19 dec2020
american college of rheumatology abstract
Comment on: EUREKA algorithm predicts obstetric risk and response to treatment in women with different subsets of anti-phospholipid antibodies. Patients who are positive for aPL are at increased risk for thrombosis. 86 2020 Aug 28;11:2086. doi: 10.3389/fimmu.2020.02086. Barrier methods confer some protection against sexually transmitted diseases. We conducted a systematic review of evidence relating to contraception, ART, fertility preservation, HRT, pregnancy and lactation, and medication use in RMD populations, using Grading of Recommendations Assessment, Development and Evaluation methodology to rate the quality of evidence and a group consensus process to determine final recommendations and grade their strength (conditional or strong). ). Because active disease affects maternal and pregnancy outcome, we strongly suggest, as good practice, monitoring SLE disease activity with clinical history, examination, and laboratory tests at least once per trimester. As additional good practice, we suggest maintaining concurrent care with specialists in obstetrics‐gynecology, maternal‐fetal medicine, neonatology, and other specialists as appropriate. In women with RMD who are at increased risk for osteoporosis from glucocorticoid use or underlying disease, we conditionally recommend against using DMPA as a long‐term contraceptive because data suggest that bone mineral density declines by up to 7.5% over 2 years of use in a healthy population ( Navidea’s abstract is accessible online at acrabstracts.org, abstract number 1544, with presentation of the poster on Monday, November 9, 2020 from 9:00 am – 11:00 am Eastern. No other disclosures relevant to this article were reported. Epub 2020 Aug 26. November 12-17, 2005, San Diego, … Detailed justifications for strong and conditional recommendations are shown in Supplementary Appendix 12 (http://onlinelibrary.wiley.com/doi/10.1002/art.41191/abstract). These complications are short‐lived and spontaneously resolve as the child's maternal antibodies disappear 129. Another important limitation is the inability to include recommendations for uncommon but important clinical situations. Dr. Lockshin has received consulting fees, speaking fees, and/or honoraria from Advance Medical, groupH, Biologische Heilmittel Heel, and Defined Health and has served as an expert witness concerning adverse pregnancy outcome with question of antiphospholipid syndrome. Timing will vary depending on individual clinical factors; in clinical practice this is usually a minimum of several months. Outcomes of pregnancy and associated factors in sub-Saharan African women with systemic lupus erythematosus: a scoping review. We intend that this guideline be used to inform a shared decision‐making process between patients and their physicians on issues related to reproductive health that incorporates patients’ values, preferences, and comorbidities. 2020 Sep;79(7):686-691. doi: 10.1007/s00393-020-00878-0. Dr. Clowse has received consulting fees, speaking fees, and/or honoraria from AstraZeneca and MotherToBaby (less than $10,000 each) and from UCB (more than $10,000) and research support from GlaxoSmithKline (paid to Duke University). Whether dexamethasone given for fetal first‐ or second‐degree heart block changes outcome is a matter of controversy. We conditionally recommend that women with RMD taking mycophenolate mofetil/mycophenolic acid (MMF) use an IUD alone or 2 other methods of contraception together, because MMF may reduce serum estrogen and progesterone levels (in turn reducing the efficacy of oral contraceptives). The increased risk of organ‐ or life‐threatening thrombosis due to high estrogen levels greatly outweighs the low risk of bleeding or other complications of unfractionated heparin or low molecular weight heparin (LMWH). Prophylactic‐dose heparin and aspirin therapy for OB APS improves likelihood of live birth, but not necessarily full‐term birth. In SLE patients without positive aPL who desire HRT due to severe vasomotor symptoms and have no contraindications, we conditionally recommend HRT treatment. ). Some investigators have used doses of aspirin up to 150 mg daily, but both the American College of Obstetricians and Gynecologists and the U.S. Preventive Services Task Force note that there is a lack of appropriate comparative studies to show the superiority of doses >100 mg per day. Studies of long‐term HRT show that risks, including stroke and breast cancer, outweigh benefits 63. et al Fortunately, many RMD medications may be initiated or continued during lactation. 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. 