title: Plasma fibrinogen along with patient-reported outcome measures enhances management of polymyalgia rheumatica: a prospective study.
abstract: OBJECTIVE
  We sought to prospectively examine the responsiveness of a number of patient-reported outcome (PRO) measures in polymyalgia rheumatica (PMR), as well as their relationship to the biomarkers erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and plasma fibrinogen.
  
  
  METHODS
  Sixty patients with PMR were divided into active (n = 25) or inactive (n = 35) disease groups based on symptoms; physician assessment; and the biomarkers ESR, CRP, and plasma fibrinogen. Groups underwent assessment at baseline and 6 weeks. Disease activity measures and relevant PRO measures were recorded. Measures of responsiveness were compared for all PRO and biomarkers.
  
  
  RESULTS
  Visual analog scale disease activity (VASDA) and VAS quality of life (VASQOL) are more responsive to change in disease activity than VAS pain, morning stiffness, Health Assessment Questionnaire (HAQ), and PMR-activity score (AS). Analysis of PMR-AS versus VASDA, VASQOL, and HAQ showed correlation coefficients of 0.87 (p < 0.001), 0.80 (p < 0.001), and 0.68 (p < 0.001), respectively. Receiver-operating curve (ROC) analysis revealed VASDA to be more specific than either HAQ (0.95 vs 0.85; p < 0.001) or VASQOL (0.95 vs 0.93; p < 0.001) for the detection of response to treatment in active PMR. Overall, fibrinogen showed superior correlation coefficients with the various PRO than either of the standard biomarkers ESR or CRP. In addition, standardized response means for fibrinogen, ESR, and CRP were 1.63, 1.2, and 1.05, respectively, indicating that plasma fibrinogen was the most responsive biomarker for assessment of change in disease activity.
  
  
  CONCLUSIONS
  VASDA and VASQOL are the most responsive PRO to changes in disease activity in PMR. In addition, plasma fibrinogen demonstrated greater responsiveness to changes in disease activity and superior correlation with the various PRO measures recorded than did the standard biomarkers ESR and CRP.
authors.affiliation: From the Department of Rheumatology, Mater Misericordiae University Hospital, Dublin; Department of Rheumatology, St. Vincents University Hospital, Dublin; and Department of Molecular and Cellular Therapeutics, Royal College of Surgeons, Dublin, Ireland.
authors.forename: Eoghan M
authors.initials: EM
authors.lastname: McCarthy
authors.forename: Paul A
authors.initials: PA
authors.lastname: MacMullan
authors.forename: Shibeb
authors.initials: S
authors.lastname: Al-Mudhaffer
authors.forename: Anne
authors.initials: A
authors.lastname: Madigan
authors.forename: Suzanne
authors.initials: S
authors.lastname: Donnelly
authors.forename: Conor J
authors.initials: CJ
authors.lastname: McCarthy
authors.forename: Eamonn S
authors.initials: ES
authors.lastname: Molloy
authors.forename: Dermot
authors.initials: D
authors.lastname: Kenny
authors.forename: Geraldine M
authors.initials: GM
authors.lastname: McCarthy
mesh_terms: D000305:Adrenal Cortex Hormones / Q000627:therapeutic use*; D000368:Aged; D000369:Aged, 80 and over; D015415:Biomarkers / Q000097:blood; D001799:Blood Sedimentation; D002097:C-Reactive Protein / Q000378:metabolism; D016903:Drug Monitoring / Q000379:methods*; D005260:Female; D005340:Fibrinogen / Q000378:metabolism*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D011111:Polymyalgia Rheumatica / Q000188:drug therapy* / Q000276:immunology / Q000378:metabolism*; D011446:Prospective Studies; D012372:ROC Curve; D012720:Severity of Illness Index; D064232:Visual Analog Scale
chemical_list: D000305:Adrenal Cortex Hormones; D015415:Biomarkers; D005340:Fibrinogen; D002097:C-Reactive Protein
keywords: BIOMARKERS; PATIENT OUTCOME MEASURES; POLYMYALGIA RHEUMATICA