1. Defining disease activity states and clinically meaningful improvement in primary Sjögren's syndrome with EULAR primary Sjögren's syndrome disease activity (ESSDAI) and patient-reported indexes (ESSPRI)
- Author
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Seror, R, Bootsma, H, Saraux, A, Bowman, S, Theander, E, Brun, Jg, Baron, G, Le Guern, V, Devauchelle Pensec, V, Ramos Casals, M, Valim, V, Dörner, T, Tzioufas, A, Gottenberg, Je, Laqué, Rs, Mandl, T, Hachulla, E, Sivils, Kl, Wf, Ng, Fauchais, A, Bombardieri, S, Priori, R, BARTOLONI BOCCI, Elena, Goeb, V, Praprotnik, S, Sumida, T, Nishiyama, S, Caporali, R, Kruize, Aa, Vollenweider, C, Ravaud, P, Meiners, P, Brito Zerón, P, Vitali, C, Mariette, X, Gerli, Roberto, Kallenberg, C, De Vita, S, Demoulins, F, Montecucco, C, Tomsic, M, Scofield, H, Valesini, G., Service de rhumatologie, AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre), Immunologie et Pathologie (EA2216), Université de Brest (UBO)-IFR148, Centre d'Investigation Clinique (CIC - Brest), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Department of Rheumatology, Lund University [Lund], Education Discours Apprentissages (EDA - EA 4071), Université Paris Descartes - Paris 5 (UPD5), Klinik für Dermatologie, Venerologie und Allergologie, Department of Pathophysiology, Medical School, University of Athens, Immuno-Rhumatologie Moléculaire, Université de Strasbourg (UNISTRA)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Lille, Droit et Santé, University of Northumbria at Newcastle [United Kingdom], Service de Médecine interne A et polyclinique médicale [CHU Limoges], CHU Limoges, Service de rhumatologie [Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), University Medical Centre, University of Tsukuba, Equipe 5 : METHODS - Méthodes de l’évaluation thérapeutique des maladies chroniques (CRESS - U1153), Université Paris Descartes - Paris 5 (UPD5)-Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Department of Internal Medicine and section of Rheumatology, Villamarina Hospital, Immunologie des Maladies Virales et Autoimmunes (IMVA - U1184), Université Paris-Sud - Paris 11 (UP11)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Strasbourg (UNISTRA), Service de rhumatologie [CHU Rouen], Université de Tsukuba = University of Tsukuba, Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA), Université Paris-Sud - Paris 11 (UP11)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Translational Immunology Groningen (TRIGR), Immunologie et Pathologie ( EA2216 ), Université de Brest ( UBO ) -IFR148, Centre d'Investigation Clinique ( CIC - Brest ), Université de Brest ( UBO ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Education Discours Apprentissages ( EDA - EA 4071 ), Université Paris Descartes - Paris 5 ( UPD5 ), Université de Strasbourg ( UNISTRA ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), CHU Rouen-Université de Rouen Normandie ( UNIROUEN ), Normandie Université ( NU ) -Normandie Université ( NU ), Equipe 5 : METHODS - Méthodes de l’évaluation thérapeutique des maladies chroniques ( CRESS - U1153 ), Université Paris Descartes - Paris 5 ( UPD5 ) -Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité ( CRESS (U1153 / UMR_A 1125) ), Institut National de la Recherche Agronomique ( INRA ) -Université Sorbonne Paris Cité ( USPC ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Institut National de la Recherche Agronomique ( INRA ) -Université Sorbonne Paris Cité ( USPC ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Immunologie des Maladies Virales et Autoimmunes ( IMVA - U1184 ), Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université Paris-Sud - Paris 11 ( UP11 ) -Commissariat à l'énergie atomique et aux énergies alternatives ( CEA ), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Sorbonne Paris Cité (USPC), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Sud - Paris 11 (UP11)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)
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0301 basic medicine ,Genetics and Molecular Biology (all) ,Male ,[SDV]Life Sciences [q-bio] ,Health Status ,Rheumatology ,Immunology ,Biochemistry, Genetics and Molecular Biology (all) ,Immunology and Allergy ,Biochemistry ,Severity of Illness Index ,RESPONSIVENESS ,DOUBLE-BLIND ,0302 clinical medicine ,EUROPEAN LEAGUE ,Epidemiology ,Prospective Studies ,SYSTEMIC-LUPUS-ERYTHEMATOSUS ,10. No inequality ,Prospective cohort study ,Non-U.S. Gov't ,Research Support, Non-U.S. Gov't ,RANDOMIZED CONTROLLED-TRIAL ,Middle Aged ,3. Good health ,Sjogren's Syndrome ,[SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system ,Patient Satisfaction ,Rheumatoid arthritis ,patient-reported indexes (ESSPRI) ,Disease Progression ,Female ,Symptom Assessment ,medicine.medical_specialty ,BELIMUMAB ,Research Support ,General Biochemistry, Genetics and Molecular Biology ,[ SDV.MHEP.RSOA ] Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system ,03 medical and health sciences ,Diagnostic Self Evaluation ,Patient satisfaction ,Internal medicine ,[ SDV.MHEP ] Life Sciences [q-bio]/Human health and pathology ,Severity of illness ,medicine ,Journal Article ,Humans ,disease activity states ,Aged ,030203 arthritis & rheumatology ,Outcomes research ,Patient perspective ,Sjøgren's Syndrome ,ROC Curve ,[ SDV ] Life Sciences [q-bio] ,EULAR primary Sjogren's syndrome disease activity ,business.industry ,RITUXIMAB TREATMENT ,medicine.disease ,EFFICACY ,RHEUMATOID-ARTHRITIS ,Clinical trial ,030104 developmental biology ,Physical therapy ,business ,ACCEPTABLE SYMPTOM STATE ,Rheumatism ,[SDV.MHEP]Life Sciences [q-bio]/Human health and pathology - Abstract
International audience; OBJECTIVES: To define disease activity levels, minimal clinically important improvement (MCII) and patient-acceptable symptom state (PASS) with the primary Sjogren's syndrome (SS) disease activity indexes: European League Against Rheumatism (EULAR) SS disease activity index (ESSDAI) and EULAR SS patient-reported index (ESSPRI). METHODS: For 790 patients from two large prospective cohorts, ESSDAI, physician evaluation of disease activity, ESSPRI and patients' satisfaction with their current health status were recorded. Receiver operating characteristic curve analyses and anchoring methods were used to estimate disease activity levels of ESSDAI and the PASS of ESSPRI. At follow-up visit, patients and physicians assessed, respectively, whether symptoms and disease activity have improved or not. An anchoring method based on this evaluation was used to estimate MCII of ESSDAI and ESSPRI. RESULTS: Low-activity (ESSDAI/=14) levels were defined. MCII of ESSDAI was defined as an improvement of at least three points. The PASS estimate was defined as an ESSPRI/=5) and define response to treatment as an improvement of ESSDAI at least three points. For addressing patient-reported outcomes, inclusion of patients with unsatisfactory symptom state (ESSPRI>/=5) and defining response as an improvement of ESSPRI at least one point or 15% seems reasonable.
- Published
- 2014