Evidence map›Paper›PMID 36607544›Full record

ArticleAdvances in therapy2023

Population Pharmacokinetics of CMAB008 (an Infliximab Biosimilar) and Remicade

Yin Su, Jing Li, Chenguang Wang, Xunmin Zhang, Sheng Hou, Huaizu Guo, Chenhui Deng, Lun Ou, Jinwei Wang

2 registry-linked trialsAbstract read
PubMed Publisher
In one paragraph

Article in Advances in therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact, top 100% 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.

NCT03478111 phase3completednot on this map

A Randomized, Double-blind, Methotrexate (MTX) Based, Parallel-group, Multicenter Phase III Study to Evaluate Efficacy and Safety of CMAB008 in Adult Patients With Moderately to Severely Active Rheumatoid Arthritis, Compared to Remicade

TypeinterventionalSponsorShanghai Biomabs Pharmaceutical Co., Ltd.Ran2018 to 2019Enrolled390ConditionsRheumatoid ArthritisArmsCMAB008, MTX, Remicade
NCT04779892 phase1completednot on this map

The Study of Infliximab (CMAB008 and Remicade) in Healthy Subjects to Compare the PK and Safety

TypeinterventionalSponsorTaizhou Mabtech Pharmaceutical Co.,LtdRan2020 to 2020Enrolled90ConditionsRheumatoid ArthritisArmsInfliximab
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 0 citations in OpenAlex.

  1. Pharmacokinetic Model Selection for Personalized Infliximab Dosing in IBD.CPT: pharmacometrics & systems pharmacology · 2026
    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 3 institutions in 1 country.

Yin SuDepartment of Rheumatology and Immunology, Peking University People's Hospital, No. 11 Xizhimen South Street, Beijing, 100044, People's Republic of China. suyin@pkuph.edu.cn.ORCID http://orcid.org/0000-0003-1364-1598
Jing LiMabpharm Limited, Taizhou, People's Republic of China.
Chenguang WangMabpharm Limited, Taizhou, People's Republic of China.
Xunmin ZhangMabpharm Limited, Taizhou, People's Republic of China.
Sheng HouMabpharm Limited, Taizhou, People's Republic of China.
Huaizu GuoMabpharm Limited, Taizhou, People's Republic of China.
Chenhui DengDepartment of Clinical Pharmacology, Linking Truth Technology Co., Ltd., Beijing, People's Republic of China.
Lun OuUnited-Power Pharma Tech Co., Ltd., Beijing, People's Republic of China.
Jinwei WangCenter for Inspection of JSMPA, No. 8 Jiangdong Street, Nanjing, 210008, People's Republic of China. 13951882291@139.com.
Jiangsu T-mab BioPharma (China) · CNNanjing Product Quality Supervision and Inspection Institute · CNPeking University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCMAB008 is a monoclonal antibody developed as a biosimilar to infliximab (Remicade

methodsThe population pharmacokinetic model was developed on the basis of intensive pharmacokinetic data from a phase 1 study in healthy male subjects and combined intensive and sparse pharmacokinetic data from a phase 3 study in patients with RA.

resultsA two-compartment model with first-order elimination adequately described CMAB008 and Remicade

conclusionsThe pharmacokinetic characteristics were similar between CMAB008 and Remicade CLINICAL

trial registrationClinicalTrials.gov identifiers NCT04779892, NCT03478111.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidBiosimilar PharmaceuticalsAlbuminsAntibodies, MonoclonalHealthy VolunteersHumansInfliximabMaleAlbuminsAntibodies, MonoclonalAntirheumatic AgentsBiosimilar PharmaceuticalsInfliximabBiosimilarInfliximabPopulation pharmacokineticRheumatoid arthritis

Identifiers

PMID36607544
OpenAlexW4313650446

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.