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

J 2022

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

KOBAYASHI, Roger H., Jiří LITZMAN, Isaac MELAMED, J Fernando MANDUJANO, Ai Lan KOBAYASHI et. al.

Základní údaje

Originální název

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

Autoři

KOBAYASHI, Roger H. (garant), Jiří LITZMAN (203 Česká republika, domácí), 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 a Sudhir GUPTA

Vydání

Clinical and Experimental Immunology, Hoboken, Wiley, 2022, 0009-9104

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30102 Immunology

Stát vydavatele

Velká Británie a Severní Irsko

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 4.600

Kód RIV

RIV/00216224:14110/22:00127499

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1093/cei/uxac092

UT WoS

000871580400001

Klíčová slova anglicky

long-term safety; prospective data; primary immunodeficiencies; subcutaneous immunoglobulin; tolerability

Štítky

14110114, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 14. 3. 2023 08:45, Mgr. Tereza Miškechová

Anotace

V originále

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.

Citovat

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 a Sudhir GUPTA. Long-term efficacy, safety, and tolerability of a subcutaneous immunoglobulin 16.5% (cutaquig (R)) in the treatment of patients with primary immunodeficiencies. Clinical and Experimental Immunology. Hoboken: Wiley, 2022, roč. 210, č. 2, s. 91-103. ISSN 0009-9104. Dostupné z: https://dx.doi.org/10.1093/cei/uxac092.

@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 a 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, roč.~210, č.~2, s.~91-103. ISSN~0009-9104. Dostupné z: https://dx.doi.org/10.1093/cei/uxac092.

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