Sindhu R Johnson1,2, Dinesh Khanna3,4, David Daikh3,4, Ricard Cervera3,4, Nathalie Costedoat-Chalumeau3,4, Dafna D Gladman3,4, Bevra H Hahn3,4, Falk Hiepe3,4, Jorge Sánchez-Guerrero3,4, Elena Massarotti3,4, Dimitrios T Boumpas3,4, Karen H Costenbader3,4, David Jayne3,4, Thomas Dörner3,4, Diane L Kamen3,4, Marta Mosca3,4, Rosalind Ramsey-Goldman3,4, Josef S Smolen3,4, David Wofsy3,4, Martin Aringer3,4. 1. From the Division of Rheumatology, Department of Medicine, Toronto Western Hospital, University of Toronto, Toronto; Division of Rheumatology, Department of Medicine, Mount Sinai Hospital, Toronto; University Health Network, and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; Division of Rheumatology, Department of Medicine, University of Michigan, Ann Arbor, Michigan; University of California, Los Angeles, Los Angeles; University of California, San Francisco, California; Brigham and Women's Hospital, Boston; Harvard Medical School, Boston, Massachusetts; Medical University of South Carolina, Charleston, South Carolina; Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA; Hospital Clínic, Barcelona, Spain; AP-HP, Cochin Hospital, Internal Medicine Department, Centre de référence maladies auto-immunes et systémiques rares d'île de France, Paris; Université Paris Descartes-Sorbonne Paris Cité, Paris; INSERM U 1153, Center for Epidemiology and Statistics Sorbonne Paris Cité (CRESS), Paris, France; Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin; Berlin Institute of Health, Department of Rheumatology and Clinical Immunology, Berlin; University Medical Center and Faculty of Medicine Carl Gustav Carus, TU Dresden, Dresden, Germany; Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico; National and Kapodestrian University of Athens, and Biomedical Research Foundation of the Athens Academy, Athens, Greece; Department of Medicine, University of Cambridge, Cambridge, UK; University of Pisa, Pisa, Italy; Medical University of Vienna, Vienna, Austria. Sindhu.Johnson@uhn.ca. 2. S.R. Johnson, MD, PhD, FRCPC, Division of Rheumatology, Department of Medicine, Toronto Western Hospital, Mount Sinai Hospital, and Institute of Health Policy, Management and Evaluation, University of Toronto; D. Khanna, MD, MS, Division of Rheumatology, Department of Medicine, University of Michigan; R. Cervera, MD, PhD, FRCP, Hospital Clínic, Barcelona; N. Costedoat-Chalumeau, MD, PhD, AP-HP, Cochin Hospital, Internal Medicine Department, Centre de référence maladies auto-immunes et systémiques rares d'île de France, and Université Paris Descartes-Sorbonne Paris Cité, and INSERM U 1153, CRESS; D.D. Gladman, MD, FRCPC, Division of Rheumatology, Department of Medicine, Toronto Western Hospital, University of Toronto; B.H. Hahn, MD, University of California, Los Angeles; F. Hiepe, MD, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Rheumatology and Clinical Immunology; J. Sánchez-Guerrero, MD, MSc, Division of Rheumatology, Department of Medicine, Mount Sinai Hospital/University Health Network, University of Toronto, and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán; E. Massarotti, MD, Brigham and Women's Hospital, and Harvard Medical School; D.T. Boumpas, MD, FACP, FACR, National and Kapodestrian University of Athens, and Biomedical Research Foundation of the Athens Academy; K.H. Costenbader, MD, MPH, Brigham and Women's Hospital, and Harvard Medical School; D. Daikh, MD, University of California, San Francisco; D. Jayne, MD FRCP, FRCPE, FMedSci, Department of Medicine, University of Cambridge; T. Dörner, MD, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Rheumatology and Clinical Immunology; D.L. Kamen, MD, MSCR, Medical University of South Carolina; M. Mosca, MD, PhD, University of Pisa; R. Ramsey-Goldman, MD, DrPH, Northwestern University Feinberg School of Medicine; J.S. Smolen, MD, Medical University of Vienna; D. Wofsy, MD, University of California, San Francisco; M. Aringer, MD, University Medical Center and Faculty of Medicine Carl Gustav Carus, TU Dresden. Sindhu.Johnson@uhn.ca. 3. From the Division of Rheumatology, Department of Medicine, Toronto Western Hospital, University of Toronto, Toronto; Division of Rheumatology, Department of Medicine, Mount Sinai Hospital, Toronto; University Health Network, and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; Division of Rheumatology, Department of Medicine, University of Michigan, Ann Arbor, Michigan; University of California, Los Angeles, Los Angeles; University of California, San Francisco, California; Brigham and Women's Hospital, Boston; Harvard Medical School, Boston, Massachusetts; Medical University of South Carolina, Charleston, South Carolina; Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA; Hospital Clínic, Barcelona, Spain; AP-HP, Cochin