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Systemic Lupus Erythematosus: HELP
Articles by Marta Mosca
Based on 59 articles published since 2008
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Between 2008 and 2019, M. Mosca wrote the following 59 articles about Lupus Erythematosus, Systemic.
 
+ Citations + Abstracts
Pages: 1 · 2 · 3
1 Guideline 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. 2017

Andreoli, L / Bertsias, G K / Agmon-Levin, N / Brown, S / Cervera, R / Costedoat-Chalumeau, N / Doria, A / Fischer-Betz, R / Forger, F / Moraes-Fontes, M F / Khamashta, M / King, J / Lojacono, A / Marchiori, F / Meroni, P L / Mosca, M / Motta, M / Ostensen, M / Pamfil, C / Raio, L / Schneider, M / Svenungsson, E / Tektonidou, M / Yavuz, S / Boumpas, D / Tincani, A. ·Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy. · Unit of Rheumatology and Clinical Immunology, Spedali Civili, Brescia, Italy. · Department of Rheumatology, Clinical Immunology and Allergy, University of Crete Medical School, Heraklion, Greece. · The Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center, Tel Hashomer, Israel. · The Faculty of Medicine, Tel Aviv University, Israel. · Royal National Hospital For Rheumatic Diseases, Bath, UK. · Department of Autoimmune Diseases, Hospital Clínic, Barcelona, Catalonia, Spain. · AP-HP, Hôpital Cochin, Centre de référence maladies auto-immunes et systémiques rares, Paris, France. · Université Paris Descartes-Sorbonne Paris Cité, Paris, France. · Rheumatology Unit, Department of Medicine, University of Padua, Italy. · Policlinic of Rheumatology, Hiller Research Unit, University Clinic Duesseldorf, Heinrich-Heine-University Duesseldorf, Duesseldorf, Germany. · Department of Rheumatology, Immunology and Allergology, University Hospital of Bern, Bern, Switzerland. · Unidade de Doenças Auto-imunes-Serviço Medicina Interna 7.2, Hospital Curry Cabral/Centro Hospitalar Lisboa Central, NEDAI/SPMI, Lisboa, Portugal. · Lupus Research Unit, The Rayne Institute, St. Thomas Hospital, London, UK. · Department of Rheumatology, Dubai Hospital, Dubai, United Arab Emirates. · EULAR PARE Patient Research Partner, London, UK. · Unit of Obstetrics and Gynaecology, Spedali Civili, Brescia, Italy. · EULAR PARE Patient Research Partner, Rome, Italy. · Department of Clinical Sciences and Community Health, University of Milan, Istituto Auxologico Italiano, Milan, Italy. · Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy. · Neonatology and Neonatal Intensive Care Unit, Spedali Civili, Brescia, Italy. · Norwegian National Advisory Unit on Pregnancy and Rheumatic Diseases, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway. · Department of Rheumatology, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania. · Department of Obstetrics and Gynaecology, University Hospital of Bern, Inselspital, Switzerland. · Rheumatology Unit, Department of Medicine, Solna, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden. · Rheumatology Unit, Joint Academic Rheumatology Programme, 1st Department of Propaedeutic Internal Medicine Athens, National and Kapodistrian University of Athens, Athens, Greece. · Department of Rheumatology, Istanbul Bilim University, Istanbul Florence Nightingale Hospital, Esentepe-Istanbul, Turkey. · 4th Department of Internal Medicine, 'Attikon' University Hospital, Medical School, University of Athens, Athens, Greece. · Joint Academic Rheumatology Program, National and Kapodestrian University of Athens, Athens, Greece. ·Ann Rheum Dis · Pubmed #27457513.

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.

2 Guideline Treat-to-target in systemic lupus erythematosus: recommendations from an international task force. 2014

van Vollenhoven, Ronald F / Mosca, Marta / Bertsias, George / Isenberg, David / Kuhn, Annegret / Lerstrøm, Kirsten / Aringer, Martin / Bootsma, Hendrika / Boumpas, Dimitrios / Bruce, Ian N / Cervera, Ricard / Clarke, Ann / Costedoat-Chalumeau, Nathalie / Czirják, László / Derksen, Ronald / Dörner, Thomas / Gordon, Caroline / Graninger, Winfried / Houssiau, Frédéric / Inanc, Murat / Jacobsen, Søren / Jayne, David / Jedryka-Goral, Anna / Levitsky, Adrian / Levy, Roger / Mariette, Xavier / Morand, Eric / Navarra, Sandra / Neumann, Irmgard / Rahman, Anisur / Rovensky, Jozef / Smolen, Josef / Vasconcelos, Carlos / Voskuyl, Alexandre / Voss, Anne / Zakharova, Helena / Zoma, Asad / Schneider, Matthias. ·Department of Medicine, Unit for Clinical Therapy Research, Inflammatory Diseases, Stockholm, Sweden, Karolinska Institutet, , Stockholm, Sweden. ·Ann Rheum Dis · Pubmed #24739325.

ABSTRACT: The principle of treating-to-target has been successfully applied to many diseases outside rheumatology and more recently to rheumatoid arthritis. Identifying appropriate therapeutic targets and pursuing these systematically has led to improved care for patients with these diseases and useful guidance for healthcare providers and administrators. Thus, an initiative to evaluate possible therapeutic targets and develop treat-to-target guidance was believed to be highly appropriate in the management of systemic lupus erythematosus (SLE) patients as well. Specialists in rheumatology, nephrology, dermatology, internal medicine and clinical immunology, and a patient representative, contributed to this initiative. The majority convened on three occasions in 2012-2013. Twelve topics of critical importance were identified and a systematic literature review was performed. The results were condensed and reformulated as recommendations, discussed, modified and voted upon. The finalised bullet points were analysed for degree of agreement among the task force. The Oxford Centre level of evidence (LoE, corresponding to the research questions) and grade of recommendation (GoR) were determined for each recommendation. The 12 systematic literature searches and their summaries led to 11 recommendations. Prominent features of these recommendations are targeting remission, preventing damage and improving quality of life. LoE and GoR of the recommendations were variable but agreement was >0.9 in each case. An extensive research agenda was identified, and four overarching principles were also agreed upon. Treat-to-target-in-SLE (T2T/SLE) recommendations were developed by a large task force of multispecialty experts and a patient representative. It is anticipated that 'treating-to-target' can and will be applicable to the care of patients with SLE.

3 Guideline European League Against Rheumatism recommendations for monitoring patients with systemic lupus erythematosus in clinical practice and in observational studies. 2010

Mosca, M / Tani, C / Aringer, M / Bombardieri, S / Boumpas, D / Brey, R / Cervera, R / Doria, A / Jayne, D / Khamashta, M A / Kuhn, A / Gordon, C / Petri, M / Rekvig, O P / Schneider, M / Sherer, Y / Shoenfeld, Y / Smolen, J S / Talarico, R / Tincani, A / van Vollenhoven, R F / Ward, M M / Werth, V P / Carmona, L. ·Correspondence to Dr Marta Mosca, University of Pisa, via Roma 67, Ospedale S. Chiara, Pisa, 56126, Italy. marta.mosca@int.med.unipi.it ·Ann Rheum Dis · Pubmed #19892750.

