{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T14:12:07Z","timestamp":1790259127056,"version":"4.1.0"},"reference-count":20,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T00:00:00Z","timestamp":1790208000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Neurol."],"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Intravenous immunoglobulin (IVIG) 10% and hyaluronidase-facilitated subcutaneous immunoglobulin (fSCIG) 10% are both used as maintenance treatments for patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). Owing to the rarity of the condition, data regarding the relationship between dose, exposure, and clinical outcomes are sparse for these therapies. This analysis aimed to characterize the relationships between dose, exposure, and clinical efficacy of IVIG 10% and fSCIG 10% in CIDP.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and methods<\/jats:title>\n                    <jats:p>Data were pooled from two phase 3 studies in patients with CIDP (NCT02549170; ADVANCE-CIDP 1) and multifocal motor neuropathy (NCT00666263). A sequential population pharmacokinetic (PK)\u2013pharmacodynamic (PD) model was developed to characterize the PK\u2013PD relationship between the PK of serum total immunoglobulin G (IgG) and, as the PD endpoint, the probability of increased adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score (higher scores indicate greater disability). The model was then used to simulate changes in total serum IgG concentrations and the PD endpoint for patients with CIDP. Dosing scenarios simulated were 6\u202fmonths of IVIG 10% or 3\u202fmonths of IVIG 10% followed by 9\u202fmonths of fSCIG 10% at dosages of 0.4, 0.8, and 1.0\u202fg\/kg every 2\u202fweeks, 1.0 and 2.0\u202fg\/kg every 3\u202fweeks, and 0.4, 0.8, 1.0, and 2.0\u202fg\/kg every 4\u202fweeks.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Our results showed that higher doses and more frequent IVIG\/fSCIG 10% administration were associated with a lower mean probability of increased adjusted INCAT score (i.e., lower probability of relapse), remaining &amp;lt; 50% in all simulations except the 0.4\u202fg\/kg every 4\u202fweeks dosage. The probability of increased adjusted INCAT score tended to be higher toward the end of the dosing interval for patients treated less frequently.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>Higher and more frequent dosing may result in more consistent treatment efficacy in patients with CIDP.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fneur.2026.1911076","type":"journal-article","created":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T13:57:46Z","timestamp":1790258266000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Immunoglobulin G dose\u2013exposure\u2013efficacy response in patients with chronic inflammatory demyelinating polyradiculoneuropathy"],"prefix":"10.3389","volume":"17","author":[{"given":"Zhaoyang","family":"Li","sequence":"first","affiliation":[{"name":"Clinical Pharmacology and Early Clinical Development, Takeda Development Center Americas, Inc.","place":["Cambridge, MA, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefan","family":"Roepcke","sequence":"additional","affiliation":[{"name":"Simulations Plus","place":["Buffalo, NY, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,9,24]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","first-page":"47","DOI":"10.1002\/mus.24109","article-title":"Patient demographics and health plan paid costs in chronic inflammatory demyelinating polyneuropathy","volume":"50","author":"Guptill","year":"2014","journal-title":"Muscle Nerve"},{"key":"ref2","doi-asserted-by":"publisher","first-page":"39","DOI":"10.1212\/WNL.0b013e3181aaea47","article-title":"Incidence and prevalence of CIDP and the association of diabetes 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demyelinating polyradiculoneuropathy: report of a joint task force-second revision","volume":"28","author":"Van den Bergh","year":"2021","journal-title":"Eur J Neurol"},{"key":"ref6","year":"2024"},{"key":"ref7","year":"2022"},{"key":"ref8","year":"2025"},{"key":"ref9","year":"2025"},{"key":"ref10","doi-asserted-by":"publisher","first-page":"895","DOI":"10.1080\/1750743X.2024.2382074","article-title":"Immunoglobulin therapies for primary immunodeficiency diseases (part 2): considerations for dosing strategies","volume":"16","author":"Li","year":"2024","journal-title":"Immunotherapy"},{"key":"ref11","doi-asserted-by":"publisher","first-page":"951","DOI":"10.1016\/j.jaci.2012.06.021","article-title":"Recombinant human hyaluronidase-facilitated subcutaneous infusion of human immunoglobulins for primary immunodeficiency","volume":"130","author":"Wasserman","year":"2012","journal-title":"J Allergy Clin Immunol"},{"key":"ref12","doi-asserted-by":"publisher","first-page":"1153","DOI":"10.1007\/s10875-012-9740-x","article-title":"Progress in gammaglobulin therapy for immunodeficiency: from subcutaneous to intravenous infusions and back again","volume":"32","author":"Wasserman","year":"2012","journal-title":"J Clin Immunol"},{"key":"ref13","doi-asserted-by":"publisher","first-page":"146","DOI":"10.1111\/cei.12485","article-title":"Current treatment options with immunoglobulin G for the individualization of care in patients with primary immunodeficiency disease","volume":"179","author":"Jolles","year":"2015","journal-title":"Clin Exp Immunol"},{"key":"ref14","doi-asserted-by":"publisher","first-page":"634181","DOI":"10.3389\/fimmu.2021.634181","article-title":"Update on infections in primary antibody deficiencies","volume":"12","author":"Demirdag","year":"2021","journal-title":"Front Immunol"},{"key":"ref15","doi-asserted-by":"publisher","first-page":"1478419","DOI":"10.3389\/fneur.2024.1478419","article-title":"Dose, exposure, and treatment regimen of intravenous immunoglobulin G in multifocal motor neuropathy","volume":"15","author":"Li","year":"2024","journal-title":"Front Neurol"},{"key":"ref16","doi-asserted-by":"publisher","first-page":"2912","DOI":"10.1002\/jps.23570","article-title":"The utility of modeling and simulation in drug development and regulatory review","volume":"102","author":"Huang","year":"2013","journal-title":"J Pharm Sci"},{"key":"ref17","doi-asserted-by":"publisher","first-page":"4367","DOI":"10.1002\/jps.23330","article-title":"Application of pharmacokinetics-pharmacodynamics\/clinical response modeling and simulation for biologics drug development","volume":"101","author":"Zhao","year":"2012","journal-title":"J Pharm Sci"},{"key":"ref18","doi-asserted-by":"publisher","first-page":"1977","DOI":"10.1002\/acn3.52098","article-title":"Dose-exposure-efficacy response of intravenous immunoglobulin G 10% in multifocal motor neuropathy","volume":"11","author":"Li","year":"2024","journal-title":"Ann Clin Transl Neurol"},{"key":"ref19","first-page":"321","article-title":"A controlled trial of intravenous immunoglobulin in multifocal motor neuropathy","volume-title":"J Peripher Nerv Syst","author":"Hahn","year":"2013"},{"key":"ref20","volume-title":"NONMEM Nonlinear Mixed Effects Modelling tool [Computer program]","year":"2025"}],"container-title":["Frontiers in Neurology"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fneur.2026.1911076\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T13:57:47Z","timestamp":1790258267000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fneur.2026.1911076\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,24]]},"references-count":20,"alternative-id":["10.3389\/fneur.2026.1911076"],"URL":"https:\/\/doi.org\/10.3389\/fneur.2026.1911076","relation":{},"ISSN":["1664-2295"],"issn-type":[{"value":"1664-2295","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,24]]},"article-number":"1911076"}}