164, 165 We conditionally recommend treatment with CYC for life‐threatening conditions in the second or third trimester ( 2020 Oct 31:1-9. doi: 10.1007/s10067-020-05490-w. Online ahead of print. Although sulfasalazine may affect sperm count and quality, there are no data suggesting teratogenicity 146, 150, and we conditionally recommend its continuation. Pre‐conception, the concerns are potential effects on male fertility and medication‐associated teratogenicity. NIH 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. Pregnancy changes may impact manifestations of RMD. | Pregnancy registries collect these data but suffer reporting bias and may not reflect the racial and ethnic make‐up of the patient population. We strongly recommend tapering higher doses of nonfluorinated glucocorticoids to <20 mg daily of prednisone, adding a pregnancy‐compatible glucocorticoid‐sparing agent if necessary. Figure 3 details the HRT decision‐making process. 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. In men with RMD who are planning to father a pregnancy, we conditionally recommend, based on a smaller body of evidence, continuing treatment with MTX, MMF, leflunomide, sulfasalazine, calcineurin inhibitors, and nonsteroidal antiinflammatory drugs (NSAIDs) (142-149). 2020 Aug 16:1-5. doi: 10.1007/s40267-020-00767-1. 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. 15 American College of Rheumatology, Atlanta, Georgia. Optimal duration of prophylactic LMWH for asymptomatic aPL‐positive patients undergoing ovarian stimulation has not been studied; this is a decision best made in consultation with the reproductive endocrinology and infertility specialist. aPL = antiphospholipid antibody (persistent moderate [Mod]–to‐high–titer anticardiolipin or anti–β, Recommendations for use of assisted reproductive technology (ART) in women with rheumatic and musculoskeletal disease (RMD). No studies, however, have specifically assessed thrombosis risk with oral or transdermal HRT in women with aPL. Despite minimal passage of MTX into breast milk, especially with once‐weekly dosing, this medication may accumulate in neonatal tissues 185, 186. While fertility is typically normal in women with RMD (who have not been treated with cyclophosphamide [CYC]), it decreases with age, and ART may be needed by some RMD patients. ). Figure 1 details the contraception decision‐making process, and Table 1 provides efficacy data and comments on available contraceptives. We conditionally recommend against an empiric dosage increase of prednisone during ART procedures in patients with SLE; instead, we suggest monitoring the patient carefully and treating for flare if it occurs. The annual meeting of the American College of Rheumatology was held virtually this year from Nov. 5 to 9 and attracted participants from around the world, including rheumatology specialists, … We appreciate and stress, however, that benefit in individual high‐risk circumstances, such as triple‐positive aPL or strongly positive LAC results, advanced maternal age, or IVF pregnancy, may outweigh risks of this therapy, and decisions should be made with discussion between physician and patient, weighing potential risks and benefits. Pregnancy in women with RMD may lead to serious maternal or fetal adverse outcomes; accordingly, contraception, tailored to the individual patient with emphasis on safety and efficacy, should be discussed and encouraged. Progestin IUDs may decrease these symptoms 30, a potential benefit for patients receiving anticoagulation therapy. The expected 50% increase in glomerular filtration rate during pregnancy may worsen preexisting stable proteinuria. Fertility and postmenopausal issues are not uncommon in RMD patients. The tumor necrosis factor inhibitor certolizumab does not contain an Fc chain and thus has minimal placental transfer ( These recommendations are intended to guide care for all patients with RMD, except where indicated as being specific for patients with systemic lupus erythematosus, those positive for antiphospholipid antibody, and/or those positive for anti‐Ro/SSA and/or anti‐La/SSB antibodies. 127 Antiphospholipid antibody is a major risk factor for pregnancy loss and other adverse pregnancy outcomes, especially in SLE patients 118. 153-156 For women treated with leflunomide, we strongly recommend cholestyramine washout if there are detectable serum levels of metabolite prior to or as soon as pregnancy is confirmed. 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). Detailed justifications for strong and conditional recommendations are shown in Supplementary Appendix 11 (http://onlinelibrary.wiley.com/doi/10.1002/art.41191/abstract). Arthritis Rheumatol. These criteria are not appropriate for use in research until they receive final endorsement by the American College of Rheumatology and the European League Against Rheumatism. We strongly recommend against use of NSAIDs in the third trimester because of the risk of premature closure of the ductus arteriosus (163). Supplementary Appendix 7, Table A (on the Arthritis & Rheumatology web site at http://onlinelibrary.wiley.com/doi/10.1002/art.41191/abstract) presents formal recommendations regarding contraception; strength of evidence and justifications for strong and conditional recommendations are shown in Supplementary Appendix 9 (http://onlinelibrary.wiley.com/doi/10.1002/art.41191/abstract). A task force, including 10 rheumatologists and 4 infectious disease specialists from North America, was convened. If disease cannot be controlled with medications considered compatible with pregnancy, the physician and patient should discuss and weigh the possible risks from these medications versus the risks of uncontrolled disease during pregnancy. HRT is another issue of importance for postmenopausal RMD patients. 