Effectiveness of rituximab treatment in primary Sjogren's syndrome: a randomized, double-blind, placebo-controlled trial
Abstract
OBJECTIVE: To study the efficacy and safety of B cell depletion with rituximab, a chimeric murine/human anti-CD20 monoclonal antibody, in patients with primary Sjögren's syndrome (SS) in a double-blind, randomized, placebo-controlled trial. METHODS: Patients with active primary SS, as determined by the revised American-European Consensus Group criteria, and a rate of stimulated whole saliva secretion of > or =0.15 ml/minute were treated with either rituximab (1,000 mg) or placebo infusions on days 1 and 15. Patients were assigned randomly to a treatment group in a ratio of 2:1 (rituximab:placebo). Followup was conducted at 5, 12, 24, 36, and 48 weeks. The primary end point was the stimulated whole saliva flow rate, while secondary end points included functional, laboratory, and subjective variables. RESULTS: Thirty patients with primary SS (29 female) were randomly allocated to a treatment group. The mean +/- SD age of the patients receiving rituximab was 43 +/- 11 years and the disease duration was 63 +/- 50 months, while patients in the placebo group were age 43 +/- 17 years and had a disease duration of 67 +/- 63 months. In the rituximab group, significant improvements, in terms of the mean change from baseline compared with that in the placebo group, were found for the primary end point of the stimulated whole saliva flow rate (P = 0.038 versus placebo) and also for various laboratory parameters (B cell and rheumatoid factor [RF] levels), subjective parameters (Multidimensional Fatigue Inventory [MFI] scores and visual analog scale [VAS] scores for sicca symptoms), and extraglandular manifestations. Moreover, in comparison with baseline values, rituximab treatment significantly improved the stimulated whole saliva flow rate (P = 0.004) and several other variables (e.g., B cell and RF levels, unstimulated whole saliva flow rate, lacrimal gland function on the lissamine green test, MFI scores, Short Form 36 health survey scores, and VAS scores for sicca symptoms). One patient in the rituximab group developed mild serum sickness-like disease. CONCLUSION: These results indicate that rituximab is an effective and safe treatment strategy for patients with primary SS.
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Several published studies reported efficacy of rituximab in primary Sjögren syndrome.
“Several published studies reported efficacy of RTX in pSS.”
From Autoimmune diseases and immune-checkpoint inhibitors for cancer therapy: Review of the literature and personalized risk-based prevention strategy (2020) · cites this paper as [132]
One randomized controlled trial reported a significant reduction in reported extraglandular manifestations and improvement of musculoskeletal features at weeks 12 and 36 (P=0.029) and vasculitis at week 24 (P=0.03).
“One RCT 132 reported a significant reduction in reported extraglandular manifestations and improvement of musculoskeletal features at weeks 12 and 36 (P ¼ 0.029) and vasculitis at week 24 (P ¼ 0.03).”
From Autoimmune diseases and immune-checkpoint inhibitors for cancer therapy: Review of the literature and personalized risk-based prevention strategy (2020) · cites this paper as [132]
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- Authors
- Meijer, J. M., Meiners, P. M., Vissink, A., Spijkervet, F. K. L., Abdulahad, W., Kamminga, N., Brouwer, E., Kallenberg, C. G. M., & Bootsma, H.
- Affiliations
- University Medical Center Groningen (NL)
- University of Groningen (NL)
- Venue
- Arthritis & Rheumatism
- Publisher
- Wiley
- Published
- 2010-03-30
- Volume
- 62
- Issue
- 4
- Pages
- 960-968
- ISSN
- 0004-3591 (ISSN-L)
- 1529-0131
- OpenAlex
- W2114850377
- Cited by
- 488
- References
- 27
- Citations by year
- 2026: 15 · 2025: 17 · 2024: 20 · 2023: 12 · 2022: 22 · 2021: 33 · 2020: 24 · 2019: 30 · 2018: 25 · 2017: 30 · 2016: 40 · 2015: 40 · 2014: 39 · 2013: 39 · 2012: 48
- FWCI
- 29.69
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Arthritis & Rheumatism (publishedVersion)
- PubMed (publishedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion)
- Topics
- Health Sciences › Medicine › Physiology › Salivary Gland Disorders and Functions
- Health Sciences › Medicine › Rheumatology › Systemic Lupus Erythematosus Research
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ocular Surface and Contact Lens
- Keywords
- primary Sjögren's syndrome, rituximab, B-cell depletion, anti-CD20 monoclonal antibody, salivary flow rate, sicca symptoms, fatigue, rheumatoid factor, lacrimal gland function, extraglandular manifestations, treatment safety, serum sickness-like reaction, autoimmune disease therapy, quality of life, health-related quality of life
- MeSH terms
- Rituximab, Adult, Antibodies, Monoclonal, Blood Cell Count, Double-Blind Method, Female, Humans, Immunoglobulin G, Lacrimal Apparatus, Male, Middle Aged, Placebos, Saliva, Sjogren's Syndrome, Antirheumatic Agents, Antibodies, Monoclonal, Murine-Derived
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