A Paper Patient-Based Flare Study in SLE

Joanna Sturgess¹, Elizabeth Allan¹, David A. Isenberg², Cynthia Aranow³, Martin Aringer⁴, Anca Askanase⁵, Sang-Cheol Bae⁶, Sasha R Bernatsky⁷, Ian N. Bruce⁸, Jill P. Buyon⁹, Ricard Cervera¹⁰, Ann Clarke¹¹, Mary Anne Dooley¹², Paul R. Fortin¹³, Ian Giles², Ellen M. Ginzler¹⁴, Dafna Gladman¹⁵, Caroline Gordon¹⁶, Bridget Griffiths¹⁷, John G. Hanly¹⁸, Murat Inanc¹⁹, Søren Jacobsen²⁰, Diane L. Kamen²¹, Munther Khamashta²², Peter Lanyon²³, S. Sam Lim²⁴, Susan Manzi²⁵, Marta Mosca²⁶, Ola Nived²⁷, Christine A. Peschken²⁸, Michelle Petri²⁹, Kenneth C. Kalunian³⁰, Anisur Rahman³¹, Rosalind Ramsey-Goldman³², Guillermo Ruiz-Irastorza³³, Jorge Sánchez-Guerrero³⁴, Matteus Schneider³⁵, Kristján Steinsson³⁶, Gunnar K. Sturfelt³⁷, Murray Urowitz^38,39, Ronald F. van Vollenhoven⁴⁰, Carlos Vasconcelos⁴¹, Daniel J Wallace⁴², Asad Zoma⁴³, Joan T. Merrill⁴⁴, Eric Morand⁴⁵, Sharon Chambers⁴⁶, Nathalie Costedoat-Chalumeau⁴⁷ and Sara Croca², ¹Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom, ²Rayne Institute, Centre for Rheumatology Research, UCL Division of Medicine, London, United Kingdom, ³Feinstein Institute for Medical Research, Mahasset, NY, ⁴Rheumatology, Universitatsklinikum, Dresden, Germany, ⁵Columbia University College of Physicians & Surgeons, New York, NY, ⁶Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea, ⁷Division of Rheumatolog, McGill Unversity Health Cener, Montreal, QC, Canada, ⁸Central Manchester University Hospital NHS Foundation Trust and Manchester Academic Health Science Centre, NIHR Manchester Musculoskeletal Biomedical Research Unit, Manchester, United Kingdom, ⁹Medicine, Division of Rheumatology, New York University School of Medicine, New York, NY, ¹⁰Department of Autoimmune Diseases, Hospital Clínic, Barcelona, Spain, ¹¹Division of Rheumatology, Department of Medicine, University of Calgary, Calgary, AB, Canada, ¹²UNC Kidney Centre, Chapel Hill, NC, ¹³Université Laval, CHU de Québec, Québec, QC, Canada, ¹⁴Medicine/Box 42, SUNY-Downstate, Brooklyn, NY, ¹⁵Rheumatology, University of Toronto, Toronto Western Hospital, Toronto, ON, Canada, ¹⁶Rheumatology (East Wing), Medical School, Birmingham, United Kingdom, ¹⁷Rheumatology, Freeman Hospital, Newcastle Upon Tyne, United Kingdom, ¹⁸Rheumatology, Division of Rheumatology, Capital Health and Dalhousie University, Halifax, NS, Canada, ¹⁹Department of Internal Medicine, Division of Rheumatology, Istanbul University, Istanbul Faculty of Medicine, Istanbul, Turkey, ²⁰Rheumatology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark, ²¹Medicine, Medical University of South Carolina, Charleston, SC, ²²Graham Hughes Lupus Research Laboratory, The Rayne Institute, St Thomas' Hospital, London, United Kingdom, ²³Rheumatology, Queens Medical Centre Nottingham, Nottingham, United Kingdom, ²⁴Emory University School of Medicine, Atlanta, GA, ²⁵Rheumatology, Allegheny Health Network, Pittsburgh, PA, ²⁶University of Pisa, Pisa, Italy, ²⁷Rheumatology, Inst of Clinical sciences, Lund, Sweden, ²⁸Rheumatology, Univ of Manitoba, Winnipeg, MB, Canada, ²⁹Rheumatology, Johns Hopkins University Hospital, Baltimore, MD, ³⁰Division of Rheumatology, Allergy & Immunology, UCSD School of Medicine Center for Innovative Therapy, La Jolla, CA, ³¹Academic Centre for Rheumatology, University College London, London, United Kingdom, ³²Northwestern University Feinberg School of Medicine, Chicago, IL, ³³Universidad del Pais Vasco, Servicio de Medicina Interna, Hospital de Cruces, Bizkaia, Spain, ³⁴Rheumatology, Mount Sinai Hospital and University Health Network, Toronto Canada, Toronto, ON, Canada, ³⁵MNR-Klinik, Heinrich-Heine-Univ Dusseldorf, Dusseldorf, Germany, ³⁶Rheumatology, Univ. Hospital, Reykjavik, Iceland, ³⁷Department of Rheumatology, Univ Hospital Lund, Lund, Sweden, ³⁸University of Toronto, Toronto, ON, Canada, ³⁹Rheumatology, U of Toronto, Toronto Western Hospital, Toronto, ON, Canada, ⁴⁰Department of Medicine, Unit for Clinical Therapy Research, Inflammatory Diseases (ClinTRID), The Karolinska Institute, Stockholm, Sweden, ⁴¹Medicina Interna, Unidade de Imunologia Clínica - Hospital Santo António, Oporto, Portugal, ⁴²Cedars-Sinai Medical Center, West Hollywood, CA, ⁴³Rheumatology, Hairmyres Hospital, East Kilbride, United Kingdom, ⁴⁴Clinical Pharmacology, Oklahoma Medical Research Foundation, Oklahoma City, OK, ⁴⁵Medicine, Monash University, Clayton, Australia, ⁴⁶TrinCay Medical Services, Camana Bay, Cayman Islands, ⁴⁷Internal Medicine Department, Cochin Hospital, “René-Descartes Paris V” University, Paris, France

