Immune globulin subcutaneous, human-klhw 20% for primary humoral immunodeficiency: An open-label, Phase III study

John W. Sleasman, William R. Lumry, Iftikhar Hussain, H. James Wedner, James B. Harris, Kecia L. Courtney, Elsa Mondou, Jiang Lin, Mark R. Stein

Research output: Contribution to journalArticlepeer-review

2 Scopus citations

Abstract

Aim: This prospective, Phase III study assessed the pharmacokinetics (PK), safety and tolerability of immune globulin subcutaneous, human - klhw 20% solution (IGSC-C 20%) in participants with primary humoral immunodeficiency (PI), compared with immune globulin injection (human), 10% caprylate/chromatography purified (IGIV-C 10%). Patients & methods: About 53 participants enrolled. Total 44 received IGIV-C 10% in the run-in phase and then entered the IV phase (with an additional nine who were already receiving IGIV-C 10% and entered the IV phase directly) for steady-state IV PK assessments. Total 49 entered the SC phase (weekly doses of IGSC-C 20% for ∼24 weeks). The PK profiles of IGIV-C 10% and IGSC-C 20% and their safety and tolerability parameters were compared. Results: At a dose adjustment factor of 1.37, IGSC-C 20% provided comparable (noninferior and bioequivalent) overall total immunoglobulin G exposure to IGIV-C 10% over an equal time interval. About 33 participants reported 79 adverse events during run-in + IV phases; 41 participants reported 141 adverse events during the SC phase, with most being local infusion site reactions. The majority of infusion site reactions were mild to moderate in severity. Conclusion: IGSC-C 20% was bioequivalent to IGIV-C 10% and was well tolerated, with a safety profile comparable with IGIV-C 10%, in this study.

Original languageEnglish
Pages (from-to)1371-1386
Number of pages16
JournalImmunotherapy
Volume11
Issue number16
DOIs
StatePublished - 2019

Keywords

  • 20% immunoglobulin
  • Xembify
  • bacterial
  • immunoglobulin replacement therapy
  • pharmacokinetics
  • primary immunodeficiency disease
  • subcutaneous administration
  • subcutaneous immunoglobulin

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