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

Ronald van Vollenhoven^{1

2}, Alexandre Voskuyl², George Bertsias³, Cynthia Aranow⁴, Martin Aringer⁵, Laurent Arnaud¹, Anca Askanase⁶, Petra Balážová⁷, Eloisa Bonfa⁸, Hendrika Bootsma⁹, Dimitrios Boumpas¹⁰, Ian Bruce¹¹, Ricard Cervera¹², Ann Clarke¹³, Cindy Coney¹⁴, Nathalie Costedoat-Chalumeau^{15

16}, László Czirják^{17

18}, Ronald Derksen¹⁹, Andrea Doria²⁰, Thomas Dörner²¹, Rebecca Fischer-Betz²², Ruth Fritsch-Stork¹⁹, Caroline Gordon²³, Winfried Graninger²⁴, Noémi Györi¹, Frédéric Houssiau²⁵, David Isenberg²⁶, Soren Jacobsen²⁷, David Jayne²⁸, Annegret Kuhn²⁹, Veronique Le Guern^{15

16}, Kirsten Lerstrøm³⁰, Roger Levy³¹, Francinne Machado-Ribeiro³¹, Xavier Mariette³², Jamil Missaykeh³³, Eric Morand³⁴, Marta Mosca³⁵, Murat Inanc³⁶, Sandra Navarra³⁷, Irmgard Neumann³⁸, Marzena Olesinska³⁹, Michelle Petri⁴⁰, Anisur Rahman²⁶, Ole Petter Rekvig⁴¹, Jozef Rovensky⁴², Yehuda Shoenfeld⁴³, Josef Smolen^{44

45}, Angela Tincani⁴⁶, Murray Urowitz⁴⁷, Bernadette van Leeuw³⁰, Carlos Vasconcelos⁴⁸, Anne Voss⁴⁹, Victoria P Werth^{50

51}, Helena Zakharova⁵², Asad Zoma⁵³, Matthias Schneider²², Michael Ward⁵⁴

Affiliations

¹ Department of Medicine, Unit for Clinical Therapy Research, Inflammatory Diseases (ClinTRID), Karolinska Institutet, D1:00 Karolinska University Hospital, Solna, Stockholm, Sweden.
² Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam, The Netherlands.
³ Department of Rheumatology, Clinical Immunology and Allergy, University of Crete School of Medicine, Iraklion, Greece.
⁴ Feinstein Institute for Medical Research, Manhasset, New York, USA.
⁵ Department of Medicine III, University Medical Center TU Dresden, Dresden, Germany.
⁶ New York University, New York, USA.
⁷ LPRe SR-Klub Motýlik, Bratislava, Slovakia.
⁸ Rheumatology Division, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.
⁹ Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
¹⁰ Department of Medicine and Joint Academic Rheumatology Program Medical School, National and Kapodestrian University of Athens, Athens, Greece.
¹¹ NIHR Manchester Biomedical Research Unit, The University of Manchester and Central Manchester Foundation Trust, Manchester, UK.
¹² Department of Autoimmune Diseases, Hospital Clinic, Barcelona, Catalonia, Spain.
¹³ Division of Rheumatology, The Arthritis Society Chair in Rheumatic Diseases Cumming School of Medicine University of Calgary, Calgary, Alberta, Canada.
¹⁴ Lupus Foundation of America, Washington DC, USA.
¹⁵ Université Paris-Decartes, Paris, France.
¹⁶ AP-HP, Hôpital Cochin, service de médecine interne, centre de reference maladies auto-immunes et systémiques rares, Paris, France.
¹⁷ Department of Rheumatology and Immunology, Institute of Bioanalysis, Institute of Family Medicine, University of Pécs, Pécs, Hungary.
¹⁸ Third Department of Internal Medicine, Semmelweis University, Budapest, Hungary.
¹⁹ Department Rheumatology and Clinical Immunology, University Medical Center, Utrecht, The Netherlands.
²⁰ Rheumatology Unit, Department of Medicine, University of Padova, Padova, Italy.
