Nomenclature for the disease widely known as Sjögren syndrome has proven unsatisfactory. Patients have perceived ‘syndrome’ as indicative of a vague collection of symptoms, prompting the Sjögren’s Foundation to abandon the term. Furthermore, the traditional distinction between ‘primary’ and ‘secondary’ forms fails to account for the complex interplay between overlapping autoimmune diseases. Following a bibliometric analysis, systematic literature review and a Delphi consensus process with equal involvement of professional and patient representatives, five recommendations are now issued. First, the term ‘Sjögren disease’ should replace ‘Sjögren syndrome’. Second, the acronym ‘SjD’ should be used as an abbreviation for ‘Sjögren disease’. Third, the descriptor ‘associated’ should be used in lieu of ‘secondary’ for Sjögren disease occurring in association with a second systemic autoimmune disease for which classification criteria are fulfilled. Fourth, Sjögren disease is the preferred terminology in common parlance and in clinical diagnosis, without differentiation as to primary and associated forms. Fifth, the differentiation between primary and associated Sjögren is recommended for scientific studies to define a homogeneous population. In conclusion, the consensus endorses ‘Sjögren disease’ as the official nomenclature to acknowledge the distinct pathogenesis of this disorder and to improve clarity in both clinical practice and research.

Objective: To systematically review all existing Sjögren disease (SjD)-related instruments reported in clinical trials for SjD. Methods: We systematically searched Medline (PubMed) and EMBASE between January 2002 and March 2023 to identify all randomized controlled trials (RCTs) using both a manual approach and artificial intelligence software (Bibliography BOT). We extracted all the instruments used as primary or secondary outcomes and assessed whether the study succeeded in improving the outcome. We also classified the instruments according to the recently defined preliminary outcome domains. Results: Among 5420 references, 60 RCTs were included, focusing either on overall disease manifestations (53%) or on a single organ/symptom (eg, dry eyes [17%], xerostomia [15%], fatigue [12%], or pulmonary function [3%]). Primary outcomes included measures of oral or ocular dryness, patient-reported outcomes (PROs), systemic activity, and other outcomes. Common instruments used were European Alliance of Associations for Rheumatology (EULAR) Sjögren Syndrome Disease Activity Index (ESSDAI), EULAR Sjögren Syndrome Patient-Reported Index, Schirmer-I test for unstimulated salivary flow, and IgG levels. ESSDAI was a primary outcome in 11 studies, with 45% of studies reaching significance, whereas none of the 16 studies with ESSDAI as a secondary outcome reached significance. PROs were the primary outcome in 34 studies. Glandular function measurements varied, with unstimulated salivary flow as the most commonly measured outcome. Life impact was assessed more frequently as a secondary outcome. Only 2 studies focused on biological activity. Conclusion: Our review highlighted the heterogeneity of SjD RCTs in both the study designs and outcomes. The use of PROs and composite outcomes has increased in recent years, highlighting a shift from objective dryness measures to more holistic patient-centered outcomes.

Background/Objectives: Sjögren’s disease (SjD) flares are incompletely understood. The patient perspective is critical to closing this gap. This retrospective social media listening (SML) study characterized the flare lexicon within the online Reddit SjD community using novel machine learning and natural language processing. Methods: Documents (posts/comments) were analyzed from the subreddit group “r/Sjogrens” (October 2012 to August 2023). Outcomes were as follows: (1) Frequency of documents mentioning flare, and contexts in which flare was mentioned; (2) clinical concepts associated with flare (analyzed using co-occurrence and pointwise mutual information [PMI]); (3) proportion of flare vs. non-flare documents relevant to SYMPTOMS or TESTING (compared using a two-proportion z-test); and (4) primary emotions mentioned in flare documents. Results: Of 59,266 documents with 5025 authors, flare was mentioned 3330 times (4.4% of documents from 19.1% of authors). Flare was discussed as a symptom (1423 instances), disease (13), or with no clinical category (1890). Flare-associated clinical concepts (co-occurrence > 100 and PMI² > 3) included SYMPTOMS (pain, fatigue, dryness of eye, xerostomia, arthralgia, stress) and BODY PARTS (eye, mouth, joints, whole body). More flare vs. non-flare documents mentioned a SYMPTOM, whereas fewer mentioned a TEST (p < 0.001 for both). Within flare documents, 36.5% expressed emotions, primarily fear (40.5% of primary emotions), happiness (17.8%), sadness (15.7%), and anger (15.5%). Conclusions: The SjD community discusses flare frequently and in context with symptoms, specifically pain, eye and mouth dryness, and fatigue. Flare conversations frequently involve negative emotions. Additional research is required to clarify the patient experience of flare, its clinical parameters, and implications.

NEW Clinical Endpoints in primary Sjögren’s Syndrome: an Interventional Trial based on stratifiYing patients (NECESSITY) is a public...