Evidence map›Paper›PMID 31068073›Full record

ArticlemAbs2019

Retrospective analysis of model-based predictivity of human pharmacokinetics for anti-IL-36R monoclonal antibody MAB92 using a rat anti-mouse IL-36R monoclonal antibody and RNA expression data (FANTOM5).

Jennifer Ahlberg, Craig Giragossian, Hua Li, Maria Myzithras, Ernie Raymond, Gary Caviness, Christine Grimaldi, Su-Ellen Brown, Rocio Perez, Danlin Yang and 9 more

Open access · goldAbstract read
In one paragraph

Article in mAbs, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.2field-weighted citation impact, top 21% 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

6 citing papers in PubMed, 8 citations in OpenAlex.

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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

19 authors at 2 institutions in 2 countries.

Jennifer Ahlberga Biotherapeutics Disccovery Research , Boehringer Ingelheim Pharmaceuticals, Inc , Ridgefield , CT , USA.ORCID 0000-0002-2892-4163
Craig Giragossiana Biotherapeutics Disccovery Research , Boehringer Ingelheim Pharmaceuticals, Inc , Ridgefield , CT , USA.
Hua Lia Biotherapeutics Disccovery Research , Boehringer Ingelheim Pharmaceuticals, Inc , Ridgefield , CT , USA.
Maria Myzithrasa Biotherapeutics Disccovery Research , Boehringer Ingelheim Pharmaceuticals, Inc , Ridgefield , CT , USA.
Ernie Raymonda Biotherapeutics Disccovery Research , Boehringer Ingelheim Pharmaceuticals, Inc , Ridgefield , CT , USA.
Gary Cavinessa Biotherapeutics Disccovery Research , Boehringer Ingelheim Pharmaceuticals, Inc , Ridgefield , CT , USA.
Christine Grimaldia Biotherapeutics Disccovery Research , Boehringer Ingelheim Pharmaceuticals, Inc , Ridgefield , CT , USA.
Su-Ellen Browna Biotherapeutics Disccovery Research , Boehringer Ingelheim Pharmaceuticals, Inc , Ridgefield , CT , USA.
Rocio Pereza Biotherapeutics Disccovery Research , Boehringer Ingelheim Pharmaceuticals, Inc , Ridgefield , CT , USA.
Danlin Yanga Biotherapeutics Disccovery Research , Boehringer Ingelheim Pharmaceuticals, Inc , Ridgefield , CT , USA.ORCID 0000-0002-5085-5950
Rachel Kroe-Barretta Biotherapeutics Disccovery Research , Boehringer Ingelheim Pharmaceuticals, Inc , Ridgefield , CT , USA.ORCID 0000-0003-1413-1223
David Josepha Biotherapeutics Disccovery Research , Boehringer Ingelheim Pharmaceuticals, Inc , Ridgefield , CT , USA.
Chandrasena Pamulapatia Biotherapeutics Disccovery Research , Boehringer Ingelheim Pharmaceuticals, Inc , Ridgefield , CT , USA.
Kelly Coblea Biotherapeutics Disccovery Research , Boehringer Ingelheim Pharmaceuticals, Inc , Ridgefield , CT , USA.
Peter Ruusb Translational Medicine, Clinical Pharmacology , Boehringer Ingelheim Pharma GmbH & Co. KG , Ingelheim am Rein , Germany.
Joseph R Woskaa Biotherapeutics Disccovery Research , Boehringer Ingelheim Pharmaceuticals, Inc , Ridgefield , CT , USA.
Rajkumar Ganesana Biotherapeutics Disccovery Research , Boehringer Ingelheim Pharmaceuticals, Inc , Ridgefield , CT , USA.ORCID 0000-0002-3431-9664
Steven Hansela Biotherapeutics Disccovery Research , Boehringer Ingelheim Pharmaceuticals, Inc , Ridgefield , CT , USA.
M Lamine Mbowa Biotherapeutics Disccovery Research , Boehringer Ingelheim Pharmaceuticals, Inc , Ridgefield , CT , USA.
Boehringer Ingelheim (United States) · USBoehringer Ingelheim (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Accurate prediction of the human pharmacokinetics (PK) of a candidate monoclonal antibody from nonclinical data is critical to maximize the success of clinical trials. However, for monoclonal antibodies exhibiting nonlinear clearance due to target-mediated drug disposition, PK predictions are particularly challenging. That challenge is further compounded for molecules lacking cross-reactivity in a nonhuman primate, in which case a surrogate antibody selective for the target in rodent may be required. For these cases, prediction of human PK must account for any interspecies differences in binding kinetics, target expression, target turnover, and potentially epitope. We present here a model-based method for predicting the human PK of MAB92 (also known as BI 655130), a humanized IgG1

Indexed as

AnimalsAntibodies, Monoclonal, HumanizedFemaleHumansMacaca fascicularisMaleMiceMice, Inbred C57BLModels, BiologicalRatsReceptors, Interleukin-1Retrospective StudiesTranscriptomeAntibodies, Monoclonal, HumanizedIL1RL2 protein, humanReceptors, Interleukin-1CAGEcross-speciesexpressionFANTOMhuman predictionmechanistic modelingmodelingmonoclonal antibodynonlinear pharmacokineticRNA transcriptomesemi-mechanisticsurrogatetarget-mediated drug dispositionTMDD

Identifiers

PMID31068073
PMCPMC6601564
OpenAlexW2944258161

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.