The labeling for Hizentra® (immune globulin subcutaneous [human] 20% liquid) has been updated with new dosing guidelines based on data from the PATH (Polyneuropathy and Treatment with Hizentra) Extension study.
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 trial that evaluated the long-term safety and efficacy of Hizentra 0.2g/kg and 0.4g/kg weekly doses, in the maintenance treatment of CIDP in patients who either completed or were being successfully rescued from CIDP relapse with intravenous immune globulin treatment in the phase 3 PATH study.
A total of 82 patients were enrolled in the extension study, with 62 patients receiving 0.4g/kg weekly and 20 patients receiving 0.2g/kg weekly. After 24 weeks, if patients were clinically stable on 0.4g/kg, they were switched to 0.2g/kg. Patients administered 0.2g/kg who experienced a relapse were started or restarted on the 0.4g/kg dose.
Results showed that relapse occurred in 47.9% and 9.7% of patients treated with Hizentra 0.2g/kg and 0.4g/kg, respectively. Disease worsening was observed in 52% of patients after dose reduction from 0.4g/kg to 0.2g/kg. After reinitiating the 0.4g/kg dose, improvement was reported in 89% of patients.
“This label update and data show that physicians can confidently adjust their patient’s subcutaneous immune globulin treatment,” said Arie Katz, Senior Medical Director at CSL Behring. “Providing consistency in a proven treatment can lessen some of the burden that patients living with CIDP may face.”
The recommended subcutaneous dose of Hizentra for CIDP is 0.2g/kg body weight per week. Based on the study data, a dose of 0.4g/kg body weight per week was also found to be safe and effective in preventing CIDP relapse. If CIDP symptoms worsen on the 0.2g/kg dose, an increase to the 0.4g/kg dose may be considered.
- Hizentra® (immune globulin subcutaneous [human] 20% Liquid) label update provides new dosing guidelines for physicians, allowing for 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 Supplement) S43.005.
- Hizentra® prescribing information. Kankakee, IL: CSL Behring LLC. 2021.