• 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 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 Goeb, Sonja Praprotnik, Takayuki Sumida, Sumusu Nishiyama, Roberto Caporali, Aike A Kruize, Cristina Vollenweider, Philippe Ravaud, Petra Meiners, Pilar Brito-Zerón, Claudio Vitali, Xavier Mariette, and EULAR Sjögren's Task Force.
• Department of Rheumatology, Hôpitaux Universitaires Paris-Sud, Assistance Publique-Hopitaux de Paris (AP-HP), Université Paris-Sud, INSERM U1012, Le Kremlin Bicêtre, France Center of Clinical Epidemiology, Hôpital Hotel Dieu, Paris, France INSERM U738, Université Paris-René Descartes, Paris, France.
• Ann. Rheum. Dis. 2016 Feb 1; 75 (2): 382-9.

ObjectivesTo 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).MethodsFor 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.ResultsLow-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%.ConclusionsThis 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.Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

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