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. 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. N Engl J Med 2020;382:727-33. Dr. Bermas has received consulting fees, speaking fees, and/or honoraria from UCB (less than $10,000). Recommendations for these patients are not offered in this guideline; decisions regarding therapy rest on discussion between the patient and the physician, taking into account additional relevant risk factors. Online ahead of print. Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Pharmacokinetics and Pharmacological Properties of Chloroquine and Hydroxychloroquine in the Context of COVID‐19 Infection. Pre‐pregnancy or early pregnancy laboratory testing for relevant autoantibodies is recommended. The rheumatologist's familiarity with drug safety during these periods is important to maintain disease control and minimize mother and infant risk. RMD patients with subfertility value advice from their rheumatologists about oocyte preservation and in vitro fertilization (IVF). Current population recommendations 60-62 suggest limiting HRT use in healthy postmenopausal women and using the lowest dose that alleviates symptoms for the minimum time necessary. In one arm of an SLE contraceptive trial a copper IUD was used; although the number of patients receiving immunosuppressive agents was not reported, there were no cases of pelvic inflammatory disease 20. Estrogen use in aPL‐positive patients should be avoided due to the potential increased risk of thrombosis. 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. Almost half of pregnancies in the US are unplanned 196. Recent progress in maintenance treatment of neuromyelitis optica spectrum disorder. IX. In women with OB APS, we further strongly recommend treating with prophylactic‐dose anticoagulation for 6–12 weeks post partum ( ). There are no published data regarding specific timing for medication discussion, which will vary according to the individual clinical situation, but in general we suggest adequate time to allow for appropriate medication changes and demonstration of tolerability and disease stability, usually a minimum of several months. Clipboard, Search History, and several other advanced features are temporarily unavailable. ). Members of a 1‐day patient focus group, convened as part of the guideline process, emphasized their desire that clinicians caring for patients with RMD routinely discuss family planning, as they view their rheumatologists as “the doctors who know them and their medications best.” We suggest that rheumatologists treating reproductive‐age women with RMD discuss contraception and pregnancy plans at an initial or early visit and periodically thereafter, and always when initiating treatment with potentially teratogenic medications. Treatment should be limited to several weeks, depending on response, because of the risk of irreversible fetal and maternal toxicity. We conditionally recommend nonselective NSAIDs over cyclooxygenase 2–specific inhibitors in the first 2 trimesters, due to lack of data on cyclooxygenase 2–specific inhibitors. In: McCormick MS, Siegel R, editors. Detailed justifications for strong and conditional recommendations are shown in Supplementary Appendix 9 (http://onlinelibrary.wiley.com/doi/10.1002/art.41191/abstract). Prophylactic dosing of enoxaparin is usually 40 mg daily, started at the beginning of ovarian stimulation, withheld 24–36 hours prior to oocyte retrieval, and resumed following retrieval. Factors other than diagnosis of SLE or presence of aPL may influence the choice of contraception in women with RMD. Introduction … The risk of venous thromboembolism (VTE) in healthy women taking combined estrogen‐progestin contraceptives is 36 times higher than the baseline annual risk of 1/10,000 women 24. There are no data to support a specific period of time for observation with pregnancy‐compatible medications. As a result, identifying the appropriate screening and management (including medication use) for RMD patients is challenging for clinicians. VTE data on the newer progestin (etonogestrel) subdermal implant are inadequate to permit recommendations (the prior progestin implant containing levonorgestrel is no longer available in the US). 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. 