Trial reportDiabetes care2014
B-lymphocyte depletion with rituximab and β-cell function: two-year results.
Trial report in Diabetes care, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07041268 (Evaluation of Effectiveness and Safety of the Rituximab Immunotherapy Plus Insulin Therapy Compared to Insulin Therapy Alone in Adolescents With Recent-Onset Type 1 Diabetes Mellitus), which is not on this map. Cited by 166 papers, 1 of them a synthesis 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.
Evaluation of Effectiveness and Safety of the Rituximab Immunotherapy Plus Insulin Therapy Compared to Insulin Therapy Alone in Adolescents With Recent-Onset Type 1 Diabetes Mellitus
Who cites it
166 citing papers in PubMed, 1 synthesis or guideline pooled it, 275 citations in OpenAlex.
- Molecular Footprints of the Immune Assault on Pancreatic Beta Cells in Type 1 Diabetes.Frontiers in endocrinology · 2020Pooled it
- Trial
- Exhausted-like CD8+ T cell phenotypes linked to C-peptide preservation in alefacept-treated T1D subjects.JCI insight · 2021Trial
- Low-dose IL-2 in children with recently diagnosed type 1 diabetes: a Phase I/II randomised, double-blind, placebo-controlled, dose-finding study.Diabetologia · 2020Trial
- Trial
- Elevated T cell levels in peripheral blood predict poor clinical response following rituximab treatment in new-onset type 1 diabetes.Genes and immunity · 2019Trial
- Low-Dose Anti-Thymocyte Globulin (ATG) Preserves β-Cell Function and Improves HbADiabetes care · 2018Trial
- Trial
- Anti-thymocyte globulin/G-CSF treatment preserves β cell function in patients with established type 1 diabetes.The Journal of clinical investigation · 2015Trial
- Combined Exendin-4 and Rituximab Treatment Improves β-Cell Function and Delays Disease Progression in NOD Mice.Biology · 2026Article
- Extended Follow-up of Type 1 Diabetes Immunotherapy Trial Participants Suggests Benign Side Effect Profile.Diabetes care · 2026Article
- Type 1 Diabetes Mellitus Pathogenesis: Mechanisms, Early Diagnostic Strategies, and Emerging Therapeutic Approaches.Pathophysiology : the official journal of the International Society for Pathophysiology · 2026Review
- Toward Personalized Medicine in Type 1 Diabetes: Understanding How Patient Heterogeneity Influences Therapeutic Efficacy.Diabetes, obesity & metabolism · 2026Review
- New and emerging therapies in type 1 diabetes mellitus.The Journal of clinical investigation · 2026Review
- Review
- Type I Interferons as Contextual Regulators of B-Cell Tolerance in Type 1 Diabetes.Biomolecules · 2026Review
- Dysregulated B cell homeostasis and the involvement of B cell-activating factor in the progression of diabetic retinopathy.Scientific reports · 2026Article
- Altered B cell metabolic pathways characterize type 1 diabetes progression.Journal of immunology (Baltimore, Md. : 1950) · 2026Article
- Can we cure autoimmunity?Current opinion in immunology · 2026Review
- Is the NOD mouse a good model for type 1 diabetes?Diabetologia · 2026Review
106 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 12 institutions in 2 countries.
Funding
Abstract
objectiveWe previously reported that selective depletion of B-lymphocytes with rituximab, an anti-CD20 monoclonal antibody, slowed decline of β-cell function in recent-onset type 1 diabetes mellitus (T1DM) at 1 year. Subjects were followed further to determine whether there was persistence of effect. RESEARCH DESIGN AND
methodsEighty-seven subjects (aged 8-40 years) were randomly assigned to, and 81 received, infusions of rituximab or placebo on days 1, 8, 15, and 22. The primary outcome-baseline-adjusted mean 2-h area under the curve (AUC) serum C-peptide during a mixed-meal tolerance test (MMTT) at 1 year-showed higher C-peptide AUC with rituximab versus placebo. Subjects were further followed with additional MMTTs every 6 months.
resultsThe rate of decline of C-peptide was parallel between groups but shifted by 8.2 months in rituximab-treated subjects. Over 30 months, AUC, insulin dose, and HbA1c were similar for rituximab and placebo. However, in evaluating change in C-peptide over the entire follow-up period, the rituximab group means were significantly larger as compared within assessment times with the placebo group means using a global test (P = 0.03). Odds ratio for loss of C-peptide to <0.2 nmol/L following rituximab was 0.565 (P = 0.064). B-lymphocytes recovered to baseline values by 18 months. Serum IgG levels were maintained in the normal range but IgM levels were depressed.
conclusionsLike several other immunotherapeutic approaches tested, in recent-onset T1DM, rituximab delays the fall in C-peptide but does not appear to fundamentally alter the underlying pathophysiology of the disease.
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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.