Long-term safety of hyaluronidase-facilitated subcutaneous immunoglobulin 10%: a European post-authorization study

Pauline M Ellerbroek, Leif G Hanitsch, Torsten Witte, Vassilios Lougaris, P Martin van Hagen, Pieter van Paassen, Jie Chen, Katharina Fielhauer, Barbara McCoy, Andras Nagy*, Leman Yel

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

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.

Original languageEnglish
Pages (from-to)679-691
Number of pages13
JournalImmunotherapy
Volume16
Issue number10
Early online date18 Jun 2024
DOIs
Publication statusPublished - 2024

Keywords

  • antibody deficiency
  • human
  • immunodeficiency diseases
  • immunoglobulins
  • inborn errors of immunity (IEI)

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