IgPro20 Well Tolerated by Most Patients With PID, According to Phase 4 Study Data

March 18, 2020
AJMC Staff

High infusion parameters for pump-assisted and manual push 20% subcutaneous immunoglobulin (SCIg), or IgPro20, were well tolerated by patients with primary immunodeficiency disorder (PID), according to a recent abstract prepared for the American Academy of Allergy, Asthma & Immunology 2020 Annual Meeting.

High infusion parameters for pump-assisted and manual push 20% subcutaneous immunoglobulin (SCIg), or IgPro20, were well tolerated by patients with primary immunodeficiency disorder (PID), according to a recent abstract prepared for the American Academy of Allergy, Asthma & Immunology 2020 Annual Meeting.

Researchers evaluated treatment-emergent adverse events (TEAEs) for IgPro20. Sold under the name Hizentra, IgPro20 was first approved for the treatment of PID and is also approved for chronic inflammatory demyelinating polyneuropathy. The study (NCT03033745) assessed safety and tolerability of increasing infusion rates/volumes.

According to the Immune Deficiency Foundation, PID consists of more than 400 rare, chronic disorders in which part of the body’s immune system is missing or functions improperly as a result of hereditary or genetic defects.

In the open-label, nonrandomized phase 4 study, patients receiving IgPro20 were assigned to:

  • Pump-assisted volume cohort (n = 15; 25-50 mL/injection site, weekly)
  • Pump-assisted flow rate cohort (n = 18; 25-100 mL/h/injection site, weekly)
  • Manual push flow rate cohort (n = 16; 30-120 mL/h/injection site; 2-7 infusions/week).

Assignments were based on prior experience with pump-assisted infusions at the highest approved IgPro20 parameters or frequent manual push infusions (~25 mL/h).

The rate of TEAEs per infusion was low across cohorts: 0.145, 0.228, and 0.085 in the pump-assisted volume cohort, the pump-assisted flow rate cohort, and the manual push flow rate cohort, respectively. There were no clinically meaningful differences in TEAE frequency, type, intensity, or duration among cohorts, and rates of TEAEs per infusion did not increase with increasing infusion parameters.

Most TEAEs were mild/moderate infusion site reactions (ISRs). There were causally related ISRs in 4 patients (26.7%) in the pump-assisted volume cohort (0.079/infusion); 1 patient discontinued due to mild injection site pain.

In the pump-assisted flow rate cohort, 8 patients (44.4%) had related ISRs (0.131/infusion); 1 patient (5.6%) reported 2 severe related ISRs, but none discontinued.

In the manual push flow rate cohort, 6 patients (37.5%) had related ISRs (0.043/infusion); 1 patient (6.3%) had a severe, unrelated serious TEAE (suicide attempt) leading to discontinuation.