Trial reportArthritis research & therapy2015
Low numbers of blood and salivary natural killer cells are associated with a better response to belimumab in primary Sjögren's syndrome: results of the BELISS study.
Trial report in Arthritis research & therapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01160666 (A Phase 2, Proof of Concept, 52-Week Open Study to Evaluate the Efficacy and Safety of Belimumab), which is not on this map. Cited by 21 papers, 1 of them a synthesis that pooled it.
What it found
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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.
A Phase 2, Proof of Concept, 52-Week Open Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS (BAFF) Antibody, in Subjects With Primary Sjögren's Syndrome
Who cites it
21 citing papers in PubMed, 1 synthesis or guideline pooled it, 48 citations in OpenAlex.
- Lymphocytes as Biomarkers of Therapeutic Response in Rheumatic Autoimmune Diseases, Is It a Realistic Goal?Clinical reviews in allergy & immunology · 2017Pooled it
- [Current treatment, foreseeable newcomer and new treatment approaches for Sjögren's disease].Zeitschrift fur Rheumatologie · 2026Review
- Inflammasomes in Sjögren's Disease: Exploring the Therapeutic Value.International journal of molecular sciences · 2026Review
- Immunophenotypic Stratification of Primary Sjögren's Syndrome Reveals Distinct Lymphocyte Profiles and Clinical Manifestations.Journal of immunology research · 2026Article
- Review
- Update on the pathophysiology and treatment of primary Sjögren syndrome.Nature reviews. Rheumatology · 2024Review
- Investigative biological therapies for primary Sjögren's syndrome.Archives of medical science : AMS · 2024Article
- Alteration of innate lymphoid cell homeostasis mainly concerns salivary glands in primary Sjögren's syndrome.RMD open · 2023Article
- The effects of B-cell-activating factor on the population size, maturation and function of murine natural killer cells.Immunology and cell biology · 2022Article
- A Computational Text Mining-Guided Meta-Analysis Approach to Identify Potential Xerostomia Drug Targets.Journal of clinical medicine · 2022Article
- Sjögren's syndrome: a systemic autoimmune disease.Clinical and experimental medicine · 2022Review
- Targeted Therapy for Primary Sjögren's Syndrome: Where are We Now?BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2021Review
- Recent Advances of Salivary Gland Biopsy in Sjögren's Syndrome.Frontiers in medicine · 2021Review
- Unique Sjögren's syndrome patient subsets defined by molecular features.Rheumatology (Oxford, England) · 2020Article
- The Expanding Field of Secondary Antibody Deficiency: Causes, Diagnosis, and Management.Frontiers in immunology · 2019Review
- Type I interferons in host defence and inflammatory diseases.Lupus science & medicine · 2019Review
- Recent advances in the search for a targeted immunomodulatory therapy for primary Sjögren's syndrome.F1000Research · 2019Review
- IFI16 filament formation in salivary epithelial cells shapes the anti-IFI16 immune response in Sjögren's syndrome.JCI insight · 2018Article
- Treating the Underlying Pathophysiology of Primary Sjögren Syndrome: Recent Advances and Future Prospects.Drugs · 2016Review
- BAFF- and APRIL-targeted therapy in systemic autoimmune diseases.Inflammation and regeneration · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionIn this study, we sought to address changes in blood lymphocyte subpopulations and labial salivary gland (LSG) inflammation after belimumab treatment in patients with primary Sjögren's syndrome (pSS) and to identify predictors of response to treatment.
methodsSequential blood lymphocyte subsets and LSG biopsies were analysed between week 0 (W0) and W28 in 15 patients with pSS treated with belimumab. Systemic response to treatment was defined as a decrease in the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index score of ≥3 points at W28.
resultsAfter belimumab, we observed a decrease in blood B lymphocytes primarily involving CD27-negative/immunoglobulin D-positive naïve B cells (p=0.008). Lymphocytic sialadenitis (focus score >1) that was present in 12 patients (80.0 %) before belimumab treatment became negative in 5 of them after treatment (p=0.03). The median (interquartile range) LSG B-cell/T-cell ratio decreased from 0.58 (0.5-0.67) to 0.50 (0.5-0.5) (p=0.06). B-cell activating factor (BAFF) staining was detected in 11 (78.6 %) of 14 patients before belimumab treatment compared with 7 (50.0 %) of 14 after belimumab therapy (p=0.10). The median percentage of BAFF-positive cells in foci significantly decreased from 27.5 % (10-40) to 5 % (0-20) (p=0.03). A systemic response was achieved in six patients (40 %). The only predictor of response was the presence of a low number of natural killer (NK) cells, both in blood (8.5 % [7-10] vs 11 % [9-21]; p=0.04) and in LSG (20.6/mm(3) [20.0-21.4] vs 30.0/mm(3) [25.0-100.0], p=0.003). Serum BAFF levels did not influence response to treatment.
conclusionsLow blood and salivary NK cell numbers are associated with a better response to belimumab. This suggests that two distinct subsets of pSS may exist: one with a predominant type I interferon (IFN)-BAFF-B-cell axis, representing good responders to belimumab; and one with a predominant type II IFN-NK cell axis, representing non-responders.
trial registrationClinicalTrials.gov identifier: NCT01160666 . Registered 9 July 2010.
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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.