Evidence map›Paper›PMID 35412216›Full record

ArticleNeurology and therapy2022

Therapeutic Effects of Batoclimab in Chinese Patients with Generalized Myasthenia Gravis: A Double-Blinded, Randomized, Placebo-Controlled Phase II Study.

Chong Yan, Rui-Sheng Duan, Huan Yang, Hai-Feng Li, Zhangyu Zou, Hua Zhang, Hongyu Zhou, Xiao-Li Li, Hao Zhou, Lidong Jiao and 7 more

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

Article in Neurology and therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04346888 (A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Pharmacodynamic and Pharmacokinetic of HBM9161), which is not on this map. Cited by 41 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 6 pooled it
7.3field-weighted citation impact, top 2% 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.

NCT04346888 phase2completednot on this map

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Pharmacodynamic and Pharmacokinetic of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis

TypeinterventionalSponsorHarbour BioMed (Guangzhou) Co. Ltd.Ran2020 to 2021Enrolled30ConditionsMyasthenia GravisArmsHBM9161 Injection (680mg and 340 mg), Placebos, HBM9161 Injection (340 mg)
3 · Its place in the literature

Who cites it

41 citing papers in PubMed, 6 syntheses or guidelines pooled it, 62 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Trial
  9. Article
  10. Article
  11. Article
  12. Review
  13. Review
  14. Review
  15. Article
  16. Review
  17. Targeting the Neonatal Fc Receptor in Autoimmune Diseases: Pipeline and Progress.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025
    Review
  18. Review
  19. Article
  20. Review
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

17 authors at 8 institutions in 1 country.

Chong Yan *Huashan Rare Disease Center, Department of Neurology, Huashan Hospital, Fudan University, Shanghai, China.
Rui-Sheng Duan *Department of Neurology, The First Affiliated Hospital of Shandong First Medical University and Shandong Provincial Qianfoshan Hospital, Jinan, China.
Huan Yang *Department of Neurology, Xiangya Hospital, Central South University, Changsha, China.
Hai-Feng LiDepartment of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.
Zhangyu ZouDepartment of Neurology, Fujian Medical University Union Hospital, Fuzhou, China.
Hua ZhangDepartment of Neurology, Beijing Hospital, Beijing, China.
Hongyu ZhouDepartment of Neurology, West China Hospital, Sichuan University, Chengdu, China.
Xiao-Li LiDepartment of Neurology, The First Affiliated Hospital of Shandong First Medical University and Shandong Provincial Qianfoshan Hospital, Jinan, China.
Hao ZhouDepartment of Neurology, Xiangya Hospital, Central South University, Changsha, China.
Lidong JiaoDepartment of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.
Jialin ChenDepartment of Neurology, Fujian Medical University Union Hospital, Fuzhou, China.
Jian YinDepartment of Neurology, Beijing Hospital, Beijing, China.
Qin DuDepartment of Neurology, West China Hospital, Sichuan University, Chengdu, China.
Michael LeeHarbour BioMed, Shanghai, China.
Yu ChenHarbour BioMed, Shanghai, China.
Xiaoxiang ChenHarbour BioMed, Shanghai, China.
Chongbo ZhaoHuashan Rare Disease Center, Department of Neurology, Huashan Hospital, Fudan University, Shanghai, China. zhao_chongbo@fudan.edu.cn.ORCID http://orcid.org/0000-0001-9481-1418
Central South University · CNShanghai Harbour Engineering Design & Research Institute · CNBeijing Hospital · CNCapital Medical University · CNFudan University · CNFujian Medical University · CNShandong Provincial QianFoShan Hospital · CNSichuan University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionWe investigated the safety and explore potential efficacy of batoclimab administered subcutaneously in Chinese patients with generalized myasthenia gravis (gMG).

methodsA randomized, double-blinded, placebo-controlled, parallel phase II study was conducted. First, in the double-blinded treatment period, eligible patients received batoclimab (680 mg), batoclimab (340 mg), or placebo on days 1, 8, 15, 22, 29, and 36. In the open-label treatment period, patients received batoclimab (340 mg) on days 50, 64, and 78. In the follow-up period, patients were examined on days 92, 106, and 120. The primary endpoint was Myasthenia Gravis Activities of Daily Living (MG-ADL) score change on day 43 from baseline.

resultsIn total, 30 eligible patients were enrolled, with 11, 10, and 9 patients in the batoclimab 680 mg, batoclimab 340 mg, and placebo groups, respectively. MG-ADL score changes from baseline to day 43 were -2.2 ± 0.9, -4.7 ± 0.6, and -4.4 ± 1.0 in the placebo, batoclimab 340 mg, and 680 mg groups, respectively. Similar changes were observed in Quantitative Myasthenia Gravis, Myasthenia Gravis Composite, and 15-item Myasthenia Gravis Quality of Life scores in the placebo, batoclimab 340 mg, and 680 mg groups, respectively. The proportion of patients with clinically significant improvement on day 43 was higher in the batoclimab groups. On day 120, all four scales in the placebo group had more significant improvement compared with the batoclimab groups, with total serum IgG levels reaching a plateau. No death or treatment-emergent adverse events (TEAEs) led to study discontinuation.

conclusionBatoclimab is effective and safe in Chinese patients with gMG.

trial registrationThis study was registered at ClinicalTrials.gov (NCT04346888) on 15 April 2020, with the first patient enrolled on 23 July 2020.

Indexed as

BatoclimabEfficacyGeneralized myasthenia gravisNeonatal Fc receptorSafety

Identifiers

PMID35412216
PMCPMC9095773
OpenAlexW4223631261

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.