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Restabilization treatment after intravenous immunoglobulin withdrawal in chronic inflammatory demyelinating polyneuropathy: Results from the pre‐randomization phase of the Polyneuropathy And Treatment with Hizentra study

Authors: Mielke, Orell; Bril, Vera; Cornblath, David R.; Lawo, John-Philip; van Geloven, Nan; Hartung, Hans-Peter; Lewis, Richard A.; +141 Authors

Restabilization treatment after intravenous immunoglobulin withdrawal in chronic inflammatory demyelinating polyneuropathy: Results from the pre‐randomization phase of the Polyneuropathy And Treatment with Hizentra study

Abstract

In patients with chronic inflammatory demyelinating polyneuropathy (CIDP), intravenous immunoglobulin (IVIG) is recommended to be periodically reduced to assess the need for ongoing therapy. However, little is known about the effectiveness of restabilization with IVIG in patients who worsen after IVIG withdrawal. In the Polyneuropathy And Treatment with Hizentra (PATH) study, the pre‐randomization period included sudden stopping of IVIG followed by 12 weeks of observation. Those deteriorating were then restabilized with IVIG. Of 245 subjects who stopped IVIG, 28 did not show signs of clinical deterioration within 12 weeks. Two hundred and seven received IVIG restabilization with an induction dose of 2 g/kg bodyweight (bw) IgPro10 (Privigen, CSL Behring, King of Prussia, Pennsylvania) and maintenance doses of 1 g/kg bw every 3 weeks for up to 13 weeks. Signs of clinical improvement were seen in almost all (n = 188; 91%) subjects. During IVIG restabilization, 35 subjects either did not show CIDP stability (n = 21, analyzed as n = 22 as an additional subject was randomized in error) or withdrew for other reasons (n = 14). Of the 22 subjects who did not achieve clinical stability, follow‐up information in 16 subjects after an additional 4 weeks was obtained. Nine subjects were reported to have improved, leaving a maximum of 27 subjects (13%) who either showed no signs of clinical improvement during the restabilization phase and 4 weeks post‐study or withdrew for other reasons. In conclusion, sudden IVIG withdrawal was effective in detecting ongoing immunoglobulin G dependency with a small risk for subjects not returning to their baseline 17 weeks after withdrawal.

Countries
Germany, Australia, Poland, Italy, Italy, Italy, Italy, Australia, Belgium, Italy, Netherlands
Keywords

2800 Neuroscience, chronic inflammatory demyelinating polyneuropathy (CIDP); inflammatory neuropathy cause and treatment (INCAT); intravenous immunoglobulin (IVIG); polyneuropathy and treatment with Hizentra (PATH); Privigen, Male, METHYLPREDNISOLONE, inflammatory neuropathy cause and treatment (INCAT), chronic inflammatory demyelinating polyneuropathy (CIDP); inflammatory neuropathy cause and treatment (INCAT); intravenous immunoglobulin (IVIG); polyneuropathy and treatment with Hizentra (PATH); Privigen; Neuroscience (all); Neurology (clinical), 150, Medizin, Polyneuropathy and treatment with Hizentra (PATH), Clinical sciences, Chronic inflammatory demyelinating polyneuropathy (CIDP), STRENGTH, Outcome Assessment, Health Care, polyneuropathy and treatment with Hizentra (PATH), Aged, 80 and over, Intravenous immunoglobulin (IVIG), General Neuroscience, Immunoglobulins, Intravenous, Middle Aged, chronic inflammatory demyelinating polyneuropathy (cidp), PATH study group, chronic inflammatory demyelinating polyneuropathy (cidp); inflammatory neuropathy cause and treatment (incat); intravenous immunoglobulin (ivig); polyneuropathy and treatment with hizentra (path); privigen, controlled-trial, POLYRADICULONEUROPATHY, Female, polyneuropathy and treatment with hizentra (path), strength, Life Sciences & Biomedicine, intravenous immunoglobulin (ivig), chronic inflammatory demyelinating polyneuropathy (CIDP); inflammatory neuropathy cause and treatment (INCAT); intravenous immunoglobulin (IVIG); polyneuropathy and treatment with Hizentra (PATH); Privigen; Adult; Aged; Aged, 80 and over; Female; Follow-Up Studies; Humans; Immunoglobulin G; Immunoglobulins, Intravenous; Immunologic Factors; Male; Middle Aged; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Young Adult; Outcome Assessment, Health Care, inflammatory neuropathy cause and treatment (incat), polyradiculoneuropathy, Adult, Clinical Neurology, 610, intravenous immunoglobulin (IVIG), CONTROLLED-TRIAL, Inflammatory neuropathy cause and treatment (INCAT), Young Adult, Journal Article, ivig, Humans, Immunologic Factors, Aged, IVIG, Science & Technology, Neurology & Neurosurgery, Neurosciences, 3202 Clinical sciences, privigen, Research Reports, Privigen, methylprednisolone, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Immunoglobulin G, 3209 Neurosciences, Neurosciences & Neurology, 2728 Clinical Neurology, chronic inflammatory demyelinating polyneuropathy (CIDP), 1109 Neurosciences, Follow-Up Studies

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selected citations
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This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
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popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
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