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) - Université de Bretagne Occidentale Access content directly
Journal Articles Annals of the Rheumatic Diseases Year : 2014

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)

Hendrika Bootsma
  • Function : Author
Simon J Bowman
  • Function : Author
Elke Theander
Johan G Brun
  • Function : Author
Véronique Le Guern
  • Function : Author
Valérie Devauchelle-Pensec
Manel Ramos-Casals
  • Function : Author
Valeria Valim
  • Function : Author
Roser Solans Laqué
  • Function : Author
Thomas Mandl
  • Function : Author
Eric Hachulla
Kathy L Sivils
  • Function : Author
Stefano Bombardieri
  • Function : Author
Roberta Priori
  • Function : Author
Elena Bartoloni
  • Function : Author
Vincent Goeb
Sumusu Nishiyama
  • Function : Author
Roberto Caporali
  • Function : Author
Aike A Kruize
  • Function : Author
Cristina Vollenweider
  • Function : Author
Petra Meiners
  • Function : Author
Pilar Brito-Zerón
  • Function : Author

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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Dates and versions

hal-01258579 , version 1 (19-01-2016)

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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, 2014, 75 (2), ⟨10.1136/annrheumdis-2014-206008⟩. ⟨hal-01258579⟩
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