ABSTRACT: OBJECTIVES: To develop recommendations for monitoring patients with systemic lupus erythematosus (SLE) in clinical practice and observational studies and to develop a standardised core set of variables to monitor SLE. METHODS: We followed the European League Against Rheumatism (EULAR) standardised procedures for guideline development. The following techniques were applied: nominal groups, Delphi surveys for prioritisation, small group discussion, systematic literature review and two Delphi rounds to obtain agreement. The panel included rheumatologists, internists, dermatologists, a nephrologist and an expert related to national research agencies. The level of evidence and grading of recommendations were determined according to the Levels of Evidence and Grades of Recommendations of the Oxford Centre for Evidence-Based Medicine. RESULTS: A total of 10 recommendations have been developed, covering the following aspects: patient assessment, cardiovascular risk factors, other risk factors (osteoporosis, cancer), infection risk (screening, vaccination, monitoring), frequency of assessments, laboratory tests, mucocutaneous involvement, kidney monitoring, neuropsychological manifestations and ophthalmology assessment. A 'core set' of minimal variables for the assessment and monitoring of patients with SLE in clinical practice was developed that included some of the recommendations. In addition to the recommendations, indications for specific organ assessments that were viewed as part of good clinical practice were discussed and included in the flow chart. CONCLUSIONS: A set of recommendations for monitoring patients with SLE in routine clinical practice has been developed. The use of a standardised core set to monitor patients with SLE should facilitate clinical practice, as well as the quality control of care for patients with SLE, and the collection and comparison of data in observational studies.

4 Review Imaging of joints in systemic lupus erythematosus. 2018

Tani, Chiara / Carli, Linda / Stagnaro, Chiara / Elefante, Elena / Signorini, Viola / Balestri, Francesca / Delle Sedie, Andrea / Mosca, Marta. ·Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Italy. chiara.tani@for.unipi.it. · Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Italy. ·Clin Exp Rheumatol · Pubmed #30296972.

ABSTRACT: Musculoskeletal symptoms are among the most common manifestations in patients with systemic lupus erythematosus (SLE), being reported in up to 95% of patients; joint and tendon involvement can range from arthralgia to severe deforming arthropathy; while myositis a rare manifestation, comorbid fibromyalgia is reported in up to 40% of SLE patients. All these manifestations have a significant impact on the patients' quality of life, possibly leading to disability and functional impairment in daily living activities. In recent years, thanks to the availability of new imaging techniques for the assessment of tendon and joint pathologies, the approach to the definition and characterisation of these manifestations in SLE is constantly evolving. In this review we will therefore illustrate the state of the art of imaging techniques in the assessment of joint involvement in SLE, focusing on ultrasounds (US) and magnetic resonance (MRI), discussing their advantages, drawbacks and possible future developments. The main findings that emerge from the recent literature is that imaging studies may allow a more accurate definition of disease subtypes revealing an unexpected higher prevalence of joint and tendon involvement with respect to what known by clinical evaluation and standard radiography. Indeed, US and MRI also made possible the identification of joints and tendons pathologies in patients with no or very mild clinical symptoms. On the other hand, the interpretation of some findings remains uncertain, as well as the validity and feasibility of this analysis in clinical practice. Thus, further studies should clarify the clinical meaning of subclinical abnormalities detected in US and MRI scans and their impact on the long-term outcomes.

5 Review Developing and Refining New Candidate Criteria for Systemic Lupus Erythematosus Classification: An International Collaboration. 2018

Tedeschi, Sara K / Johnson, Sindhu R / Boumpas, Dimitrios / Daikh, David / Dörner, Thomas / Jayne, David / Kamen, Diane / Lerstrøm, Kirsten / Mosca, Marta / Ramsey-Goldman, Rosalind / Sinnette, Corine / Wofsy, David / Smolen, Josef S / Naden, Raymond P / Aringer, Martin / Costenbader, Karen H. ·Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts. · Toronto Western Hospital and University of Toronto, Toronto, Ontario, Canada. · University of Crete, Heraklion, Greece. · University of California at San Francisco and VA Medical Center, San Francisco. · Charite University Hospitals, Berlin, Germany. · University of Cambridge, Cambridge, UK. · Medical University of South Carolina, Charleston. · LUPUS EUROPE, Farum, Denmark. · University of Pisa, Pisa, Italy. · Northwestern University, Chicago, Illinois. · University of California at San Francisco. · Medical University of Vienna, Vienna Austria. · McMaster University, Hamilton, Ontario, Canada. · University Medical Center Carl Gustav Carus, Technical University of Dresden, Dresden, Germany. ·Arthritis Care Res (Hoboken) · Pubmed #28692774.

ABSTRACT: OBJECTIVE: To define candidate criteria within multiphase development of systemic lupus erythematosus (SLE) classification criteria, jointly supported by the American College of Rheumatology and the European League Against Rheumatism. Prior steps included item generation and reduction by Delphi exercise, further narrowed to 21 items in a nominal group technique exercise. Our objectives were to apply an evidence-based approach to the 21 candidate criteria, and to develop hierarchical organization of criteria within domains. METHODS: A literature review identified the sensitivity and specificity of the 21 candidate criteria. Data on the performance of antinuclear antibody (ANA) as an entry criterion and operating characteristics of the candidate criteria in early SLE patients were evaluated. Candidate criteria were hierarchically organized into clinical and immunologic domains, and definitions were refined in an iterative process. RESULTS: Based on the data, consensus was reached to use a positive ANA of ≥1:80 titer (HEp-2 cells immunofluorescence) as an entry criterion and to have 7 clinical and 3 immunologic domains, with hierarchical organization of criteria within domains. Definitions of the candidate criteria were specified. CONCLUSION: Using a data-driven process, consensus was reached on new, refined criteria definitions and organization based on operating characteristics. This work will be followed by a multicriteria decision analysis exercise to weight criteria and to identify a threshold score for classification on a continuous probability scale.

6 Review Treat to target, remission and low disease activity in SLE. 2017

Morand, Eric F / Mosca, Marta. ·Centre for Inflammatory Diseases, Monash University School of Clinical Sciences, Monash Medical Centre, Melbourne, Australia. Electronic address: eric.morand@monash.edu. · Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy. ·Best Pract Res Clin Rheumatol · Pubmed #29224676.

