Severe Health-Related Quality-of-life Impairment in Active Primary Sjögren's Syndrome Is Driven by Patient-Reported Outcomes: Data from a Large Therapeutic Trial.

International audienceTo identify the principal determinants of health-related quality-of-life [HR-QoL] impairment in patients with active primary Sjögren's syndrome [pSS] participating in a large therapeutic trial [TEARS]. At the inclusion visit for the TEARS trial, 120 patients with active pSS completed the Short Form survey 36 [SF36], a validated HR-QoL assessment tool. Univariate then multivariate linear regression analyses were used to assess associations linking SF36 physical and mental components to demographic data, patient-reported outcomes [symptom intensity assessments for dryness, pain and fatigue, including the EULAR SS Patient Reported Index (ESSPRI)], objective measures of dryness and autoimmunity, and physician evaluation of systemic activity [using the EULAR SS Disease Activity Index (ESSDAI)]. SF36 scores indicated marked HR-QoL impairments in our population with active pSS. Approximately 1/3 of the patients had low, moderate and high systemic activity according to the ESSDAI. ESSPRI and ESSDAI scores were moderately but significantly correlated. The factors most strongly associated with HR-QoL impairment were patient-reported symptoms, best assessed using the ESSPRI, with pain and ocular dryness intensity showing independent associations with HR-QoL. Conversely, systemic activity level was not associated with HR-QoL impairment in multivariate analyses, even in the patient subset with ESSDAI values indicating moderate-to-high systemic activity. The cardinal symptoms of pSS (dryness, pain and fatigue, best assessed using the ESSPRI) are stronger predictors of HR-QoL impairment than systemic involvement (assessed by the ESSDAI), and should be used as endpoints in future therapeutic trials focusing on patients' well-being. New consensual and data-driven response criteria are needed for pSS studies. This article is protected by copyright. All rights reserved