The Eular Initiative

Because national studies aimed at producing disease status criteria for SS may suffer from limitations, particularly in terms of content validity and amplitude of data collection, a multinational initiative sponsored by EULAR (European League Against Rheumatism) has recently begun. This is aimed at defining and validating a EULAR activity index for SS. A promoting committee, which includes investigators from 6 European countries and a large number of investigators from other European and overseas countries, has been constituted. These investigators have proven experience in the clinical management of patients with SS. The conceptual framework of the project begins with the consideration that the clinical spectrum of SS may vary from a relatively stable or slowly progressive disorder (commonly limited to exocrine gland involvement and accompanied by constitutional symptoms as fatigue and pain because of musculoskeletal involvement) to a more aggressive and systemic disorder with a number of extraglandular features, usually accompanied by serologic signs of autoimmune activation. Thus, the task force of the project decided that at least two indices are needed. The first one should be able to assess sicca complaints and subjective symptoms, such as fatigue and pain; the second should be more oriented to assess global activity as expressed by the systemic features of the disease. Thus, two different arms of the study have been planned and are ongoing in parallel. Once both patient-reported and systemic activity indices are available, their validation in a second independent study will be required before use in therapeutic trials and daily clinical practice.

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