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).
Raphaèle SerorHendrika BootsmaAlain SarauxSimon J BowmanElke TheanderJohan G BrunGabriel BaronVéronique Le GuernValérie Devauchelle-PensecManuel Ramos-CasalsValeria ValimThomas DörnerAthanasios TzioufasJacques-Eric GottenbergRoser Solans LaquéThomas MandlEric HachullaKathy L SivilsWan-Fai NgAnne-Laure FauchaisStefano BombardieriRoberta PrioriElena BartoloniVincent GoebSonja PraprotnikTakayuki SumidaSumusu NishiyamaRoberto CaporaliAike A KruizeCristina VollenweiderPhilippe RavaudPetra MeinersPilar Brito-ZerónClaudio VitaliXavier Mariettenull nullPublished in: Annals of the rheumatic diseases (2014)
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.
Keyphrases
- disease activity
- patient reported
- systemic lupus erythematosus
- rheumatoid arthritis
- patient reported outcomes
- rheumatoid arthritis patients
- ankylosing spondylitis
- clinical trial
- juvenile idiopathic arthritis
- case report
- high intensity
- risk factors
- current status
- randomized controlled trial
- combination therapy
- phase iii
- drug induced