Trial reportAnnals of the rheumatic diseases2018
Effect of rituximab on a salivary gland ultrasound score in primary Sjögren's syndrome: results of the TRACTISS randomised double-blind multicentre substudy.
Trial report in Annals of the rheumatic diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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
45 citing papers in PubMed, 3 syntheses or guidelines pooled it, 103 citations in OpenAlex.
- A Systematic Review and Meta-Analysis of 19 Randomized Controlled Trials of Iguratimod Combined With Other Therapies for Sjogren's Syndrome.Frontiers in immunology · 2022Pooled it
- World Workshop on Oral Medicine VII: Immunobiologics for salivary gland disease in Sjögren's syndrome: A systematic review.Oral diseases · 2019Pooled it
- Systematic Review of Safety and Efficacy of Rituximab in Treating Immune-Mediated Disorders.Frontiers in immunology · 2019Pooled it
- Efficacy and safety of iguratimod in patients with primary Sjögren's syndrome: a multicentre randomised controlled trial.RMD open · 2025Trial
- Long-term effectiveness of a novel intra-oral electro-stimulator for the treatment of dry mouth in patients with Sjogren's syndrome: A randomised sham-controlled feasibility study (LEONIDAS-1).Journal of oral pathology & medicine : official publication of the International Association of Oral Pathologists and the American Academy of Oral Pathology · 2023Trial
- Efficacy and safety of abatacept in active primary Sjögren's syndrome: results of a phase III, randomised, placebo-controlled trial.Annals of the rheumatic diseases · 2021Trial
- Managing Sjögren's Disease in Pediatric Patients.Paediatric drugs · 2026Review
- From Molecular Pathophysiology to Clinical Trial Design in Sjögren's Disease: A Three-Axis Framework.International journal of molecular sciences · 2026Review
- Review
- Evaluation of Effectiveness of Long-Term Therapy with Russian Rituximab Biosimilar (Acellbia) in Sjogren's Disease in Real Clinical Practice.Doklady. Biochemistry and biophysics · 2026Article
- Plasmablasts as Translational Biomarkers in Autoimmune Diseases: From Cellular Dynamics to Clinical Decision-Making.Current issues in molecular biology · 2026Review
- Spatiotemporal orchestration of the salivary gland immune microenvironment in Sjögren's disease: a multidimensional framework of epithelial licensing, lymphoid neogenesis, and stromal remodeling.Frontiers in immunology · 2026Review
- From immune activation to symptom burden: mechanisms and translational implications of immune-symptom uncoupling in Sjögren's disease.Frontiers in immunology · 2026Review
- From endotypes to therapeutic targets: exploring the potential of precision treat-to-target approaches in primary Sjögren's disease.Clinical rheumatology · 2025Review
- Practical Use of Ultrasound in Modern Rheumatology-From A to Z.Life (Basel, Switzerland) · 2024Review
- Treatment of non-systemic Sjögren's syndrome: Potential prevention of systematization with immunosuppressant agent/biotherapy.Journal of translational autoimmunity · 2024Article
- A case report of AQP4-IgG-seropositive refractory neuromyelitis optica spectrum disorder patient with Sjögren's syndrome and pancytopenia treated with inebilizumab.Frontiers in neurology · 2024Article
- Emerging treatment for Sjögren's disease: a review of recent phase II and III trials.Expert opinion on emerging drugs · 2023Review
- Overview of Ultrasound in Dentistry for Advancing Research Methodology and Patient Care Quality with Emphasis on Periodontal/Peri-implant Applications.Zeitschrift fur medizinische Physik · 2023Review
- Outline of Salivary Gland Pathogenesis of Sjögren's Syndrome and Current Therapeutic Approaches.International journal of molecular sciences · 2023Review
Corrections and comments
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Authors and funding
27 authors at 19 institutions in 1 country.
Funding
Abstract
objectivesTo compare the effects of rituximab versus placebo on salivary gland ultrasound (SGUS) in primary Sjögren's syndrome (PSS) in a multicentre, multiobserver phase III trial substudy.
methodsSubjects consenting to SGUS were randomised to rituximab or placebo given at weeks 0, 2, 24 and 26, and scanned at baseline and weeks 16 and 48. Sonographers completed a 0-11 total ultrasound score (TUS) comprising domains of echogenicity, homogeneity, glandular definition, glands involved and hypoechoic foci size. Baseline-adjusted TUS values were analysed over time, modelling change from baseline at each time point. For each TUS domain, we fitted a repeated-measures logistic regression model to model the odds of a response in the rituximab arm (≥1-point improvement) as a function of the baseline score, age category, disease duration and time point.
results52 patients (n=26 rituximab and n=26 placebo) from nine centres completed baseline and one or more follow-up visits. Estimated between-group differences (rituximab-placebo) in baseline-adjusted TUS were -1.2 (95% CI -2.1 to -0.3; P=0.0099) and -1.2 (95% CI -2.0 to -0.5; P=0.0023) at weeks 16 and 48. Glandular definition improved in the rituximab arm with an OR of 6.8 (95% CI 1.1 to 43.0; P=0.043) at week 16 and 10.3 (95% CI 1.0 to 105.9; P=0.050) at week 48.
conclusionsWe demonstrated statistically significant improvement in TUS after rituximab compared with placebo. This encourages further research into both B cell depletion therapies in PSS and SGUS as an imaging biomarker. TRIAL REGISTRATION NUMBER: 65360827, 2010-021430-64; Results.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.