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@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 and 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, vol.~10, No~40, p.~1-12. ISSN~1664-3224. Available from: https://dx.doi.org/10.3389/fimmu.2019.00040.
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