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 1 Hendrika Bootsma Alain Saraux 2, 3 Simon J Bowman Elke Theander 4 Johan G Brun Gabriel Baron 5 Véronique Le Guern Valérie Devauchelle-Pensec 2 Manel Ramos-Casals Valeria Valim Thomas Dörner 6 Athanasios Tzioufas 7 Jacques-Eric Gottenberg 8 Roser Solans Laqué Thomas Mandl Eric Hachulla 9 Kathy L Sivils Wan-Fai Ng 10 Anne-Laure Fauchais 11 Stefano Bombardieri Roberta Priori Elena Bartoloni Vincent Goeb 12 Sonja Praprotnik 13 Takayuki Sumida 14 Sumusu Nishiyama Roberto Caporali Aike A Kruize Cristina Vollenweider Philippe Ravaud 15 Petra Meiners Pilar Brito-Zerón Claudio Vitali 16 Xavier Mariette 1, 17
Abstract : 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<5), moderate-activity (5/=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 points and MCII as a decrease of at least one point or 15%. 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.
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http://hal.univ-brest.fr/hal-01258579
Contributeur : Ghislaine Calvez <>
Soumis le : mardi 19 janvier 2016 - 11:58:49
Dernière modification le : mardi 5 juin 2018 - 10:14:34

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Raphaèle Seror, Hendrika Bootsma, Alain Saraux, Simon J Bowman, Elke Theander, et al.. 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). Annals of the Rheumatic Diseases, BMJ Publishing Group, 2014, 75 (2), 〈10.1136/annrheumdis-2014-206008〉. 〈hal-01258579〉

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