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@article{2240838,
author = {Kobayashi, Roger H. and Litzman, Jiří and Melamed, Isaac and Mandujano, J Fernando and Kobayashi, Ai Lan and Ritchie, Bruce and Geng, Bob and Atkinson, T Prescott and Rehman, Syed and Hoeller, Sonja and TurpelandKantor, Eva and Kreuwel, Huub and Speer, J. C. and Gupta, Sudhir},
article_location = {Hoboken},
article_number = {2},
doi = {http://dx.doi.org/10.1093/cei/uxac092},
keywords = {long-term safety; prospective data; primary immunodeficiencies; subcutaneous immunoglobulin; tolerability},
language = {eng},
issn = {0009-9104},
journal = {Clinical and Experimental Immunology},
title = {Long-term efficacy, safety, and tolerability of a subcutaneous immunoglobulin 16.5% (cutaquig (R)) in the treatment of patients with primary immunodeficiencies},
url = {https://academic.oup.com/cei/article/210/2/91/6754250?login=true},
volume = {210},
year = {2022}
}
TY - JOUR
ID - 2240838
AU - 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
PY - 2022
TI - Long-term efficacy, safety, and tolerability of a subcutaneous immunoglobulin 16.5% (cutaquig (R)) in the treatment of patients with primary immunodeficiencies
JF - Clinical and Experimental Immunology
VL - 210
IS - 2
SP - 91-103
EP - 91-103
PB - Wiley
SN - 00099104
KW - long-term safety
KW - prospective data
KW - primary immunodeficiencies
KW - subcutaneous immunoglobulin
KW - tolerability
UR - https://academic.oup.com/cei/article/210/2/91/6754250?login=true
N2 - 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.
ER -
KOBAYASHI, Roger H., Jiří LITZMAN, Isaac MELAMED, J Fernando MANDUJANO, Ai Lan KOBAYASHI, Bruce RITCHIE, Bob GENG, T Prescott ATKINSON, Syed REHMAN, Sonja HOELLER, Eva TURPEL-KANTOR, Huub KREUWEL, J. C. SPEER and Sudhir GUPTA. Long-term efficacy, safety, and tolerability of a subcutaneous immunoglobulin 16.5\%{} (cutaquig (R)) in the treatment of patients with primary immunodeficiencies. \textit{Clinical and Experimental Immunology}. Hoboken: Wiley, 2022, vol.~210, No~2, p.~91-103. ISSN~0009-9104. Available from: https://dx.doi.org/10.1093/cei/uxac092.
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