Intravenous immunoglobulin for maintenance treatment of chronic inflammatory demyelinating polyneuropathy

a multicentre, open-label, 52-week phase III trial

Glovenin-I CIDP Study Group

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

OBJECTIVE: Short-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.

METHODS: This 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.

RESULTS: At 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.

CONCLUSIONS: Maintenance 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).

Original languageEnglish
Pages (from-to)832-838
Number of pages7
JournalJournal of neurology, neurosurgery, and psychiatry
Volume88
Issue number10
DOIs
Publication statusPublished - Oct 1 2017

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Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Intravenous Immunoglobulins
Passive Immunization
Therapeutics
Recurrence
Lacunar Stroke
Phase III Clinical Trials
Cerebral Infarction
Outcome Assessment (Health Care)
Hypertension
Safety

ASJC Scopus subject areas

  • Surgery
  • Clinical Neurology
  • Psychiatry and Mental health

Cite this

@article{aa33d5e2b2ca47f18b86768e15d28499,
title = "Intravenous immunoglobulin for maintenance treatment of chronic inflammatory demyelinating polyneuropathy: a multicentre, open-label, 52-week phase III trial",
abstract = "OBJECTIVE: Short-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.METHODS: This 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.RESULTS: At 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.CONCLUSIONS: Maintenance 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).",
author = "{Glovenin-I CIDP Study Group} and Satoshi Kuwabara and Masahiro Mori and Sonoko Misawa and Miki Suzuki and Kazutoshi Nishiyama and Tatsuro Mutoh and Shizuki Doi and Norito Kokubun and Mikiko Kamijo and Hiroo Yoshikawa and Koji Abe and Yoshihiko Nishida and Kazumasa Okada and Kenji Sekiguchi and Ko Sakamoto and Susumu Kusunoki and Gen Sobue and Ryuji Kaji",
year = "2017",
month = "10",
day = "1",
doi = "10.1136/jnnp-2017-316427",
language = "English",
volume = "88",
pages = "832--838",
journal = "Journal of Neurology, Neurosurgery and Psychiatry",
issn = "0022-3050",
publisher = "BMJ Publishing Group",
number = "10",

}

TY - JOUR

T1 - Intravenous immunoglobulin for maintenance treatment of chronic inflammatory demyelinating polyneuropathy

T2 - a multicentre, open-label, 52-week phase III trial

AU - Glovenin-I CIDP Study Group

AU - Kuwabara, Satoshi

AU - Mori, Masahiro

AU - Misawa, Sonoko

AU - Suzuki, Miki

AU - Nishiyama, Kazutoshi

AU - Mutoh, Tatsuro

AU - Doi, Shizuki

AU - Kokubun, Norito

AU - Kamijo, Mikiko

AU - Yoshikawa, Hiroo

AU - Abe, Koji

AU - Nishida, Yoshihiko

AU - Okada, Kazumasa

AU - Sekiguchi, Kenji

AU - Sakamoto, Ko

AU - Kusunoki, Susumu

AU - Sobue, Gen

AU - Kaji, Ryuji

PY - 2017/10/1

Y1 - 2017/10/1

N2 - OBJECTIVE: Short-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.METHODS: This 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.RESULTS: At 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.CONCLUSIONS: Maintenance 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).

AB - OBJECTIVE: Short-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.METHODS: This 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.RESULTS: At 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.CONCLUSIONS: Maintenance 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).

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U2 - 10.1136/jnnp-2017-316427

DO - 10.1136/jnnp-2017-316427

M3 - Article

VL - 88

SP - 832

EP - 838

JO - Journal of Neurology, Neurosurgery and Psychiatry

JF - Journal of Neurology, Neurosurgery and Psychiatry

SN - 0022-3050

IS - 10

ER -