ABSTRACT: Despite improvements in survival, outcomes of contemporary treatment of systemic lupus erythematosus (SLE) are unacceptable. Unlike in many diseases, treat-to-target (T2T) approaches have not been adopted in SLE, owing to a lack of validated targets to treat towards. Therefore, it is a key goal to validate target state definitions such as low disease activity and remission, and test their implementation in clinical practice and clinical trials. In this article, we review recent advances in T2T approaches in SLE, and emerging evidence-based consensus on definitions of remission and low disease activity that are needed to underpin such approaches. We conclude that, while more work is needed, much has been achieved and at least for low disease activity the lupus low disease activity state definition appears to have utility and validity for the study of SLE. Application to routine clinical care awaits validation of improved outcomes from T2T studies based on these targets.

7 Review Pregnancy and menopause in patients with systemic lupus erythematosus and/or antiphospholipid syndrome. Practical messages from the EULAR guidelines. 2017

Vagelli, Roberta / Tani, Chiara / Mosca, Marta. · ·Pol Arch Intern Med · Pubmed #28120818.

ABSTRACT: Over the last few decades, reproductive medicine has observed an improvement in the management and outcome of pregnancy in connective tissue diseases, such as systemic lupus erythematosus (SLE) and antiphospholipid syndrome (APS). However, pregnancy and related issues remain a challenge in these patients. In routine clinical practice, health professionals dealing with SLE and APS need to consider the numerous aspects of the reproductive life of their patients, such as pregnancy, family planning, fertility, contraception, cancer surveillance, and menopause. The new European League Against Rheumatism recommendations for women's health and family planning reflect the need for a novel approach to communication in the patient-physician relationship. Preconception counseling is essential to ensure optimal pregnancy outcomes through a careful risk stratification involving disease activity, organ involvement, autoantibody profile, use of drugs, and previous pregnancy outcomes, as well as to ensure better preventive and therapeutic strategies to limit complications. In patients with stable/inactive disease and low risk of thrombosis, adequate hormonal contraception and menopausal replacement therapy should be recommended. Assisted reproductive techniques can be safely used in these patients, but anticoagulation or low-dose aspirin (or both) should be added in those with positive antiphospholipid antibody titers. All menstruating women should be counseled on the possibility to preserve fertility with gonadotropin- ‑releasing hormone analogues if receiving alkylating agents. Strict clinical, serological, laboratory, and multidisciplinary monitoring during pregnancy is mandatory to early recognize and effectively treat disease flares or obstetric complications. Doppler ultrasonography and fetal biometry should be regularly performed, especially in the second and third trimesters. Physicians should recommend screening for cervical dysplasia related to human papillomavirus (HPV) infection, especially during immunosuppressive therapy, and HPV immunization can be used in women with stable/inactive disease.

8 Review A framework for remission in SLE: consensus findings from a large international task force on definitions of remission in SLE (DORIS). 2017

van Vollenhoven, Ronald / Voskuyl, Alexandre / Bertsias, George / Aranow, Cynthia / Aringer, Martin / Arnaud, Laurent / Askanase, Anca / Balážová, Petra / Bonfa, Eloisa / Bootsma, Hendrika / Boumpas, Dimitrios / Bruce, Ian / Cervera, Ricard / Clarke, Ann / Coney, Cindy / Costedoat-Chalumeau, Nathalie / Czirják, László / Derksen, Ronald / Doria, Andrea / Dörner, Thomas / Fischer-Betz, Rebecca / Fritsch-Stork, Ruth / Gordon, Caroline / Graninger, Winfried / Györi, Noémi / Houssiau, Frédéric / Isenberg, David / Jacobsen, Soren / Jayne, David / Kuhn, Annegret / Le Guern, Veronique / Lerstrøm, Kirsten / Levy, Roger / Machado-Ribeiro, Francinne / Mariette, Xavier / Missaykeh, Jamil / Morand, Eric / Mosca, Marta / Inanc, Murat / Navarra, Sandra / Neumann, Irmgard / Olesinska, Marzena / Petri, Michelle / Rahman, Anisur / Rekvig, Ole Petter / Rovensky, Jozef / Shoenfeld, Yehuda / Smolen, Josef / Tincani, Angela / Urowitz, Murray / van Leeuw, Bernadette / Vasconcelos, Carlos / Voss, Anne / Werth, Victoria P / Zakharova, Helena / Zoma, Asad / Schneider, Matthias / Ward, Michael. ·Department of Medicine, Unit for Clinical Therapy Research, Inflammatory Diseases (ClinTRID), Karolinska Institutet, D1:00 Karolinska University Hospital, Solna, Stockholm, Sweden. · Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam, The Netherlands. · Department of Rheumatology, Clinical Immunology and Allergy, University of Crete School of Medicine, Iraklion, Greece. · Feinstein Institute for Medical Research, Manhasset, New York, USA. · Department of Medicine III, University Medical Center TU Dresden, Dresden, Germany. · New York University, New York, USA. · LPRe SR-Klub Motýlik, Bratislava, Slovakia. · Rheumatology Division, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil. · Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands. · Department of Medicine and Joint Academic Rheumatology Program Medical School, National and Kapodestrian University of Athens, Athens, Greece. · NIHR Manchester Biomedical Research Unit, The University of Manchester and Central Manchester Foundation Trust, Manchester, UK. · Department of Autoimmune Diseases, Hospital Clinic, Barcelona, Catalonia, Spain. · Division of Rheumatology, The Arthritis Society Chair in Rheumatic Diseases Cumming School of Medicine University of Calgary, Calgary, Alberta, Canada. · Lupus Foundation of America, Washington DC, USA. · Université Paris-Decartes, Paris, France. · AP-HP, Hôpital Cochin, service de médecine interne, centre de reference maladies auto-immunes et systémiques rares, Paris, France. · Department of Rheumatology and Immunology, Institute of Bioanalysis, Institute of Family Medicine, University of Pécs, Pécs, Hungary. · Third Department of Internal Medicine, Semmelweis University, Budapest, Hungary. · Department Rheumatology and Clinical Immunology, University Medical Center, Utrecht, The Netherlands. · Rheumatology Unit, Department of Medicine, University of Padova, Padova, Italy. · Department Medicine/Rheumatology and Clinical Immunology, Charite Universitätsmedizin Berlin, Berlin, Germany. · Polyclinic of Rheumatology, Hiller Research Unit, University Clinic Duesseldorf, Heinrich-Heine-University, Duesseldorf, Germany. · Rheumatology Research Group, Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK. · Division of Rheumatology, Medical University of Graz, Graz, Austria. · Service de Rhumatologie, Cliniques universitaires Saint-Luc, Pôle de pathologies rhumatismales inflammatoires et systémiques, Institut de Recherche Expérimentale et Clinique, Université catholique de Louvain, Bruxelles, Belgium. · Department of Medicine, The Centre for Rheumatology, University College London, UK. · Copenhagen Lupus and Vasculitis Clinic, Center for Rheumatology and Spine Diseases, Copenhagen, Denmark. · Department of Medicine, University of Cambridge, Cambridge, UK. · Interdisciplinary Center for Clinical Trials (IZKS), University Medical Center Mainz, Mainz, Germany. · LUPUS EUROPE, co-opted trustee for research, Essex UK. · Rheumatology Department, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil. · Université Paris-Sud; Assistance Publique-Hôpitaux de Paris, Hôpitaux Universitaires Paris-sud; INSERM U1184, Le Kremlin Bicêtre, France. · Bone Densitometry Unit, Monla Hospital, Tripoli, Lebanon. · Monash University, Faculty of Medicine, Nursing & Health Sciences, Monash Medical Centre, Clayton, Australia. · Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy. · Department of Internal Medicine, Division of Rheumatology, Istanbul University, Istanbul Medical Faculty, Istanbul, Turkey. · University of Santo Tomas, Manila, Philippines. · Vasculitis.at, Vienna, Austria. · Department of Connective Tissues Diseases, National Institute of Geriatrics, Rheumatology and Rehabilitation, Warsaw, Poland. · Johns Hopkins University School of Medicine, Baltimore, Maryland, USA. · RNA and Molecular Pathology Research Group, Institute of Medical Biology, Health Science Faculty, University of Tromsø, Tromsø, Norway. · National Institute for Rheumatic Diseases, Piešťany, Slovak Republic. · Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center (Affiliated to Tel-Aviv University), Tel-Aviv, Israel. · Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria. · 2nd Department of Medicine, Hietzing Hospital, Vienna, Austria. · Dipartimento di Scienze Cliniche e Sperimentali, Università degli Studi di Brescia, U.O. Reumatologia e Immunolgia Clinica, Spedali Civili di Brescia, Brescia, Italy. · Centre for Prognosis Studies in the Rheumatic Diseases, Senior Scientist Krembil Research Institute, Professor Medicine, University of Toronto, Toronto Western Hospital EW 1-409, Toronto, Canada. · Unidade de Imunologia Clínica, Hospital Santo António, Centro Hospitalar do Porto, UMIB, Instituto de Ciencias Biomédicas Abel Salazar, Universidade do Porto, Porto, Portugal. · Department of Rheumatology, Odense University Hospital, University of Southern Denmark, Denmark. · Corporal Michael J. Crescenz VA Medical Center (Philadelphia), Philadelphia, Philadelphia, USA. · Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA. · Nephrology Unit, City Clinical Hospital n.a. S.P. Botkin, Moscow, Russia. · Lanarkshire Centre for Rheumatology, Hairmyres Hospital, Scotland, UK. · National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda, Maryland, USA. ·Ann Rheum Dis · Pubmed #27884822.

