Infection rates and tolerability of three different immunoglobulin administration modalities in patients with primary immunodeficiency diseases

Immunotherapy. 2022 Mar;14(4):215-224. doi: 10.2217/imt-2021-0256. Epub 2021 Dec 21.

Abstract

Aim: This post hoc analysis evaluated the efficacy and overall tolerability of immunoglobulin (Ig) treatment modalities (intravenous Ig [iv.Ig], subcutaneous Ig [sc.Ig] and facilitated sc.Ig [fsc.Ig]). Materials & methods: A total of 30 participants with primary immunodeficiency diseases aged ≥2 years sequentially received iv.Ig, sc.Ig and fsc.Ig during consecutive clinical studies. Results: For iv.Ig, sc.Ig and fsc.Ig, rates of validated acute serious bacterial infections/participant-year (0, 0.09 and 0.04, respectively) and all infections/participant year (4.17, 3.68 and 2.42, respectively) were similarly low; rates of systemic and local causally related adverse events/participant-year were 5.60, 1.93 and 0.88, respectively and 0.13, 0.92 and 1.57, respectively. Conclusion: fsc.Ig provided similar efficacy to iv.Ig and sc.Ig. Clinical Trial registration: NCT00546871, NCT00814320, NCT01175213 (ClinicalTrials.gov).

Keywords: IgG; PID; facilitated subcutaneous immunoglobulin; fsc.Ig; intravenous immunoglobulin; iv.Ig; phase III; primary immunodeficiency diseases; sc.Ig; subcutaneous immunoglobulin.

Publication types

  • Clinical Trial, Phase II
  • Clinical Trial, Phase III
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Bacterial Infections / epidemiology*
  • Child
  • Child, Preschool
  • Comorbidity
  • Female
  • Humans
  • Immunization, Passive / methods*
  • Immunoglobulins / administration & dosage
  • Immunoglobulins / therapeutic use*
  • Infusions, Subcutaneous
  • Male
  • Primary Immunodeficiency Diseases / drug therapy*
  • Primary Immunodeficiency Diseases / epidemiology*
  • Primary Immunodeficiency Diseases / immunology
  • Retrospective Studies
  • Treatment Outcome

Substances

  • Immunoglobulins

Associated data

  • ClinicalTrials.gov/NCT00546871
  • ClinicalTrials.gov/NCT00814320
  • ClinicalTrials.gov/NCT01175213