Evidence map›Paper›PMID 34041738›Full record

Trial reportClinical pharmacology and therapeutics2021

Quantitative Clinical Pharmacology Supports the Bridging From i.v. Dosing and Approval of s.c. Rituximab in B-Cell Hematological Malignancies.

Candice Jamois, Ekaterina Gibiansky, Leonid Gibiansky, Clarisse Chavanne, Peter N Morcos, Christine McIntyre, Martin Barrett, Linda Lundberg, Artem Zharkov, Axel Boehnke and 1 more

Open access · greenAbstract readClinical Trial
In one paragraph

Trial report in Clinical pharmacology and therapeutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.7field-weighted citation impact, top 30% 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

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Article
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 2 institutions in 2 countries.

Candice JamoisClinical Pharmacology, Pharmaceutical Sciences, Pharma Research and Early Development, Roche Innovation Center Basel, Basel, Switzerland.
Ekaterina GibianskyQuantPharm LLC, North Potomac, Maryland, USA.
Leonid GibianskyQuantPharm LLC, North Potomac, Maryland, USA.
Clarisse ChavanneClinical Pharmacology, Pharmaceutical Sciences, Pharma Research and Early Development, Roche Innovation Center Basel, Basel, Switzerland.
Peter N MorcosClinical Pharmacology, Pharmaceutical Sciences, Pharma Research and Early Development, Roche Innovation Center Basel, Basel, Switzerland.
Christine McIntyrePharma Research and Early Development, Roche Innovation Center Welwyn, Welwyn Garden City, UK.
Martin BarrettPharma Research and Early Development, Roche Innovation Center Welwyn, Welwyn Garden City, UK.
Linda LundbergPharma Development Clinical Oncology, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
Artem ZharkovPharma Development Medical Affairs, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
Axel BoehnkePharma Development Clinical Oncology, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
Nicolas FreyClinical Pharmacology, Pharmaceutical Sciences, Pharma Research and Early Development, Roche Innovation Center Basel, Basel, Switzerland.
Roche (Switzerland) · CHRoche (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A fixed-dose subcutaneous (s.c.) formulation of the anti-CD20 antibody, rituximab, has been developed to address safety, infusion time, and patient comfort concerns relating to intravenous (i.v.) dosing, and has been approved based upon a pharmacokinetic (PK)-clinical bridging strategy, which demonstrated noninferiority of s.c. vs. i.v. dosing in malignancies, including follicular lymphoma (FL) and chronic lymphocytic leukemia (CLL). A clinical development plan was undertaken to identify rituximab s.c. doses achieving noninferior exposure to rituximab i.v., and to confirm PK-clinical bridging, with the same efficacy and similar safety. This drew upon data from 1,579 patients with FL, CLL, or diffuse large B-cell lymphoma in 5 clinical studies, and showed minimum steady-state serum concentration (C

Indexed as

Administration, IntravenousAntineoplastic Agents, ImmunologicalDose-Response Relationship, DrugFemaleHumansInjections, SubcutaneousLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Large B-Cell, DiffuseMalePharmacology, ClinicalRituximabAntineoplastic Agents, ImmunologicalRituximab

Identifiers

PMID34041738
PMCPMC8597022
OpenAlexW3165470995

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.