Evidence map›Paper›PMID 38004515›Full record

ArticlePharmaceutics2023

Population Pharmacodynamic Modelling of the CD19+ Suppression Effects of Rituximab in Paediatric Patients with Neurological and Autoimmune Diseases.

Natalia Riva, Lucas Brstilo, Aymara Sancho-Araiz, Manuel Molina, Andrea Savransky, Georgina Roffé, Marianela Sanz, Silvia Tenembaum, Maria M Katsicas, Iñaki F Trocóniz and 1 more

Open access · goldAbstract read
In one paragraph

Article in Pharmaceutics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.0field-weighted citation impact, top 22% of its field
1 · What the graph read from 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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
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  3. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 3 institutions in 2 countries.

Natalia RivaPharmacometrics & Systems Pharmacology Research Unit, Department of Pharmaceutical Sciences, School of Pharmacy and Nutrition, University of Navarra, 31008 Pamplona, Spain.ORCID 0000-0001-8359-4040
Lucas BrstiloUnit of Innovative Treatments, Hospital de Pediatría JP Garrahan, Buenos Aires C1245 CABA, Argentina.ORCID 0009-0008-6222-003X
Aymara Sancho-AraizPharmacometrics & Systems Pharmacology Research Unit, Department of Pharmaceutical Sciences, School of Pharmacy and Nutrition, University of Navarra, 31008 Pamplona, Spain.ORCID 0000-0001-7139-165X
Manuel MolinaUnit of Innovative Treatments, Hospital de Pediatría JP Garrahan, Buenos Aires C1245 CABA, Argentina.
Andrea SavranskyNeurology Service, Hospital de Pediatría JP Garrahan, Buenos Aires C1245 CABA, Argentina.
Georgina RofféLaboratory of Cellular Immunology, Hospital de Pediatría JP Garrahan, Buenos Aires C1245 CABA, Argentina.
Marianela SanzLaboratory of Cellular Immunology, Hospital de Pediatría JP Garrahan, Buenos Aires C1245 CABA, Argentina.
Silvia TenembaumNeurology Service, Hospital de Pediatría JP Garrahan, Buenos Aires C1245 CABA, Argentina.ORCID 0000-0001-6544-4356
Maria M KatsicasImmunology and Rheumatology Service, Hospital de Pediatría JP Garrahan, Buenos Aires C1245 CABA, Argentina.
Iñaki F TrocónizPharmacometrics & Systems Pharmacology Research Unit, Department of Pharmaceutical Sciences, School of Pharmacy and Nutrition, University of Navarra, 31008 Pamplona, Spain.ORCID 0000-0003-3700-8658
Paula SchaiquevichUnit of Innovative Treatments, Hospital de Pediatría JP Garrahan, Buenos Aires C1245 CABA, Argentina.ORCID 0000-0002-2568-4731
Garrahan Hospital · ARConsejo Nacional de Investigaciones Científicas y Técnicas · ARNavarre Institute of Health Research · ES

Funding

Fundación Garrahan, Argentina
6 · The paper itself

Abstract

backgroundLimited pharmacotherapy and the failure of conventional treatments in complex pathologies in children lead to increased off-label use of rituximab. We aimed to characterize the time course of CD19+ B lymphocytes (CD19+) under treatment with intravenous rituximab in children with neurologic and autoimmune diseases and to evaluate the impact of covariates (i.e., demographics, diagnosis and substitution between innovator and biosimilar product) on rituximab pharmacodynamics and disease activity.

methodsPre- and post-drug infusion CD19+ in peripheral blood were prospectively registered. A population pharmacodynamic model describing the time course of CD19+ was developed with NONMEM v7.4. Simulations of three different rituximab regimens were performed to assess the impact on CD19+. Logistic regression analysis was performed to identify predictors of clinical response recorded through disease activity scores.

results281 measurements of CD19+ lymphocyte counts obtained from 63 children with neurologic (

conclusionsRituximab pharmacodynamics was described in a real-world setting in children suffering from autoimmune and neurologic diseases. Diagnosis, substitution between innovator rituximab and its biosimilars or type of regimen did not affect rituximab-induced depletion of CD19+ nor the clinical response in this cohort of patients. According to this study, rituximab frequency and dosage may be chosen based on clinical convenience or safety reasons without affecting CD19+ repopulation times. Further studies in larger populations are required to confirm these results.

Indexed as

biosimilar pharmaceuticalsNONMEMpaediatricspharmacodynamicsrituximab

Identifiers

PMID38004515
PMCPMC10674351
OpenAlexW4388197418

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.