PMID- 30778345
OWN - NLM
STAT- MEDLINE
DCOM- 20191220
LR  - 20230106
IS  - 1664-3224 (Electronic)
IS  - 1664-3224 (Linking)
VI  - 10
DP  - 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.
PG  - 40
LID - 10.3389/fimmu.2019.00040 [doi]
LID - 40
AB  - 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.
FAU - Kobayashi, Roger H
AU  - Kobayashi RH
AD  - UCLA School of Medicine, Los Angeles, CA, United States.
FAU - Gupta, Sudhir
AU  - Gupta S
AD  - Division of Basic and Clinical Immunology, University of California, Irvine, 
      Irvine, CA, United States.
FAU - Melamed, Isaac
AU  - Melamed I
AD  - IMMUNOe Research Center, Centennial, CO, United States.
FAU - Mandujano, J Fernando
AU  - Mandujano JF
AD  - Pediatric Pulmonary Associates of North Texas, Frisco, TX, United States.
FAU - Kobayashi, Ai Lan
AU  - Kobayashi AL
AD  - Midlands Pediatrics, Papillion, NE, United States.
FAU - Ritchie, Bruce
AU  - Ritchie B
AD  - Division of Hematology, Department of Medicine, University of Alberta Hospital, 
      Edmonton, AB, Canada.
FAU - Geng, Bob
AU  - Geng B
AD  - Divisions of Adult and Pediatric Allergy and Immunology, University of 
      California, San Diego, La Jolla, CA, United States.
FAU - Atkinson, Thomas Prescott
AU  - Atkinson TP
AD  - Department of Pediatric Allergy, Asthma and Immunology, University of Alabama, 
      Birmingham, AL, United States.
FAU - Rehman, Syed
AU  - Rehman S
AD  - Allergy and Asthma Center Inc., Toledo, OH, United States.
FAU - Turpel-Kantor, Eva
AU  - Turpel-Kantor E
AD  - Octapharma Pharmazeutika Produktionsges.m.b.H., Vienna, Austria.
FAU - Litzman, Jiri
AU  - Litzman J
AD  - Department of Clinical Immunology and Allergology, St Anne's University Hospital 
      in Brno, Faculty of Medicine, Masaryk University, Brno, Czechia.
LA  - eng
SI  - ClinicalTrials.gov/NCT01888484
PT  - Case Reports
PT  - Research Support, Non-U.S. Gov't
DEP - 20190204
PL  - Switzerland
TA  - Front Immunol
JT  - Frontiers in immunology
JID - 101560960
RN  - 0 (Immunoglobulin G)
RN  - 0 (Immunoglobulins, Intravenous)
RN  - 0 (Octagam)
SB  - IM
EIN - Front Immunol. 2022 Dec 20;13:1110388. PMID: 36605207
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Child
MH  - Child, Preschool
MH  - Female
MH  - Humans
MH  - *Immunization, Passive/methods
MH  - Immunoglobulin G/administration & dosage/blood
MH  - Immunoglobulins, Intravenous/administration & dosage/pharmacokinetics/therapeutic 
      use
MH  - Immunologic Deficiency Syndromes/*drug therapy
MH  - Infusions, Subcutaneous
MH  - Male
MH  - Middle Aged
MH  - Young Adult
PMC - PMC6369354
OTO - NOTNLM
OT  - SCIG
OT  - antibodies
OT  - immunoglobulins
OT  - infections
OT  - infusion site reactions
OT  - primary immunodeficiencies
EDAT- 2019/02/20 06:00
MHDA- 2019/12/21 06:00
PMCR- 2019/01/01
CRDT- 2019/02/20 06:00
PHST- 2018/10/18 00:00 [received]
PHST- 2019/01/09 00:00 [accepted]
PHST- 2019/02/20 06:00 [entrez]
PHST- 2019/02/20 06:00 [pubmed]
PHST- 2019/12/21 06:00 [medline]
PHST- 2019/01/01 00:00 [pmc-release]
AID - 10.3389/fimmu.2019.00040 [doi]
PST - epublish
SO  - Front Immunol. 2019 Feb 4;10:40. doi: 10.3389/fimmu.2019.00040. eCollection 2019.