Publication details

Long-term efficacy, safety, and tolerability of a subcutaneous immunoglobulin 16.5% (cutaquig (R)) in the treatment of patients with primary immunodeficiencies

Authors

KOBAYASHI Roger H. LITZMAN Jiří MELAMED Isaac MANDUJANO J Fernando KOBAYASHI Ai Lan RITCHIE Bruce GENG Bob ATKINSON T Prescott REHMAN Syed HOELLER Sonja TURPEL-KANTOR Eva KREUWEL Huub SPEER J. C. GUPTA Sudhir

Year of publication 2022
Type Article in Periodical
Magazine / Source Clinical and Experimental Immunology
MU Faculty or unit

Faculty of Medicine

Citation
Web https://academic.oup.com/cei/article/210/2/91/6754250?login=true
Doi http://dx.doi.org/10.1093/cei/uxac092
Keywords long-term safety; prospective data; primary immunodeficiencies; subcutaneous immunoglobulin; tolerability
Description 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 (R)) 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 74% 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.

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