Hizentra

01/01/2020 - "IgPro20 maintained or improved QOL in most subjects with CIDP, consistent with the PATH study findings that both IgPro20 doses were efficacious in maintaining CIDP."
03/01/2023 - "The PATH clinical study of Hizentra maintenance in CIDP was used to determine clinical inputs for relapse rates at initial assessment (24 weeks) and at 52 weeks for Hizentra. "
03/01/2023 - "Hizentra AE rates from the US Hizentra prescribing information were assessed but were not included in the model as the AEs in CIDP were mild, easily treated, and self-limited. "
01/01/2022 - "IgPro20 was shown to be efficacious as a maintenance therapy for CIDP when relapse was defined using I-RODS. "
01/01/2019 - "Long-term safety and efficacy of subcutaneous immunoglobulin IgPro20 in CIDP: PATH extension study."

01/01/2018 - "A total of 88% of polyneuropathy and treatment with hizentra subjects felt the subcutaneous method was 'easy to learn'. "
01/01/2021 - "Electrophysiological testing in chronic inflammatory demyelinating polyneuropathy patients treated with subcutaneous immunoglobulin: The Polyneuropathy And Treatment with Hizentra (PATH) study."
01/01/2019 - "In the Polyneuropathy And Treatment with Hizentra (PATH) study, the pre-randomization period included sudden stopping of IVIG followed by 12 weeks of observation. "
01/01/2019 - "Restabilization treatment after intravenous immunoglobulin withdrawal in chronic inflammatory demyelinating polyneuropathy: Results from the pre-randomization phase of the Polyneuropathy And Treatment with Hizentra study."
01/01/2021 - "The two main objectives of this analysis were to (i) characterize the relationship between immunoglobulin (Ig) exposure and chronic inflammatory demyelinating polyneuropathy (CIDP) disease severity using data from 171 patients with CIDP who received either subcutaneous Ig (IgPro20; Hizentra® ) or placebo (PATH study), and to (ii) simulate and compare exposure coverage with various dosing approaches considering weekly dosing to be the reference dose. "

01/01/2022 - "The infection rate decreased from 0.54 per patient during the 6 months before IgPro20 to 0.39 per patient during IgPro20 treatment. "
02/01/2014 - "Self-administered Hizentra afforded sustained effective protection from infections and favorable tolerability during an extended treatment period of up to 3 years."
01/01/2022 - "Safety was determined from reported adverse events (AEs), adverse drug reactions, and serious AEs (SAEs); effectiveness was assessed by infection rates after the first IgPro20 dose. "
10/01/2011 - "Hizentra(®) maintained or improved serum IgG levels without dose increases and effectively protected patients against infections."
09/01/2010 - "IgPro20 effectively protected patients with PID against infections and maintained serum IgG levels without causing unexpected AEs."

01/01/2022 - "Four patients (PID n = 3, SID n = 1) reported SAEs but two were unrelated to IgPro20 administration. "
01/01/2022 - "Of 85 patients receiving IgPro20 in the safety analysis, 39 developed AEs (45.9%; PID n = 28, SID n = 11). "
01/01/2022 - "Patients who received IgPro20 due to PID or SID were included after informed consent. "
12/01/2021 - "Using IQVIA's PharMetrics® Plus database, patients with SID who received IgPro10/IgPro20 in the 12 months post-diagnosis (IgRT users) were matched to patients with SID not receiving IgRT (non-IgRT users). "
01/01/2022 - "In Japan, IgPro20 was considered safe and effective among patients with agammaglobulinemia or hypogammaglobulinemia due to PID or SID."

01/01/2022 - "Real-world results with IgPro20 for hypo- or agammaglobulinemia in Japan."
01/01/2022 - "In Japan, IgPro20 was considered safe and effective among patients with agammaglobulinemia or hypogammaglobulinemia due to PID or SID."
01/01/2022 - "In Japan, IgPro20 (Hizentra® ; l-proline-stabilized 20% human subcutaneous immunoglobulin) is approved for agammaglobulinemia or hypogammaglobulinemia due to PID or secondary immunodeficiency (SID); however, its safety and effectiveness has not previously been assessed in a real-world setting. "