ABSTRACT: OBJECTIVES: Treat-to-target recommendations have identified 'remission' as a target in systemic lupus erythematosus (SLE), but recognise that there is no universally accepted definition for this. Therefore, we initiated a process to achieve consensus on potential definitions for remission in SLE. METHODS: An international task force of 60 specialists and patient representatives participated in preparatory exercises, a face-to-face meeting and follow-up electronic voting. The level for agreement was set at 90%. RESULTS: The task force agreed on eight key statements regarding remission in SLE and three principles to guide the further development of remission definitions:1. Definitions of remission will be worded as follows: CONCLUSIONS: The work of this international task force provides a framework for testing different definitions of remission against long-term outcomes.

9 Review Health information technologies in systemic lupus erythematosus: focus on patient assessment. 2016

Tani, Chiara / Trieste, Leopoldo / Lorenzoni, Valentina / Cannizzo, Sara / Turchetti, Giuseppe / Mosca, Marta. ·Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Italy. · Institute of Management, Scuola Superiore Sant'Anna, Pisa, Italy. · Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Italy. marta.mosca@med.unipi.it. ·Clin Exp Rheumatol · Pubmed #27762204.

ABSTRACT: Recent advances in health information technologies (HIT) in systemic lupus erythematosus have included electronic databases and registries, computerised clinical charts for patient monitoring, computerised diagnostic tools, computerised prediction rules and, more recently, disease-specific applications for mobile devices for physicians, health care professionals, and patients. Traditionally, HIT development has been oriented primarily to physicians and public administrators. However, more recent development of patient-centered Apps could improve communication and empower patients in the daily management of their disease. Economic advantages could also result from the use of HIT, including these Apps by collecting real life data that could be used in both economic analyses and to improve patient care.

10 Review Leukopenia, lymphopenia, and neutropenia in systemic lupus erythematosus: Prevalence and clinical impact--A systematic literature review. 2015

Carli, Linda / Tani, Chiara / Vagnani, Sabrina / Signorini, Viola / Mosca, Marta. ·Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Via Roma 67, Pisa 56100, Italy; GenOMeC PhD, University of Siena, Italy. · Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Via Roma 67, Pisa 56100, Italy. · Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Via Roma 67, Pisa 56100, Italy. Electronic address: marta.mosca@med.unipi.it. ·Semin Arthritis Rheum · Pubmed #26170228.

ABSTRACT: OBJECTIVE: To systematically review the available evidence to evaluate (1) the prevalence and degree of leukopenia, lymphopenia, and neutropenia in patients with systemic lupus erythematosus (SLE), (2) whether these conditions carry a major infection risk for patients, and (3) whether a treatment with colony stimulating factors (CSF) can be an effective and safe option in SLE patients with leukopenia. MATERIAL AND METHODS: MedLine and Embase were searched by including MeSH terms, text words, and subheadings "systemic lupus erythematosus," "leukopenia" (first search), and "colony stimulating factor" (second search). Inclusion and exclusion criteria were a priori defined and two reviewers screened the retrieved articles for selection criteria; data from the included studies were recorded in ad hoc standard forms; the results were synthesized and transported to evidence tables. RESULTS: A total of 17 articles were included in the systematic literature review: nine articles were retrieved for the first research question and 11 for the second while no articles satisfied the inclusion criteria for the third research question. The prevalence of leukopenia is reported in 22-41.8% of cases and lymphopenia is reported cumulatively from 15% to 82% of the patients while neutropenia is described in 20-40% of the patients. There is no evidence of a significant association between overall reduction of white blood cells and infection occurrence while some studies found a strong association between low lymphocytes/neutrophils count and the risk of major infections. Only case reports and case series have been found to investigate the safety of CSF in SLE patients. CONCLUSIONS: The results of this systematic literature review are inconclusive for many aspects related to the original research questions and highlight the need for further studies. Indeed, the strength of the evidence is not sufficiently robust to draw specific recommendations on how to balance between the need to treat the patient with SLE with immunosuppressive drugs and the risk of severe infections.