Hospital, Internal Medicine Department, Centre de référence maladies auto-immunes et systémiques rares d'île de France, Paris; Université Paris Descartes-Sorbonne Paris Cité, Paris; INSERM U 1153, Center for Epidemiology and Statistics Sorbonne Paris Cité (CRESS), Paris, France; Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin; Berlin Institute of Health, Department of Rheumatology and Clinical Immunology, Berlin; University Medical Center and Faculty of Medicine Carl Gustav Carus, TU Dresden, Dresden, Germany; Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico; National and Kapodestrian University of Athens, and Biomedical Research Foundation of the Athens Academy, Athens, Greece; Department of Medicine, University of Cambridge, Cambridge, UK; University of Pisa, Pisa, Italy; Medical University of Vienna, Vienna, Austria. 4. S.R. Johnson, MD, PhD, FRCPC, Division of Rheumatology, Department of Medicine, Toronto Western Hospital, Mount Sinai Hospital, and Institute of Health Policy, Management and Evaluation, University of Toronto; D. Khanna, MD, MS, Division of Rheumatology, Department of Medicine, University of Michigan; R. Cervera, MD, PhD, FRCP, Hospital Clínic, Barcelona; N. Costedoat-Chalumeau, MD, PhD, AP-HP, Cochin Hospital, Internal Medicine Department, Centre de référence maladies auto-immunes et systémiques rares d'île de France, and Université Paris Descartes-Sorbonne Paris Cité, and INSERM U 1153, CRESS; D.D. Gladman, MD, FRCPC, Division of Rheumatology, Department of Medicine, Toronto Western Hospital, University of Toronto; B.H. Hahn, MD, University of California, Los Angeles; F. Hiepe, MD, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Rheumatology and Clinical Immunology; J. Sánchez-Guerrero, MD, MSc, Division of Rheumatology, Department of Medicine, Mount Sinai Hospital/University Health Network, University of Toronto, and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán; E. Massarotti, MD, Brigham and Women's Hospital, and Harvard Medical School; D.T. Boumpas, MD, FACP, FACR, National and Kapodestrian University of Athens, and Biomedical Research Foundation of the Athens Academy; K.H. Costenbader, MD, MPH, Brigham and Women's Hospital, and Harvard Medical School; D. Daikh, MD, University of California, San Francisco; D. Jayne, MD FRCP, FRCPE, FMedSci, Department of Medicine, University of Cambridge; T. Dörner, MD, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Rheumatology and Clinical Immunology; D.L. Kamen, MD, MSCR, Medical University of South Carolina; M. Mosca, MD, PhD, University of Pisa; R. Ramsey-Goldman, MD, DrPH, Northwestern University Feinberg School of Medicine; J.S. Smolen, MD, Medical University of Vienna; D. Wofsy, MD, University of California, San Francisco; M. Aringer, MD, University Medical Center and Faculty of Medicine Carl Gustav Carus, TU Dresden.
Abstract
OBJECTIVE: Given the complexity and heterogeneity of systemic lupus erythematosus (SLE), high-performing classification criteria are critical to advancing research and clinical care. A collaborative effort by the European League Against Rheumatism and the American College of Rheumatology was undertaken to generate candidate criteria, and then to reduce them to a smaller set. The objective of the current study was to select a set of criteria that maximizes the likelihood of accurate classification of SLE, particularly early disease. METHODS: An independent panel of international SLE experts and the SLE classification criteria steering committee (conducting SLE research in Canada, Mexico, United States, Austria, Germany, Greece, France, Italy, and Spain) ranked 43 candidate criteria. A consensus meeting using nominal group technique (NGT) was conducted to reduce the list of criteria for consideration. RESULTS: The expert panel NGT exercise reduced the candidate criteria for SLE classification from 43 to 21. The panel distinguished potential "entry criteria," which would be required for classification, from potential "additive criteria." Potential entry criteria were antinuclear antibody (ANA) ≥ 1:80 (HEp-2 immunofluorescence), and low C3 and/or low C4. The use of low complement as an entry criterion was considered potentially useful in cases with negative ANA. Potential additive criteria included lupus nephritis by renal biopsy, autoantibodies, cytopenias, acute and chronic cutaneous lupus, alopecia, arthritis, serositis, oral mucosal lesions, central nervous system manifestations, and fever. CONCLUSION: The NGT exercise resulted in 21 candidate SLE classification criteria. The next phases of SLE classification criteria development will require refinement of criteria definitions, evaluation of the ability to cluster criteria into domains, and evaluation of weighting of criteria.
