{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,18]],"date-time":"2026-04-18T06:57:37Z","timestamp":1776495457971,"version":"3.51.2"},"reference-count":19,"publisher":"Springer Science and Business Media LLC","issue":"3","license":[{"start":{"date-parts":[[2017,3,18]],"date-time":"2017-03-18T00:00:00Z","timestamp":1489795200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2017,3,18]],"date-time":"2017-03-18T00:00:00Z","timestamp":1489795200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["J Clin Immunol"],"published-print":{"date-parts":[[2017,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n          <jats:sec>\n            <jats:title>Purpose<\/jats:title>\n            <jats:p>This phase 3, multicenter, open-label, randomized, two-period, crossover bioequivalence trial evaluated the safety, tolerability, and pharmacokinetics of intravenous immunoglobulins (IVIGs) Gammaplex 5% and Gammaplex 10% in 33 adults and 15 children with primary immunodeficiency diseases (PIDs).<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods<\/jats:title>\n            <jats:p>Eligible adults received five Gammaplex 5% infusions followed by five Gammaplex 10% infusions, or vice versa, stratified by a 21- or 28-day dosing regimen. Pediatric subjects received five Gammaplex 10% infusions only.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results<\/jats:title>\n            <jats:p>The primary objective, to demonstrate the bioequivalence of Gammaplex 10% and Gammaplex 5% at the 28-day dosing interval, was met based on the Gammaplex 10%\/Gammaplex 5% ratio of area under the concentration versus time curve (AUC<jats:sub>0\u201328<\/jats:sub>) values. Throughout the study, total immunoglobulin G trough levels were well maintained, with total values generally \u2265600\u00a0mg\/dL (minimum level for study inclusion). At the dosing schedules and infusion rates used in this study, safety and tolerability were comparable and acceptable in adult and pediatric PID subjects treated with Gammaplex 10% and 5%.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions<\/jats:title>\n            <jats:p>In this study, the first direct comparison of 5% IVIG and 10% IVIG products in PID subjects, the pharmacokinetic analysis demonstrated bioequivalence of Gammaplex 10% and Gammaplex 5% at the 28-day dosing interval. The Gammaplex 10% formulation was safe and well tolerated in pediatric and adult PID subjects. Based on the results from this bridging study in PID subjects, Gammaplex 10% could be expected to have a therapeutic effect similar to the licensed Gammaplex 5%, which has demonstrated efficacy and tolerability in patients with PID and idiopathic thrombocytopenic purpura.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1007\/s10875-017-0383-9","type":"journal-article","created":{"date-parts":[[2017,3,18]],"date-time":"2017-03-18T08:10:49Z","timestamp":1489824649000},"page":"301-310","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Evaluation of the Safety, Tolerability, and Pharmacokinetics of Gammaplex\u00ae 10% Versus Gammaplex\u00ae 5% in Subjects with Primary Immunodeficiency"],"prefix":"10.1007","volume":"37","author":[{"given":"Richard L.","family":"Wasserman","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Isaac R.","family":"Melamed","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark R.","family":"Stein","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephen","family":"Jolles","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Miranda","family":"Norton","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James N.","family":"Moy","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"for the GMX07 Study Group","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2017,3,18]]},"reference":[{"key":"383_CR1","doi-asserted-by":"publisher","first-page":"410","DOI":"10.1111\/j.1365-2249.2007.03432.x","volume":"149","author":"P Wood","year":"2007","unstructured":"Wood P, Stanworth S, Burton J, Jones A, Peckham DG, Green T, et al. Recognition, clinical diagnosis and management of patients with primary antibody deficiencies: a systematic review. Clin Exp Immunol. 2007;149:410\u201323.","journal-title":"Clin Exp Immunol"},{"key":"383_CR2","unstructured":"Jolles S. Subcutaneous and intramuscular immune globulin therapy [updated 22 December 2015]. http:\/\/www.uptodate.com\/contents\/subcutaneous-and-intramuscular-immune-globulin-therapy. Accessed 9 September 2016."},{"key":"383_CR3","doi-asserted-by":"publisher","first-page":"171","DOI":"10.1016\/j.tmrv.2013.05.004","volume":"27","author":"ER Stiehm","year":"2013","unstructured":"Stiehm ER. Adverse effects of human immunoglobulin therapy. 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Allergol Immunopathol (Madr). 2014;42:136\u201341.","journal-title":"Allergol Immunopathol (Madr)"}],"updated-by":[{"DOI":"10.1007\/s10875-017-0418-2","type":"erratum","label":"Erratum","source":"publisher","updated":{"date-parts":[[2017,7,17]],"date-time":"2017-07-17T00:00:00Z","timestamp":1500249600000}}],"container-title":["Journal of Clinical Immunology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10875-017-0383-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s10875-017-0383-9\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10875-017-0383-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,9,2]],"date-time":"2021-09-02T17:15:07Z","timestamp":1630602907000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s10875-017-0383-9"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,3,18]]},"references-count":19,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2017,4]]}},"alternative-id":["383"],"URL":"https:\/\/doi.org\/10.1007\/s10875-017-0383-9","relation":{"erratum":[{"id-type":"doi","id":"10.1007\/s10875-017-0418-2","asserted-by":"object"}]},"ISSN":["0271-9142","1573-2592"],"issn-type":[{"value":"0271-9142","type":"print"},{"value":"1573-2592","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,3,18]]},"assertion":[{"value":"28 October 2016","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"8 March 2017","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"18 March 2017","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Compliance with Ethical Standards"}},{"value":"RLW has served as a consultant for ADMA Biologics, Bio Products Laboratories, Grifols, Kedrion, Korean Green Cross, ProMetic, Shire, and Therapure; as an investigator for ADMA Biologics, Bio Products Laboratories, CSL Behring, Kedrion, Shire, and ProMetic; and as a speaker for Baxter\/Shire and CSL Behring.IRM has served as a clinical trial investigator for Bio Products Laboratory.MRS has served as a consultant and speaker for Baxter Healthcare, Green Cross, and CSL Behring; and as an investigator for ADMA Biologics, Green Cross, ProMetic, Bio Products Laboratories, and Kedrion.SJ reports consulting, speaker, travel, advisory board, and research support from CSL Behring, Baxter, Bio Products Laboratory, Biotest, SOBI, Shire, Viropharma, and Octapharma.MN is an employee of Bio Products Laboratory.JNM has served as a clinical trial investigator for Bio Products Laboratory, a consultant for Baxter and ProMetic, and an iDMC member for MacroCure and Octapharma.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}},{"value":"This study was supported by Bio Products Laboratory (Study GMX07).","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}}]}}