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Rituximab, B-Lymphocyte Depletion, and Preservation of Beta-Cell Function
Open accessAbstract
BACKGROUND: The immunopathogenesis of type 1 diabetes mellitus is associated with T-lymphocyte autoimmunity. However, there is growing evidence that B lymphocytes play a role in many T-lymphocyte-mediated diseases. It is possible to achieve selective depletion of B lymphocytes with rituximab, an anti-CD20 monoclonal antibody. This phase 2 study evaluated the role of B-lymphocyte depletion in patients with type 1 diabetes. METHODS: We conducted a randomized, double-blind study in which 87 patients between 8 and 40 years of age who had newly diagnosed type 1 diabetes were assigned to receive infusions of rituximab or placebo on days 1, 8, 15, and 22 of the study. The primary outcome, assessed 1 year after the first infusion, was the geometric mean area under the curve (AUC) for the serum C-peptide level during the first 2 hours of a mixed-meal tolerance test. Secondary outcomes included safety and changes in the glycated hemoglobin level and insulin dose. RESULTS: At 1 year, the mean AUC for the level of C peptide was significantly higher in the rituximab group than in the placebo group. The rituximab group also had significantly lower levels of glycated hemoglobin and required less insulin. Between 3 months and 12 months, the rate of decline in C-peptide levels in the rituximab group was significantly less than that in the placebo group. CD19+ B lymphocytes were depleted in patients in the rituximab group, but levels increased to 69% of baseline values at 12 months. More patients in the rituximab group than in the placebo group had adverse events, mostly grade 1 or grade 2, after the first infusion. The reactions appeared to be minimal with subsequent infusions. There was no increase in infections or neutropenia with rituximab. CONCLUSIONS: A four-dose course of rituximab partially preserved beta-cell function over a period of 1 year in patients with type 1 diabetes. The finding that B lymphocytes contribute to the pathogenesis of type 1 diabetes may open a new pathway for exploration in the treatment of patients with this condition. (ClinicalTrials.gov number, NCT00279305.)
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“Disappointingly, after promising phase 1–2 trials in patients with recent-onset type 1 diabetes and detectable endogenous insulin production, phase 3 trials of anti-CD3 antibodies (otelixizumab and teplizumab), and the Diamyd vaccine (GAD-alum immunotherapy) did not meet primary endpoints.135–141”
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“These drugs include a monoclonal antibody against the B-cell CD20 receptor (rituximab),147 monoclonal antibodies against the T-cell CD3 receptor (teplizumab148,149 and otelixizumab150), cytotoxic T-lymphocyte protein 4 (CTLA4)-immunoglobulin-mediated co-stimulatory blockade with abatacept,151 and alefacept,152”
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Metadata
- Authors
- Pescovitz, M. D., Greenbaum, C. J., Krause-Steinrauf, H., Becker, D. J., Gitelman, S. E., Goland, R., Gottlieb, P. A., Marks, J. B., McGee, P. F., Moran, A. M., Raskin, P., Rodriguez, H., Schatz, D. A., Wherrett, D., Wilson, D. M., Lachin, J. M., & Skyler, J. S.
- Affiliations
- Indiana University School of Medicine (US)
- Benaroya Research Institute (US)
- George Washington University (US)
- University of Pittsburgh (US)
- University of California, San Francisco (US)
- Columbia University (US)
- University of Colorado Health (US)
- University of Miami (US)
- University of Minnesota (US)
- The University of Texas Southwestern Medical Center (US)
- University of Florida (US)
- University of Toronto (CA)
- Stanford University (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2009-11-26
- Volume
- 361
- Issue
- 22
- Pages
- 2143-2152
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC6410357
- OpenAlex
- W2064431167
- Cited by
- 1,093
- References
- 39
- Citations by year
- 2026: 45 · 2025: 65 · 2024: 56 · 2023: 55 · 2022: 56 · 2021: 64 · 2020: 53 · 2019: 49 · 2018: 49 · 2017: 45 · 2016: 57 · 2015: 63 · 2014: 72 · 2013: 98 · 2012: 89
- FWCI
- 51.38
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- IUScholarWorks (Indiana University) (submittedVersion)
- Purdue University Indianapolis (Indiana University) (submittedVersion)
- PMC
- Funders
- American Diabetes Association
- Juvenile Diabetes Research Foundation International
- Eli Lilly and Company
- Biogen
- Osiris Therapeutics
- MacroGenics
- National Institutes of Health
- Genentech
- National Institute of Allergy and Infectious Diseases
- National Institute of Diabetes and Digestive and Kidney Diseases (R21DK077329, U01DK061058, U01DK061034, U01DK103282)
- National Institute of Child Health and Human Development
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
- Life Sciences › Immunology and Microbiology › Immunology › T-cell and B-cell Immunology
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Keywords
- rituximab, B-cell depletion, type 1 diabetes, beta-cell preservation, anti-CD20 monoclonal antibody, C-peptide, CD19+ B cells, immunopathogenesis, newly diagnosed type 1 diabetes, HbA1c, insulin dose
- MeSH terms
- Rituximab, Adolescent, Adult, Antibodies, Monoclonal, B-Lymphocytes, C-Peptide, Child, Diabetes Mellitus, Type 1, Double-Blind Method, Female, Glycated Hemoglobin, Humans, Immunoglobulin M, Immunologic Factors, Male, Area Under Curve, Insulin-Secreting Cells, Young Adult, Antibodies, Monoclonal, Murine-Derived
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