The label for Hizentra® (immunoglobulin subcutaneous [human] 20% fluid) has been updated with new dosing guidelines based on data from the PATH Extension Study (Polyneuropathy and Treatment with Hizentra).
Hizentra is indicated for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment. The PATH Extension Study was a 48-week, open-label study that evaluated the long-term safety and effectiveness of weekly doses of 0.2 g / kg and 0.4 g / kg Hizentra in maintenance therapy for CIDP in patients who received either completed or were successfully rescued from the CIDP relapse with intravenous immunoglobulin treatment in the Phase 3 PATH trial.
A total of 82 patients were enrolled in the extension study, with 62 patients receiving 0.4 g / kg weekly and 20 patients receiving 0.2 g / kg weekly. When patients were clinically stable at 0.4 g / kg after 24 weeks, they were switched to 0.2 g / kg. Patients who were administered 0.2 g / kg and who relapsed were started or restarted at the 0.4 g / kg dose.
The results showed that 47.9% and 9.7% of patients treated with Hizentra 0.2 g / kg and 0.4 g / kg, respectively, experienced relapse. Worsening of the disease was observed in 52% of patients after reducing the dose from 0.4 g / kg to 0.2 g / kg. When the dose of 0.4 g / kg was restarted, an improvement was reported in 89% of patients.
“This update to the label and the data show that clinicians can safely customize their patient’s subcutaneous immunoglobulin treatment,” said Arie Katz, senior medical director at CSL Behring. “Providing consistent treatment can reduce the burden on patients with CIDP.”
The recommended subcutaneous dose of Hizentra for CIDP is 0.2 g / kg body weight per week. Based on the study data, a dose of 0.4 g / kg body weight per week was also found to be safe and effective in preventing CIDP relapse. If CIDP symptoms worsen at the dose of 0.2 g / kg, an increase in dose to 0.4 g / kg may be considered.
- Hizentra® (subcutaneous immunoglobulin) [human] The 20% Liquid) label update offers clinicians new dosage guidelines that allow greater flexibility in treating CIDP patients. [press release]. King of Prussia, PA: CSL Behring; April 29, 2021.
- Van Schaik IN, Mielke O., Bril V. et al. Long-term safety and efficacy of subcutaneous immunoglobulin IgPro20 in CIDP: the PATH extension study. Neurology. Apr 2019, 92 (15 addendum) S43.005.
- Hizentra® prescribing information. Kankakee, IL: CSL Behring LLC. 2021.
This article originally appeared on MPR
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