title: Patient-perceived flares in rheumatoid arthritis: A sub-analysis of the STRASS treatment tapering strategy trial.
abstract: OBJECTIVE
  Patient's and physician's perspective can differ in rheumatoid arthritis (RA). The aim was to define the concept of patient-reported flares.
  
  
  METHODS
  Post-hoc analysis of a randomized controlled trial of a step-down strategy in RA patients treated with anti-TNF, in DAS28-remission for ≥6 months, randomized to either "spacing" or "maintaining" anti-TNF. The occurrence of patient-reported flares (PRF) was evaluated every 3 months for 18 months by: "Over the last 3 months, did you experience symptoms suggestive of disease exacerbation?". Visits with and without PRF were compared, using a linear mixed effects model, in terms of symptoms, disability based on the Health Assessment Questionnaire, quality of life based on Short Form 36 Health Survey and DAS28-based relapses (DBR), defined as an increase of DAS28>0.6 and an absolute value of DAS28>2.6. The agreement between PRF and DBR was measured by the kappa coefficient on repeated data.
  
  
  RESULTS
  In all, 137 patients were analyzed: mean age 55±11 years, females 78%, mean RA duration 9.5±8.0 years. Over the 18 months, PRF concerned 27.2% of the 940 available visits. DBR and PRF were observed in 24% and 16% of 940 visits for 137 patients respectively. All the items were associated with PRF with standardized effect size between -0.58 (SF36 PCS) and 0.87 (DAS28). The agreement between PRF and DBR was moderate (κ=0.44).
  
  
  CONCLUSIONS
  The concept of flare refers to more than just RA disease activity.
authors.affiliation: Sorbonne Universités, UPMC Université Paris 06, Institut Pierre-Louis d'Épidémiologie et de Santé Publique, GRC-UPMC 08 (EEMOIS), 75013 Paris, France; Department of rheumatology, Pitié-Salpêtrière Hospital, AP-HP, 75013 Paris, France; Rheumatology Department, Groupe Hospitalier Paris Saint-Joseph, 75014 Paris, France; Brest University, Rheumatology Department, La Cavale-Blanche University Hospital, 29000 Brest, France. Electronic address: aportier@hpsj.fr.
authors.forename: Agnès
authors.initials: A
authors.lastname: Portier
authors.affiliation: Sorbonne Universités, UPMC Université Paris 06, Institut Pierre-Louis d'Épidémiologie et de Santé Publique, GRC-UPMC 08 (EEMOIS), 75013 Paris, France; Department of rheumatology, Pitié-Salpêtrière Hospital, AP-HP, 75013 Paris, France; Brest University, Rheumatology Department, La Cavale-Blanche University Hospital, 29000 Brest, France.
authors.forename: Laure
authors.initials: L
authors.lastname: Gossec
authors.affiliation: Département d'Épidémiologie et Recherche clinique, Hôpital Bichat, AP-HP, 75018 Paris, France; Inserm, CIC-EC 1425, UMR 1123, ECEVE, 75018 Paris, France; Université Paris Diderot, Sorbonne Paris Cité, UMR 1123, 75018 Paris, France; Brest University, Rheumatology Department, La Cavale-Blanche University Hospital, 29000 Brest, France.
authors.forename: Florence
authors.initials: F
authors.lastname: Tubach
authors.affiliation: Département d'Épidémiologie et Recherche clinique, Hôpital Bichat, AP-HP, 75018 Paris, France; Inserm, CIC-EC 1425, UMR 1123, ECEVE, 75018 Paris, France; Université Paris Diderot, Sorbonne Paris Cité, UMR 1123, 75018 Paris, France; Brest University, Rheumatology Department, La Cavale-Blanche University Hospital, 29000 Brest, France.
authors.forename: Toni
authors.initials: T
authors.lastname: Alfaiate
authors.affiliation: Aix-Marseille University, AP-HM, Rheumatology Department, Sainte-Marguerite Hospital, 13006 Marseille, France; Brest University, Rheumatology Department, La Cavale-Blanche University Hospital, 29000 Brest, France.
authors.forename: Thao
authors.initials: T
authors.lastname: Pham
authors.affiliation: Rheumatology Department, Clermont-Ferrand University Hospital, 63000 Clermont-Ferrand, France; Brest University, Rheumatology Department, La Cavale-Blanche University Hospital, 29000 Brest, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Saraux
authors.affiliation: Rheumatology Department, Clermont-Ferrand University Hospital, 63000 Clermont-Ferrand, France; Brest University, Rheumatology Department, La Cavale-Blanche University Hospital, 29000 Brest, France.
authors.forename: Martin
authors.initials: M
authors.lastname: Soubrier
authors.affiliation: Victor-Segalen-Bordeaux 2 University, Rheumatology Department, Pellegrin University Hospital, 33000 Bordeaux, France; Brest University, Rheumatology Department, La Cavale-Blanche University Hospital, 29000 Brest, France.
authors.forename: Thierry
authors.initials: T
authors.lastname: Schaeverbeke
authors.affiliation: Burgundy University, Rheumatology Department, Dijon University Hospital, 21000 Dijon, France; Brest University, Rheumatology Department, La Cavale-Blanche University Hospital, 29000 Brest, France.
authors.forename: Jean-Francis
authors.initials: JF
authors.lastname: Maillefert
authors.affiliation: Paris Sud University-Paris 11, AP-HP, Rheumatology Department, Bicêtre Hospital, 94700 Le Kremlin-Bicêtre, France; Brest University, Rheumatology Department, La Cavale-Blanche University Hospital, 29000 Brest, France.
authors.forename: Xavier
authors.initials: X
authors.lastname: Mariette
authors.affiliation: Département d'Épidémiologie et Recherche clinique, Hôpital Bichat, AP-HP, 75018 Paris, France; Inserm, CIC-EC 1425, UMR 1123, ECEVE, 75018 Paris, France; Université Paris Diderot, Sorbonne Paris Cité, UMR 1123, 75018 Paris, France; Brest University, Rheumatology Department, La Cavale-Blanche University Hospital, 29000 Brest, France.
authors.forename: David
authors.initials: D
authors.lastname: Hajage
authors.affiliation: Sorbonne Universités, UPMC Université Paris 06, Institut Pierre-Louis d'Épidémiologie et de Santé Publique, GRC-UPMC 08 (EEMOIS), 75013 Paris, France; Department of rheumatology, Pitié-Salpêtrière Hospital, AP-HP, 75013 Paris, France; Brest University, Rheumatology Department, La Cavale-Blanche University Hospital, 29000 Brest, France.
authors.forename: Bruno
authors.initials: B
authors.lastname: Fautrel
mesh_terms: D000328:Adult; D000368:Aged; D018501:Antirheumatic Agents / Q000008:administration & dosage*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000503:physiopathology*; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000071066:Patient Reported Outcome Measures; D011379:Prognosis; D018570:Risk Assessment; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000008:administration & dosage / Q000037:antagonists & inhibitors*
chemical_list: D018501:Antirheumatic Agents; D014409:Tumor Necrosis Factor-alpha
keywords: Flares; Pain; Questionnaires; Rheumatoid arthritis; TNF-blockers