PMID- 30626238
OWN - NLM
STAT- MEDLINE
DCOM- 20200213
LR  - 20200213
IS  - 1750-7448 (Electronic)
IS  - 1750-743X (Linking)
VI  - 11
IP  - 5
DP  - 2019 Apr
TI  - Tolerability of subcutaneous immunoglobulin 20%, Ig20Gly, in pediatric patients 
      with primary immunodeficiencies.
PG  - 397-406
LID - 10.2217/imt-2018-0088 [doi]
AB  - AIM: To assess Ig20Gly tolerability in pediatric patients with primary 
      immunodeficiencies. PATIENTS & METHODS: Infusion parameters and tolerability were 
      analyzed in pediatric patients (aged 2-5 years [n = 6], 6-11 years [n = 22] and 
      12-17 years [n = 22]) receiving Ig20Gly in two Phase II/III trials. RESULTS: Of 
      2624 Ig20Gly infusions, >99% did not require any rate reduction, interruption or 
      discontinuation due to adverse events (AEs). Median maximum infusion rates and 
      volumes/site were higher in patients 12-17 years of age (30 ml/h/site; 
      30 ml/site) versus 6-11 years (20 ml/h/site; 15 ml/site) and 2-5 years 
      (18 ml/h/site; 14 ml/site). Rates of causally related systemic and local AEs 
      (0.009 and 0.063 AEs/infusion) were low. CONCLUSION: Ig20Gly infused at 
      relatively high rates and volumes was well tolerated in children.
FAU - Paris, Kenneth
AU  - Paris K
AD  - LSU Health Sciences Center, Children's Hospital of New Orleans, New Orleans, LA 
      70118, USA.
FAU - Haddad, Elie
AU  - Haddad E
AD  - Department of Pediatrics, Department of Microbiology, Infectious Diseases & 
      Immunology, University of Montreal, CHU Sainte-Justine, 3175 Ch de la 
      Cote-Sainte-Catherine, Montreal, QC H3T 1C5 Quebec, Canada.
FAU - Borte, Michael
AU  - Borte M
AD  - Department of Pediatrics, Hospital St. Georg Leipzig, ImmunoDeficiency Center 
      Leipzig, Delitzscher Strasse 141, Leipzig, D - 04129, Germany.
FAU - Brodszki, Nicholas
AU  - Brodszki N
AD  - Department of Pediatric Immunology, Skane University Hospital, Lasarettsgatan 48, 
      Lund, 22185, Sweden.
FAU - Derfalvi, Beata
AU  - Derfalvi B
AD  - 2nd Department of Pediatrics, Semmelweis University, Tuzolto u. 7, Budapest 1094, 
      Hungary.
FAU - Marodi, Laszlo
AU  - Marodi L
AD  - Rockefeller University, 1230 York Ave, New York, NY 10065, USA (at the time of 
      the study: PID Clinical Unit & Laboratory, Department of Dermatology, Venerology 
      & Dermatooncology, Semmelweis University, Budapest, Hungary).
FAU - Hussain, Iftikhar
AU  - Hussain I
AD  - Department of Allergy and Immunology, Allergy, Asthma, & Immunology Center, 7307 
      S Yale Ave, Suite 200, Tulsa, OK, 74136, USA.
FAU - Darter, Amy
AU  - Darter A
AD  - Allergy, Immunology, and Asthma, Oklahoma Institute of Allergy & Asthma Clinical 
      Research, 1810 E Memorial Rd, Oklahoma City, OK 73131, USA.
FAU - Engl, Werner
AU  - Engl W
AD  - Shire, Vienna DC-Tower 1, Donau-City-Strasse 7, Vienna, 1220, Austria.
FAU - Leibl, Heinz
AU  - Leibl H
AD  - Shire, Vienna DC-Tower 1, Donau-City-Strasse 7, Vienna, 1220, Austria.
FAU - McCoy, Barbara
AU  - McCoy B
AD  - Shire, Vienna DC-Tower 1, Donau-City-Strasse 7, Vienna, 1220, Austria.
FAU - Yel, Leman
AU  - Yel L
AD  - Shire, 650 E Kendall St, Cambridge, MA, 02142, USA.
AD  - Division of Basic & Clinical Immunology, University of California at Irvine, 1001 
      Health Sciences Rd, Irvine, CA 92697, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01218438
SI  - ClinicalTrials.gov/NCT01412385
PT  - Clinical Trial, Phase II
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20190109
PL  - England
TA  - Immunotherapy
JT  - Immunotherapy
JID - 101485158
RN  - 0 (Immunoglobulins, Intravenous)
SB  - IM
MH  - Adolescent
MH  - Child
MH  - Child, Preschool
MH  - Female
MH  - Humans
MH  - Immunoglobulins, Intravenous/*administration & dosage/adverse effects
MH  - Infusions, Subcutaneous
MH  - Injections, Subcutaneous
MH  - Male
MH  - Primary Immunodeficiency Diseases/*drug therapy
OTO - NOTNLM
OT  - Ig20Gly
OT  - immunodeficiencies
OT  - pediatric
OT  - tolerability
EDAT- 2019/01/11 06:00
MHDA- 2020/02/14 06:00
CRDT- 2019/01/11 06:00
PHST- 2019/01/11 06:00 [pubmed]
PHST- 2020/02/14 06:00 [medline]
PHST- 2019/01/11 06:00 [entrez]
AID - 10.2217/imt-2018-0088 [doi]
PST - ppublish
SO  - Immunotherapy. 2019 Apr;11(5):397-406. doi: 10.2217/imt-2018-0088. Epub 2019 Jan 
      9.