Onboarding Experience of Patients With Primary Immunodeficiency Diseases Who Switched to Subcutaneous Human Immune Globulin 20% (Ig20Gly) From Intravenous or Subcutaneous Immune Globulin 10%
Saturday, March 3, 2018
South Hall A2 (Convention Center)
Sudhir Gupta, Iftikhar Hussain, Kenneth Paris, Mark Stein, Barbara McCoy, Ping Wang, Christopher J. Rabbat, Leman Yel
RATIONALE: Subcutaneous immune globulin (SCIG) 20%, Ig20Gly (Cuvitru®), was safe and efficacious in a phase 2/3 North American study (NCT01218438) in patients with primary immunodeficiency diseases (PIDD). This post hoc analysis assessed the onboarding experience with Ig20Gly by examining infusion parameters based on prestudy treatment (intravenous IG [IVIG] or SCIG).

METHODS: Patients aged ≥2 years who were treated with IVIG (IV-switchers) or SCIG (SC-switchers) immediately before study entry received Gammagard Liquid (IVIG10%) at the monthly dose equivalent to their recent prestudy treatment for 3 months. All patients were then switched to once-weekly Ig20Gly for ~1 year.

RESULTS: Infusion rates of ≥60 mL/h/site for more than one infusion were reached by 58.8% (30/51) of IV-switchers and 65.2% (15/23) of SC-switchers; the median infusion number when patients first reached 60 mL/h/site was 3 for both groups. Infusions were completed in <1 or 1–2 hours in 41.8% and 50.9% of 2784 infusions in IV-switchers and 75.8% and 19.9% of 1378 infusions in SC-switchers, respectively (median infusion duration, 1.07 hour [IV-switchers] and 0.82 hour [SC-switchers]). IV-switchers administered 63.7% (450/706) of infusions with dose volumes of 0–59 mL using 1 infusion site; whereas SC-switchers administered 45.7% (307/672) of infusions with dose volumes of 0–59 mL using 1 infusion site. IV-switchers and SC-switchers administered 84.2% (1525/1812) and 72.7% (482/663) of infusions with dose volumes of 60–119 using 2 infusion sites, respectively.

CONCLUSIONS: Comparable Ig20Gly infusion rates but higher infusion durations and lower number of infusion sites by volume were observed for patients who previously received IVIG versus SCIG.