11 Review Development and validation of a new algorithm for attribution of neuropsychiatric events in systemic lupus erythematosus. 2015

Bortoluzzi, Alessandra / Scirè, Carlo Alberto / Bombardieri, Stefano / Caniatti, Luisa / Conti, Fabrizio / De Vita, Salvatore / Doria, Andrea / Ferraccioli, Gianfranco / Gremese, Elisa / Mansutti, Elisa / Mathieu, Alessandro / Mosca, Marta / Padovan, Melissa / Piga, Matteo / Tincani, Angela / Tola, Maria Rosaria / Tomietto, Paola / Valesini, Guido / Zen, Margherita / Govoni, Marcello / Anonymous920810. ·Department of Medical Science, Section of Hematology and Rheumatology, University of Ferrara and Azienda Ospedaliero Universitaria Sant'Anna di Cona, Ferrara, Epidemiology Unit, Italian Society of Rheumatology, Milan, Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Department of Neuroscience, S. Anna Hospital, Cona, Ferrara, Department of Internal Medicine and Medical Specialties, Sapienza University of Rome, Rome, Rheumatology Clinic, Azienda Ospedaliero Universitaria 'S. Maria della Misericordia' and DSMB, Department of Medical and Biological Sciences, University of Udine, Udine, Department of Clinical and Experimental Medicine, Division of Rheumatology, University of Padova, Padova, Division of Rheumatology and Internal Medicine, Institute of Rheumatology and Affine Sciences, CIC, Catholic University of the Sacred Heart, Rome, Rheumatology Unit, Department of Medical Sciences, University of Cagliari and AOU University Clinic, Cagliari, Rheumatology and Clinical Immunology Unit, Spedali Civili and University of Brescia, Brescia and Internal Medicine, AOU 'Ospedali Riuniti' of Trieste, Trieste, Italy brtlsn1@unife.it. · Department of Medical Science, Section of Hematology and Rheumatology, University of Ferrara and Azienda Ospedaliero Universitaria Sant'Anna di Cona, Ferrara, Epidemiology Unit, Italian Society of Rheumatology, Milan, Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Department of Neuroscience, S. Anna Hospital, Cona, Ferrara, Department of Internal Medicine and Medical Specialties, Sapienza University of Rome, Rome, Rheumatology Clinic, Azienda Ospedaliero Universitaria 'S. Maria della Misericordia' and DSMB, Department of Medical and Biological Sciences, University of Udine, Udine, Department of Clinical and Experimental Medicine, Division of Rheumatology, University of Padova, Padova, Division of Rheumatology and Internal Medicine, Institute of Rheumatology and Affine Sciences, CIC, Catholic University of the Sacred Heart, Rome, Rheumatology Unit, Department of Medical Sciences, University of Cagliari and AOU University Clinic, Cagliari, Rheumatology and Clinical Immunology Unit, Spedali Civili and University of Brescia, Brescia and Internal Medicine, AOU 'Ospedali Riuniti' of Trieste, Trieste, Italy. ·Rheumatology (Oxford) · Pubmed #25339643.

ABSTRACT: OBJECTIVE: The aim of this study was to develop and validate an algorithm to assist the attribution of neuropsychiatric (NP) events to underlying disease in SLE patients. METHODS: Phase 1 identified and categorized candidate items to be included in the algorithm for the attribution of an NP event to SLE and their relative weights through a literature-informed consensus-driven process. Using a retrospective training cohort of SLE, phase 2 validated items selected in phase 1 and refined weights through a data-driven process, fitting items as independent variables and expert evaluation (clinical judgement) as reference standard in logistic models. Phase 3 consisted of a validation process using an external multicentre retrospective SLE cohort. RESULTS: Phase 1 identified four different items: timing of the NP event, type of event, confounding factors and favouring factors. The training and validating cohorts included 228 and 221 patients, respectively. Each patient experienced at least one NP event characterized using the ACR case definition. In these samples, items selected in phase 1 showed good performance in discriminating patients with NPSLE: the area under the receiver operating characteristic curve using dichotomous outcomes was 0.87 in the training set and 0.82 in the validating set. Relevant cut-offs of the validated score identify events with a positive predictive value of 100% (95% CI 93.2, 100) and 86.3% (95% CI 76.2, 93.2) in the training and validating cohorts, respectively. CONCLUSION: A new algorithm based on a probability score was developed and validated to determine the relationship between NP events and SLE.

12 Review TNF-alpha inhibitors in Systemic Lupus Erythematosus. A case report and a systematic literature review. 2015

Mosca, Marta / Tani, Chiara / Filice, Maria Elena / Carli, Linda / Delle Sedie, Andrea / Vagnani, Sabrina / Della Rossa, Alessandra / Baldini, Chiara / Bombardieri, Stefano. ·Department of Clinical and Experimental Medicine, Rheumatology Unit, University of Pisa , Pisa Italy. ·Mod Rheumatol · Pubmed #24252029.

ABSTRACT: Joint involvement is a common manifestation of systemic lupus erythematosus (SLE) and is described as a non-erosive mild synovitis. However some SLE patients may present a more severe joint involvement requiring aggressive therapy. We describe the case of a SLE patient with a severe arthritis unresponsive to methotrexate, successfully treated with anti-TNF-alpha drug as induction therapy and we report the results of a systematic literature review on the use of TNF-alpha inhibitors in SLE.

13 Review Indices to assess patients with systemic lupus erythematosus in clinical trials, long-term observational studies, and clinical care. 2014

Castrejón, I / Tani, C / Jolly, M / Huang, A / Mosca, M. ·Division of Rheumatology, Rush University School of Medicine, Chicago, USA. isabelcastrejonf@gmail.com. ·Clin Exp Rheumatol · Pubmed #25365095.

ABSTRACT: This review summarises most currently used indices to assess and monitor patients with systemic lupus erythematosus (SLE) in clinical trials, long-term observational studies, and clinical care. Six SLE disease activity indices include the British Isles Lupus Assessment Group Index (BILAG), European Consensus Lupus Activity Measurement (ECLAM), Systemic Lupus Activity Measure (SLAM), Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), Lupus Activity Index (LAI), and Systemic Lupus Erythematosus Activity Questionnaire (SLAQ). Three SLE responder indices include Responder Index for Lupus Erythematosus (RIFLE), SLE Responder Index (SRI), and BILAG Based Combined Lupus Assessment (BICLA). Three SLE damage indices include the Systemic Lupus International Collaborating Clinics/American College of Rheumatology-Damage Index (SLICC/ACE-DI), Lupus Damage Index Questionnaire (LDIQ), and Brief Index of Lupus Damage (BILD). The SLAQ, LDIQ and the BILD are patient self-report questionnaires, which appear to give similar information to physician-completed indices, but are pragmatically more easily completed as patients do almost all the work. Additional self-report indices which have been used to assess and monitor patients with in SLE include a generic general health short form 36 (SF36), a SLE-specific Lupus Patient Reported Outcome (LupusPRO), and a generic rheumatology index, Routine Assessment of Patient Index Data 3 (RAPID3). These activity, response, damage and patient self-report indices have been validated at different levels with no consensus about what it is the most appropriate for every setting. Sensitive and feasible assessment of SLE in clinical trials, observational studies, and busy clinical settings remains a challenge to the rheumatology community.

