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Rituximab therapy is a promising treatment for primary Sjögren's syndrome (pSS).1 ,2 So far, treatment studies performed in patients with pSS lacked the use of a uniform outcome measure to monitor disease activity.
Recently, the European League Against Rheumatism (EULAR) developed the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI).3 ESSDAI was shown to be able to monitor disease activity in patient profile and open-label studies.4 ,5 To further study the utility of ESSDAI for clinical studies, we assessed the responsiveness of ESSDAI after rituximab treatment in a randomised controlled trial (RCT) of patients with pSS.6
As the principal investigator (HB) was involved in the development of ESSDAI, the database of a single-centre, randomised, double-blind, placebo-controlled trial (see ref. 6 for details) was prospectively completed with regard to all ESSDAI domains, namely the cutaneous, respiratory, renal, articular, muscular, peripheral and central nervous system, haematological, glandular, constitutional, …