title: How should lupus flares be measured? Deconstruction of the safety of estrogen in lupus erythematosus national assessment-systemic lupus erythematosus disease activity index flare index.
abstract: OBJECTIVE
  Accurate assessment of lupus flares is critical but problematic in clinical trials. This study examined the impact of modifications to the classic Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-SLEDAI flare index (cSFI).
  
  
  METHODS
  Ninety-one SLE patient records were evaluated at two visits at which the SLEDAI and BILAG had been scored prospectively. The cSFI was compared with an experimental version (eSFI) that eliminated medication criteria and separated the mild/moderate flare category into its components by clinical judgement based on records. The revised SFI (SFI-R) and some physician's global assessments (PGAs) were also scored using chart notes.
  
  
  RESULTS
  eSFI-rated moderate flares had higher PGA and BILAG scores than those rated as mild. When medication criteria were excluded, 42 of 55 cSFI severe flares and 15 of 49 mild/moderate flares were downgraded in severity. Comparing flares that remained severe with those that were downgraded, disease activity was higher by PGA (P < 0.001), SLEDAI (P < 0.001), BILAG (P < 0.001), number of active BILAG organs (P < 0.04) and flaring SFI-R organs (P < 0.01). PGA (P < 0.001) and the number of SFI-R domains flaring (P < 0.001) were higher in mild/moderate eSFI flares than in those that were downgraded. Twenty-one of 83 (25%) medication changes occurred with no flare. Forty-six of 52 (88%) medication changes defining severe flare by cSFI involved patients rated by physicians with no, mild or moderate flares.
  
  
  CONCLUSIONS
  A deconstructed flare index improves the discrimination of mild from moderate flares and selects more ill patients with true clinical worsening for each category of flare.
authors.affiliation: Arthritis and Clinical Immunology Research Program, Oklahoma Medical Research Foundation, Department of Internal Medicine, Section of Rheumatology, University of Oklahoma Health Science Center and Clinical Pharmacology Research Program, Oklahoma Medical Research Foundation, Oklahoma City, OK, USA. aikaterini-thanou@omrf.org.
authors.forename: Aikaterini
authors.initials: A
authors.lastname: Thanou
authors.affiliation: Arthritis and Clinical Immunology Research Program, Oklahoma Medical Research Foundation, Department of Internal Medicine, Section of Rheumatology, University of Oklahoma Health Science Center and Clinical Pharmacology Research Program, Oklahoma Medical Research Foundation, Oklahoma City, OK, USA.
authors.forename: Eliza
authors.initials: E
authors.lastname: Chakravarty
authors.affiliation: Arthritis and Clinical Immunology Research Program, Oklahoma Medical Research Foundation, Department of Internal Medicine, Section of Rheumatology, University of Oklahoma Health Science Center and Clinical Pharmacology Research Program, Oklahoma Medical Research Foundation, Oklahoma City, OK, USA. Arthritis and Clinical Immunology Research Program, Oklahoma Medical Research Foundation, Department of Internal Medicine, Section of Rheumatology, University of Oklahoma Health Science Center and Clinical Pharmacology Research Program, Oklahoma Medical Research Foundation, Oklahoma City, OK, USA.
authors.forename: Judith A
authors.initials: JA
authors.lastname: James
authors.affiliation: Arthritis and Clinical Immunology Research Program, Oklahoma Medical Research Foundation, Department of Internal Medicine, Section of Rheumatology, University of Oklahoma Health Science Center and Clinical Pharmacology Research Program, Oklahoma Medical Research Foundation, Oklahoma City, OK, USA.
authors.forename: Joan T
authors.initials: JT
authors.lastname: Merrill
mesh_terms: D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D005938:Glucocorticoids / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D008137:Longitudinal Studies; D008180:Lupus Erythematosus, Systemic / Q000175:diagnosis* / Q000188:drug therapy; D009825:Oklahoma; D011241:Prednisone / Q000008:administration & dosage / Q000627:therapeutic use; D012008:Recurrence; D015203:Reproducibility of Results; D012720:Severity of Illness Index
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D005938:Glucocorticoids; D011241:Prednisone
keywords: BILAG; SELENA-SLEDAI flare index; SLEDAI; medications; outcome measures; physician’s global assessment; revised SELENA flare index; systemic lupus erythematosus
references.citation: Ann Rheum Dis. 2011 Jan;70(1):54-9
references.pmid: 20833737
references.citation: Ann Intern Med. 2005 Jun 21;142(12 Pt 1):953-62
references.pmid: 15968009
references.citation: N Engl J Med. 2005 Dec 15;353(24):2550-8
references.pmid: 16354891
references.citation: Arthritis Rheum. 2010 Oct;62(10):3077-87
references.pmid: 20533545
references.citation: Lupus. 2011 Apr;20(5):453-62
references.pmid: 21148601
references.citation: Lupus. 1999;8(8):685-91
references.pmid: 10568907
references.citation: Lupus. 2011 Jun;20(7):709-16
references.pmid: 21478286
references.citation: Arthritis Rheum. 1997 Sep;40(9):1725
references.pmid: 9324032
references.citation: Arthritis Rheum. 2011 Dec;63(12):3918-30
references.pmid: 22127708