14 Review Neuropsychiatric questionnaires in systemic lupus erythematosus. 2014

Tani, C / Palagini, L / Moraes-Fontes, M F / Carli, L / Mauri, M / Bombardieri, S / Mosca, M. ·Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy. chiaratani78@gmail.com. ·Clin Exp Rheumatol · Pubmed #25365091.

ABSTRACT: Patients with systemic lupus erythematosus (SLE) can be affected by a multitude of neurologic and psychiatric symptoms with a wide range of prevalence and severity. Irrespectively from attribution to SLE or other causes, neuropsychiatric (NP) symptoms strongly impact short-term and long-term outcomes, thus NP evaluation during routine clinical practice in SLE should be undertaken regularly. The assessment of NP involvement in SLE patients is challenging and the available diagnostic tools fail to guarantee optimal diagnostic accuracy, sensitivity to changes as well as feasibility in routine clinical care. Standardised questionnaires (both physician-administered and self-reported) can offer valuable help to the treating physician to capture all possible NP syndromes; few SLE-specific NP questionnaire have been developed but validation in large cohort or cross-cultural adaptations are still pending. On the other hand, general instruments have been largely applied to SLE patients. Both kinds of questionnaires can address all possible NP manifestations either globally or, more frequently, focus on specific NP symptoms. These latter have been mainly used in SLE to detect and classify mild and subtle symptoms, more likely to be overlooked during routine clinical assessment such as headache, cognitive impairment and psychiatric manifestations. In conclusion, this literature review highlights a clear case for validation studies in this area and the wider implementation of questionnaires to assess NP involvement is still warranted. The broader use of such instruments could have important consequences; first of all, by standardising symptom assessment, a better definition of the prevalence of NP manifestation across different centres could be achieved. Secondly, prospective studies could allow for the evaluation of clinical significance of mild symptoms and their impact on the patient's function and quality of life.

15 Review The diagnosis and classification of undifferentiated connective tissue diseases. 2014

Mosca, Marta / Tani, Chiara / Vagnani, Sabrina / Carli, Linda / Bombardieri, Stefano. ·Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Italy. Electronic address: marta.mosca@med.unipi.it. · Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Italy. · Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Italy; Dottorato Genomec, University of Siena, Italy. ·J Autoimmun · Pubmed #24518855.

ABSTRACT: The term undifferentiated connective tissue disease (UCTD) refers to unclassifiable systemic autoimmune diseases which share clinical and serological manifestations with definite connective tissue diseases (CTDs) but not fulfilling any of the existing classification criteria. In this review we will go through the more recent evidence on UCTD and we will discuss in what extent the availability of new criteria for the CTDs could interfere with the "UCTD concept". The development of criteria able to identify early phases of defined CTD, may help in the differentiation of stable UCTD form their early stages and may offer a valuable guide to the treating physician to set up appropriate follow up schedules as well as therapeutic protocols. This simplified subset of CTD could offer a model to study clinic pathological correlations as well as the role of possible environmental factors in the development of autoimmunity.

16 Review The diagnosis and classification of mixed connective tissue disease. 2014

Tani, Chiara / Carli, Linda / Vagnani, Sabrina / Talarico, Rosaria / Baldini, Chiara / Mosca, Marta / Bombardieri, Stefano. ·Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Italy. · Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Italy; Dottorato Genomec, University of Siena, Italy. · Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Italy. Electronic address: s.bombardieri@med.unipi.it. ·J Autoimmun · Pubmed #24461387.

ABSTRACT: The term "mixed connective tissue disease" (MCTD) concerns a systemic autoimmune disease typified by overlapping features between two or more systemic autoimmune diseases and the presence of antibodies against the U1 small nuclear ribonucleoprotein autoantigen (U1snRNP). Since the first description of this condition in 1972, the understanding of clinical manifestations and long-term outcome of MCTD have significantly advanced. Polyarthritis, Raynaud's phenomenon, puffy fingers, lung involvement and esophageal dysmotility are the most frequently reported symptoms among the different cohorts during the course of the disease. Moreover, in recent years a growing interest has been focused on severe organ involvement such as pulmonary arterial hypertension and interstitial lung disease which can accrue during the long-term follow-up and can still significantly influence disease prognosis. Over the last years, significant advances have been made also in disease pathogenesis understanding and a central pathogenetic role of anti-U1RNP autoantibodies has clearly emerged. Although controversies on disease definition and classification still persist, MCTD identifies a group of patients in whom increased surveillance for specific manifestations and prognostic stratification became mandatory to improve patient's outcomes.

17 Review Sleep disorders and systemic lupus erythematosus. 2014

Palagini, L / Tani, C / Mauri, M / Carli, L / Vagnani, S / Bombardieri, S / Gemignani, A / Mosca, M. ·1Psychiatry Unit, University of Pisa, Pisa, Italy. ·Lupus · Pubmed #24421291.

ABSTRACT: OBJECTIVE: Sleep disturbances are often seen in rheumatic diseases, including systemic lupus erythematosus (SLE). However, the prevalence of sleep disorders in SLE as well as the contributing factors to their occurrence remain poorly understood. The aim of this paper is to review the clinical and psychobiological data on the relationship between sleep disturbances and SLE. METHOD: We performed a systematic search of MEDLINE, EMBASE and PsychINFO, using MeSH headings and keywords for "sleep disorders" and "SLE." RESULTS: Nine studies reporting the relationship between sleep disorders and SLE were found. Prevalence rates of sleep disorders ranged between 55% and 85%; differences in assessment techniques appeared to be a major source of this variability. In the majority of the studies an association between sleep disorders and disease activity, pain and fatigue has been reported. Psychosocial variables, depression, steroid use, and the role that sleep disruption has on pain, inflammation and cytokines, have been hypothesized as possible psychobiological factors. CONCLUSIONS: Sleep disorders appear to occur in more than half of patients with SLE and appear to be associated with disease activity. Pain and fatigue are also related to sleep disorders. Among the hypotheses on the possible mechanisms underlining the association between sleep disorders and SLE, psychosocial/psychological factors, especially depression, were the most frequently reported.

18 Review New drugs in systemic lupus erythematosus: when to start and when to stop. 2013

Mosca, Marta / van Vollenhoven, Ronald. ·Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Italy. marta.mosca@med.unipi.it. ·Clin Exp Rheumatol · Pubmed #24129144.

