Journal ArticleDOI
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)
Raphaèle Seror,Raphaèle Seror,Hendrika Bootsma,Alain Saraux,Simon J Bowman,Elke Theander,Johan G. Brun,Gabriel Baron,Véronique Le Guern,Valérie Devauchelle-Pensec,Manel Ramos-Casals,Valeria Valim,Thomas Dörner,Athanasios G. Tzioufas,Jacques-Eric Gottenberg,Roser Solans Laqué,Thomas Mandl,Eric Hachulla,Kathy L. Sivils,Wan-Fai Ng,Anne-Laure Fauchais,Stefano Bombardieri,Roberta Priori,Elena Bartoloni,Vincent Goëb,Sonja Praprotnik,Takayuki Sumida,Sumusu Nishiyama,Roberto Caporali,Aike A. Kruize,C. Vollenweider,Philippe Ravaud,Petra M. Meiners,Pilar Brito-Zerón,Claudio Vitali,Xavier Mariette +35 more
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TLDR
This study determined disease activity levels, PASS and MCII of ESSDAI and ESSPRI, which will help designing future clinical trials in SS and the proposal is to include patients with moderate activity and define response to treatment as an improvement of E SSDAI at least three points.Abstract:
Objectives To define disease activity levels, minimal clinically important improvement (MCII) and patient-acceptable symptom state (PASS) with the primary Sjogren9s 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 Conclusions This study determined disease activity levels, PASS and MCII of ESSDAI and ESSPRI. These results will help designing future clinical trials in SS. For evaluating systemic complications, the proposal is to include patients with moderate activity (ESSDAI≥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.read more
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Sjögren syndrome
Pilar Brito-Zerón,W. Baldini,Hendrika Bootsma,Simon J. Bowman,Roland Jonsson,Xavier Mariette,Kathy L. Sivils,Elke Theander,Athanasios G. Tzioufas,Manuel Ramos-Casals +9 more
TL;DR: Knowledge of SjS has progressed substantially, but this disease is still characterized by sicca symptoms, the systemic involvement of disease, lymphocytic infiltration to exocrine glands, the presence of anti-Ro/SSA and anti-La/SSB autoantibodies and the increased risk of lymphoma in patients with SJS.
Journal ArticleDOI
EULAR recommendations for the management of Sjögren's syndrome with topical and systemic therapies.
Manuel Ramos-Casals,Pilar Brito-Zerón,Stefano Bombardieri,Hendrika Bootsma,Salvatore De Vita,Thomas Dörner,Benjamin A Fisher,Jacques-Eric Gottenberg,Gabriela Hernández-Molina,Agnes Kocher,Belchin Kostov,Aike A. Kruize,Thomas Mandl,Wan-Fai Ng,Soledad Retamozo,Raphaèle Seror,Yehuda Shoenfeld,Antoni Sisó-Almirall,Athanasios G. Tzioufas,Claudio Vitali,Simon J Bowman,Xavier Mariette +21 more
TL;DR: The 2019 EULAR recommendations synthesise current thinking on SjS treatment in a set of overarching principles and recommendations and it is hoped that the current recommendations will be broadly applied in clinical practice and/or serve as a template for national societies to develop local recommendations.
Journal ArticleDOI
EULAR Sjögren's syndrome disease activity index (ESSDAI): a user guide.
Raphaèle Seror,Simon J Bowman,Pilar Brito-Zerón,Elke Theander,Hendrika Bootsma,Athanasios G. Tzioufas,Jacques-Eric Gottenberg,Manel Ramos-Casals,Thomas Dörner,Philippe Ravaud,Claudio Vitali,Xavier Mariette,Karsten Asmussen,Soren Jacobsen,Elena Bartoloni,Roberto Gerli,Johannes W. Bijlsma,Aike A. Kruize,Stefano Bombardieri,Arthur Bookman,Cees Kallenberg,Petra M. Meiners,Johan G Brun,Roland Jonsson,Roberto Caporali,Steven E. Carsons,Salvatore De Vita,Nicoletta Del Papa,Valérie Devauchelle,Alain Saraux,Anne-Laure Fauchais,Jean Sibilia,Eric Hachulla,Gabor G. Illei,David Isenberg,Adrian Jones,Menelaos Manoussakis,Thomas Mandl,Lennart Jacobsson,Frederic Demoulins,Carlomaurizio Montecucco,Wan-Fai Ng,Sumusu Nishiyama,Roald Omdal,Ann Parke,Sonja Praprotnik,Matjia Tomsic,Elizabeth Price,Hal Scofield,Kathy L Sivils,Josef S Smolen,Roser Solans Laqué,Serge Steinfeld,Nurhan Sutcliffe,Takayuki Sumida,Guido Valesini,Valeria Valim,Frederick B Vivino,C. Vollenweider +58 more
TL;DR: A user guide for the ESSDAI is provided, which provides definitions and precisions on the rating of each domain, and includes some minor improvement of the score to integrate advance in knowledge of disease manifestations.
Journal ArticleDOI
Rheumatoid Factor and Disease Activity Are Independent Predictors of Lymphoma in Primary Sjögren's Syndrome
Gaetane Nocturne,Alexandre Virone,Wan-Fai Ng,V. Le Guern,Eric Hachulla,Divi Cornec,Claire Daien,Olivier Vittecoq,Boris Bienvenu,Christian Marcelli,Daniel Wendling,Zahir Amoura,Robin Dhote,Christian Lavigne,R. Fior,J.-E. Gottenberg,Raphaèle Seror,Xavier Mariette +17 more
TL;DR: To define parameters predictive of lymphoma development in patients with primary Sjögren's syndrome (SS), parameters are defined and histopathological parameters are analyzed.
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