A Multicentre Study on the Efficacy, Safety and Pharmacokinetics of IqYmune®, a Highly Purified 10% Liquid Intravenous Immunoglobulin, in Patients with Primary Immune Deficiency

Abstract

This multicentre, open-label, prospective, single-arm study was designed to evaluate the efficacy, pharmacokinetics, and safety of IqYmune®, a highly purified 10% polyvalent immunoglobulin preparation for intravenous administration in patients with primary immunodeficiency. IqYmune® was administered to 62 patients (aged 2–61 years) with X-linked agammaglobulinemia or common variable immune deficiency at a dose from 0.22 to 0.97 g/kg every 3 to 4 weeks for 12 months with an infusion rate up to 8 mL/kg/h. A pharmacokinetic study was performed at steady state between the 8th and the 9th infusion. A single case of serious bacterial infection was observed, leading to an annualized rate of serious bacterial infections/patient (primary endpoint) of 0.017 (98% CI: 0.000, 0.115). Overall, 228 infections were reported, most frequently bronchitis, chronic sinusitis, nasopharyngitis and upper respiratory tract infection. The mean annualized rate of infections was 3.79/patient. A lower risk of infections was associated with an IgG trough level > 8 g/L (p = 0.01). The mean annualized durations of absence from work or school and of hospitalization due to infections were 1.01 and 0.89 days/patient, respectively. The mean serum IgG trough level before the 6th infusion was 7.73 g/L after a mean dose of IqYmune® of 0.57 g/kg. The pharmacokinetic profile of IqYmune® was consistent with that of other intravenous immunoglobulins. Overall, 15.5% of infusions were associated with an adverse event occurring within 72 h post infusion. Headache was the most common adverse event. In conclusion, IqYmune® was shown to be effective and well tolerated in patients with primary immunodeficiency.

Efficacy and safety of high infusion rate IVIG in CIDP

“…Our percentage of patients with TAEs is at the lower end of adverse event rates, as reported in a Cochrane systematic review of IVIG TAEs, which ranged between 0.6% and 71% 11 . However, the frequency of TAEs for infusion rates in this study are similar to other cohorts 12,13 …”

“…The safety of higher rates for IVIG infusion have been previously documented 4,5,12,14 . However, these studies did not investigate the safety of higher infusion rates in a population entirely comprised of patients with CIDP using 10% IVIG.…”

An international multicenter efficacy and safety study of IqYmune in initial and maintenance treatment of patients with chronic inflammatory demyelinating polyradiculoneuropathy: PRISM study

“…4 IqYmune (I10E for code product) is a highly purified, ready-touse, 10% liquid preparation of normal human immunoglobulin (100 mg/mL) for intravenous administration. This formulation is obtained from thousands of healthy donors and has been shown to be effective and well tolerated in patients with primary immunodeficiency 5 (PID), multifocal motor neuropathy 6 (MMN), and primary immune thrombocytopenia (ITP). 7 IqYmune was designed in a novel purification process based on the quality by design (QbD) approach 8 This study aimed to demonstrate the improvement of disability by IqYmune in adult patients with CIDP previously treated with IVIg or not.…”

“…IqYmune (I10E for code product) is a highly purified, ready‐to‐use, 10% liquid preparation of normal human immunoglobulin (100 mg/mL) for intravenous administration. This formulation is obtained from thousands of healthy donors and has been shown to be effective and well tolerated in patients with primary immunodeficiency 5 (PID), multifocal motor neuropathy 6 (MMN), and primary immune thrombocytopenia (ITP) 7 …”

IqYmune® is an effective maintenance treatment for multifocal motor neuropathy: A randomised, double‐blind, multi‐center cross‐over non‐inferiority study vs Kiovig®—The LIME Study

“…IqYmune® is a highly purified 10% liquid preparation of normal human immunoglobulin for intravenous administration that has been shown to be effective and well‐tolerated in patients with primary immunodeficiency . It has been approved since 2015 in Europe, as a replacement therapy for primary immunodeficiency syndrome and for various types of hypogammaglobulinemia, and for immunomodulation in primary immune thrombocytopenia, Guillain‐Barré syndrome, and Kawasaki disease.…”