Evidence map›Paper›PMID 38726639›Full record

Trial reportEuropean journal of neurology2024

A multicenter, randomized, open-label, phase 2 clinical study of telitacicept in adult patients with generalized myasthenia gravis.

Jian Yin, Mingming Zhao, Xianhao Xu, Meini Zhang, Zucai Xu, Zunbo Li, Xinyue Qin, Zhuyi Li, Chongbo Zhao, Hongyu Zhou and 19 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase II
In one paragraph

Trial report in European journal of neurology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04302103 (A Study of RC18, a Recombinant Human B Lymphocyte Stimulator Receptor), which is not on this map. Cited by 38 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT04302103 phase2completednot on this map

A Study of RC18, a Recombinant Human B Lymphocyte Stimulator Receptor:Immunoglobulin G( IgG ) Fc Fusion Protein for Injection for the Treatment of Subjects With Systemic Myasthenia Gravis

TypeinterventionalSponsorRemeGen Co., Ltd.Ran2020 to 2022Enrolled29ConditionsSystemic Myasthenia GravisArmsRC18 160mg, RC18 240 mg
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Article
  6. Article
  7. [Research progress on the application of telitacicept in rheumatism and autoimmune diseases].Zhejiang da xue xue bao. Yi xue ban = Journal of Zhejiang University. Medical sciences · 2026
    Review
  8. Article
  9. Review
  10. Telitacicept as a New Therapeutic Avenue for Generalized Myasthenia Gravis and Thymoma-Associated Myasthenia Gravis.Journal of neuroimmune pharmacology : the official journal of the Society on NeuroImmune Pharmacology · 2026
    Article
  11. Article
  12. Review
  13. Article
  14. Article
  15. Observational
  16. Article
  17. Review
  18. Article
  19. Article
  20. Circulating inflammatory proteins as pathogenic mediators and potential therapeutic targets in myasthenia gravis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2025
    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

29 authors.

Jian YinDepartment of Neurology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, China.ORCID 0009-0003-2054-7281
Mingming ZhaoDepartment of Neurology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, China.
Xianhao XuDepartment of Neurology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, China.
Meini ZhangDepartment of Neurology, First Hospital of Shanxi Medical University, Taiyuan, China.
Zucai XuDepartment of Neurology, Affiliated Hospital of Zunyi Medical University, Zunyi, China.
Zunbo LiDepartment of Neurology, Xi'an Gaoxin Hospital, Xi'an, China.
Xinyue QinDepartment of Neurology, First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Zhuyi LiDepartment of Neurology, Tangdu Hospital, Air Force Medical University of PLA (formerly known as the Fourth Military Medical University), Xi'an, China.
Chongbo ZhaoDepartment of Neurology, Huashan Hospital, Fudan University, Shanghai, China.ORCID 0000-0001-9481-1418
Hongyu ZhouDepartment of Neurology, West China Hospital, Sichuan University, Chengdu, China.
Ying MaDepartment of Neurology, Affiliated Hospital of North Sichuan Medical College, Nanchong, China.
Wenfeng CaoDepartment of Neurology, Jiangxi Provincial People's Hospital, Nanchang, China.
Guoping WangDepartment of Neurology, Anhui Provincial Hospital, Hefei, China.
Yongzhong LinDepartment of Neurology, Second Affiliated Hospital of Dalian Medical University, Dalian, China.
Jizhong ZhangDepartment of Neurology, Nanyang First People's Hospital, Nanyang, China.
Xu ZhangDepartment of Neurology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.
Hongbin CaiDepartment of Neurology, Lanzhou University Second Hospital, Lanzhou, China.
Weidong QianDepartment of Neurology, First Affiliated Hospital of Bengbu Medical College, Bengbu, China.
Yiqi WangDepartment of Neurology, Zhejiang Provincial People's Hospital, Hangzhou, China.
Xinghu ZhangDepartment of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Guangzhi LiuDepartment of Neurology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.
Jiawei WangDepartment of Neurology, Beijing Tongren Hospital, Capital Medical University, Beijing, China.
Wei QiuDepartment of Neurology, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.ORCID 0000-0002-0880-958X
Lianqiu MinDepartment of Neurology, First Affiliated Hospital of Jinzhou Medical University, Jinzhou, China.
Jing LiDepartment of Neurology, Xiangya Hospital, Central South University, Changsha, China.
Hui DengDepartment of Neurology, First Hospital of Jilin University, Changchun, China.
Lan ChuDepartment of Neurology, Affiliated Hospital of Guizhou Medical University, Guiyang, China.
Yifan ZhangDepartment of Neurology, Affiliated Hospital of Guizhou Medical University, Guiyang, China.
Jianmin FangSchool of Life Science and Technology, Tongji University, Shanghai, China.

Funding

National High Level Hospital Clinical Reaearch Funding BJ-2023-111RemeGen Co., Ltd
6 · The paper itself

Abstract

background and purposeThis study aimed to investigate the clinical efficacy and safety of telitacicept in patients with generalized myasthenia gravis (gMG) who tested positive for acetylcholine receptor antibodies or muscle-specific kinase antibodies and were receiving standard-of-care therapy.

methodsPatients meeting the eligibility criteria were randomly assigned to receive telitacicept subcutaneously once a week for 24 weeks in addition to standard-of-care treatment. The primary efficacy endpoint was the mean change in the quantitative myasthenia gravis (QMG) score from baseline to week 24. Secondary efficacy endpoints included mean change in QMG score from baseline to week 12 and gMG clinical absolute score from baseline to week 24. Additionally, safety, tolerability and pharmacodynamics were assessed.

resultsTwenty-nine of the 41 patients screened were randomly selected and enrolled. The mean (± standard deviation [SD]) reduction in QMG score from baseline to week 24 was 7.7 (± 5.34) and 9.6 (± 4.29) in the 160 mg and 240 mg groups, respectively. At week 12, mean reductions in QMG scores for these two groups were 5.8 (± 5.85) and 9.5 (± 5.03), respectively, indicating rapid clinical improvement. Safety analysis revealed no adverse events leading to discontinuation or mortalities. All patients showed consistent reductions in serum immunoglobulin (Ig) A, IgG and IgM levels throughout the study.

conclusionTelitacicept demonstrated safety, good tolerability and reduced clinical severity throughout the study period. Further validation of the clinical efficacy of telitacicept in gMG will be conducted in an upcoming phase 3 clinical trial.

Indexed as

Myasthenia GravisAdultAgedFemaleHumansMaleMiddle AgedReceptors, CholinergicTreatment OutcomeReceptors, Cholinergicautoimmune diseaseB lymphocyte stimulatorclinical trialimmunotherapymyasthenia gravis

Identifiers

PMID38726639
PMCPMC11235933

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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.