Ronald van Vollenhoven1,2, 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-Chalumeau15,16, László Czirják17,18, 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 Guern15,16, 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 Smolen44,45, Angela Tincani46, Murray Urowitz47, Bernadette van Leeuw30, Carlos Vasconcelos48, Anne Voss49, Victoria P Werth50,51, Helena Zakharova52, Asad Zoma53, Matthias Schneider22, Michael Ward54. 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.
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. 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/.
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. 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/.
Authors: Vivek Nagaraja; Marco Matucci-Cerinic; Daniel E Furst; Masataka Kuwana; Yannick Allanore; Christopher P Denton; Ganesh Raghu; Vallerie Mclaughlin; Panduranga S Rao; James R Seibold; John D Pauling; Michael L Whitfield; Dinesh Khanna Journal: Arthritis Rheumatol Date: 2020-05-18 Impact factor: 10.995