Systemic IgG exposure and safety in patients with primary immunodeficiency: a randomized crossover study comparing a novel investigational wearable infusor versus the Crono pump.

Richard L Wasserman, Charlotte Cunningham-Rundles, John Anderson, Patricia Lugar, Michael Palumbo, Niraj C Patel, Jutta Hofmann, Fiona Glassman, Eileen Rogers, Michaela Praus, Mikhail A Rojavin

Immunotherapy 2022 Nov

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Aim: A novel, Investigational Wearable Infusor (IWI) was evaluated in a randomized, controlled, crossover, open-label study to determine if its delivery of subcutaneous immunoglobulin (IgPro20) achieved a comparable area under the concentration-time curve (AUC) for immunoglobulin G (IgG) versus the Crono S-PID-50 infusion pump (CP). EudraCT: 2016-003798-16. Materials & methods: Patients with primary immunodeficiency (PID) were randomized to receive IgPro20 in Sequence 1 (CP/IWI) or 2 (IWI/CP). The primary end point was AUC for IgG during the final week of each 4-week period. Results: 23 patients were enrolled. Evaluation of area under the concentration-time curve from time 0 (pre-infusion) to 7 days after infusion (AUC0-7 days) (IWI: 1806 h*g/l; CP: 1829 h*g/l) and geometric mean ratio indicated comparable AUCs for IgG for both devices. Conclusion: Similar IgG exposure, indicated by AUC values, can be achieved with IgPro20 using the IWI or CP in PID.

Citation

Richard L Wasserman, Charlotte Cunningham-Rundles, John Anderson, Patricia Lugar, Michael Palumbo, Niraj C Patel, Jutta Hofmann, Fiona Glassman, Eileen Rogers, Michaela Praus, Mikhail A Rojavin. Systemic IgG exposure and safety in patients with primary immunodeficiency: a randomized crossover study comparing a novel investigational wearable infusor versus the Crono pump. Immunotherapy. 2022 Nov;14(16):1315-1328