title: Severe Health-Related Quality of Life Impairment in Active Primary Sjögren's Syndrome and Patient-Reported Outcomes: Data From a Large Therapeutic Trial.
abstract: To identify the principal determinants of health-related quality of life (HRQOL) impairment in patients with active primary Sjögren's syndrome (SS) participating in a large therapeutic trial, Tolerance and Efficacy of Rituximab in Primary Sjögren's Syndrome (TEARS).
  
  
  
  At the inclusion visit for the TEARS trial, 120 patients with active primary SS completed the Short Form 36 health survey (SF-36), a validated HRQOL assessment tool. Univariate then multivariate linear regression analyses were used to assess associations linking SF-36 physical and mental components to demographic data, patient-reported outcomes (symptom intensity assessments for dryness, pain, and fatigue, including the European League Against Rheumatism [EULAR] Sjögren's Syndrome Patient Reported Index [ESSPRI]), objective measures of dryness and autoimmunity, and physician evaluation of systemic activity (using the EULAR Sjögren's Syndrome Disease Activity Index [ESSDAI]).
  
  
  
  SF-36 scores indicated marked HRQOL impairments in our population with active primary SS. Approximately one-third of the patients had low, moderate, and high systemic activity according to the ESSDAI. ESSPRI and ESSDAI scores were moderately but significantly correlated. The factors most strongly associated with HRQOL impairment were patient-reported symptoms, best assessed using the ESSPRI, with pain and ocular dryness intensity showing independent associations with HRQOL. Conversely, systemic activity level was not associated with HRQOL impairment in multivariate analyses, even in the patient subset with ESSDAI values indicating moderate-to-high systemic activity.
  
  
  
  The cardinal symptoms of primary SS (dryness, pain, and fatigue, best assessed using the ESSPRI) are stronger predictors of HRQOL impairment than systemic involvement (assessed by the ESSDAI) and should be used as end points in future therapeutic trials focusing on patients' well-being. New consensual and data-driven response criteria are needed for primary SS studies.
authors.affiliation: Centre Hospitalier Universitaire de la Cavale Blanche, and EA 2216, INSERM ESPRI, ERI29, Université de Brest, LabEx IGO, Brest, France.
authors.forename: Divi
authors.initials: D
authors.lastname: Cornec
authors.affiliation: Centre Hospitalier Universitaire de la Cavale Blanche, and EA 2216, INSERM ESPRI, ERI29, Université de Brest, LabEx IGO, Brest, France.
authors.forename: Valérie
authors.initials: V
authors.lastname: Devauchelle-Pensec
authors.affiliation: Assistance Publique-Hôpitaux de Paris, Hôpitaux Universitaires Paris-Sud, INSERM U1184, Université Paris-Sud, Le Kremlin Bicêtre, France.
authors.forename: Xavier
authors.initials: X
authors.lastname: Mariette
authors.affiliation: Centre Hospitalier Universitaire de la Cavale Blanche, and EA 2216, INSERM ESPRI, ERI29, Université de Brest, LabEx IGO, Brest, France.
authors.forename: Sandrine
authors.initials: S
authors.lastname: Jousse-Joulin
authors.affiliation: Hôtel-Dieu, Centre Hospitalier Universitaire Nantes, Nantes, France.
authors.forename: Jean-Marie
authors.initials: JM
authors.lastname: Berthelot
authors.affiliation: Centre Hospitalier Universitaire, Hôpital Sud, Rennes, France.
authors.forename: Aleth
authors.initials: A
authors.lastname: Perdriger
authors.affiliation: Hôpital Cochin, Paris, France.
authors.forename: Xavier
authors.initials: X
authors.lastname: Puéchal
authors.affiliation: Hôpital Cochin, Paris, France.
authors.forename: Véronique
authors.initials: V
authors.lastname: Le Guern
authors.affiliation: Hôpitaux Universitaires de Strasbourg and Université de Strasbourg, Strasbourg, France.
authors.forename: Jean
authors.initials: J
authors.lastname: Sibilia
authors.affiliation: Hôpitaux Universitaires de Strasbourg and Université de Strasbourg, Strasbourg, France.
authors.forename: Jacques-Eric
authors.initials: JE
authors.lastname: Gottenberg
authors.affiliation: Hôpital Européen, Marseille, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Chiche
authors.affiliation: Hôpital Claude Huriez and Université Lille Nord-de-France, Lille, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Hachulla
authors.affiliation: Hôpital Claude Huriez and Université Lille Nord-de-France, Lille, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Yves Hatron
authors.affiliation: Centres Hospitaliers Régionaux Universitaires de Amiens, Amiens, France.
authors.forename: Vincent
authors.initials: V
authors.lastname: Goeb
authors.affiliation: Centre Hospitalier Universitaire Ambroise Paré, Boulogne, France.
authors.forename: Gilles
authors.initials: G
authors.lastname: Hayem
authors.affiliation: Centre Hospitalier Universitaire Lapeyronie, Montpellier, France.
authors.forename: Jacques
authors.initials: J
authors.lastname: Morel
authors.affiliation: Centre Hospitalier J. Monod, Montivilliers, France.
authors.forename: Charles
authors.initials: C
authors.lastname: Zarnitsky
authors.affiliation: Hôpital Gabriel Montpied, Clermont-Ferrand, France.
authors.forename: Jean Jacques
authors.initials: JJ
authors.lastname: Dubost
authors.affiliation: Centres Hospitaliers Régionaux Universitaires Morvan, Brest, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Saliou
authors.affiliation: EA 2216, INSERM ESPRI, ERI29, Université de Brest, LabEx IGO, and Centre Hospitalier Universitaire Morvan, and EA 2216, Université Bretagne Occidentale, Brest, France.
authors.forename: Jacques Olivier
authors.initials: JO
authors.lastname: Pers
authors.affiliation: Assistance Publique-Hôpitaux de Paris, Hôpitaux Universitaires Paris-Sud, INSERM U1184, Université Paris-Sud, Le Kremlin Bicêtre, France.
authors.forename: Raphaèle
authors.initials: R
authors.lastname: Seror
authors.affiliation: Centre Hospitalier Universitaire de la Cavale Blanche, and EA 2216, INSERM ESPRI, ERI29, Université de Brest, LabEx IGO, Brest, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Saraux
mesh_terms: D000328:Adult; D000368:Aged; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D017281:Cost of Illness; D005260:Female; D006801:Humans; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D000071066:Patient Reported Outcome Measures; D011446:Prospective Studies; D011788:Quality of Life; D000069283:Rituximab / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D012859:Sjogren's Syndrome / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology*; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D000069283:Rituximab