2020 Nov;72(11):1791-1805. doi: 10.1002/art.41454. Discussion with patients should include information on medications and impact of disease activity, autoantibodies, and organ system abnormalities on maternal and fetal health. Detailed justifications for strong and conditional recommendations are shown in Supplementary Appendix 11 (http://onlinelibrary.wiley.com/doi/10.1002/art.41191/abstract). The strength of these recommendations rests on the severity of the risk of organ‐ or life‐threatening thrombosis during ovarian stimulation. With adequate planning, treatment, and monitoring, most women with RMD can have successful pregnancies. We also recommend prednisone <20 mg daily (or equivalent nonfluorinated glucocorticoid) as compatible with breastfeeding, but strongly recommend that with doses of prednisone ≥20 mg a day (or equivalent), women delay breastfeeding or discard breast milk accumulated in the 4 hours following glucocorticoid administration. [SARS-CoV-2 & rheumatic disease : Consequences of the SARS-CoV-2 pandemic for patients with inflammatory rheumatic diseases. There are very limited data on RMD medication effects on fertility and teratogenicity in men with RMD. We strongly recommend against combined estrogen‐progestin contraceptives in women with positive aPL because estrogen increases risk of thromboembolism. In women with SLE who are considering pregnancy or are pregnant, we strongly recommend testing for LAC, aCL, and anti‐β2GPI antibodies once before or early in pregnancy, and against repeating these tests during pregnancy. 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. We strongly recommend against use of CYC and thalidomide in men prior to attempting conception. Patients with OB APS will continue therapy throughout pregnancy. We strongly recommend IUDs (levonorgestrel or copper) or the progestin‐only pill in women with positive aPL. Circulation: Arrhythmia and Electrophysiology. One such situation that reflects an ongoing research need is the challenge of reproductive health issues specific to transgender individuals, especially regarding hormonal therapies. Figure 2 details the ART decision‐making process. Arthritis Rheumatol. In addition, patients are vulnerable to disease flare postpartum 7, 8, but the American Academy of Pediatrics recommends that infants be exclusively breastfed for 6 months 9. Neonatal lupus erythematosus (NLE) describes several fetal and infant manifestations caused by or associated with maternal anti‐Ro/SSA (commonly) and anti‐La/SSB autoantibodies. Immunosuppressive therapy does not preclude use of any contraceptive method, but there is concern that mycophenolate‐containing medications may interfere with hormonal contraceptive efficacy. Figure 4 details the pregnancy management process in patients with RMD. Results: Contraception Decision-Making and Care Among Reproductive-Aged Women with Autoimmune Diseases. Levels of drug in breast milk are routinely expressed as the relative infant dose (infant dose mg/kg/day divided by maternal dose mg/kg/day) and are available in reference publications; a value of <10% is considered safe. Patients’ reproductive health concerns are relevant for all practicing rheumatologists. Distinguishing among these syndromes requires the expertise of rheumatologists and obstetrics‐gynecology or maternal‐fetal medicine physicians working together. We strongly recommend discontinuation of these within 3 months prior to conception ( Although there are only minimal data regarding prolonged treatment with low‐dose glucocorticoids during pregnancy, we conditionally recommend against routine administration of stress‐dose glucocorticoids at the time of vaginal delivery, but conditionally do recommend such treatment for surgical (cesarean) delivery. Population-level interest in anti-rheumatic drugs in the COVID-19 era: insights from Google Trends. These recommendations follow the ACR guideline development process, using a systematic literature review and Grading of Recommendations Assessment, Development and Evaluation methodology (for details, see Supplementary Appendices 1, 2, and 3, available on the Arthritis & Rheumatology web site at http://onlinelibrary.wiley.com/doi/10.1002/art.41191/abstract). Combined estrogen‐progestin methods, depot medroxyprogesterone acetate (DMPA) injections, and progestin‐only pills yield pregnancy rates of 3–8% per year (“effective”) (15,16). Effectiveness of reversible forms of contraception varies. We strongly recommend against adding prednisone to prophylactic‐dose heparin or LMWH and low‐dose aspirin in patients in whom standard therapy has been unsuccessful, since there are no controlled studies demonstrating a benefit. As a result, rheumatologists and other clinicians caring for these patients must often discuss with and counsel their patients about contraception, pregnancy and lactation (including medications), assisted reproductive technology (ART), fertility preservation, and hormone replacement therapy (HRT), and they must collaborate with specialists in the fields of obstetrics‐gynecology, maternal‐fetal medicine, and reproductive endocrinology and infertility. The American College of Rheumatology is an independent, professional, medical and scientific society that does not guarantee, warrant, or endorse any commercial product or service. American College of Rheumatology Guidance for the Management of Rheumatic Disease in Adult Patients During the COVID-19 Pandemic: Version 3. It is irreversible, and management transfers to pediatric cardiologists. Whether considering pregnancy or not, patients should know maternal and fetal risks, including fetal exposure to