{"id":27449,"date":"2025-03-14T11:00:00","date_gmt":"2025-03-14T10:00:00","guid":{"rendered":"https:\/\/inmuno.es\/index.php\/2025\/03\/14\/efficacy-safety-tolerability-and-serum-igg-trough-levels-of-hyaluronidase-facilitated-subcutaneous-immunoglobulin-10-in-us-pediatric-patients-with-primary-immunodeficiency-diseases\/"},"modified":"2025-03-14T11:00:00","modified_gmt":"2025-03-14T10:00:00","slug":"efficacy-safety-tolerability-and-serum-igg-trough-levels-of-hyaluronidase-facilitated-subcutaneous-immunoglobulin-10-in-us-pediatric-patients-with-primary-immunodeficiency-diseases","status":"publish","type":"post","link":"https:\/\/inmuno.es\/index.php\/2025\/03\/14\/efficacy-safety-tolerability-and-serum-igg-trough-levels-of-hyaluronidase-facilitated-subcutaneous-immunoglobulin-10-in-us-pediatric-patients-with-primary-immunodeficiency-diseases\/","title":{"rendered":"Efficacy, Safety, Tolerability, and Serum IgG Trough Levels of Hyaluronidase-Facilitated Subcutaneous Immunoglobulin 10% in US Pediatric Patients with Primary Immunodeficiency Diseases"},"content":{"rendered":"<div>\n<p><b>J Clin Immunol<\/b>. 2025 Mar 14;45(1):81. doi: 10.1007\/s10875-025-01862-6.<\/p>\n<p><b>ABSTRACT<\/b><\/p>\n<p>PURPOSE: To investigate the efficacy, safety, tolerability, and serum IgG trough levels of hyaluronidase-facilitated subcutaneous immunoglobulin (fSCIG) 10% in US pediatric patients with primary immunodeficiency diseases (PIDDs).<\/p>\n<p>METHODS: This phase 3, open-label, prospective study (NCT03277313) was conducted at 17 US centers. Eligible patients aged 2 to &lt; 16 years had PIDDs and had received immunoglobulin G (IgG) at a consistent dose for \u2265 3 months before screening. Participants received fSCIG 10% via dose ramp-up for up to 6 weeks (Epoch 1), then every 3-4 weeks for \u2264 3 years (Epoch 2). The primary endpoint was the rate of acute serious bacterial infections (ASBIs).<\/p>\n<p>RESULTS: Data were provided by 44 participants for Epoch 1 (mean \u00b1 SD age: 9.0 \u00b1 3.6 years) and 43 (97.7%) for Epoch 2; 34 (77.3%) completed the study. Two ASBIs (both bacterial pneumonia) were reported in one participant with specific antibody deficiency. The mean rate of ASBIs was 0.04 events\/participant-year (99% upper confidence interval limit: 0.20), significantly lower than the regulatory-defined threshold of 1.0 (p &lt; 0.001). The mean rate of all infections was 3.12 events\/participant-year. Stable mean serum IgG trough levels were maintained during Epoch 2 (10.4, 9.2, and 9.2 g\/L at Months 0, 6, and 12, respectively). Most related treatment-emergent adverse events were mild or moderate in severity. No participant developed anti-recombinant human hyaluronidase neutralizing antibodies; 1\/44 participants (2.3%) developed binding antibodies.<\/p>\n<p>CONCLUSION: fSCIG 10% effectively prevented ASBIs in pediatric patients with PIDDs, with a favorable safety profile consistent with previous clinical studies.<\/p>\n<p>PMID:<a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/40085358\/?utm_source=WordPress&amp;utm_medium=rss&amp;utm_campaign=journals&amp;utm_content=8102137&amp;ff=20250314184919&amp;v=2.18.0.post9+e462414\">40085358<\/a> | DOI:<a href=\"https:\/\/doi.org\/10.1007\/s10875-025-01862-6\">10.1007\/s10875-025-01862-6<\/a><\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>J Clin Immunol. 2025 Mar 14;45(1):81. doi: 10.1007\/s10875-025-01862-6. ABSTRACT PURPOSE: To investigate the efficacy, safety, tolerability, and serum IgG trough levels of hyaluronidase-facilitated subcutaneous immunoglobulin (fSCIG) 10% in US pediatric patients with primary immunodeficiency diseases (PIDDs). METHODS: This phase 3, open-label, prospective study (NCT03277313) was conducted at 17 US centers. Eligible patients aged 2 to &#8230; <a title=\"Efficacy, Safety, Tolerability, and Serum IgG Trough Levels of Hyaluronidase-Facilitated Subcutaneous Immunoglobulin 10% in US Pediatric Patients with Primary Immunodeficiency Diseases\" class=\"read-more\" href=\"https:\/\/inmuno.es\/index.php\/2025\/03\/14\/efficacy-safety-tolerability-and-serum-igg-trough-levels-of-hyaluronidase-facilitated-subcutaneous-immunoglobulin-10-in-us-pediatric-patients-with-primary-immunodeficiency-diseases\/\" aria-label=\"Read more about Efficacy, Safety, Tolerability, and Serum IgG Trough Levels of Hyaluronidase-Facilitated Subcutaneous Immunoglobulin 10% in US Pediatric Patients with Primary Immunodeficiency Diseases\">Read more<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[69,42],"tags":[],"class_list":["post-27449","post","type-post","status-publish","format-standard","hentry","category-journal-of-clinical-immunology","category-publicaciones"],"_links":{"self":[{"href":"https:\/\/inmuno.es\/index.php\/wp-json\/wp\/v2\/posts\/27449","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/inmuno.es\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/inmuno.es\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/inmuno.es\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/inmuno.es\/index.php\/wp-json\/wp\/v2\/comments?post=27449"}],"version-history":[{"count":0,"href":"https:\/\/inmuno.es\/index.php\/wp-json\/wp\/v2\/posts\/27449\/revisions"}],"wp:attachment":[{"href":"https:\/\/inmuno.es\/index.php\/wp-json\/wp\/v2\/media?parent=27449"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/inmuno.es\/index.php\/wp-json\/wp\/v2\/categories?post=27449"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/inmuno.es\/index.php\/wp-json\/wp\/v2\/tags?post=27449"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}