Infection Rates and Tolerability of Three Different Immunoglobulin Administration Modalities in Patients with Primary Immunodeficiency Diseases.

This post hoc analysis evaluated the efficacy and overall tolerability of immunoglobulin (Ig) treatment modalities (intravenous Ig [iv.lg], subcutaneous Ig [sc.lg] and facilitated sc.lg [fsc.lg]). Materials & methods: A total of 30 participants with primary immunodeficiency diseases aged >= 2 years sequentially received iv.lg, sc.lg and fsc.lg during consecutive clinical studies. Results: For iv.lg, sc.lg and fsc.lg, 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.lg provided similar efficacy to iv.lg and sc.lg.