Evidence map›Paper›PMID 36896910›Full record

ArticleCPT: pharmacometrics & systems pharmacology2023

PK/PD modeling to characterize placebo and treatment effect of omalizumab for chronic spontaneous urticaria.

Elise Oh, Russ Wada, Kha Le, Yanan Zheng, Jin Jin, Victor Poon, Kit Wong, Ryan Owen, Kenta Yoshida

Open access · goldAbstract read
In one paragraph

Article in CPT: pharmacometrics & systems pharmacology, 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
1.2field-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

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. 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

9 authors at 2 institutions in 2 countries.

Elise OhDepartment of Clinical Pharmacology, Genentech, Inc., South San Francisco, California, USA.
Russ WadaQuantitative Solutions Inc., Menlo Park, California, USA.
Kha LeDepartment of Clinical Pharmacology, Genentech, Inc., South San Francisco, California, USA.
Yanan ZhengDepartment of Clinical Pharmacology, Genentech, Inc., South San Francisco, California, USA.
Jin JinDepartment of Clinical Pharmacology, Genentech, Inc., South San Francisco, California, USA.
Victor PoonDepartment of Clinical Pharmacology, Genentech, Inc., South San Francisco, California, USA.
Kit WongOMNI Biomarker Development, Genentech, Inc., South San Francisco, California, USA.
Ryan OwenDepartment of Clinical Pharmacology, Genentech, Inc., South San Francisco, California, USA.
Kenta YoshidaDepartment of Clinical Pharmacology, Genentech, Inc., South San Francisco, California, USA.ORCID 0000-0003-4967-3831
Biomarker Technologies (China) · CNQuantitative BioSciences · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The pharmacokinetic (PK) characteristics of omalizumab and its pharmacodynamic (PD) effect in patients has yet to be fully characterized in chronic spontaneous urticaria, which could elucidate its pathogenesis and treatment response. This study has two objectives; (1) characterize the population PK of omalizumab and its PD effect on IgE, and (2) develop a drug effect model of omalizumab in urticaria (via change in weekly itch severity score). The target-mediated population of PK/PD model incorporating omalizumab-IgE binding and turnover adequately described PK and PD of omalizumab. The effect compartment model and linear drug effect and additive placebo response adequately described placebo and treatment effects of omalizumab. Several baseline covariates were identified for PK/PD and drug effect models. The developed model has the potential to aid in understanding variability in PK/PD as well as response to omalizumab treatment.

Indexed as

Anti-Allergic AgentsChronic UrticariaChronic DiseaseHumansImmunoglobulin EOmalizumabTreatment OutcomeAnti-Allergic AgentsImmunoglobulin EOmalizumab

Identifiers

PMID36896910
PMCPMC10272305
OpenAlexW4323811454

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.