Evidence map›Paper›PMID 36964872›Full record

ArticleRheumatology and therapy2023

Efficacy and Safety of CMAB008 Compared with Innovator Infliximab in Patients with Moderate-to-Severe Rheumatoid Arthritis Receiving Concomitant Methotrexate: A Randomized, Double-blind, Multi-center, Phase III Non-inferiority Study.

Hua Ye, Shengyun Liu, Jian Xu, Kexia Chai, Dongyi He, Yongfei Fang, Qibing Xie, Huaxiang Liu, Ying Liu, Bingzhu Hua and 23 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Rheumatology and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03478111 (A Randomized, Double-blind, Methotrexate), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 34% 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
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Review
  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

33 authors at 20 institutions in 1 country.

Hua Ye *Rheumatology Department, Peking University People's Hospital, No. 11, XiZhimen South Street, Beijing, 100044, China.
Shengyun Liu *Rheumatology and Immunology Department, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Jian Xu *Rheumatology and Immunology Department, First Affiliated Hospital of Kunming Medical University, Kunming, China.
Kexia ChaiRheumatology and Immunology Department, Qinghai University Affiliated Hospital, Xining, China.
Dongyi HeArthrology Department, Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai, China.
Yongfei FangRheumatology and Immunology Department of Traditional Chinese Medicine, The Southwest Hospital of Army Medical University, Chongqing, China.
Qibing XieRheumatology and Immunology Department, West China Hospital Sichuan University, Chengdu, China.
Huaxiang LiuDepartment of Rheumatology, Qilu Hospital of Shandong University, Jinan, China.
Ying LiuRheumatology and Immunology Department of Traditional Chinese Medicine, The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, China.
Bingzhu HuaRheumatology and Immunology Department, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, China.
Jiankang HuRheumatology and Immunology Department, Pingxiang People's Hospital, Pingxiang, China.
Zhiyi ZhangRheumatology and Immunology Department, The First Affiliated Hospital of Harbin Medical University, Harbin, China.
Mingxuan ZhouImmunology Department, The Second Affiliated Hospital of Fujian Medical University, Quanzhou, China.
Dongbao ZhaoRheumatology and Immunology Department, Changhai Hospital of Shanghai, Shanghai, China.
Yan LiRheumatology and Immunology Department, The First Affiliated Hospital of Xiamen University, Xiamen, China.
Zhenyu JiangRheumatology and Immunology Department, The First Hospital of Jilin University, Changchun, China.
Meimei WangRheumatology and Immunology Department, Zhongda Hospital Southeast University, Nanjing, China.
Jingyang LiRheumatology and Immunology Department, Zhuzhou Central Hospital, Zhuzhou, China.
Zhuoli ZhangRheumatology and Immunology Department, Peking University First Hospital, Beijing, China.
Xiaomei LiRheumatology and Immunology Department, Anhui Provincial Hospital, Hefei, China.
Yang LiRheumatology and Immunology Department, The Second Affiliated Hospital of Harbin Medical University, Harbin, China.
Erwei SunRheumatology and Immunology Department, The Third Affiliated Hospital of Southern Medical University, Guangzhou, China.
Liqi BiRheumatology and Immunology Department, China-Japan Union Hospital of Jilin University, Changchun, China.
Wei WeiRheumatology and Immunology Department, Tianjin Medical University General Hospital, Tianjin, China.
Ning TieRheumatology and Immunology Department, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot City, China.
Lan HeRheumatology and Immunology Department, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Xiangyang HuangRheumatology and Immunology Department, The Second Xiangya Hospital of Central South University, Changsha, China.
Yan ZhangRheumatology and Immunology Department, The Second Affiliated Hospital, Tangdu Hospital The Air Force Military Medical University, Xi'an, China.
Qingchun HuangRheumatology Department, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.
Xiaofei WangRheumatology and Immunology Department, Shengjing Hospital of China Medical University, Shenyang, China.
Xiangyuan LiuRheumatology and Immunology Department, Peking University Third Hospital, Beijing, China.
Jing LiMabpharm Limited, Taizhou, China.
Yin SuRheumatology Department, Peking University People's Hospital, No. 11, XiZhimen South Street, Beijing, 100044, China. suyin@pkuph.edu.cn.ORCID http://orcid.org/0000-0003-1364-1598
Harbin Medical University · CNPeking University · CNJilin University · CNZhuzhou Central Hospital · CNAnhui Provincial Hospital · CNArmy Medical University · CNCentral South University · CNChina Medical University · CNFirst Affiliated Hospital of Xi'an Jiaotong University · CNFirst Affiliated Hospital of Zhengzhou University · CNFujian Medical University · CNInner Mongolia Medical University · CNJiangxi Pingxiang People's Hospital · CNKunming Medical University · CNNanjing Drum Tower Hospital · CNQilu Hospital of Shandong University · CNQinghai University Affiliated Hospital · CNSecond Military Medical University · CNShandong University of Traditional Chinese Medicine · CNShanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine · CN

Funding

Chinese National Key Technology R&D Program 2018ZX09301002-001
6 · The paper itself

Abstract

objectivesThe aim of this work is to verify the non-inferior efficacy and safety of CMAB008 compared with innovator infliximab in rheumatoid arthritis patients combined with methotrexate.

methodsWe conducted a randomized, double-blinded, parallel, positive control design, multicenter study, with a stable dose of methotrexate. Patients were enrolled randomly with a ratio of 1:1 to receive intravenously CMAB008 3 mg/kg or innovator infliximab 3 mg/kg at weeks 0, 2, 6, 14, 22 and 30. The primary efficacy endpoint was American College of Rheumatology 20% improvement criteria (ACR20) response rate at week 30. The non-inferiority was established if the lower limit of the one-sided 97.5% confidence interval (CI) for the difference was more than - 15% and the equivalence was established if the two-sided 95% CI was within ± 15% in an exploratory equivalence analysis. The secondary endpoints included other efficacy assessment parameters, as well as immunogenicity, safety, and pharmacokinetics.

resultsIn the full analysis population (FAS), 110 (57.6%) of 191 patients in the CMAB008 group and 120 (62.2%) of 193 patients in the innovator infliximab group reached the primary outcome of ACR20 at week 30. The differences of the rates were - 4.6% and the lower limit of one-sided 97.5% confidence interval was - 14.29%, not less than the lower limit of the non-inferiority margin (- 15%); so CMAB008 was non-inferior to innovator infliximab. Further, CMAB008 was equivalent to innovator infliximab both in FAS (difference - 4.6%, 95% CI - 14.29% to 5.12%) and PPS (difference - 3.3%, 95% CI - 13.18% to 6.62%). The efficacy, safety, immunogenicity, and pharmacokinetics are highly similar between CMAB008 and innovator infliximab.

conclusionsNon-inferior efficacy of CMAB008 to innovator infliximab is illustrated with similar early and lasting therapeutic effects, and the equivalence is further demonstrated. CMAB008 is well tolerated and has semblable safety compared with the innovator infliximab. TRIAL REGISTRATION NUMBER: NCT03478111.

Indexed as

BiosimilarClinical equivalenceCMAB008InfliximabRheumatoid arthritis

Identifiers

PMID36964872
PMCPMC10140208
OpenAlexW4360941916

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.