ABSTRACT: Survival of patients with systemic lupus erythematosus (SLE) has greatly improved compared to earlier decades. However, this improvement appears to have reached a plateau. In addition, damage accrual appears to have an important impact on patient prognosis. In this scenario a number of new drugs targeting different pathways of the immune response are being developed, and some are already available in clinical practice. In clinical practice and in clinical trials, the indications for treating SLE patients with new drugs are active or refractory disease despite standard-of-care treatment. While RCTs are able to document the capacity of new drugs to control the disease in selected patients, many important questions arise from clinical practice and at present are largely unanswered. When should we start a new drug? Should this drug be introduced early, as are anti-TNF drugs in rheumatoid arthritis? Perhaps some drugs should be initiated only after a patient's incomplete response? How many traditional drugs should be used and for how long, before considering a new therapy? Should we stop an effective drug and if yes, when and how? Additional studies and data derived from registries and observational studies will give valuable evidence to answer these questions. In this article, we review indications for the use of new drugs in SLE, and examine existing data on patient outcome after withdrawal, focusing our attention on rituximab and belimumab.

19 Review Withdrawal of therapy in non-renal systemic lupus erythematosus: is this an achievable goal? 2013

Mosca, Marta / Tani, Chiara / Aringer, Martin. ·Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Italy. marta.mosca@med.unipi.it. ·Clin Exp Rheumatol · Pubmed #24129142.

ABSTRACT: Survival of patients with systemic lupus erythematosus (SLE) has greatly improved over the decades. Many reasons for treatment withdrawal may be faced by the physician during the disease course, such as inactivity of disease, damage accrual, risks of long-term side effects, or potential interactions with other drugs required to treat concomitant conditions, as well as patients' preferences. Therefore, analysis of long-term therapy and treatment withdrawal is important. We have examined the available literature concerning withdrawal of therapy, with attention to glucocorticoids, antimalarial drugs and traditional immunosuppressive drugs in SLE patients who did not have renal disease. We expanded our search to address two questions: i) advantages of long-term therapy in SLE (i.e. reduction of flares, reduction of damage accrual, improved survival); and (ii) burden/side effects of therapy in SLE. Studies are needed to: i) define remission in SLE; ii) define the advantages of long-term therapy in non-renal lupus in terms of prevention of flares; iii) clarify the risks related with long-term immunosuppressive therapy; iv) identify the appropriate patient at the appropriate time for withdrawal of corticosteroids or immunosuppressive therapy; and v) define withdrawal/tapering strategies.

20 Review Depression and systemic lupus erythematosus: a systematic review. 2013

Palagini, L / Mosca, M / Tani, C / Gemignani, A / Mauri, M / Bombardieri, S. ·Psychiatry Unit, Department of Neuroscience, University of Pisa, Italy. lpalagini@tiscali.it ·Lupus · Pubmed #23427220.

ABSTRACT: OBJECTIVE: Systemic lupus erythematosus (SLE) is a chronic, relapsing-remitting autoimmune disorder that involves multiple organ systems including the central nervous system. Among the items included in the nomenclature for neuropsychiatric SLE, mood disorders have been identified. The aim of this paper is to review the clinical and psychobiological relationship between depression and SLE. METHOD: We performed a systematic search of MEDLINE, EMBASE, PsychINFO, using MeSH headings and keywords for 'depression' and 'SLE'. RESULTS: Seventeen studies reported depressive disorders, with prevalence rates in the range 17-75%. Three studies reported the most frequent symptoms, which may be represented by fatigue, weakness, somatic disorders and sleep disorders. Suicide ideation was much higher than in the general population. Nine studies analysed the relationship to SLE disease activity. The results of the available literature are contradictory. Psychobiological hypotheses have been considered in 13 studies. Among the psychobiological hypotheses which might underline the plausibility of their relationship, 'psychosocial factors' were the most frequently reported. CONCLUSIONS: Differences in assessment techniques appear to be the main explanation for the variability in findings and important methodological limitations are present in the available literature to definitively point to the prevalence of depression, type of depression and most prevalent symptoms. To date, the relationship between depression and SLE disease activity also appears controversial. Methodological limitations are present in the available literature and it would be necessary to develop evidence-based guidelines to improve the diagnosis of depression in SLE. Identification of SLE-specific biomarkers of depression also has high priority.

21 Review Systemic lupus erythematosus and the economic perspective: a systematic literature review and points to consider. 2012

Turchetti, Giuseppe / Yazdany, Jinoos / Palla, Ilaria / Yelin, Edward / Mosca, Marta. ·Istituto di Management, Scuola Superiore Sant'Anna, Pisa, Italy. g.turchetti@sssup.it ·Clin Exp Rheumatol · Pubmed #23072767.

ABSTRACT: Systemic lupus erythematosus (SLE) is a chronic, disabling, progressive disease, with many associated comorbidities, affecting patients during prime working years resulting in a high economic burden on society, producing high direct, indirect and intangible costs. In this article, our goals are two-fold. First, we review and discuss studies published in the period 2002-2012 concerning costs of SLE and point out gaps in the published literature. Second, we propose further research studies to advance our understanding of the economic perspective in SLE in the current area of new and emerging therapies. The literature evaluating disease costs in SLE remains limited and to date has only included a small number of countries. Despite these limitations, available studies indicate that SLE has significant socio-economic ramifications. Future studies are needed, especially to assess novel biologic therapies which have been made available or currently under investigation for SLE. An interesting approach in these new economic evaluations in SLE may be represented by the selection of the targets of the treatment to include in the cost-effectiveness and cost-utility analyses. Future treat-to-target strategies will likely include evaluation of their pharmacoeconomic implications.

22 Review Systemic lupus erythematosus one disease or many? 2012

Agmon-Levin, N / Mosca, M / Petri, M / Shoenfeld, Y. ·The Zabludowicz Center for Autoimmune Diseases Sheba Medical Center, Tel Hashomer, Israel. ·Autoimmun Rev · Pubmed #22041578.

ABSTRACT: Systemic lupus erythematosus (SLE) characterizes by a variety of clinical manifestations and the presence of a wide profile of autoantibodies. This clinical and serological heterogeneity raised the question: is SLE a single disease with varied phenotypes, or a similar phenotype shared by different diseases with diverse pathogenic mechanisms? Herein we debate the clinical, genetic, hormonal and serological differences typically observed in SLE on the one hand, and the numerous similarities between subtypes of this disease on the other. Leading to the conclusion that SLE may be considered not as a single disease but rather as a single syndrome, which defines by a set of signs, symptoms, or phenomena that occur together and suggest a particular abnormality. Additionally, the accumulated knowledge on gene expression pathways, autoantibodies clusters, hormonal and environmental factors associated with SLE may allow a better classification of this syndrome and updating of SLE criteria. This may further allow targeted biologics and other therapies as well as "personalized medicine" to begin.

