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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)

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Clinical and epidemiological research
Extended report
A framework for remission in SLE: consensus findings from a large international task force on definitions of remission in SLE (DORIS)
  1. Ronald van Vollenhoven1,2,
  2. Alexandre Voskuyl2,
  3. George Bertsias3,
  4. Cynthia Aranow4,
  5. Martin Aringer5,
  6. Laurent Arnaud1,
  7. Anca Askanase6,
  8. Petra Balážová7,
  9. Eloisa Bonfa8,
  10. Hendrika Bootsma9,
  11. Dimitrios Boumpas10,
  12. Ian Bruce11,
  13. Ricard Cervera12,
  14. Ann Clarke13,
  15. Cindy Coney14,
  16. Nathalie Costedoat-Chalumeau15,16,
  17. László Czirják17,18,
  18. Ronald Derksen19,
  19. Andrea Doria20,
  20. Thomas Dörner21,
  21. Rebecca Fischer-Betz22,
  22. Ruth Fritsch-Stork19,
  23. Caroline Gordon23,
  24. Winfried Graninger24,
  25. Noémi Györi1,
  26. Frédéric Houssiau25,
  27. David Isenberg26,
  28. Soren Jacobsen27,
  29. David Jayne28,
  30. Annegret Kuhn29,
  31. Veronique Le Guern15,16,
  32. Kirsten Lerstrøm30,
  33. Roger Levy31,
  34. Francinne Machado-Ribeiro31,
  35. Xavier Mariette32,
  36. Jamil Missaykeh33,
  37. Eric Morand34,
  38. Marta Mosca35,
  39. Murat Inanc36,
  40. Sandra Navarra37,
  41. Irmgard Neumann38,
  42. Marzena Olesinska39,
  43. Michelle Petri40,
  44. Anisur Rahman26,
  45. Ole Petter Rekvig41,
  46. Jozef Rovensky42,
  47. Yehuda Shoenfeld43,
  48. Josef Smolen44,45,
  49. Angela Tincani46,
  50. Murray Urowitz47,
  51. Bernadette van Leeuw30,
  52. Carlos Vasconcelos48,
  53. Anne Voss49,
  54. Victoria P Werth50,51,
  55. Helena Zakharova52,
  56. Asad Zoma53,
  57. Matthias Schneider22,
  58. Michael Ward54
  1. 1Department of Medicine, Unit for Clinical Therapy Research, Inflammatory Diseases (ClinTRID), Karolinska Institutet, D1:00 Karolinska University Hospital, Solna, Stockholm, Sweden
  2. 2Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam, The Netherlands
  3. 3Department of Rheumatology, Clinical Immunology and Allergy, University of Crete School of Medicine, Iraklion, Greece
  4. 4Feinstein Institute for Medical Research, Manhasset, New York, USA
  5. 5Department of Medicine III, University Medical Center TU Dresden, Dresden, Germany
  6. 6New York University, New York, USA
  7. 7LPRe SR—Klub Motýlik, Bratislava, Slovakia
  8. 8Rheumatology Division, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil
  9. 9Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands
  10. 10Department of Medicine and Joint Academic Rheumatology Program Medical School, National and Kapodestrian University of Athens, Athens, Greece
  11. 11NIHR Manchester Biomedical Research Unit, The University of Manchester and Central Manchester Foundation Trust, Manchester, UK
  12. 12Department of Autoimmune Diseases, Hospital Clinic, Barcelona, Catalonia, Spain
  13. 13Division of Rheumatology, The Arthritis Society Chair in Rheumatic Diseases Cumming School of Medicine University of Calgary, Calgary, Alberta, Canada
  14. 14Lupus Foundation of America, Washington DC, USA
  15. 15Université Paris-Decartes, Paris, France
  16. 16AP-HP, Hôpital Cochin, service de médecine interne, centre de reference maladies auto-immunes et systémiques rares, Paris, France
  17. 17Department of Rheumatology and Immunology, Institute of Bioanalysis, Institute of Family Medicine, University of Pécs, Pécs, Hungary
  18. 18Third Department of Internal Medicine, Semmelweis University, Budapest, Hungary
  19. 19Department Rheumatology and Clinical Immunology, University Medical Center, Utrecht, The Netherlands
  20. 20Rheumatology Unit, Department of Medicine, University of Padova, Padova, Italy
  21. 21Department Medicine/Rheumatology and Clinical Immunology, Charite Universitätsmedizin Berlin, Berlin, Germany
  22. 22Polyclinic of Rheumatology, Hiller Research Unit, University Clinic Duesseldorf, Heinrich-Heine-University, Duesseldorf, Germany
