ArticleBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2021
Factors Influencing Infusion-Related Reactions Following Dosing of Reference Rituximab and PF-05280586, a Rituximab Biosimilar.
Article in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02213263 (A PHASE 3, RANDOMIZED, DOUBLE-BLIND STUDY OF PF-05280586 VERSUS RITUXIMAB FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH CD20-POSITIVE, LOW TUMOR BURDEN, FOLLICULAR LYMPHOMA), which is not on this map. Cited by 13 papers.
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 3, randomized, double-blind study of pf-05280586 versus rituximab for the first-line treatment of patients with cd20-positive, low tumor burden, follicular lymphoma
Who cites it
13 citing papers in PubMed, 17 citations in OpenAlex.
- Safety and efficacy of ravulizumab in patients with NMOSD previously treated with rituximab: A post hoc analysis of the CHAMPION-NMOSD trial.Multiple sclerosis (Houndmills, Basingstoke, England) · 2026Trial
- Targeting the pMHC-TCR Interaction: Molecular Strategies and Therapeutic Potential in Autoimmunity.International journal of molecular sciences · 2026Review
- Rituximab with low-dose glucocorticoids for treating refractory membranous nephropathy: a prospective single-center cohort study.Frontiers in pharmacology · 2026Article
- Incidence and implications of anti-rituximab antibodies in nephropathies and other immune-mediated diseases: a narrative review.Frontiers in immunology · 2026Review
- Rituximab-associated adverse events in nephrotic syndrome: A systematic review and meta-analysis.Heliyon · 2025Article
- Effectiveness and safety of rituximab monotherapy versus conventional regimens for adult idiopathic membranous nephropathy: real-world retrospective study.Frontiers in immunology · 2025Review
- Observation of rituximab as initial treatment in patients with minimal change disease- a retrospective study.Frontiers in immunology · 2025Article
- Rituximab monotherapy versus glucocorticoid therapy for adult minimal change disease: a retrospective study on noninferiority.Frontiers in nephrology · 2025Article
- Effectiveness of fractionated rituximab in preventing tumor lysis syndrome in aggressive B-cell lymphoma: Insights from real-life clinical practice.Cancer reports (Hoboken, N.J.) · 2024Article
- The efficacy and safety of rituximab with or without glucocorticoid in inducing remission of MCD with different clinical presentations in adults: a retrospective study.Clinical kidney journal · 2024Article
- Severe Hypersensitivity Reactions at Biosimilar versus Originator Rituximab Treatment Initiation, Switch and Over Time: A Cohort Study on the French National Health Data System.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023Article
- Efficacy and safety of rituximab for primary membranous nephropathy with different clinical presentations: a retrospective study.Frontiers in immunology · 2023Article
- A novel rituximab administration protocol to minimize infusion-related adverse reactions in patients with B-cell lymphoma.International journal of clinical pharmacy · 2022Article
Corrections and comments
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Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundInfusion-related reactions (IRRs) are the most common adverse event (AE) associated with infusion of rituximab, an anti-CD20 monoclonal antibody.
objectiveOur objective was to evaluate the impact of dosing/infusion patterns and certain baseline characteristics on IRR occurrence during the first rituximab infusion administered as the biosimilar PF-05280586 (RTX-PF) or reference rituximab sourced from the EU (RTX-EU, MabThera PATIENTS AND
methodsRituximab (RTX-PF, n=196; RTX-EU, n=198) was administered (375 mg/m
resultsMedian rituximab infusion duration on day 1 was 3.50 h for each of the two groups. There was a positive correlation between infusion rate and all-grade IRRs occurring within 24 h after infusion (p < 0.0001). Patients who developed IRRs had a higher median baseline CD20+ level. IRR incidence was unaffected by baseline ADA status. Drug exposure did not predict IRR incidence. Baseline tumor burden was similar between patients with and without IRRs.
conclusionsResults of this analysis provide a better understanding of IRRs after the first rituximab (RTX-PF or RTX-EU) infusion and demonstrate a potential correlation of infusion rate and other factors with IRR at the individual and population levels. Infusion-rate escalation steps continue to be needed to manage IRRs. TRIAL REGISTRATION (DATE OF REGISTRATION): ClinicalTrials.gov Identifier: NCT02213263 (11 August 2014); and EudraCT: 2014-000132-41 (10 October 2014).
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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.