Open AccessInfection rates and tolerability of three different immunoglobulin administration modalities in patients with primary immunodeficiency diseases
Author(s) -
Richard L. Wasserman,
Sudhir Gupta,
Mark R. Stein,
Christopher J. Rabbat,
Werner Engl,
Heinz Leibl,
Leman Yel
Publication year - 2021
Publication title -
immunotherapy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.127
H-Index - 48
eISSN - 1750-7448
pISSN - 1750-743X
DOI - 10.2217/imt-2021-0256
Subject(s) - tolerability , medicine , adverse effect , antibody , clinical trial , primary immunodeficiency , immunodeficiency , immunology , post hoc analysis , gastroenterology , immune system , disease
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)