Long-term safety of hyaluronidase-facilitated subcutaneous immunoglobulin 10%: a European post-authorization study.
| Autor: | Ellerbroek PM; Department of Internal Medicine & Infectious Diseases, University Medical Centre of Utrecht, Utrecht, 3584 CX, The Netherlands., Hanitsch LG; Institute of Medical Immunology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin & Humboldt Universität zu Berlin, Augustenburger Platz 1 & Berlin Institute of Health, BIH Centre for Regenerative Therapies, Berlin, 13353, Germany., Witte T; Medical School Hannover, Hannover, 30625, Germany., Lougaris V; Department of Clinical & Experimental Sciences, Università degli Studi di Brescia, Brescia, 25121, Italy., Hagen PMV; Erasmus University Medical Center, Departments of Internal Medicine & Immunology, Rotterdam, 3015 GD, The Netherlands., Paassen PV; Maastricht University, Faculty of Health, Medicine & Life Sciences, Maastricht, 6229 ER, The Netherlands., Chen J; Takeda Development Center Americas, Inc., Cambridge, MA 02139, USA., Fielhauer K; Baxalta Innovations GmbH, a Takeda company, Vienna, 1221, Austria., McCoy B; Baxalta Innovations GmbH, a Takeda company, Vienna, 1221, Austria., Nagy A; Baxalta Innovations GmbH, a Takeda company, Vienna, 1221, Austria., Yel L; Takeda Development Center Americas, Inc., Cambridge, MA 02139, USA. |
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| Jazyk: | angličtina |
| Zdroj: | Immunotherapy [Immunotherapy] 2024; Vol. 16 (10), pp. 679-691. Date of Electronic Publication: 2024 Jun 18. |
| DOI: | 10.1080/1750743X.2024.2354091 |
| Abstrakt: | Aim: To assess the long-term safety of hyaluronidase-facilitated subcutaneous immunoglobulin (fSCIG) 10% in European routine clinical practice. Materials & methods: This prospective, noninterventional, open-label, post-authorization safety study (EUPAS5812) sourced data on adverse events, immunogenicity, treatment regimens and product administration for 106 adult patients prescribed fSCIG 10% across 17 sites in six European countries from July 2014 to February 2020. Results: In total, 1171 treatment-emergent adverse events were reported in 94 patients (88.7%); 25.5% of these events were considered related to fSCIG 10%. Positive binding antibody titers developed in three patients; no neutralizing antibodies to recombinant human hyaluronidase were detected. Conclusion: This real-world study of fSCIG 10% is the longest to date and confirms its long-term safety and tolerability in adults with antibody deficiency diseases. |
| Databáze: | MEDLINE |
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