{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T14:34:24Z","timestamp":1791470064075,"version":"4.3.4"},"reference-count":18,"publisher":"Springer Science and Business Media LLC","issue":"8","license":[{"start":{"date-parts":[[2024,8,19]],"date-time":"2024-08-19T00:00:00Z","timestamp":1724025600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,8,19]],"date-time":"2024-08-19T00:00:00Z","timestamp":1724025600000},"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":[[2024,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Facilitated subcutaneous immunoglobulin (fSCIG) 10% is an immunoglobulin replacement therapy that utilizes recombinant human hyaluronidase (rHuPH20) to enhance immunoglobulin dispersion and absorption, allowing for longer treatment intervals similar to intravenous immunoglobulin (up to once monthly). fSCIG 10% is indicated in the USA for treating adults and children aged\u2009\u2265\u20092 years with primary immunodeficiency diseases (PIDs). This prospective, non-interventional, open-label, multicenter, post-authorization safety study (NCT02593188) was conducted in the USA from November 2015 to October 2021 to assess the long-term safety of fSCIG 10% in routine clinical practice. Patients with PIDs aged\u2009\u2265\u200916 years who were prescribed and\/or had started fSCIG 10% treatment were enrolled. In total, 253 patients were enrolled and included (full analysis set). Participants received fSCIG 10% treatment for a median (interquartile range) of 10.0 (3.5\u201311.8) months, with the majority of infusions administered every 4 weeks (54.4% [1197\/2201 infusions]) and at home (62.6% [1395\/2230 infusions]). Overall, 98.5% of infusions were administered without rate reduction, interruption, or discontinuation due to adverse events (AEs). Treatment-related, non-serious AEs were experienced by 52 patients (20.6%, 284 events). Two patients (0.8%) each experienced one treatment-related serious AE (aseptic meningitis and deep vein thrombosis). Development of antibodies against rHuPH20 was uncommon; 14\/196 patients (7.1%) tested positive for binding antibodies (titer\u2009\u2265\u20091:160) with no neutralizing antibodies detected. There was no relationship between anti-rHuPH20 antibody positivity and the occurrence of treatment-related serious or non-serious AEs. Long-term, repeated self-administration of fSCIG 10% was well tolerated in US clinical practice by patients with PIDs.<\/jats:p>","DOI":"10.1007\/s10875-024-01769-8","type":"journal-article","created":{"date-parts":[[2024,8,19]],"date-time":"2024-08-19T09:02:22Z","timestamp":1724058142000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Long-Term Safety of Facilitated Subcutaneous Immunoglobulin 10% Treatment in US Clinical Practice in Patients with Primary Immunodeficiency Diseases: Results from a Post-Authorization Safety Study"],"prefix":"10.1007","volume":"44","author":[{"given":"Arye","family":"Rubinstein","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohsen","family":"Mabudian","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Donald","family":"McNeil","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Niraj C.","family":"Patel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard L.","family":"Wasserman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sudhir","family":"Gupta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paz","family":"Carrasco","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jie","family":"Chen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Enrique","family":"Garcia","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andras","family":"Nagy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leman","family":"Yel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,8,19]]},"reference":[{"key":"1769_CR1","doi-asserted-by":"publisher","first-page":"1035","DOI":"10.2217\/imt-2017-0092","volume":"9","author":"RL Wasserman","year":"2017","unstructured":"Wasserman RL. Recombinant human hyaluronidase-facilitated subcutaneous immunoglobulin infusion in primary immunodeficiency diseases. Immunotherapy. 2017;9:1035\u201350.","journal-title":"Immunotherapy"},{"key":"1769_CR2","doi-asserted-by":"publisher","first-page":"951","DOI":"10.1016\/j.jaci.2012.06.021","volume":"130","author":"RL Wasserman","year":"2012","unstructured":"Wasserman RL, Melamed I, Stein MR, Gupta S, Puck J, Engl W, et al. Recombinant human hyaluronidase-facilitated subcutaneous infusion of human immunoglobulins for primary immunodeficiency. J Allergy Clin Immunol. 2012;130:951\u2013e711.","journal-title":"J Allergy Clin Immunol"},{"key":"1769_CR3","unstructured":"HYQVIA [immune globulin infusion 10% (human) with recombinant human hyaluronidase] solution, for subcutaneous administration. 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Ethics committee approval was obtained centrally and locally at each site prior to site initiation.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval"}},{"value":"All patients and\/or their legally authorized representative signed and dated an informed consent form before entering into the study, according to applicable regulatory requirements. Any patient could voluntarily withdraw consent for continued participation and data collection.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to Participate"}},{"value":"AR, MM, and DMcN have nothing to disclose. NCP receives research funds from the Takeda group of companies and CSL Behring, and is on speakers\u2019 bureaux for the Takeda group of companies, CSL Behring, and Horizon Therapeutics. RLW has received grants and personal fees from ADMA Biologics, CSL Behring, Evolve Biologics, Green Cross BioPharma, Grifols, and the Takeda group of companies, and grants from GC Biopharma, Kedrion, Octapharma, and the Takeda group of companies. SG has received a grant from Takeda for investigator-initiated research, has been an investigator on sponsored clinical trials for Octapharma and Takeda, and has been a consultant for Avilar. PC and AN are employees of Baxalta Innovations GmbH, a Takeda company, and are Takeda shareholders. JC and EG are employees of Takeda Development Center Americas, Inc. LY is a Takeda shareholder and was an employee of Takeda Development Center Americas, Inc. at the time of the study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing Interests"}}],"article-number":"181"}}