  23. 23Rheumatology Research Group, Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK
  24. 24Division of Rheumatology, Medical University of Graz, Graz, Austria
  25. 25Service 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. 26Department of Medicine, The Centre for Rheumatology, University College London, UK
  27. 27Copenhagen Lupus and Vasculitis Clinic, Center for Rheumatology and Spine Diseases, Copenhagen, Denmark
  28. 28Department of Medicine, University of Cambridge, Cambridge, UK
  29. 29Interdisciplinary Center for Clinical Trials (IZKS), University Medical Center Mainz, Mainz, Germany
  30. 30LUPUS EUROPE, co-opted trustee for research, Essex UK
  31. 31Rheumatology Department, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil
  32. 32Université Paris-Sud; Assistance Publique-Hôpitaux de Paris, Hôpitaux Universitaires Paris-sud; INSERM U1184, Le Kremlin Bicêtre, France
  33. 33Bone Densitometry Unit, Monla Hospital, Tripoli, Lebanon
  34. 34Monash University, Faculty of Medicine, Nursing & Health Sciences, Monash Medical Centre, Clayton, Australia
  35. 35Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy
  36. 36Department of Internal Medicine, Division of Rheumatology, Istanbul University, Istanbul Medical Faculty, Istanbul, Turkey
  37. 37University of Santo Tomas, Manila, Philippines
  38. 38Vasculitis.at, Vienna, Austria
  39. 39Department of Connective Tissues Diseases, National Institute of Geriatrics, Rheumatology and Rehabilitation, Warsaw, Poland
  40. 40Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
  41. 41RNA and Molecular Pathology Research Group, Institute of Medical Biology, Health Science Faculty, University of Tromsø, Tromsø, Norway
  42. 42National Institute for Rheumatic Diseases, Piešťany, Slovak Republic
  43. 43Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center (Affiliated to Tel-Aviv University), Tel-Aviv, Israel
  44. 44Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria
  45. 452nd Department of Medicine, Hietzing Hospital, Vienna, Austria
  46. 46Dipartimento di Scienze Cliniche e Sperimentali, Università degli Studi di Brescia, U.O. Reumatologia e Immunolgia Clinica, Spedali Civili di Brescia, Brescia, Italy
  47. 47Centre 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. 48Unidade de Imunologia Clínica, Hospital Santo António, Centro Hospitalar do Porto, UMIB, Instituto de Ciencias Biomédicas Abel Salazar, Universidade do Porto, Porto, Portugal
  49. 49Department of Rheumatology, Odense University Hospital, University of Southern Denmark, Denmark
  50. 50Corporal Michael J. Crescenz VA Medical Center (Philadelphia), Philadelphia, Philadelphia, USA
  51. 51Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA
  52. 52Nephrology Unit, City Clinical Hospital n.a. S.P. Botkin, Moscow, Russia
  53. 53Lanarkshire Centre for Rheumatology, Hairmyres Hospital, Scotland, UK
  54. 54National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda, Maryland, USA
  1. Correspondence to Dr Ronald van Vollenhoven, Amsterdam Rheumatology and Immunology Center ARC, Amsterdam, 1100 DD, The Netherlands; r.f.vanvollenhoven{at}amc.uva.nl

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.

  • Systemic Lupus Erythematosus
  • Outcomes research
  • Disease Activity

https://doi.org/10.1136/annrheumdis-2016-209519

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    Footnotes

    • Handling editor Tore K Kvien

    • Twitter Follow Dimitrios T Boumpas at @none

    • Competing interests RvVreports having received Research Support and Grants from AbbVie, Amgen, BMS, GSK, Pfizer, Roche, UCB, and Consultancy or honoraria from AbbVie, Biotest, BMS, Celgene, Crescendo, GSK, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, UCB, Vertex. LAreports having received travel grants, consultancy or honoraria from Adelphivalues, Amgen, Eli Lilly, GSK, LFB, Menarini France, MSD, Raison de santé.

    • Provenance and peer review Not commissioned; externally peer reviewed.

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