²¹ Department Medicine/Rheumatology and Clinical Immunology, Charite Universitätsmedizin Berlin, Berlin, Germany.
²² Polyclinic of Rheumatology, Hiller Research Unit, University Clinic Duesseldorf, Heinrich-Heine-University, Duesseldorf, Germany.
²³ Rheumatology Research Group, Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
²⁴ Division of Rheumatology, Medical University of Graz, Graz, Austria.
²⁵ 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.
²⁶ Department of Medicine, The Centre for Rheumatology, University College London, UK.
²⁷ Copenhagen Lupus and Vasculitis Clinic, Center for Rheumatology and Spine Diseases, Copenhagen, Denmark.
²⁸ Department of Medicine, University of Cambridge, Cambridge, UK.
²⁹ Interdisciplinary Center for Clinical Trials (IZKS), University Medical Center Mainz, Mainz, Germany.
³⁰ LUPUS EUROPE, co-opted trustee for research, Essex UK.
³¹ Rheumatology Department, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil.
³² Université Paris-Sud; Assistance Publique-Hôpitaux de Paris, Hôpitaux Universitaires Paris-sud; INSERM U1184, Le Kremlin Bicêtre, France.
³³ Bone Densitometry Unit, Monla Hospital, Tripoli, Lebanon.
³⁴ Monash University, Faculty of Medicine, Nursing & Health Sciences, Monash Medical Centre, Clayton, Australia.
³⁵ Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
³⁶ Department of Internal Medicine, Division of Rheumatology, Istanbul University, Istanbul Medical Faculty, Istanbul, Turkey.
³⁷ University of Santo Tomas, Manila, Philippines.
³⁸ Vasculitis.at, Vienna, Austria.
³⁹ Department of Connective Tissues Diseases, National Institute of Geriatrics, Rheumatology and Rehabilitation, Warsaw, Poland.
⁴⁰ Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
⁴¹ RNA and Molecular Pathology Research Group, Institute of Medical Biology, Health Science Faculty, University of Tromsø, Tromsø, Norway.
⁴² National Institute for Rheumatic Diseases, Piešťany, Slovak Republic.
⁴³ Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center (Affiliated to Tel-Aviv University), Tel-Aviv, Israel.
⁴⁴ Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria.
⁴⁵ 2nd Department of Medicine, Hietzing Hospital, Vienna, Austria.
⁴⁶ Dipartimento di Scienze Cliniche e Sperimentali, Università degli Studi di Brescia, U.O. Reumatologia e Immunolgia Clinica, Spedali Civili di Brescia, Brescia, Italy.
⁴⁷ 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.
⁴⁸ Unidade de Imunologia Clínica, Hospital Santo António, Centro Hospitalar do Porto, UMIB, Instituto de Ciencias Biomédicas Abel Salazar, Universidade do Porto, Porto, Portugal.
⁴⁹ Department of Rheumatology, Odense University Hospital, University of Southern Denmark, Denmark.
⁵⁰ Corporal Michael J. Crescenz VA Medical Center (Philadelphia), Philadelphia, Philadelphia, USA.
⁵¹ Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA.
⁵² Nephrology Unit, City Clinical Hospital n.a. S.P. Botkin, Moscow, Russia.
⁵³ Lanarkshire Centre for Rheumatology, Hairmyres Hospital, Scotland, UK.
⁵⁴ National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda, Maryland, USA.