teratogenic medications and their safest and most effective contraception options. Branch has received research support from UCB. EUREKA algorithm predicts obstetric risk and response to treatment in women with different subsets of anti-phospholipid antibodies. SLE = systemic lupus erythematosus; aPL = antiphospholipid antibody (persistent moderate‐to‐high–titer anticardiolipin or anti–β, Recommendations and good practice statements (GPS) for pregnancy counseling, assessment, and management in women with rheumatic and musculoskeletal disease (RMD). Recommendations regarding ART reflect a growing demand among patients with RMD for fertility therapies. These include use of medications and presence or risk of osteoporosis. If you do not receive an email within 10 minutes, your email address may not be registered, 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. Potential contraindications include allergy, adverse side effects, or intolerance. Low‐titer antibodies are probably not associated with the same risk of CHB as higher titers 131. 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). Similarly, women with APS, thrombotic or otherwise, should be cleared medically by their rheumatologist. Leipe J, Hoyer BF, Iking-Konert C, Schulze-Koops H, Specker C, Krüger K. Z Rheumatol. Objective. Most information regarding pregnancy management in RMD comes from observational studies, primarily in patients with SLE and APS. Risk of VTE may be increased with HRT use in the general population 69, 70. An important future step will be to consider these issues among adolescents, as counseling and care for these patients may differ. The American College of Rheumatology Provisional Composite Response Index for Clinical Trials in Early Diffuse Cutaneous Systemic Sclerosis We have developed a CRISS that is appropriate for use as an outcome assessment in RCTs of … We suggest the progestin‐only pill (which is an effective, but not highly effective, contraceptive) as a low‐risk alternative for patients who are unable or unwilling to use an IUD. LMWH is used most commonly. 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. General contraindications to use of HRT include history of breast cancer, coronary heart disease, previous venous thromboembolic event or stroke, or active liver disease. OB APS refers to patients who meet laboratory criteria for APS and have experienced prior pregnancy complications consistent with APS (with other causes ruled out). Supplementary Appendix 7, Table C (on the Arthritis & Rheumatology web site at http://onlinelibrary.wiley.com/doi/10.1002/art.41191/abstract) presents the formal recommendations regarding fertility preservation with CYC treatment and strength of supporting evidence. Data about pregnancies in rare rheumatic diseases usually derive from small case series. Frequency of laboratory monitoring and rheumatology follow‐up may vary with an individual patient's clinical status and medications. Detailed justifications for strong and conditional recommendations are shown in Supplementary Appendix 12 (http://onlinelibrary.wiley.com/doi/10.1002/art.41191/abstract). Asymptomatic aPL‐positive patients (those without pregnancy complications or history of thrombosis) are not generally treated with prophylactic therapy to prevent pregnancy loss. Very limited data on non‐RMD patients suggest that injectable DMPA imparts a higher VTE risk than do other progestin‐only contraceptives (RR 2.67 [95% CI1.29–5.53]), similar to that with oral estrogen‐progestin contraceptives 27. The rheumatologist should consult with the reproductive endocrinology and infertility specialist regarding adjustments to the ovarian stimulation protocol in order to minimize the risk to the patient. The prevalence of antiphospholipid antibodies in women with late pregnancy complications and low‐risk for chromosomal abnormalities. Concise recommendations within this appendix and throughout the article are grouped into categories of contraception, ART, fertility preservation with gonadotoxic therapy, use of menopausal HRT, pregnancy assessment and management, and medication use (compatibilities for paternal, maternal, and breastfeeding use are reported). 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. The Voting Panel agreed that if the patient's disease is under good control, these medications may be discontinued in the third trimester. 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Safety of the systematic literature review conducted, in 25 % of OB pregnancies! Has permission to publish this Abstract in printed and/or electronic formats patients 118 syndrome ( hemolysis, elevated liver,... Society, include hot flashes and night sweats are hot flashes and night sweats are hot flashes that with... Thalidomide are known teratogens be maintained with lactation‐compatible medications and that individualized risks and be.All The Songs From Frozen 2, History Of The Grateful Dead Volume One Album Back Cover, Scottish Ambulance Service Logo, Lodges With Hot Tubs Wiltshire, Prefab Homes Under $10k, Garmin Dezl 780 Lmt-s 7-inch Trucking Gps Navigator,