Hyaluronidase-Facilitated Subcutaneous Immunoglobulin 10% as Maintenance Therapy for Japanese Patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy and Multifocal Motor Neuropathy: A Phase 3, Open-label Clinical Trial
Abstract
Objective This study investigated the efficacy, safety, and tolerability of hyaluronidase-facilitated subcutaneous immunoglobulin (fSCIG) 10% as maintenance therapy in Japanese patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and multifocal motor neuropathy (MMN).Methods This phase 3, multicenter, open-label study (NCT05084053, jRCT2051210110) comprised a ≤8-week screening/baseline period, a 6-month fSCIG 10% treatment period (Epoch 1), and ≥6 months' extended treatment (Epoch 2). fSCIG 10% was administered at each patient's previous intravenous immunoglobulin (IVIG) dose and interval. The primary endpoints were relapse rate (≥1-point increase in adjusted Inflammatory Neuropathy Cause and Treatment disability score) for CIDP and change from baseline in maximum handgrip strength (more affected hand) for MMN.Patients Adults with CIDP (N=19) or MMN (N=7) on stable IVIG dose.Results In the CIDP group, no patient developed a relapse during Epoch 1; the upper bound of the 95% confidence interval (CI) was 17.65%, below the preset efficacy threshold (57%). For MMN, median (range) and mean (95% CI) change from baseline in maximum grip strength (more affected hand) was 0.0 (-16, 18) and -1.1 (-12.9, 10.6) kPa, respectively. In the CIDP/MMN combined safety analysis across 12 months, 262 treatment-emergent adverse events (TEAEs; 96 systemic, 166 local) in 18 patients (69.2%) were considered fSCIG 10% related. No severe or serious TEAEs occurred.Conclusion fSCIG 10% prevented CIDP relapse and maintained a stable disease course in MMN in Japanese patients. The treatment was well tolerated, with no severe or serious adverse events related to the treatment.
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BibTeX
@article{kuwabara2026hyaluronidasefacilitated,
title = {{Hyaluronidase-Facilitated Subcutaneous Immunoglobulin 10% as Maintenance Therapy for Japanese Patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy and Multifocal Motor Neuropathy: A Phase 3, Open-label Clinical Trial}},
author = {Satoshi Kuwabara and Kazumoto Shibuya and Yuji Tomizawa and Hidenori Ogata and Sayuri Shima and Atsushi Kuga and Chihiro Suzuki and Kentarou Kudou and Zhaoyang Li and Ay Hakan and Sonoko Misawa and On behalf of the HyQvia Japan CIDP/MMN Study Group},
journal = {Internal Medicine},
year = {2026},
month = aug,
doi = {10.2169/internalmedicine.6875-25},
url = {https://www.jstage.jst.go.jp/article/internalmedicine/advpub/0/advpub_6875-25/_article},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Hyaluronidase-Facilitated Subcutaneous Immunoglobulin 10% as Maintenance Therapy for Japanese Patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy and Multifocal Motor Neuropathy: A Phase 3, Open-label Clinical Trial
AU - Satoshi Kuwabara
AU - Kazumoto Shibuya
AU - Yuji Tomizawa
AU - Hidenori Ogata
AU - Sayuri Shima
AU - Atsushi Kuga
AU - Chihiro Suzuki
AU - Kentarou Kudou
AU - Zhaoyang Li
AU - Ay Hakan
AU - Sonoko Misawa
AU - On behalf of the HyQvia Japan CIDP/MMN Study Group
PY - 2026
DA - 2026/08/19
JO - Internal Medicine
DO - 10.2169/internalmedicine.6875-25
UR - https://www.jstage.jst.go.jp/article/internalmedicine/advpub/0/advpub_6875-25/_article
AB - Objective This study investigated the efficacy, safety, and tolerability of hyaluronidase-facilitated subcutaneous immunoglobulin (fSCIG) 10% as maintenance therapy in Japanese patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and multifocal motor neuropathy (MMN).Methods This phase 3, multicenter, open-label study (NCT05084053, jRCT2051210110) comprised a ≤8-week screening/baseline period, a 6-month fSCIG 10% treatment period (Epoch 1), and ≥6 months' extended treatment (Epoch 2). fSCIG 10% was administered at each patient's previous intravenous immunoglobulin (IVIG) dose and interval. The primary endpoints were relapse rate (≥1-point increase in adjusted Inflammatory Neuropathy Cause and Treatment disability score) for CIDP and change from baseline in maximum handgrip strength (more affected hand) for MMN.Patients Adults with CIDP (N=19) or MMN (N=7) on stable IVIG dose.Results In the CIDP group, no patient developed a relapse during Epoch 1; the upper bound of the 95% confidence interval (CI) was 17.65%, below the preset efficacy threshold (57%). For MMN, median (range) and mean (95% CI) change from baseline in maximum grip strength (more affected hand) was 0.0 (-16, 18) and -1.1 (-12.9, 10.6) kPa, respectively. In the CIDP/MMN combined safety analysis across 12 months, 262 treatment-emergent adverse events (TEAEs; 96 systemic, 166 local) in 18 patients (69.2%) were considered fSCIG 10% related. No severe or serious TEAEs occurred.Conclusion fSCIG 10% prevented CIDP relapse and maintained a stable disease course in MMN in Japanese patients. The treatment was well tolerated, with no severe or serious adverse events related to the treatment.
SN - 1349-7235
SN - 0918-2918
ER -