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

Richard L Wasserman1, Sudhir Gupta2, Mark Stein3

  • 1Research Department, Allergy Partners of North Texas Research, Dallas, TX 75230, USA.

Immunotherapy
|December 21, 2021
PubMed

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:
IgGPIDfacilitated subcutaneous immunoglobulinfsc.Igintravenous immunoglobuliniv.Igphase IIIprimary immunodeficiency diseasessc.Igsubcutaneous immunoglobulin

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