{
  "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.",
  "abstract_shown": true,
  "affiliations": [],
  "article_type": null,
  "arxiv": null,
  "author_total": 12,
  "authors": [
    {
      "name": "Satoshi Kuwabara"
    },
    {
      "name": "Kazumoto Shibuya"
    },
    {
      "name": "Yuji Tomizawa"
    },
    {
      "name": "Hidenori Ogata"
    },
    {
      "name": "Sayuri Shima"
    },
    {
      "name": "Atsushi Kuga"
    },
    {
      "name": "Chihiro Suzuki"
    },
    {
      "name": "Kentarou Kudou"
    },
    {
      "name": "Zhaoyang Li"
    },
    {
      "name": "Ay Hakan"
    },
    {
      "name": "Sonoko Misawa"
    },
    {
      "name": "On behalf of the HyQvia Japan CIDP/MMN Study Group"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/4h7cv2gzxwyfd.bib",
  "cited_by": 0,
  "doi": "10.2169/internalmedicine.6875-25",
  "fulltext_url": "https://www.jstage.jst.go.jp/article/internalmedicine/advpub/0/advpub_6875-25/_article",
  "id": "4h7cv2gzxwyfd",
  "issns": [
    "1349-7235",
    "0918-2918"
  ],
  "landing_url": "https://www.jstage.jst.go.jp/article/internalmedicine/advpub/0/advpub_6875-25/_article",
  "language": null,
  "licence": "CC-BY-NC-ND",
  "licence_label": "CC BY-NC-ND",
  "licence_source": "journal",
  "licence_url": "https://creativecommons.org/licenses/by-nc-nd/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "jstage-journal",
      "medicine/general"
    ],
    [
      "openalex",
      "2728|Peripheral Neuropathies and Disorders"
    ]
  ],
  "openalex": "W7203723457",
  "pdf_url": "https://www.jstage.jst.go.jp/article/internalmedicine/advpub/0/advpub_6875-25/_pdf",
  "pmcid": null,
  "pmid": null,
  "published": "2026-08-19",
  "publisher": null,
  "ris": "https://research.draconitic.com/paper/4h7cv2gzxwyfd.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:17:31Z",
      "native_id": "10.2169/internalmedicine.6875-25",
      "source": "jstage",
      "url": "https://www.jstage.jst.go.jp/article/internalmedicine/advpub/0/advpub_6875-25/_article"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2728|Peripheral Neuropathies and Disorders",
      "subfield": "neurology"
    }
  ],
  "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",
  "title_text": "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",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T12:17:31Z",
  "url": "https://research.draconitic.com/paper/4h7cv2gzxwyfd",
  "venue": "Internal Medicine",
  "versions": []
}