OBJECTIVE: Given the complexity and heterogeneity of systemic lupus erythematosus (SLE), high-performing classification criteria are critical to advancing research and clinical care. A collaborative effort by the European League Against Rheumatism and the American College of Rheumatology was undertaken to generate candidate criteria, and then to reduce them to a smaller set. The objective of the current study was to select a set of criteria that maximizes the likelihood of accurate classification of SLE, particularly early disease. METHODS: An independent panel of international SLE experts and the SLE classification criteria steering committee (conducting SLE research in Canada, Mexico, United States, Austria, Germany, Greece, France, Italy, and Spain) ranked 43 candidate criteria. A consensus meeting using nominal group technique (NGT) was conducted to reduce the list of criteria for consideration. RESULTS: The expert panel NGT exercise reduced the candidate criteria for SLE classification from 43 to 21. The panel distinguished potential "entry criteria," which would be required for classification, from potential "additive criteria." Potential entry criteria were antinuclear antibody (ANA) ≥ 1:80 (HEp-2 immunofluorescence), and low C3 and/or low C4. The use of low complement as an entry criterion was considered potentially useful in cases with negative ANA. Potential additive criteria included lupus nephritis by renal biopsy, autoantibodies, cytopenias, acute and chronic cutaneous lupus, alopecia, arthritis, serositis, oral mucosal lesions, central nervous system manifestations, and fever. CONCLUSION: The NGT exercise resulted in 21 candidate SLE classification criteria. The next phases of SLE classification criteria development will require refinement of criteria definitions, evaluation of the ability to cluster criteria into domains, and evaluation of weighting of criteria.
Authors: Sara K Tedeschi; Sindhu R Johnson; Dimitrios T Boumpas; David Daikh; Thomas Dörner; Betty Diamond; Søren Jacobsen; David Jayne; Diane L Kamen; W Joseph McCune; Marta Mosca; Rosalind Ramsey-Goldman; Guillermo Ruiz-Irastorza; Matthias Schneider; Murray Urowitz; David Wofsy; Josef S Smolen; Raymond P Naden; Martin Aringer; Karen H Costenbader Journal: Ann Rheum Dis Date: 2019-01-28 Impact factor: 19.103
Authors: Maka Gegenava; Hannelore Jacqueline Lucia Beaart; Rory Caitlin Monahan; Elisabeth Brilman; Liesbeth J J Beaart-van de Voorde; Cesar Magro-Checa; Tom W J Huizinga; Gerda M Steup-Beekman Journal: RMD Open Date: 2019-06-05
Authors: Martin Aringer; Karen Costenbader; David Daikh; Ralph Brinks; Marta Mosca; Rosalind Ramsey-Goldman; Josef S Smolen; David Wofsy; Dimitrios T Boumpas; Diane L Kamen; David Jayne; Ricard Cervera; Nathalie Costedoat-Chalumeau; Betty Diamond; Dafna D Gladman; Bevra Hahn; Falk Hiepe; Søren Jacobsen; Dinesh Khanna; Kirsten Lerstrøm; Elena Massarotti; Joseph McCune; Guillermo Ruiz-Irastorza; Jorge Sanchez-Guerrero; Matthias Schneider; Murray Urowitz; George Bertsias; Bimba F Hoyer; Nicolai Leuchten; Chiara Tani; Sara K Tedeschi; Zahi Touma; Gabriela Schmajuk; Branimir Anic; Florence Assan; Tak Mao Chan; Ann Elaine Clarke; Mary K Crow; László Czirják; Andrea Doria; Winfried Graninger; Bernadett Halda-Kiss; Sarfaraz Hasni; Peter M Izmirly; Michelle Jung; Gábor Kumánovics; Xavier Mariette; Ivan Padjen; José M Pego-Reigosa; Juanita Romero-Diaz; Íñigo Rúa-Figueroa Fernández; Raphaèle Seror; Georg H Stummvoll; Yoshiya Tanaka; Maria G Tektonidou; Carlos Vasconcelos; Edward M Vital; Daniel J Wallace; Sule Yavuz; Pier Luigi Meroni; Marvin J Fritzler; Ray Naden; Thomas Dörner; Sindhu R Johnson Journal: Arthritis Rheumatol Date: 2019-08-06 Impact factor: 15.483
Authors: Guillermo J Pons-Estel; Manuel Francisco Ugarte-Gil; Guillermina B Harvey; Daniel Wojdyla; Rosana Quintana; Verónica Saurit; Enrique R Soriano; Eloisa Bonfa; Loreto Massardo; Mario Cardiel; Luis M Vila; Russell Griffin; Bernardo A Pons-Estel; Graciela S Alarcón Journal: RMD Open Date: 2020-01
Authors: J S Massias; E M D Smith; E Al-Abadi; K Armon; K Bailey; C Ciurtin; J Davidson; J Gardner-Medwin; K Haslam; D P Hawley; A Leahy; V Leone; F McErlane; D Mewar; G Modgil; R Moots; C Pilkington; A V Ramanan; S Rangaraj; P Riley; A Sridhar; N Wilkinson; M W Beresford; C M Hedrich Journal: Lupus Date: 2020-03-31 Impact factor: 2.911