Evidence map›Paper›PMID 28768822›Full record

Trial reportJournal of neurology, neurosurgery, and psychiatry2017

Intravenous immunoglobulin for maintenance treatment of chronic inflammatory demyelinating polyneuropathy: a multicentre, open-label, 52-week phase III trial.

Satoshi Kuwabara, Masahiro Mori, Sonoko Misawa, Miki Suzuki, Kazutoshi Nishiyama, Tatsuro Mutoh, Shizuki Doi, Norito Kokubun, Mikiko Kamijo, Hiroo Yoshikawa and 9 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Journal of neurology, neurosurgery, and psychiatry, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01824251 (NPB-01), which is not on this map. Cited by 30 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 4 pooled it
4.4field-weighted citation impact, top 5% 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.

NCT01824251 phase3completednot on this map

NPB-01(Intravenous Immunoglobulin) Maintenance Therapy for Patients With Chronic Inflammatory Demyelinating Polyneuropathy.

TypeinterventionalSponsorNihon Pharmaceutical Co., LtdRan2013 to 2015Enrolled49ConditionsChronic Inflammatory Demyelinating PolyneuropathyArmsNPB-01
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 4 syntheses or guidelines pooled it, 53 citations in OpenAlex.

  1. Guideline
  2. Subcutaneous immunoglobulins (SCIG) for chronic inflammatory demyelinating polyneuropathy (CIDP): A comprehensive systematic review of clinical studies and meta-analysis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Efficacy and safety of IVIG in CIDP: Combined data of the PRIMA and PATH studies.Journal of the peripheral nervous system : JPNS · 2019
    Trial
  9. Trial
  10. Review
  11. Article
  12. Review
  13. Article
  14. Restoring immune tolerance in pemphigus vulgaris.Proceedings of the National Academy of Sciences of the United States of America · 2024
    Article
  15. Review
  16. Article
  17. Review
  18. Article
  19. Review
  20. 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

19 authors at 16 institutions in 1 country.

Satoshi KuwabaraDepartment of Neurology, Chiba University Hospital, Chiba, Japan.ORCID 0000-0002-4716-8578
Masahiro MoriDepartment of Neurology, Chiba University Hospital, Chiba, Japan.
Sonoko MisawaDepartment of Neurology, Chiba University Hospital, Chiba, Japan.
Miki SuzukiDepartment of Neurology, Tokyo Women's Medical University, Tokyo, Japan.
Kazutoshi NishiyamaDepartment of Neurology, Kitasato University School of Medicine, Sagamihara, Japan.
Tatsuro MutohDepartment of Neurology, Fujita Health University School of Medicine, Toyoake, Japan.
Shizuki DoiDepartment of Neurology, National Hospital Organization Hokkaido Medical Center, Sapporo, Japan.
Norito KokubunDepartment of Neurology, Dokkyo Medical University, Tochigi, Japan.
Mikiko KamijoDepartment of Neurology, Chubu Rosai Hospital, Nagoya, Japan.
Hiroo YoshikawaDivision of Neurology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan.
Koji AbeDepartment of Neurology, Okayama University School of Medicine, Okayama, Japan.
Yoshihiko NishidaDepartment of Neurology, Itsuki Hospital, Tokushima, Japan.
Kazumasa OkadaDepartment of Neurology, University of Occupational and Environmental Health School of Medicine, Kitakyushu, Japan.
Kenji SekiguchiDivision of Neurology, Kobe University Graduate School of Medicine, Kobe, Japan.
Ko SakamotoNihon Pharmaceutical Co., Ltd, Tokyo, Japan.
Susumu KusunokiDepartment of Neurology, Kindai University Faculty of Medicine, Osaka, Japan.
Gen SobueDepartment of Neurology, Nagoya University School of Medicine, Nagoya, Japan.
Ryuji KajiDepartment of Neurology, Tokushima University School of Medicine, Tokushima, Japan.
Glovenin-I CIDP Study Group
Chiba University Hospital · JPChubu Rosai Hospital · JPDokkyo Medical University · JPFujita Health University · JPHyogo Medical University · JPKindai University · JPKitasato University · JPKobe University · JPNagoya University · JPNational Hospital Organization Hokkaido Medical Center · JPNihon Pharmaceutical University · JPOkayama University · JPTakatsuki General Hospital · JPTokushima University · JPTokyo Women's Medical University · JPUniversity of Occupational and Environmental Health Japan · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveShort-term efficacy of induction therapy with intravenous immunoglobulin (Ig) in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) is well established. However, data of previous studies on maintenance therapy were limited up to 24-week treatment period. We aimed to investigate the efficacy and safety of longer-term intravenous Ig therapy for 52 weeks.

methodsThis study was an open-label phase 3 clinical trial conducted in 49 Japanese tertiary centres. 49 patients with CIDP who fulfilled diagnostic criteria were included. After an induction intravenous Ig therapy (0.4 g/kg/day for five consecutive days), maintenance dose intravenous Ig (1.0 g/kg) was given every 3 weeks for up to 52 weeks. The primary outcome measures were the responder rate at week 28 and relapse rate at week 52. The response and relapse were defined with the adjusted Inflammatory Neuropathy Cause and Treatment scale.

resultsAt week 28, the responder rate was 77.6% (38/49 patients; 95% CI 63% to 88%), and the 38 responders continued the maintenance therapy. At week 52, 4 of the 38 (10.5%) had a relapse (95% CI 3% to 25%). During 52 weeks, 34 (69.4%) of the 49 enrolled patients had a maintained improvement. Adverse events were reported in 94% of the patients; two patients (66-year-old and 76-year-old men with hypertension or diabetes) developed cerebral infarction (lacunar infarct with good recovery), and the other adverse effects were mild and resolved by the end of the study period.

conclusionsMaintenance treatment with 1.0 g/kg intravenous Ig every 3 weeks is an efficacious therapy for patients with CIDP, and approximately 70% of them had a sustained remission for 52 weeks. Thrombotic complications should be carefully monitored, particularly in elderly patients with vascular risk factors. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (NCT01824251).

Indexed as

Treatment OutcomeFemaleHumansImmunoglobulins, IntravenousJapanMaleMiddle AgedPolyradiculoneuropathy, Chronic Inflammatory DemyelinatingRecurrenceTime FactorsImmunoglobulins, Intravenous

Identifiers

PMID28768822
PMCPMC5629934
OpenAlexW2740384497

What OpenQuestion holds

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LicenceCC BY-NC
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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.