Browsing by Author "Costedoat-Chalumeau, N"
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- Antiphospholipid Syndrome: State of the Art on Clinical Practice GuidelinesPublication . Limper, M; Scirè, CA; Talarico, R; Amoura, Z; Avcin, T; Basile, M; Burmester, G; Carli, L; Cervera, R; Costedoat-Chalumeau, N; Doria, A; Dörner, T; Eurico Fonseca, J; Galetti, I; Hachulla, E; Launay, D; Lourenco, F; Macieira, C; Meroni, P; Montecucco, CM; Moraes-Fontes, MF; Mouthon, L; Nalli, C; Ramoni, V; Tektonidou, M; van Laar, JM; Bombardieri, S; Schneider, M; Smith, V; Vieira, A; Cutolo, M; Mosca, M; Tincani, AAntiphospholipid syndrome (APS) is a rare disease characterised by venous and/or arterial thrombosis, pregnancy complications and the presence of specific autoantibodies called antiphospholipid antibodies. This review aims to identify existing clinical practice guidelines (CPG) as part of the ERN ReCONNET project, aimed at evaluating existing CPGs or recommendations in rare and complex diseases. Seventeen papers providing important data were identified; however, the literature search highlighted the scarceness of reliable clinical data to develop CPGs. With no formal clinical guidelines in place, diagnosis and treatment of APS is largely based on consensus and expert opinion. Patients' unmet need refers to the understanding of the disease and its clinical picture and implications, the need of education for patients, family members and healthcare providers, as well as to the development of monitoring pathways involving multiple healthcare providers.
- Effect of Additional Treatments Combined with Conventional Therapies in Pregnant Patients with High-Risk Antiphospholipid Syndrome: A Multicentre StudyPublication . Ruffatti, A; Tonello, M; Hoxha, A; Sciascia, S; Cuadrado, MJ; Latino, JO; Udry, S; Reshetnyak, T; Costedoat-Chalumeau, N; Morel, N; Marozio, L; Tincani, A; Andreoli, L; Haladyj, E; Meroni, PL; Gerosa, M; Alijotas-Reig, J; Tenti, S; Mayer-Pickel, K; Simchen, MJ; Bertero, MT; De Carolis, S; Ramoni, V; Mekinian, A; Grandone, E; Maina, A; Serrano, F; Pengo, V; Khamashta, MAThe effect of additional treatments combined with conventional therapy on pregnancy outcomes was examined in high-risk primary antiphospholipid syndrome (PAPS) patients to identify the most effective treatment strategy. The study's inclusion criteria were (1) positivity to lupus anticoagulant alone or associated with anticardiolipin and/or anti-β2 glycoprotein I antibodies; (2) a history of severe maternal-foetal complications (Group I) or a history of one or more pregnancies refractory to conventional therapy leading to unexplained foetal deaths not associated with severe maternal-foetal complications (Group II). Two different additional treatments were considered: oral-low-dose steroids (10-20 mg prednisone daily) and/or 200 to 400 mg daily doses of hydroxychloroquine and parenteral-intravenous immunoglobulins at 2 g/kg per month and/or plasma exchange. The study's primary outcomes were live birth rates and pregnancy complications. A total of 194 pregnant PAPS patients attending 20 tertiary centres were retrospectively enrolled. Hydroxychloroquine was found to be linked to a significantly higher live birth rate with respect to the other oral treatments in the Group II patients. The high (400 mg) versus low (200 mg) doses of hydroxychloroquine (p = 0.036) and its administration before versus during pregnancy (p = 0.021) were associated with a significantly higher live birth rate. Hydroxychloroquine therapy appeared particularly efficacious in the PAPS patients without previous thrombosis. Parenteral treatments were associated with a significantly higher live birth rate with respect to the oral ones (p = 0.037), particularly in the Group I patients. In conclusion, some additional treatments were found to be safe and efficacious in high-risk PAPS pregnant women.
