (GPS) for hormone replacement therapy (HRT) use in postmenopausal women with rheumatic and musculoskeletal disease (RMD). | CHB rarely occurs after week 26. 2019; … If conception does not occur, semen analysis should be considered. EUREKA algorithm predicts obstetric risk and response to treatment in women with different subsets of anti-phospholipid antibodies. Because women with RMD may experience disease flare post partum and require treatment, it is important to balance benefits of disease control with risk of infant exposure through breast milk. Other high‐risk scenarios include severe renal insufficiency, cardiomyopathy, or valvular dysfunction. We acknowledge, however, that this recommendation is based on a lack of compelling data rather than data showing no clear benefit, and also that potential risk with this therapy is likely to be strongly affected by daily dosage, with higher doses imparting greater risk of side effects. We conditionally recommend treatment with azathioprine/6‐mercaptopurine, calcineurin inhibitors, NSAIDs and the non–TNF inhibitor biologic agents (anakinra, rituximab, belimumab, abatacept, tocilizumab, secukinumab, and ustekinumab) as compatible with breastfeeding ( To date, the task force has approved 80 guidance statements: 36 with moderate and 44 with high consensus. IX. Detailed justifications for strong and conditional recommendations are shown in Supplementary Appendix 12 (http://onlinelibrary.wiley.com/doi/10.1002/art.41191/abstract). The calcium demand of fetal bone development and breastfeeding may worsen maternal osteoporosis. Results from a nationwide study in the United Kingdom performed prospectively from late pregnancy, International consensus statement on an update of the classification criteria for definite antiphospholipid syndrome (APS), Risk of unintended pregnancy among women with systemic lupus erythematosus. To provide guidance to rheumatology providers on the management of adult rheumatic disease in the context of the coronavirus disease 2019 (COVID-19) pandemic. Management of OB APS is one area with moderately strong evidence, but treatment for women with recurring adverse outcomes despite standard therapy is needed. ). If a patient is already taking HCQ, we strongly recommend continuing it during pregnancy; if she is not taking HCQ, we conditionally recommend starting it if there is no contraindication. ). Treatment of Autoimmune Bullous Diseases During Pregnancy and Lactation: A Review Focusing on Pemphigus and Pemphigoid Gestationis. Elective Termination of Pregnancy in Autoimmune Rheumatic Diseases: Experience From Two Databases. Get the latest public health information from CDC: https://www.coronavirus.gov, Get the latest research information from NIH: https://www.nih.gov/coronavirus, Find NCBI SARS-CoV-2 literature, sequence, and clinical content: https://www.ncbi.nlm.nih.gov/sars-cov-2/. The results of this study will be presented by Michael George, M.D., of the University of Pennsylvania during the annual meeting of the American College of Rheumatology … Ovarian insufficiency risk with CYC treatment depends on patient age and cumulative monthly CYC dose 48; measures of ovarian function remained stable during treatment according to the Euro‐Lupus protocol 49. This site: Browse 2020 abstracts in numerical order SARS-CoV-2 & rheumatic in... 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