Evidence map›Paper›PMID 41187618›Full record

ArticleEBioMedicine2025

Comparison of rituximab induction and maintenance regimens in anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitis: PK/PD modelling of ANCA and gammaglobulin levels in real-world patients.

Blaise Pasquiers, Benoit Blanchet, Xavier Puéchal, Xavier Declèves, Pascal Cohen, Claire Goulvestre, Marion Casadevall, Inès Benhabiles, Michel Vidal, David Ternant and 2 more

Abstract readComparative Study
PubMed Full text at PMC Publisher
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Article in EBioMedicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from 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.

2 · The registry

The trial behind it

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3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

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5 · Who and what money

Authors and funding

12 authors.

Blaise PasquiersUniversité Paris Cité, INSERM, Optimisation Thérapeutique en Neuropharmacologie OTEN U1144, 75006, Paris, France; PhinC Development, 36 Rue Victor Basch, Massy, France.
Benoit BlanchetBiologie du Médicament - Toxicologie, Cochin University Hospital, AP-HP, Paris, France; Université Paris Cité, Faculty of Pharmacy, CNRS UMR8038, Inserm U1268, CARPEM, Paris, France.
Xavier PuéchalDepartment of Internal Medicine, National Referral Center for Rare Systemic Autoimmune Diseases, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris, Paris, France; Université Paris Cité, F-75006, Paris, France.
Xavier DeclèvesUniversité Paris Cité, INSERM, Optimisation Thérapeutique en Neuropharmacologie OTEN U1144, 75006, Paris, France; Biologie du Médicament - Toxicologie, Cochin University Hospital, AP-HP, Paris, France.
Pascal CohenDepartment of Internal Medicine, National Referral Center for Rare Systemic Autoimmune Diseases, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris, Paris, France.
Claire GoulvestreLaboratory of Immunology, Cochin University Hospital, AP-HP, Paris, France.
Marion CasadevallDepartment of Internal Medicine, National Referral Center for Rare Systemic Autoimmune Diseases, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris, Paris, France.
Inès BenhabilesBiologie du Médicament - Toxicologie, Cochin University Hospital, AP-HP, Paris, France.
Michel VidalBiologie du Médicament - Toxicologie, Cochin University Hospital, AP-HP, Paris, France; Université Paris Cité, Faculty of Pharmacy, CNRS UMR8038, Inserm U1268, CARPEM, Paris, France.
David TernantUniversité de Tours, EA 4245 T2I, Tours, France; Service de Pharmacologie Médicale, CHRU de Tours, Tours, France.
Benjamin TerrierDepartment of Internal Medicine, National Referral Center for Rare Systemic Autoimmune Diseases, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris, Paris, France; Université Paris Cité, F-75006, Paris, France.
Alicja PuszkielUniversité Paris Cité, INSERM, Optimisation Thérapeutique en Neuropharmacologie OTEN U1144, 75006, Paris, France; Biologie du Médicament - Toxicologie, Cochin University Hospital, AP-HP, Paris, France. Electronic address: alicja.puszkiel@aphp.fr.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe aimed to provide pharmacokinetic-pharmacodynamic (PK/PD) rationale for selecting the optimal induction and maintenance dosing regimens in ANCA-associated vasculitis (AAV) using a population modelling approach based on PK, ANCA, and gammaglobulins data from a real-world cohort.

methodsA total of 121 patients with 296 plasma rituximab concentrations (99 and 197 in the induction and maintenance phases, respectively), 439 ANCA levels and 559 gammaglobulin levels were included in the analysis. Simulations of induction (375 mg/m

findingsThe PK/PD model satisfactorily described the relationship between rituximab, gammaglobulins and ANCA concentrations over time. Both induction regimens resulted in a similar number of patients achieving serological remission and hypogammaglobulinaemia at 6 months. In the maintenance phase, increasing the dose (to 1000 mg) or the frequency of administration (Q4M versus Q6M) was associated with a higher number of patients with serological remission at month 24, but also with a higher risk of hypogammaglobulinaemia. In the maintenance phase, 500 mg Q6M (start at month 4 or 6), had a significantly higher utility score than 1000 mg Q4M.

interpretationThis PK/PD study can inform clinical decisions regarding the choice between different rituximab induction and maintenance regimens in patients with AAV in daily practice.

fundingThis study received no funding.

Indexed as

Antibodies, Antineutrophil CytoplasmicAnti-Neutrophil Cytoplasmic Antibody-Associated Vasculitisgamma-GlobulinsRituximabAdultAgedFemaleHumansMaintenance ChemotherapyMaleMiddle AgedModels, BiologicalRemission InductionTreatment OutcomeAntibodies, Antineutrophil Cytoplasmicgamma-GlobulinsRituximabAnti-neutrophil cytoplasmic antibodiesAnti-neutrophil cytoplasmic antibodies-associated vasculitisGammaglobulinsPK/PDPopulation pharmacokineticsRituximab

Identifiers

PMID41187618
PMCPMC12677076

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