23 Review Glucocorticoids in systemic lupus erythematosus. 2011

Mosca, M / Tani, C / Carli, L / Bombardieri, S. ·Department of Internal Medicine, University of Pisa, Italy. marta.mosca@med.unipi.it ·Clin Exp Rheumatol · Pubmed #22018198.

ABSTRACT: Glucocorticoids (GCs) remain the cornerstone of the treatment of systemic lupus erythematosus (SLE), despite advances in immunosuppressive drugs, therapeutic protocols and development of new drugs. GCs rapidly control disease activity in mild as well as in severe disease, although these effects might not be maintained over time. The majority of SLE patients have received GC treatment; in some cohorts up to 80% of patients continue this treatment indefinitely as 'maintenance' therapy, at low doses of less than 7.5 mg/day. The positive effects of GCs are diminished by adverse effects, particularly at high doses. The cumulative dose of GCs clearly is related to adverse effects. Several unresolved issues in GC treatment of SLE include the optimal doses to be used in induction and maintenance, and in particular how high the dose for how long. It remains unclear whether GCs should be continued indefinitely and, if not, when and how this treatment should be discontinued. Both clinical trials and observational data will help to clarify these issues.

24 Review Development of quality indicators to evaluate the monitoring of SLE patients in routine clinical practice. 2011

Mosca, M / Tani, C / Aringer, M / Bombardieri, S / Boumpas, D / Cervera, R / Doria, A / Jayne, D / Khamashta, M A / Kuhn, A / Gordon, C / Petri, M / Schneider, M / Shoenfeld, Y / Smolen, J S / Talarico, R / Tincani, A / Ward, M M / Werth, V P / Carmona, L. ·Rheumatology Unit, Department of Internal Medicine, University of Pisa, Italy. marta.mosca@int.med.unipi.it ·Autoimmun Rev · Pubmed #21224016.

ABSTRACT: The assessment of systemic lupus erythematosus (SLE) patients in routine clinical practice is mainly based on the experience of the treating physician. This carries the risk of unwanted variability. Variability may have an impact on the quality of care offered to SLE patients, thereby affecting outcomes. Recommendations represent systematically developed statements to help practitioners in reducing variability. However, major difficulties arise in the application of recommendations into clinical practice. In this respect, the use of quality indicators may raise the awareness among rheumatologists regarding potential deficiencies in services and improve the quality of health care. The aim of this study was to develop a set of quality indicators (QI) for SLE by translating into QIs the recently developed EULAR Recommendations for monitoring SLE patients in routine clinical practice and observational studies. Eleven QIs have been developed referring to the use of validated activity and damage indices in routine clinical practice, general evaluation of drug toxicity, evaluation of comorbidities, eye evaluation, laboratory assessment, evaluation of the presence of chronic viral infections, documentation of vaccination and of antibody testing at baseline. A disease specific set of quality assessment tools should help physicians deliver high quality of care across populations. Routine updates will be needed.

25 Clinical Trial Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 2 trial. 2018

Wallace, Daniel J / Furie, Richard A / Tanaka, Yoshiya / Kalunian, Kenneth C / Mosca, Marta / Petri, Michelle A / Dörner, Thomas / Cardiel, Mario H / Bruce, Ian N / Gomez, Elisa / Carmack, Tara / DeLozier, Amy M / Janes, Jonathan M / Linnik, Matthew D / de Bono, Stephanie / Silk, Maria E / Hoffman, Robert W. ·Division of Rheumatology, Cedars-Sinai Medical Center, University of California at Los Angeles, Los Angeles, CA, USA. Electronic address: danielwallac@gmail.com. · Division of Rheumatology, Zucker School of Medicine at Hofstra, Northwell, New York, NY, USA. · The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan. · Division of Rheumatology, University of California at San Diego School of Medicine, La Jolla, CA, USA. · Division of Rheumatology, University of Pisa, Pisa, Italy. · Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, USA. · Division of Rheumatology, Charite Universitätsmedizin Berlin, Berlin, Germany. · Centro de Investigación Clínica de Morelia SC, Morelia, México. · Arthritis Research UK Centre for Epidemiology, Faculty of Biology, Medicine and Health, The University of Manchester and NIHR Manchester Biomedical Research Centre, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK. · Eli Lilly and Company, Indianapolis, IN, USA. · Lilly Biotechnology Center, San Diego, CA, USA. ·Lancet · Pubmed #30043749.

ABSTRACT: BACKGROUND: Patients with systemic lupus erythematosus have substantial unmet medical need. Baricitinib is an oral selective Janus kinase (JAK)1 and JAK2 inhibitor that we hypothesised might have therapeutic benefit in patients with systemic lupus erythematosus. METHODS: In this double-blind, multicentre, randomised, placebo-controlled, 24-week phase 2 study, patients were recruited from 78 centres in 11 countries. Eligible patients were aged 18 years or older, had a diagnosis of systemic lupus erythematosus, and had active disease involving skin or joints. We randomly assigned patients (1:1:1) to receive once-daily baricitinib 2 mg, baricitinib 4 mg, or placebo for 24 weeks. The primary endpoint was the proportion of patients achieving resolution of arthritis or rash at week 24, as defined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K). Efficacy and safety analyses included all patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, number NCT02708095. FINDINGS: Between March 24, 2016, and April 27, 2017, 314 patients were randomly assigned to receive placebo (n=105), baricitinib 2 mg (n=105), or baricitinib 4 mg (n=104). At week 24, resolution of SLEDAI-2K arthritis or rash was achieved by 70 (67%) of 104 patients receiving baricitinib 4 mg (odds ratio [OR] vs placebo 1·8, 95% CI 1·0-3·3; p=0·0414) and 61 (58%) of 105 patients receiving baricitinib 2 mg (OR 1·3, 0·7-2·3; p=0·39). Adverse events were reported in 68 (65%) patients in the placebo group, 75 (71%) patients in the baricitinib 2 mg group, and 76 (73%) patients in the baricitinib 4 mg group. Serious adverse events were reported in ten (10%) patients receiving baricitinib 4 mg, 11 (10%) receiving baricitinib 2 mg, and five (5%) receiving placebo; no deaths were reported. Serious infections were reported in six (6%) patients with baricitinib 4 mg, two (2%) with baricitinib 2 mg, and one (1%) with placebo. INTERPRETATION: The baricitinib 4 mg dose, but not the 2 mg dose, significantly improved the signs and symptoms of active systemic lupus erythematosus in patients who were not adequately controlled despite standard of care therapy, with a safety profile consistent with previous studies of baricitinib. This study provides the foundation for future phase 3 trials of JAK1/2 inhibition with baricitinib as a new potential oral therapy for systemic lupus erythematosus. FUNDING: Eli Lilly and Company.

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