{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,26]],"date-time":"2026-09-26T05:35:52Z","timestamp":1790400952593,"version":"4.1.0"},"reference-count":15,"publisher":"Oceanside Publications Inc.","issue":"6","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["allergy asthma proc"],"published-print":{"date-parts":[[2024,11,1]]},"abstract":"<jats:p><jats:bold>Background:<\/jats:bold> Inadequate production of immunoglobulin G (IgG) antibodies renders patients with primary immunodeficiency susceptible to infection by numerous pathogens, some of which can lead to severe asthma exacerbation and possible death. These patients who are immunocompromised\n are often reliant on intravenous immunoglobulin (IVIG) therapies, which provide passive antibodies against various respiratory pathogens, including measles virus and encapsulated bacteria.  <jats:bold>Objective:<\/jats:bold> We conducted a subanalysis of data from a multicenter, multinational,\n phase III, open-label bioequivalence study to compare protective concentrations of IgG antibodies provided by a 5% and a 10% IVIG product in patients with primary immunodeficiency.  <jats:bold>Methods:<\/jats:bold> Patients on stable 21- or 28-day regimens of previous IVIG products were assigned\n to receive study treatment (adults: 5% IVIG and 10% IVIG; children: 10% IVIG) at doses of 300\u2010800 mg\/kg per infusion. Trough concentrations of total IgG, IgG subclasses, measles-neutralizing antibodies, and IgG against Haemophilus influenzae type b and Streptococcus pneumoniae serotypes\n were evaluated.  <jats:bold>Results:<\/jats:bold> A total of 48 patients (33 adults ages 16\u201055 years; 15 children ages 2\u201015 years) were enrolled and received treatment. No statistically significant differences in trough concentrations of total IgG, IgG subclasses, measles-neutralizing\n antibodies, or IgG directed at encapsulated bacteria were observed between the 5% and 10% formulations in analyses by age (adult or pediatric) or infusion schedule (every 21 or 28 days). All evaluated patients had trough IgG concentrations above accepted thresholds for protection against disease.\n  <jats:bold>Conclusion:<\/jats:bold> These findings support the conclusion that, at dose levels and infusion schedules prescribed in clinical practice, this 5% and 10% IVIG product provided consistent, predictable, and bioequivalent IgG concentrations for adult and pediatric patients with primary immunodeficiency\n disease. Both formulations delivered trough antibody concentrations of total IgG, measles-neutralizing antibodies, and antibodies against encapsulated bacteria that are above thresholds accepted as protective.Clinical trial NCT01963143, &lt;ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\"\n ext-link-type=\"uri\" xlink:href=\"http:\/\/www.clinicaltrials.gov\"&gt;www.clinicaltrials.gov&lt;\/ext-link&gt;<\/jats:p>","DOI":"10.2500\/aap.2024.45.240033","type":"journal-article","created":{"date-parts":[[2024,9,14]],"date-time":"2024-09-14T01:05:34Z","timestamp":1726275934000},"page":"414-420","source":"Crossref","is-referenced-by-count":2,"title":["Protective antibody concentrations in primary immunodeficiency following infusion with 5% or 10% intravenous immunoglobulin"],"prefix":"10.2500","volume":"45","author":[{"given":"Martyn","family":"Paddick","sequence":"first","affiliation":[{"name":"From the Research and Development Department, Kedrion Biopharma, Elstree, United Kingdom;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kim","family":"Clark","sequence":"additional","affiliation":[{"name":"Global Medical Affairs, Kedrion Biopharma, Fort Lee, New Jersey; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric","family":"Wolford","sequence":"additional","affiliation":[{"name":"Global Clinical Research and Operations, Kedrion Biopharma, Fort Lee, New Jersey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"More","sequence":"additional","affiliation":[{"name":"From the Research and Development Department, Kedrion Biopharma, Elstree, United Kingdom;"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1355","reference":[{"key":"B1","doi-asserted-by":"crossref","first-page":"780140","DOI":"10.3389\/fimmu.2021.780140","article-title":"The PID principles of care: where are we now? A global status report on the PID life index","volume":"12","author":"Nordin","year":"2021","journal-title":"Front