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This article is from the NEJM Journal Watch Low, Standard, and High Doses of IVIg for Maintenance in CIDP Comparative Review of Low, Standard, and High Doses of IVIg for Maintenance in CIDP Author: Leana Doherty, MD This randomization All three doses tested were safe and effective and showed dose-dependent responses
.
This industry-funded, international, randomized trial examined the use of low-dose (0.
5 g/kg), standard-dose (1.
0 g/kg), and high-dose (2.
0 g/kg) intravenous immunoglobulin (IVIg) for Safety and efficacy of maintenance therapy in chronic inflammatory demyelinating polyneuropathy (CIDP)
.
Participants who had previously received corticosteroids (87.
1%) or IVIg (12.
9%) were included in the trial
.
We reduced the patient's corticosteroid and IVIg doses during the washout period until disease progression occurred
.
142 patients received induction therapy with IVIg (2.
0 g/kg) and were randomly assigned (1:2:1) to receive 0.
5 g/kg, 1.
0 g/kg, or 2.
0 g/kg every 3 weeks.
IVIg treatment for a total of 24 weeks
.
The primary outcome was the rate of remission in the standard-dose group, defined as a ≥1-point improvement in the adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) scale score (a measure of upper and lower extremity disability).
10-point scale)
.
In the 0.
5 g/kg, 1.
0 mg/kg, and 2.
0 g/kg dose groups, 65%, 80% (meeting the primary outcome measure), and 92% of patients, respectively, had an INCAT score improvement of ≥1 point; this significant trend
.
Grip strength and patient-reported activity scores also showed similar dose-dependent improvements
.
Most patients responded within 6 weeks
.
The low-dose group had the highest proportion of patients who dropped out of the trial early (20% vs.
10.
5% in the high-dose group), and these patients were considered non-responders in the analysis, but all participants in the low-dose group who dropped out had the same INCAT score at the time of withdrawal.
improved
.
Headache was the only apparent dose-related adverse event
.
There were no reports of thromboembolic events
.
Review guidelines recommend adjusting IVIg maintenance therapy based on individual patient needs
.
This is the first randomized study to demonstrate that both low-dose and high-dose IVIg maintenance therapy may be well tolerated
.
However, larger studies with sufficient statistical power are needed to demonstrate and quantify dose-dependent improvement, determine which patient characteristics predict response to specific doses, and guide drug reductions
.
Reviewed article Cornblath DR et al.
Randomized trial of three IVIg doses for treating chronic inflammatory demyelinating polyneuropathy.
Brain 2022 Jan 17; [e-pub].
(https://doi.
org/10.
1093/brain/awab422) NEJM Journal Metadata NEJM Journal Watch is published by the NEJM Group.
It invites internationally renowned doctors to comment on important papers in the medical field and helps doctors understand and apply the latest developments
.
"NEJM Frontiers of Medicine" translates several articles every week, publishes them on the app and official website, and selects 2-3 articles and publishes them on WeChat
.
Copyright Information This article was translated, written or commissioned by the NEJM Frontiers in Medicine, jointly created by Jiahui Medical Research and Education Group (J-Med) and The New England Journal of Medicine (NEJM)
.
The full text of the Chinese translation and the included figures are exclusively authorized by the NEJM Group
.
If you want to reprint, please leave a message or contact nejmqianyan@nejmqianyan.
cn
.
Unauthorized translation is an infringement, and the copyright owner reserves the right to pursue legal responsibility
.
.
This industry-funded, international, randomized trial examined the use of low-dose (0.
5 g/kg), standard-dose (1.
0 g/kg), and high-dose (2.
0 g/kg) intravenous immunoglobulin (IVIg) for Safety and efficacy of maintenance therapy in chronic inflammatory demyelinating polyneuropathy (CIDP)
.
Participants who had previously received corticosteroids (87.
1%) or IVIg (12.
9%) were included in the trial
.
We reduced the patient's corticosteroid and IVIg doses during the washout period until disease progression occurred
.
142 patients received induction therapy with IVIg (2.
0 g/kg) and were randomly assigned (1:2:1) to receive 0.
5 g/kg, 1.
0 g/kg, or 2.
0 g/kg every 3 weeks.
IVIg treatment for a total of 24 weeks
.
The primary outcome was the rate of remission in the standard-dose group, defined as a ≥1-point improvement in the adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) scale score (a measure of upper and lower extremity disability).
10-point scale)
.
In the 0.
5 g/kg, 1.
0 mg/kg, and 2.
0 g/kg dose groups, 65%, 80% (meeting the primary outcome measure), and 92% of patients, respectively, had an INCAT score improvement of ≥1 point; this significant trend
.
Grip strength and patient-reported activity scores also showed similar dose-dependent improvements
.
Most patients responded within 6 weeks
.
The low-dose group had the highest proportion of patients who dropped out of the trial early (20% vs.
10.
5% in the high-dose group), and these patients were considered non-responders in the analysis, but all participants in the low-dose group who dropped out had the same INCAT score at the time of withdrawal.
improved
.
Headache was the only apparent dose-related adverse event
.
There were no reports of thromboembolic events
.
Review guidelines recommend adjusting IVIg maintenance therapy based on individual patient needs
.
This is the first randomized study to demonstrate that both low-dose and high-dose IVIg maintenance therapy may be well tolerated
.
However, larger studies with sufficient statistical power are needed to demonstrate and quantify dose-dependent improvement, determine which patient characteristics predict response to specific doses, and guide drug reductions
.
Reviewed article Cornblath DR et al.
Randomized trial of three IVIg doses for treating chronic inflammatory demyelinating polyneuropathy.
Brain 2022 Jan 17; [e-pub].
(https://doi.
org/10.
1093/brain/awab422) NEJM Journal Metadata NEJM Journal Watch is published by the NEJM Group.
It invites internationally renowned doctors to comment on important papers in the medical field and helps doctors understand and apply the latest developments
.
"NEJM Frontiers of Medicine" translates several articles every week, publishes them on the app and official website, and selects 2-3 articles and publishes them on WeChat
.
Copyright Information This article was translated, written or commissioned by the NEJM Frontiers in Medicine, jointly created by Jiahui Medical Research and Education Group (J-Med) and The New England Journal of Medicine (NEJM)
.
The full text of the Chinese translation and the included figures are exclusively authorized by the NEJM Group
.
If you want to reprint, please leave a message or contact nejmqianyan@nejmqianyan.
cn
.
Unauthorized translation is an infringement, and the copyright owner reserves the right to pursue legal responsibility
.