{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T18:56:55Z","timestamp":1792177015882,"version":"4.4.0"},"reference-count":18,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2021,8,1]],"date-time":"2021-08-01T00:00:00Z","timestamp":1627776000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100008322","name":"CSL Behring","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008322","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["CPT Pharmacom &amp; Syst Pharma"],"published-print":{"date-parts":[[2021,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    The two main objectives of this analysis were to (i) characterize the relationship between immunoglobulin (Ig) exposure and chronic inflammatory demyelinating polyneuropathy (CIDP) disease severity using data from 171 patients with CIDP who received either subcutaneous Ig (IgPro20; Hizentra\n                    <jats:sup>\u00ae<\/jats:sup>\n                    ) or placebo (PATH study), and to (ii) simulate and compare exposure coverage with various dosing approaches considering weekly dosing to be the reference dose. IgG pharmacokinetic (PK) parameters, including those from a previous population PK model, were used to predict individual IgG profile and exposure metrics. Treatment\u2010related changes in Inflammatory Neuropathy Cause and Treatment (INCAT) scores were best described by a maximum effect (E\n                    <jats:sub>max<\/jats:sub>\n                    ) model as a function of \u0394IgG (total serum IgG at INCAT score assessment minus baseline IgG levels before intravenous Ig restabilization). Simulations indicate that flexible dosing from daily to biweekly (every other week) provide an exposure coverage equivalent to that of a weekly Ig dose.\n                  <\/jats:p>","DOI":"10.1002\/psp4.12647","type":"journal-article","created":{"date-parts":[[2021,6,4]],"date-time":"2021-06-04T05:22:36Z","timestamp":1622784156000},"page":"839-850","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Pharmacometric analysis linking immunoglobulin exposure to clinical efficacy outcomes in chronic inflammatory demyelinating polyneuropathy"],"prefix":"10.1002","volume":"10","author":[{"given":"Michael A.","family":"Tortorici","sequence":"first","affiliation":[{"name":"CSL Behring King of Prussia Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Theresa","family":"Yuraszeck","sequence":"additional","affiliation":[{"name":"CSL Behring King of Prussia Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Cornblath","sequence":"additional","affiliation":[{"name":"Department of Neurology Johns Hopkins University School of Medicine Baltimore Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vera","family":"Bril","sequence":"additional","affiliation":[{"name":"Ellen and Martin Prosserman Centre for Neuromuscular Diseases Division of Neurology Department of Medicine University Health Network University of Toronto Toronto Canada"},{"name":"Institute for Research and Medical Consultations Imam Abdulrahman Bin Faisal University Dammam Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hans\u2010Peter","family":"Hartung","sequence":"additional","affiliation":[{"name":"Department of Neurology, UKD and Center for Neurology and Neuropsychiatry LVR Klinikum Medical Faculty Heinrich Heine University D\u00fcsseldorf Germany"},{"name":"Brain and Mind Centre University of Sydney Sydney Australia"},{"name":"Medical University of Vienna Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gen","family":"Sobue","sequence":"additional","affiliation":[{"name":"Department of Neurology Nagoya University Graduate School of Medicine Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard A.","family":"Lewis","sequence":"additional","affiliation":[{"name":"Department of Neurology Cedars\u2010Sinai Medical Center Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ingemar S. J.","family":"Merkies","sequence":"additional","affiliation":[{"name":"Department of Neurology Maastricht University Medical Center Maastricht The Netherlands"},{"name":"Cura\u00e7ao Medical Center Willemstad Cura\u00e7ao"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John\u2010Philip","family":"Lawo","sequence":"additional","affiliation":[{"name":"CSL Behring Marburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michaela","family":"Praus","sequence":"additional","affiliation":[{"name":"CSL Behring Marburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Billie L.","family":"Durn","sequence":"additional","affiliation":[{"name":"CSL Behring King of Prussia Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Orell","family":"Mielke","sequence":"additional","affiliation":[{"name":"CSL Behring Marburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xuewen","family":"Ma","sequence":"additional","affiliation":[{"name":"CSL Behring King of Prussia Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Petra","family":"Jauslin","sequence":"additional","affiliation":[{"name":"Certara Princeton New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc","family":"Pfister","sequence":"additional","affiliation":[{"name":"University of Basel Basel Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ivo N.","family":"van Schaik","sequence":"additional","affiliation":[{"name":"Department of Neurology Amsterdam University Medical Centres University of Amsterdam Amsterdam The Netherlands"},{"name":"Spaarne Gasthuis Haarlem The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the PATH study group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,8]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1136\/jnnp-2014-309697"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(19)30144-9"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/jns5.12048"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00415-013-6938-7"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/jns.12242"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1080\/00207454.2016.1269328"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.3810\/pgm.2013.11.2712"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(17)30378-2"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-016-1466-2"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/jns5.12017"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/ana.1088"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10928-007-9080-2"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1023\/A:1011579109640"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1177\/0091270010378409"},{"key":"e_1_2_9_16_1","unstructured":"US Food and Drug Administration.CSL Behring. HIZENTRA (Immune Globulin Subcutaneous [Human]): Prescribing Information;2018.https:\/\/www.fda.gov\/files\/vaccines %20blood%20&%20biologics\/published\/Package\u2010Insert\u2010\u2010\u2010Hizentra.pdf. Accessed January 26 2021."},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/ene.12080"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/jns.12262"},{"key":"e_1_2_9_19_1","article-title":"Correlation of the IgG levels with functional outcomes in the PATH subcutaneous immunoglobulin in CIDP study","author":"Cornblath DR","journal-title":"J Peripher Nerv Syst"}],"container-title":["CPT: Pharmacometrics &amp; Systems Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/psp4.12647","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/psp4.12647","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/psp4.12647","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,28]],"date-time":"2023-08-28T13:47:43Z","timestamp":1693230463000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1002\/psp4.12647"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,8]]},"references-count":18,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2021,8]]}},"alternative-id":["10.1002\/psp4.12647"],"URL":"https:\/\/doi.org\/10.1002\/psp4.12647","archive":["Portico"],"relation":{},"ISSN":["2163-8306","2163-8306"],"issn-type":[{"value":"2163-8306","type":"print"},{"value":"2163-8306","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,8]]},"assertion":[{"value":"2020-09-10","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-04-21","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-08-01","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}