A New Study

A new study, conducted by CLS Behring, has found that a new method of administration for Hizentra as a treatment for primary immunodeficiency (PI), could improve quality of life for patients. This is a manual push method which could simplify the process for patients and give them more flexibility in their treatment.

Hizentra is used in 60 countries and is the most prescribed immunoglobulin for PI. It was first approved by the FDA in 2010 for PI, and then in 2018 for chronic inflammatory demyelinating polyneuropathy (CIDP).

This study was published in the Journal of Allergy and Clinical Immunology. 

The trial met its primary endpoint, with positive results for most patients in all cohorts. Besides the new method of administration, this study also found that Hizentra can be infused faster and at higher volumes.

Study Details

This was an open-label multi center study which was not randomized. It included 49 patients (both adults and children) who were currently taking a stable infusion of Hizentra. There were three cohorts, decided based on patient’s prior experience with manual infusions. For each cohort, increasing doses were evaluated for four weeks at a time.

• Pump-assisted volume (15 patients)
  • Weekly infusions
  • 25, 40, and 50 mL per injection site
• Pump-assisted flow rate (18 patients)
  • Weekly infusions
  • Flow rate = 25, 50, 75, and 100 mL per hour per injection site
• Manual push administration flow rate  (16 patients)
  • 2-7 infusions. each week
  • Flow rate = 30, 60, and 120 mL per hour per injection site

The primary endpoint of this study was the rate of response, per each infusion level. This study also investigated safety and tolerability.

Results

The rate of response was defined by the percent of participants who completed at least 75% of the infusions for the pump assisted cohorts, or 60% of infusions for the manual push cohort.

For the pump-assisted volume administration, the 25 ml group had a response rate of 86.7%, and the 40 and 50 ml group had a 73.3% response rate. For the flow rate cohort, responses for the 25 and 50 ml per hour group were 77.8%, the 75 ml per hour group was 66.7%, and the 100ml per hour group was 61.1%.

For the manual push administration, the cohort with .5 and 1ml per minute infusion had a 100% response rate. For the 2ml per minute it was 87.5%.

There were low rates of adverse effects documented for all cohorts. The most common were reactions at the infusion site. It’s amazing that adverse events did not vary amongst the infusion increases in frequency, type of AE, intensity, or duration.

Researchers are optimistic that this new method, faster infusion, and higher volume of infusion, will be extremely beneficial to PI patients.

 You can read more about these findings here.