Clinical Efficacy, Safety and Tolerability of a New
Subcutaneous Immunoglobulin 16.5% (Octanorm [Cutaquig (R)]) in
the Treatment of Patients With Primary Immunodeficiencies

J 2019

Clinical Efficacy, Safety and Tolerability of a New Subcutaneous Immunoglobulin 16.5% (Octanorm [Cutaquig (R)]) in the Treatment of Patients With Primary Immunodeficiencies

KOBAYASHI, Roger H., Sudhir GUPTA, Isaac MELAMED, Fernando J. MANDUJANO, Ai Lan KOBAYASHI et. al.

Základní údaje

Originální název

Clinical Efficacy, Safety and Tolerability of a New Subcutaneous Immunoglobulin 16.5% (Octanorm [Cutaquig (R)]) in the Treatment of Patients With Primary Immunodeficiencies

Autoři

KOBAYASHI, Roger H. (840 Spojené státy, garant), Sudhir GUPTA (840 Spojené státy), Isaac MELAMED (840 Spojené státy), Fernando J. MANDUJANO (840 Spojené státy), Ai Lan KOBAYASHI (840 Spojené státy), Bruce RITCHIE (124 Kanada), Bob GENG (840 Spojené státy), Thomas Prescott ATKINSON (840 Spojené státy), Syed REHMAN (840 Spojené státy), Eva TURPEL-KANTOR (40 Rakousko) a Jiří LITZMAN (203 Česká republika, domácí)

Vydání

Frontiers in Immunology, LAUSANNE, FRONTIERS MEDIA SA, 2019, 1664-3224

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30102 Immunology

Stát vydavatele

Švýcarsko

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 5.085

Kód RIV

RIV/00216224:14110/19:00109451

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.3389/fimmu.2019.00040

UT WoS

000457623800001

Klíčová slova anglicky

primary immunodeficiencies; immunoglobulins; antibodies; SCIG; infections; infusion site reactions

Štítky

14110114, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 15. 4. 2019 15:23, Soňa Böhmová

Anotace

V originále

Introduction: Subcutaneously administered immunoglobulin (SCIG) is increasingly used to treat patients with primary immunodeficiencies (PIDs). Octanorm (marketed as cutaquig (R) in USA and Canada) is a new 16.5% solution of human SCIG, manufactured by a process based on that of the intravenous preparation (IVIG) octagam (R). Objectives: To investigate the efficacy, safety and tolerability of octanorm in a prospective, open-label, single-arm phase 3 study involving adult and pediatric patients with PIDs (NCT01888484; clinicaltrials. gov/ct2/show/NCT01888484). Methods: Patients who were previously treated with IVIG received a total of 64 weekly SCIG infusions, including 12 weekly infusions during the wash-in/wash-out period, followed by 52 weekly infusions during the evaluation period. Results: A total of 61 patients aged 2-73 years received 3,497 infusions of octanorm. The mean dose per patient was 0.175 g/kg/infusion. The mean calculated dose conversion factor from the patients' previous IVIG dose for octanorm was 1.37. No serious bacterial infections developed during the study. The rate of other infections per person-year during the primary observation period was 3.43 (upper 95% CI 4.57). All but one non-bacterial infection were mild or moderate in intensity. IgG trough levels were constant during the course of the study. Eleven patients (18.0%) experienced 14 mild or moderate systemic adverse events (AEs) related to octanorm. The rate of related AEs per infusion was 0.004. In 76.7% of infusions, no infusion site reactions were observed and only two (0.3%) reactions were deemed severe. The incidence of site reactions decreased with successive infusions. Conclusion: The new 16.5% SCIG octanorm was shown to be efficacious in preventing infections in PIDs, and was well tolerated.

Citovat

KOBAYASHI, Roger H., Sudhir GUPTA, Isaac MELAMED, Fernando J. MANDUJANO, Ai Lan KOBAYASHI, Bruce RITCHIE, Bob GENG, Thomas Prescott ATKINSON, Syed REHMAN, Eva TURPEL-KANTOR a Jiří LITZMAN. Clinical Efficacy, Safety and Tolerability of a New Subcutaneous Immunoglobulin 16.5% (Octanorm [Cutaquig (R)]) in the Treatment of Patients With Primary Immunodeficiencies. Frontiers in Immunology. LAUSANNE: FRONTIERS MEDIA SA, 2019, roč. 10, č. 40, s. 1-12. ISSN 1664-3224. Dostupné z: https://dx.doi.org/10.3389/fimmu.2019.00040.