Immunol"},{"key":"B2","doi-asserted-by":"crossref","first-page":"627","DOI":"10.3389\/fimmu.2014.00627","article-title":"Primary immune deficiencies \u2013 principles of care","volume":"5","author":"Chapel","year":"2014","journal-title":"Front Immunol"},{"key":"B3","doi-asserted-by":"crossref","first-page":"449","DOI":"10.3904\/kjim.2018.413","article-title":"Association between primary immunodeficiency and asthma exacerbation in adult asthmatics","volume":"35","author":"Lee","year":"2020","journal-title":"Korean J Intern Med"},{"key":"B4","doi-asserted-by":"crossref","first-page":"210","DOI":"10.3390\/v8080210","article-title":"Measles virus host invasion and pathogenesis","volume":"8","author":"Laksono","year":"2016","journal-title":"Viruses"},{"key":"B5","first-page":"1","article-title":"Prevention of measles, rubella, congenital rubella syndrome, and mumps, 2013: summary recommendations of the Advisory Committee on Immunization Practices (ACIP)","volume":"62","author":"McLean","year":"2013","journal-title":"MMWR Recomm Rep"},{"key":"B6","doi-asserted-by":"crossref","first-page":"1186","DOI":"10.1016\/j.jaci.2015.04.049","article-title":"Practice parameter for the diagnosis and management of primary immunodeficiency","volume":"136","author":"Bonilla","year":"2015","journal-title":"J Allergy Clin Immunol"},{"key":"B7","year":"2023"},{"key":"B8","first-page":"37","article-title":"X-linked agammaglobulinemia: investigation of clinical and laboratory findings, novel gene mutations and prevention of infective complications in long-term follow-up.","volume":"10","author":"Yildirim","year":"2021","journal-title":"Am J Clin Exp Immunol"},{"key":"B9","first-page":"63","article-title":"Erratum: X-linked agammaglobulinemia: investigation of clinical and laboratory findings, novel gene mutations and prevention of infective complications in long-term follow-up.","volume":"10","author":"Yildirim","year":"2021","journal-title":"Am J Clin Exp Immunol"},{"key":"B10","doi-asserted-by":"crossref","first-page":"301","DOI":"10.1007\/s10875-017-0383-9","article-title":"Evaluation of the safety, tolerability, and pharmacokinetics of Gammaplex\u00ae 10% versus Gammaplex\u00ae 5% in subjects with primary immunodeficiency","volume":"37","author":"Wasserman","year":"2017","journal-title":"J Clin Immunol"},{"key":"B11","doi-asserted-by":"crossref","first-page":"613","DOI":"10.1007\/s10875-017-0418-2","article-title":"Erratum: Evaluation of the safety, tolerability, and pharmacokinetics of Gammaplex\u00ae 10% versus Gammaplex\u00ae 5% in subjects with primary immunodeficiency","volume":"37","author":"Wasserman","year":"2017","journal-title":"J Clin Immunol"},{"key":"B12","article-title":"Letter to immune globulin (human) licensed manufacturers"},{"key":"B13","doi-asserted-by":"crossref","first-page":"592","DOI":"10.3390\/jcm10040592","article-title":"Trough concentrations of specific antibodies in primary immunodeficiency patients receiving intravenous immunoglobulin replacement therapy","volume":"10","author":"Hassin","year":"2021","journal-title":"J Clin Med"},{"key":"B14","doi-asserted-by":"crossref","first-page":"1036","DOI":"10.1093\/infdis\/162.5.1036","article-title":"Measles antibody: Reevaluation of protective titers","volume":"162","author":"Chen","year":"1990","journal-title":"J Infect Dis"},{"key":"B15","doi-asserted-by":"crossref","first-page":"1705","DOI":"10.1016\/j.jaip.2017.12.002","article-title":"Prevalence and outcomes of primary immunodeficiency in hospitalized children in the United States","volume":"6","author":"Rubin","year":"2018","journal-title":"J Allergy Clin Immunol Pract"}],"container-title":["Allergy and Asthma Proceedings"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ingentaconnect.com\/content\/ocean\/aap\/2024\/00000045\/00000006\/art00011","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,11,9]],"date-time":"2024-11-09T04:33:38Z","timestamp":1731126818000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ingentaconnect.com\/content\/10.2500\/aap.2024.45.240033"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,11,1]]},"references-count":15,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2024,11,1]]}},"alternative-id":["1088-5412(20241101)45:6L.414;1-"],"URL":"https:\/\/doi.org\/10.2500\/aap.2024.45.240033","relation":{},"ISSN":["1088-5412"],"issn-type":[{"value":"1088-5412","type":"print"}],"subject":[],"published":{"date-parts":[[2024,11,1]]}}}