PMID: 27884822
DOI: 10.1136/annrheumdis-2016-209519

Free article

Review

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

Ronald van Vollenhoven et al. Ann Rheum Dis. 2017 Mar.

Free article

. 2017 Mar;76(3):554-561.

doi: 10.1136/annrheumdis-2016-209519. Epub 2016 Nov 24.

Authors

Affiliations

¹ Department of Medicine, Unit for Clinical Therapy Research, Inflammatory Diseases (ClinTRID), Karolinska Institutet, D1:00 Karolinska University Hospital, Solna, Stockholm, Sweden.
² Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam, The Netherlands.
³ Department of Rheumatology, Clinical Immunology and Allergy, University of Crete School of Medicine, Iraklion, Greece.
⁴ Feinstein Institute for Medical Research, Manhasset, New York, USA.
⁵ Department of Medicine III, University Medical Center TU Dresden, Dresden, Germany.
⁶ New York University, New York, USA.
⁷ LPRe SR-Klub Motýlik, Bratislava, Slovakia.
⁸ Rheumatology Division, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.
⁹ Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
¹⁰ Department of Medicine and Joint Academic Rheumatology Program Medical School, National and Kapodestrian University of Athens, Athens, Greece.
¹¹ NIHR Manchester Biomedical Research Unit, The University of Manchester and Central Manchester Foundation Trust, Manchester, UK.
¹² Department of Autoimmune Diseases, Hospital Clinic, Barcelona, Catalonia, Spain.
¹³ Division of Rheumatology, The Arthritis Society Chair in Rheumatic Diseases Cumming School of Medicine University of Calgary, Calgary, Alberta, Canada.
¹⁴ Lupus Foundation of America, Washington DC, USA.
¹⁵ Université Paris-Decartes, Paris, France.
¹⁶ AP-HP, Hôpital Cochin, service de médecine interne, centre de reference maladies auto-immunes et systémiques rares, Paris, France.
¹⁷ Department of Rheumatology and Immunology, Institute of Bioanalysis, Institute of Family Medicine, University of Pécs, Pécs, Hungary.
¹⁸ Third Department of Internal Medicine, Semmelweis University, Budapest, Hungary.
¹⁹ Department Rheumatology and Clinical Immunology, University Medical Center, Utrecht, The Netherlands.
²⁰ Rheumatology Unit, Department of Medicine, University of Padova, Padova, Italy.
²¹ Department Medicine/Rheumatology and Clinical Immunology, Charite Universitätsmedizin Berlin, Berlin, Germany.
²² Polyclinic of Rheumatology, Hiller Research Unit, University Clinic Duesseldorf, Heinrich-Heine-University, Duesseldorf, Germany.
²³ Rheumatology Research Group, Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
²⁴ Division of Rheumatology, Medical University of Graz, Graz, Austria.
²⁵ 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.
²⁶ Department of Medicine, The Centre for Rheumatology, University College London, UK.
²⁷ Copenhagen Lupus and Vasculitis Clinic, Center for Rheumatology and Spine Diseases, Copenhagen, Denmark.
²⁸ Department of Medicine, University of Cambridge, Cambridge, UK.
²⁹ Interdisciplinary Center for Clinical Trials (IZKS), University Medical Center Mainz, Mainz, Germany.
³⁰ LUPUS EUROPE, co-opted trustee for research, Essex UK.
³¹ Rheumatology Department, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil.
³² Université Paris-Sud; Assistance Publique-Hôpitaux de Paris, Hôpitaux Universitaires Paris-sud; INSERM U1184, Le Kremlin Bicêtre, France.
³³ Bone Densitometry Unit, Monla Hospital, Tripoli, Lebanon.
³⁴ Monash University, Faculty of Medicine, Nursing & Health Sciences, Monash Medical Centre, Clayton, Australia.
³⁵ Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
³⁶ Department of Internal Medicine, Division of Rheumatology, Istanbul University, Istanbul Medical Faculty, Istanbul, Turkey.
³⁷ University of Santo Tomas, Manila, Philippines.
³⁸ Vasculitis.at, Vienna, Austria.
³⁹ Department of Connective Tissues Diseases, National Institute of Geriatrics, Rheumatology and Rehabilitation, Warsaw, Poland.
⁴⁰ Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
⁴¹ RNA and Molecular Pathology Research Group, Institute of Medical Biology, Health Science Faculty, University of Tromsø, Tromsø, Norway.
⁴² National Institute for Rheumatic Diseases, Piešťany, Slovak Republic.
⁴³ Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center (Affiliated to Tel-Aviv University), Tel-Aviv, Israel.
⁴⁴ Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria.
⁴⁵ 2nd Department of Medicine, Hietzing Hospital, Vienna, Austria.
⁴⁶ Dipartimento di Scienze Cliniche e Sperimentali, Università degli Studi di Brescia, U.O. Reumatologia e Immunolgia Clinica, Spedali Civili di Brescia, Brescia, Italy.
⁴⁷ 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.
⁴⁸ Unidade de Imunologia Clínica, Hospital Santo António, Centro Hospitalar do Porto, UMIB, Instituto de Ciencias Biomédicas Abel Salazar, Universidade do Porto, Porto, Portugal.
⁴⁹ Department of Rheumatology, Odense University Hospital, University of Southern Denmark, Denmark.
⁵⁰ Corporal Michael J. Crescenz VA Medical Center (Philadelphia), Philadelphia, Philadelphia, USA.
⁵¹ Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA.
⁵² Nephrology Unit, City Clinical Hospital n.a. S.P. Botkin, Moscow, Russia.
⁵³ Lanarkshire Centre for Rheumatology, Hairmyres Hospital, Scotland, UK.
⁵⁴ National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda, Maryland, USA.

PMID: 27884822
DOI: 10.1136/annrheumdis-2016-209519

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: remission in SLE is a durable state characterised by …………………. (reference to symptoms, signs, routine labs).2. For defining remission, a validated index must be used, for example, clinical systemic lupus erythematosus disease activity index (SLEDAI)=0, British Isles lupus assessment group (BILAG) 2004 D/E only, clinical European consensus lupus outcome measure (ECLAM)=0; with routine laboratory assessments included, and supplemented with physician's global assessment.3. Distinction is made between remission off and on therapy: remission off therapy requires the patient to be on no other treatment for SLE than maintenance antimalarials; and remission on therapy allows patients to be on stable maintenance antimalarials, low-dose corticosteroids (prednisone ≤5 mg/day), maintenance immunosuppressives and/or maintenance biologics.The task force also agreed that the most appropriate outcomes (dependent variables) for testing the prognostic value (construct validity) of potential remission definitions are: death, damage, flares and measures of health-related quality of life.

Conclusions: The work of this international task force provides a framework for testing different definitions of remission against long-term outcomes.

Keywords: Disease Activity; Outcomes research; Systemic Lupus Erythematosus.

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

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

Affiliations

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

Authors

Affiliations

Abstract

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LinkOut - more resources

Full Text Sources

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Medical