@article{1521040,
   author = {Kobayashi, Roger H. and Gupta, Sudhir and Melamed, Isaac and Mandujano, Fernando J. and Kobayashi, Ai Lan and Ritchie, Bruce and Geng, Bob and Atkinson, Thomas Prescott and Rehman, Syed and TurpelandKantor, Eva and Litzman, Jiří},
   article_location = {LAUSANNE},
   article_number = {40},
   doi = {http://dx.doi.org/10.3389/fimmu.2019.00040},
   keywords = {primary immunodeficiencies; immunoglobulins; antibodies; SCIG; infections; infusion site reactions},
   language = {eng},
   issn = {1664-3224},
   journal = {Frontiers in Immunology},
   title = {Clinical Efficacy, Safety and Tolerability of a New Subcutaneous Immunoglobulin 16.5% (Octanorm [Cutaquig (R)]) in the Treatment of Patients With Primary Immunodeficiencies},
   url = {http://dx.doi.org/10.3389/fimmu.2019.00040},
   volume = {10},
   year = {2019}
}

TY  - JOUR
ID  - 1521040
AU  - Kobayashi, Roger H. - Gupta, Sudhir - Melamed, Isaac - Mandujano, Fernando J. - Kobayashi, Ai Lan - Ritchie, Bruce - Geng, Bob - Atkinson, Thomas Prescott - Rehman, Syed - Turpel-Kantor, Eva - Litzman, Jiří
PY  - 2019
TI  - Clinical Efficacy, Safety and Tolerability of a New Subcutaneous Immunoglobulin 16.5% (Octanorm [Cutaquig (R)]) in the Treatment of Patients With Primary Immunodeficiencies
JF  - Frontiers in Immunology
VL  - 10
IS  - 40
SP  - 1-12
EP  - 1-12
PB  - FRONTIERS MEDIA SA
SN  - 16643224
KW  - primary immunodeficiencies
KW  - immunoglobulins
KW  - antibodies
KW  - SCIG
KW  - infections
KW  - infusion site reactions
UR  - http://dx.doi.org/10.3389/fimmu.2019.00040
L2  - http://dx.doi.org/10.3389/fimmu.2019.00040
N2  - Introduction: Subcutaneously administered immunoglobulin (SCIG) is increasingly used to treat patients with primary immunodeficiencies (PIDs). Octanorm (marketed as cutaquig (R) in USA and Canada) is a new 16.5% solution of human SCIG, manufactured by a process based on that of the intravenous preparation (IVIG) octagam (R). Objectives: To investigate the efficacy, safety and tolerability of octanorm in a prospective, open-label, single-arm phase 3 study involving adult and pediatric patients with PIDs (NCT01888484; clinicaltrials. gov/ct2/show/NCT01888484). Methods: Patients who were previously treated with IVIG received a total of 64 weekly SCIG infusions, including 12 weekly infusions during the wash-in/wash-out period, followed by 52 weekly infusions during the evaluation period. Results: A total of 61 patients aged 2-73 years received 3,497 infusions of octanorm. The mean dose per patient was 0.175 g/kg/infusion. The mean calculated dose conversion factor from the patients' previous IVIG dose for octanorm was 1.37. No serious bacterial infections developed during the study. The rate of other infections per person-year during the primary observation period was 3.43 (upper 95% CI 4.57). All but one non-bacterial infection were mild or moderate in intensity. IgG trough levels were constant during the course of the study. Eleven patients (18.0%) experienced 14 mild or moderate systemic adverse events (AEs) related to octanorm. The rate of related AEs per infusion was 0.004. In 76.7% of infusions, no infusion site reactions were observed and only two (0.3%) reactions were deemed severe. The incidence of site reactions decreased with successive infusions. Conclusion: The new 16.5% SCIG octanorm was shown to be efficacious in preventing infections in PIDs, and was well tolerated.
ER  -

KOBAYASHI, Roger H., Sudhir GUPTA, Isaac MELAMED, Fernando J. MANDUJANO, Ai Lan KOBAYASHI, Bruce RITCHIE, Bob GENG, Thomas Prescott ATKINSON, Syed REHMAN, Eva TURPEL-KANTOR a Jiří LITZMAN. Clinical Efficacy, Safety and Tolerability of a New Subcutaneous Immunoglobulin 16.5\%{} (Octanorm [Cutaquig (R)]) in the Treatment of Patients With Primary Immunodeficiencies. \textit{Frontiers in Immunology}. LAUSANNE: FRONTIERS MEDIA SA, 2019, roč.~10, č.~40, s.~1-12. ISSN~1664-3224. Dostupné z: https://dx.doi.org/10.3389/fimmu.2019.00040.

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