ArticlePloS one
High-Grade Salivary-Gland Involvement, Assessed by Histology or Ultrasonography, Is Associated with a Poor Response to a Single Rituximab Course in Primary Sjögren's Syndrome: Data from the TEARS Randomized Trial.
Article in PloS one. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 3 of them syntheses that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- British Society for Rheumatology guideline on management of adult and juvenile onset Sjögren disease.Rheumatology (Oxford, England) · 2025Guideline
- World Workshop on Oral Medicine VII: Immunobiologics for salivary gland disease in Sjögren's syndrome: A systematic review.Oral diseases · 2019Pooled it
- Lymphocytes as Biomarkers of Therapeutic Response in Rheumatic Autoimmune Diseases, Is It a Realistic Goal?Clinical reviews in allergy & immunology · 2017Pooled it
- Effect of rituximab on a salivary gland ultrasound score in primary Sjögren's syndrome: results of the TRACTISS randomised double-blind multicentre substudy.Annals of the rheumatic diseases · 2018Trial
- From Molecular Pathophysiology to Clinical Trial Design in Sjögren's Disease: A Three-Axis Framework.International journal of molecular sciences · 2026Review
- Inflammation-Driven Lymphoid Structures: Organization, Function, and Clinical Impact Across Autoimmunity, Cancer, and Checkpoint Toxicity.Immunological reviews · 2026Review
- Machine and Deep Learning Approaches Applied to Classify Gougerot-Sjögren Syndrome and Jointly Segment Salivary Glands.Bioengineering (Basel, Switzerland) · 2023Article
- Histopathology, salivary flow and ultrasonography of the parotid gland: three complementary measurements in primary Sjögren's syndrome.Rheumatology (Oxford, England) · 2022Article
- Sjögren syndrome: looking forward to the future.Therapeutic advances in musculoskeletal disease · 2022Review
- Salivary Gland Ultrasound in Primary Sjögren's Syndrome: Current and Future Perspectives.Open access rheumatology : research and reviews · 2022Review
- Targeted Therapy for Primary Sjögren's Syndrome: Where are We Now?BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2021Review
- Rituximab Therapy for Primary Sjögren's Syndrome.Frontiers in pharmacology · 2021Review
- Biological Therapy in Primary Sjögren's Syndrome: Effect on Salivary Gland Function and Inflammation.Frontiers in medicine · 2021Review
- Ultrasonographic characteristics of major salivary glands in anti-centromere antibody-positive primary Sjögren's syndrome.PloS one · 2021Article
- Recent Advances of Salivary Gland Biopsy in Sjögren's Syndrome.Frontiers in medicine · 2021Review
- Imaging in Primary Sjögren's Syndrome.Journal of clinical medicine · 2020Review
- Salivary gland ultrasound in the diagnostic workup of juvenile Sjögren's syndrome and mixed connective tissue disease.Pediatric rheumatology online journal · 2020Article
- Diagnostic accuracy of salivary gland ultrasound in Sjögren's syndrome: A systematic review and meta-analysis.Therapeutic advances in musculoskeletal disease · 2020Review
- The Utility of Major Salivary Gland Ultrasonographic Parameters in the Diagnosis of Sjögren Syndrome.Disease markers · 2019Article
- Comparison of 2002 AECG and 2016 ACR/EULAR classification criteria and added value of salivary gland ultrasonography in a patient cohort with suspected primary Sjögren's syndrome.Arthritis research & therapy · 2017Article
Corrections and comments
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Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo determine whether the severity of salivary-gland involvement, assessed using salivary gland ultrasonography [SGUS], histological focus score, or the unstimulated whole salivary flow [UWSF], was associated with the response to rituximab in patients with primary Sjögren's syndrome [pSS]. MATERIALS AND
methodsAmong the 120 patients with pSS enrolled in the randomised TEARS trial of rituximab versus placebo, 35 underwent either centralised minor salivary-gland biopsy or SGUS at inclusion. The echostructure of each parotid and submandibular gland was graded on a scale of 0 to 4. Histologic minor salivary gland involvement was assessed by the focus score. Among rituximab-treated patients with available data (n = 14), half met the Sjögren's Syndrome Responder Index [SSRI]-30 definition of a response at week 24.
resultsThe SGUS score correlated positively to the focus score [r = 0.61] and negatively to the UWSF [r = -0.68]. The focus score was not correlated to the UWSF. The median total SGUS grade at inclusion was 9 [6-11] in responders versus 16 [11-16] in non-responders [p = 0.04]. The proportion of SSRI-30 responders was 0% among patients with SGUS grade 4 and 88% among those with SGUS grade ≤3. Low baseline SGUS scores were associated with sicca-related outcomes improvement, but not with fatigue or biological improvement. Median baseline focus score was 0.3 [0.0-1.3] in the responders versus 4.0 [2.7-5.3] in the non-responders [p = 0.02]. Baseline UWSF was not associated with the response rate.
conclusionIn patients with pSS, the highest SGUS grade or a high histological focus score is associated with absence of a response to a single rituximab course after 6 months. Further studies, including more patients and different treatment strategies, are required to confirm the clinical utility of these potential biomarkers in pSS.
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