Περίληψη:
Objectives To define disease activity levels, minimal clinically important improvement (MCII) and patientacceptable 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 patientreported 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 patientreported 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.
Συγγραφείς:
Seror, R.
Bootsma, H.
Saraux, A.
Bowman, S.J.
Theander, E.
Brun, J.G.
Baron, G.
Le Guern, V.
Devauchelle-Pensec, V.
Ramos-Casals, M.
Valim, V.
Dörner, T.
Tzioufas, A.
Gottenberg, J.-E.
Laqué, R.S.
Mandl, T.
Hachulla, E.
Sivils, K.L.
Ng, W.-F.
Fauchais, A.-L.
Bombardieri, S.
Priori, R.
Bartoloni, E.
Goeb, V.
Praprotnik, S.
Sumida, T.
Nishiyama, S.
Caporali, R.
Kruize, A.A.
Vollenweider, C.
Ravaud, P.
Meiners, P.
Brito-Zerón, P.
Vitali, C.
Mariette, X.
Gerli, R.
Kallenberg, C.
De Vita, S.
Demoulins, F.
Montecucco, C.
Tomsic, M.
Scofield, H.
Valesini, G.
EULAR Sjogren's Task Force
Λέξεις-κλειδιά:
azathioprine; corticosteroid; hydroxychloroquine; methotrexate; rituximab, adult; aged; Article; clinical evaluation; cohort analysis; disease activity; disease activity score; disease course; disease duration; European League Against Rheumatism Sjogren syndrome disease activity index; European League Against Rheumatism Sjogren syndrome patient reported index; female; follow up; health status; human; major clinical study; male; medical assessment; methodology; minimal clinically important improvement; patient satisfaction; priority journal; prospective study; receiver operating characteristic; Sjoegren syndrome; symptom; treatment outcome; health status; middle aged; procedures; psychology; self evaluation; severity of illness index; Sjogren's Syndrome; symptom assessment, Aged; Diagnostic Self Evaluation; Disease Progression; Female; Health Status; Humans; Male; Middle Aged; Patient Satisfaction; Prospective Studies; ROC Curve; Severity of Illness Index; Sjogren's Syndrome; Symptom Assessment
