A prospective study and its long-term extension examined whether weekly treatment of patients with primary immunodeficiencies (PIDs) with a 16.5% subcutaneous immunoglobulin (SCIg; cutaquig®) confers acceptable efficacy, safety, and tolerability over a follow-up of up to 238 weeks (>4 years). Seventy-five patients received 4462 infusions during up to 70 weeks of follow-up in the main study and 27 patients received 2777 infusions during up to 168 weeks of follow-up in the extension. In the main study, there were no serious bacterial infections (SBIs), and the annual rate of other infections was 3.3 (95% CI 2.4, 4.5). One SBI was recorded in the extension, for an SBI rate of 0.02 (upper 99% CI 0.19). The annual rate of all infections over the duration of the extension study was 2.2 (95% CI 1.2, 3.9). Only 15.0% (1085) of 7239 infusions were associated with infusion site reactions (ISRs), leaving 85.0% (6153) of infusions without reactions. The majority of ISRs were mild and transient. ISR incidence decreased over time, from 36.9% to 16% during the main study and from 9% to 2.3% during the extension. The incidence of related systemic adverse events was 14.7% in the main study and 7.4% in the extension. In conclusion, this prospective, long-term study with cutaquig showed maintained efficacy and low rates of local and systemic adverse reactions in PID patients over up to 238 weeks of follow-up.

Allergy and Asthma Center Inc Toledo OH USA

Department of Clinical Immunology and Allergology St Anne's University Hospital in Brno Faculty of Medicine Masaryk University Brno Czechia

Department of Pediatric Allergy Asthma and Immunology University of Alabama Birmingham AL USA

Division of Basic and Clinical Immunology University of California Irvine Irvine CA USA

Division of Hematology Department of Medicine University of Alberta Hospital Edmonton AB Canada

Divisions of Allergy and Immunology University of California San Diego La Jolla CA USA

IMMUNOe Research Center Centennial CO USA

Midlands Pediatrics Papillion NE USA

Octapharma Pharmazeutika Produktionsges m b H Vienna Austria

Octapharma US Paramus NJ USA

Pediatric Pulmonary Associates of North Texas Frisco TX USA

UCLA School of Medicine Los Angeles CA USA

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