Evidence map›Paper›PMID 35765176›Full record

Trial reportClinical and translational science2022

Rituximab pediatric drug development: Pharmacokinetic and pharmacodynamic modeling to inform regulatory approval for rituximab treatment in patients with granulomatosis with polyangiitis or microscopic polyangiitis.

Candice Jamois, Leonid Gibiansky, Clarisse Chavanne, Melissa Cheu, Patricia B Lehane, Pooneh Pordeli, Simone Melega, Jacques Gaudreault

Open access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Clinical and translational science, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 25% 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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Review
  6. Review
  7. Diagnostic workup of childhood interstitial lung disease.European respiratory review : an official journal of the European Respiratory Society · 2023
    Review
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

8 authors at 5 institutions in 3 countries.

Candice JamoisClinical Pharmacology, Pharmaceutical Sciences, Pharma Research and Early Development, Roche Innovation Center Basel, Basel, Switzerland.
Leonid GibianskyQuantPharm LLC, North Potomac, Maryland, USA.
Clarisse ChavanneClinical Pharmacology, Pharmaceutical Sciences, Pharma Research and Early Development, Roche Innovation Center Basel, Basel, Switzerland.
Melissa CheuBioAnalytical Sciences, Genentech Inc., South San Francisco, California, USA.
Patricia B LehaneClinical Development, Roche, Welwyn Garden City, UK.
Pooneh PordeliRoche Canada, Mississauga, Ontario, Canada.
Simone MelegaF. Hoffmann-La Roche Ltd., Basel, Switzerland.
Jacques GaudreaultJJG Pharma Consulting, Basel, Switzerland.
Roche (Switzerland) · CHBioanalytica (Switzerland) · CHJain PharmaBiotech (Switzerland) · CHRoche (Canada) · CARoche (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Anti-neutrophil cytoplasmic antibody-associated vasculitides granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) are rare, potentially organ- and life-threatening autoimmune conditions affecting adult and pediatric patients. An open-label phase II study was conducted to determine safe and effective dosing regimens of rituximab in pediatric patients with GPA/MPA. To determine the selection of an appropriate dose regimen in children for induction and maintenance, a population pharmacokinetic approach was used (nonlinear mixed-effect modeling), combining pediatric data with data from adults with GPA/MPA. The time course of B-cell depletion was assessed in both populations. The exposure-effect relationship was assessed by logistic regression. Twenty-five pediatric patients (80% female patients; age range, 6-17 years) were enrolled in the trial and received the induction regimen of intravenous rituximab 375 mg/m

Indexed as

Granulomatosis with PolyangiitisMicroscopic PolyangiitisAdolescentAdultChildFemaleHumansMaleRituximabRituximab

Identifiers

PMID35765176
PMCPMC9468568
OpenAlexW4283700364

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.