Infusion Parameters and Adverse Events in Patients With Primary Immunodeficiency Diseases Who Switched to Subcutaneous Human Immune Globulin 20% (Ig20Gly) From Intravenous or Subcutaneous Immune Globulin

RATIONALE: Ig20Gly (Cuvitru^®) is a new subcutaneous human immune globulin (Ig) 20% preparation for the treatment of primary immunodeficiency diseases (PIDD). To evaluate whether the previous route of Ig administration affects the tolerability or infusion characteristics of Ig20Gly, we assessed rates of causally related local and systemic adverse events (AEs) and infusion parameters from patients whose immediate prestudy treatment was IVIG (IV-switchers) or SCIG (SC-switchers) from a phase 2/3 North American study (NCT01218438).

METHODS: Patients aged ≥2 years were initially switched to Gammagard Liquid (IVIG10%) for 3 months at the monthly dose equivalent of their most recent prestudy treatment of IVIG or SCIG. Patients then received once-weekly Ig20Gly for ~1 year.

RESULTS: Of 74 patients treated with Ig20Gly, 68.9% were IV-switchers. No serious or severe causally related AEs were reported during Ig20Gly treatment. Rates of causally related local and systemic AEs were slightly lower for IV-switchers (0.007/infusion and 0.012/infusion, respectively) versus SC-switchers (0.035/infusion and 0.039/infusion). The percentage of infusions with causally related local AEs (IV-switchers, 0.6%; SC-switchers, 3.1%) and systemic AEs (IV-switchers, 0.9%; SC-switchers, 3.5%) was generally low. IV-switchers versus SC-switchers had a slightly higher median infusion volume/site (42.5 vs 34.5mL) and median infusion duration (1.07 vs 0.82 hours). In both IV- and SC-switchers, a similar percentage of patients infused ≥60 mL/site (70.6% and 73.9%, respectively), and most infusions required ≤2 sites (86.8% and 81.0%).

CONCLUSIONS: Ig20Gly administration was associated with low rates of causally related local and systemic AEs. Infusion parameters were comparable for patients who received prior IVIG or SCIG.