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). Issue 2 (5th December 2014)

• Record Type: Journal Article
• Authors: Seror, Raphaèle; Bootsma, Hendrika; Saraux, Alain; Bowman, Simon J; Theander, Elke; Brun, Johan G; Baron, Gabriel; Le Guern, Véronique; Devauchelle-Pensec, Valérie; Ramos-Casals, Manel; Valim, Valeria; Dörner, Thomas; Tzioufas, Athanasios; Gottenberg, Jacques-Eric; Solans Laqué, Roser; Mandl, Thomas; Hachulla, Eric; Sivils, Kathy L; Ng, Wan-Fai; Fauchais, Anne-Laure; Bombardieri, Stefano; Priori, Roberta; Bartoloni, Elena; Goeb, Vincent; Praprotnik, Sonja; Sumida, Takayuki; Nishiyama, Sumusu; Caporali, Roberto; Kruize, Aike A; Vollenweider, Cristina; Ravaud, Philippe; Meiners, Petra; Brito-Zerón, Pilar; Vitali, Claudio; Mariette, Xavier;
• Other Names: author non-byline.; Gerli Roberto author non-byline.; Kallenberg Cees author non-byline.; Brun Johan G author non-byline.; De Vita Salvatore author non-byline.; Devauchelle Valerie author non-byline.; Gottenberg Jacques Eric author non-byline.; Demoulins Frederic author non-byline.; Montecucco Carlomaurizio author non-byline.; Tomsic Matija author non-byline.; Casals Manel Ramos author non-byline.; Scofield Hal author non-byline.; Valesini Guido author non-byline.; Devauchelle Valerie author non-byline.; Saraux Alain author non-byline.; Dubost Jean-Jacques author non-byline.; Fauchais Anne-Laure author non-byline.; Sibilia Jean author non-byline.; Hayem Gilles author non-byline.; Hatron Pierre- Yves author non-byline.; Larroche Claire author non-byline.; Guern Veronique Le author non-byline.; Puéchal Xavier author non-byline.; Morel Jacques author non-byline.; Pedriger Aleth author non-byline.; Rist Stephanie author non-byline.; Sene Damien author non-byline.; Vittecoq Olivier author non-byline.
• Is Part Of: Annals of the rheumatic diseases. Volume 75:Issue 2(2016)
• Page Start: 382
• Page End: 389
• Publication Date: 2014-12-05
• Subjects: Sjøgren's Syndrome -- Outcomes research -- Patient perspective; Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2014-206008
• Languages: English
• ISSNs: 0003-4967

Abstract

Abstract : Objectives: To define disease activity levels, minimal clinically important improvement (MCII) and patient-acceptable symptom state (PASS) with the primary Sjögren'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≤ESSDAI≤13) and high-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 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.