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: Systemic lupus erythematosus (SLE)

Session Information

Date: Sunday, November 8, 2015

Title: Systemic Lupus Erythematosus - Clinical Aspects and Treatment Poster Session I

Session Type: ACR Poster Session A

Session Time: 9:00AM-11:00AM

ACR Abstract – A Paper Patient-Based Flare Study in Systemic Lupus Erythematosus (SLE)

Isenberg D, Sturgess J, Allan E, Aranow C, Aringer M, Askanase A, Sang-Cheol B, Bernatsky S, Bruce I, Buyon J, Cervera R, Chambers S, Cortedoat-Chalumeau N, Croca S, Clarke A, Dooley Mary Anne, Fortin P, Giles I, Ginzler E, Gladman D, Gordon C, Griffiths B, Hanly J, Inanc M, Jacobsen S, Kamen D, Khamashta M, Lanyon P, Lim, Manzi S, Moreland E, Mosca M, Nived O, Peschken C, Petri M, Kalunian K, Rahman A, Ramsey-Goldman R, Ruiz-Irastorza G, Sanchez-Guerrero J, Schneider M, Steinsson K, Sturfet G, Urowitz M, van Vollenhoven R, Vasconcelos C, Wallace D, Zoma A, Merrill J

Background/Purpose:

Data are restricted with regard to the usefulness of activity indices when assessing flares in patients with SLE. One study of 16 flaring SLE patients provided modest encouragement (1) but a recent cohort review (2) indicated that medication changes may not be appropriate in defining the degrees of flare. We now report assessments of flares from 989 SLE case histories provided by rheumatologists from over 30 centres in 10 different countries.

Methods:

Each case history was abstracted from medical records of real patients and provided together with an opinion as to whether each patient was experiencing a severe, moderate or mild flare or ‘ongoing/grumbling’ disease. Two further opinions were sought on each case history from the panel of rheumatologists and ultimately 451 patient histories, for which there was complete agreement about their flare status were selected for further study. Six different pairs of rheumatologists, were each asked to agree the assessments of approximately 30 cases using BILAG 2004 or SELENA-SLEDAI flare indices or the revised SELENA flare index.

Results:

For all three tools, the Flare classification generated by each, matched the consensus view of the cases in a similar proportion of times [BILAG-2004 – 66%; SELENA Flare – 65%; SELENA-SLEDAI – 75%; the slightly higher rate in the SELENA-SLEDAI being due to the single mild/moderate category].The corresponding weighted kappas for each tool were BILAG 0:82; SELENA flare 0.64; SELENA-SLEDAI 0.59).