- 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 SyndromePublication . Andreoli, L; Bertsias, GK; Agmon-Levin, N; Brown, S; Cervera, R; Costedoat-Chalumeau, N; Doria, A; Fischer-Betz, R; Forger, F; Moraes-Fontes, MF; Khamashta, M; King, J; Lojacono, A; Marchiori, F; Meroni, PL; Mosca, M; Motta, M; Ostensen, M; Pamfil, C; Raio, L; Schneider, M; Svenungsson, E; Tektonidou, M; Yavuz, S; Boumpas, D; Tincani, AOBJECTIVES: 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.
- Systemic Lupus Erythematosus: State of the Art on Clinical Practice GuidelinesPublication . Tamirou, F; Arnaud, L; Talarico, R; Scirè, CA; Alexander, T; Amoura, Z; Avcin, T; Bortoluzzi, A; Cervera, R; Conti, F; Cornet, A; Devilliers, H; Doria, A; Frassi, M; Fredi, M; Govoni, M; Houssiau, F; Lladò, A; Macieira, C; Martin, T; Massaro, Laura; Moraes-Fontes, MF; Pamfil, C; Paolino, S; Tani, C; Tas, SW; Tektonidou, M; Tincani, A; Van Vollenhoven, RF; Bombardieri, S; Burmester, G; Eurico, FJ; Galetti, I; Hachulla, E; Mueller-Ladner, U; Schneider, M; Smith, V; Cutolo, M; Mosca, M; Costedoat-Chalumeau, NSystemic lupus erythematosus (SLE) is the paradigm of systemic autoimmune diseases characterised by a wide spectrum of clinical manifestations with an unpredictable relapsing-remitting course. The aim of the present work was to identify current available clinical practice guidelines (CPGs) for SLE, to provide their review and to identify physicians' and patients' unmet needs. Twenty-three original guidelines published between 2004 and 2017 were identified. Many aspects of disease management are covered, including global disease management, lupus nephritis and neuropsychiatric involvement, management of pregnancies, vaccinations and comorbidities monitoring. Unmet needs relate with disease management of some clinical manifestations and adherence to treatment. Many patient's unmet needs have been identified starting with faster diagnosis, need for more therapeutic options, guidelines on lifestyle issues, attention to quality of life and adequate education.
- The Impact of COVID-19 on Rare and Complex Connective Tissue Diseases: the Experience of ERN ReCONNETPublication . Talarico, R; Aguilera, S; Alexander, T; Amoura, Z; Antunes, A; Arnaud, L; Avcin, T; Beretta, L; Bombardieri, S; Burmester, G; Cannizzo, S; Cavagna, L; Chaigne, B; Cornet, A; Costedoat-Chalumeau, N; Doria, A; Ferraris, A; Fischer-Betz, R; Fonseca, J; Frank, C; Gaglioti, A; Galetti, I; Grunert, J; Guimarães, V; Hachulla, E; Houssiau, F; Iaccarino, L; Krieg, T; Limper, M; Malfait, F; Mariette, X; Marinello, D; Martin, T; Matthews, L; Matucci-Cerinic, M; Meyer, A; Montecucco, C; Mouthon, L; Müller-Ladner, U; Rednic, S; Romão, V; Schneider, M; Smith, V; Sulli, A; Tamirou, F; Taruscio, D; Taulaigo, A; Terol, E; Tincani, A; Ticciati, S; Turchetti, G; van Hagen, P; van Laar, J; Vieira, A; de Vries-Bouwstra, J; Cutolo, M; Mosca, MDuring the COVID-19 pandemic, the need to provide high-level care for a large number of patients with COVID-19 has affected resourcing for, and limited the routine care of, all other conditions. The impact of this health emergency is particularly relevant in the rare connective tissue diseases (rCTDs) communities, as discussed in this Perspective article by the multi-stakeholder European Reference Network on Rare and Complex Connective Tissue and Musculoskeletal Diseases (ERN ReCONNET). The clinical, organizational and health economic challenges faced by health-care providers, institutions, patients and their families during the SARS-CoV-2 outbreak have demonstrated the importance of ensuring continuity of care in the management of rCTDs, including adequate diagnostics and monitoring protocols, and highlighted the need for a structured emergency strategy. The vulnerability of patients with rCTDs needs to be taken into account when planning future health policies, in preparation for not only the post-COVID era, but also any possible new health emergencies.