Of particular note was a consistent pattern across all three tools of over-scoring moderate flares as severe. Closer examination of the data suggests that this over-scoring is driven by treatment. Removal of treatment decisions from the assessment of flare using the SELENA-Flare and SELENA-SLEDAI tools led to an increase in the proportion of correctly assessed cases to 72% and 80% respectively (weighted kappa; 0.68 and 0.74).

Conclusion:

Distinguishing different types of flare in patients with SLE remains a challenge. Given the difficulty caused by the inadequate provision of data in some of the case histories (making accurate BILAG assessment in particular problematic on occasion) the results are nevertheless very encouraging.

The overall performance characteristics of these flare instruments suggest that they can be useful in clinical trials where results are studied at the group level, whereas in clinical flare assessment must still be based on clinical judgement.

1. Isenberg D et a. Am Rheum Dis 2011; 70; 54

2. Thanou et al. Rheumatology 2014; 53; 2175

Disclosure: J. Sturgess, None; E. Allan, None; D. A. Isenberg, Bristol-Myers Squibb, 2; C. Aranow, None; M. Aringer, None; A. Askanase, None; S. C. Bae, None; S. R Bernatsky, None; I. N. Bruce, Bristol-Myers Squibb, 2; J. P. Buyon, Bristol-Myers Squibb, 2; R. Cervera, None; A. Clarke, None; M. A. Dooley, Lilly, 9,Aurinia, 9,GSK, 5,Genentech and Biogen IDEC Inc., 5,EMD Serono, 5,Medimmune, 5,UCB, 5; P. R. Fortin, None; I. Giles, None; E. M. Ginzler, None; D. Gladman, Abbott, Bristol Myers Squibb, Celgene, Johnson & Johnson, MSD, Novartis, Pfizer, UCB Pharma, 5,Abbott, Bristol Myers Squibb, Celgene, Johnson & Johnson, MSD, Novartis, Pfizer, UCB Pharma, 2; C. Gordon, None; B. Griffiths, None; J. G. Hanly, None; M. Inanc, None; S. Jacobsen, Bristol-Myers Squibb, 2; D. L. Kamen, None; M. Khamashta, Bristol-Myers Squibb, 2; P. Lanyon, None; S. S. Lim, None; S. Manzi, Bristol-Myers Squibb, 2,Bristol-Myers Squibb, 2; M. Mosca, None; O. Nived, Bristol-Myers Squibb, 2; C. A. Peschken, None; M. Petri, None; K. C. Kalunian, Bristol-Myers Squibb, 2; A. Rahman, None; R. Ramsey-Goldman, None; G. Ruiz-Irastorza, Bristol-Myers Squibb, 2; J. Sánchez-Guerrero, None; M. Schneider, None; K. Steinsson, Bristol-Myers Squibb, 2; G. K. Sturfelt, Bristol-Myers Squibb, 2; M. Urowitz, Bristol-Myers Squibb, 2; R. F. van Vollenhoven, AbbVie, BMS, GSK, Pfizer, Roche, UCB, 2,AbbVie, Biotest, BMS, Crescendo, GSK, Janssen, Lilly, Merck, Pfizer, Roche, UCB, Vertex, 5; C. Vasconcelos, None; D. J. Wallace, Bristol-Myers Squibb, 2; A. Zoma, Bristol-Myers Squibb, 2; J. T. Merrill, Bristol-Myers Squibb, 2; E. Morand, None; S. Chambers, None; N. Costedoat-Chalumeau, None; S. Croca, None.

To cite this abstract in AMA style:

Sturgess J, Allan E, Isenberg DA, Aranow C, Aringer M, Askanase A, Bae SC, R Bernatsky S, Bruce IN, Buyon JP, Cervera R, Clarke A, Dooley MA, Fortin PR, Giles I, Ginzler EM, Gladman D, Gordon C, Griffiths B, Hanly JG, Inanc M, Jacobsen S, Kamen DL, Khamashta M, Lanyon P, Lim SS, Manzi S, Mosca M, Nived O, Peschken CA, Petri M, Kalunian KC, Rahman A, Ramsey-Goldman R, Ruiz-Irastorza G, Sánchez-Guerrero J, Schneider M, Steinsson K, Sturfelt GK, Urowitz M, van Vollenhoven RF, Vasconcelos C, Wallace DJ, Zoma A, Merrill JT, Morand E, Chambers S, Costedoat-Chalumeau N, Croca S. A Paper Patient-Based Flare Study in SLE [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/a-paper-patient-based-flare-study-in-sle/. Accessed .

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