PMID- 33738703
OWN - NLM
STAT- MEDLINE
DCOM- 20210531
LR  - 20221207
IS  - 1865-3774 (Electronic)
IS  - 0925-5710 (Linking)
VI  - 113
IP  - 6
DP  - 2021 Jun
TI  - Safety and tolerability of IgPro10 in Japanese primary immunodeficiency patients: 
      a registrational study.
PG  - 921-929
LID - 10.1007/s12185-021-03106-w [doi]
AB  - Studies investigating the safety of IgPro10 (Privigen((R)), CSL Behring, King of 
      Prussia, PA, USA) in Japanese patients with primary immunodeficiency (PID) are 
      lacking. This study evaluated safety and tolerability of IgPro10 in Japanese 
      patients with PID. In this prospective, open-label, single-arm, registrational 
      study for Japan, IgPro10 was administered intravenously at pre-study doses of 
      138-556 mg/kg body weight per 3-/4-weekly dosing cycle for up to 4 months. 
      Frequency and intensity of adverse events (AEs), their relationship to IgPro10 
      and AE rate per infusion (AERI) were evaluated. Of 11 enrolled patients, 10 
      completed the study. The median (range) total duration of exposure was 16.14 
      (4.1-16.3) weeks. Eight patients reported 19 AEs, none severe (based on maximum 
      severity), giving an AERI of 0.442. One AE was deemed related to IgPro10 
      treatment. Three patients experienced temporally associated AEs. No serious AEs 
      or deaths were reported. Nine patients (90%) who completed the study tolerated 
      flow rates of >/= 8 mg/kg/min; 5 tolerated 12 mg/kg/min (7.2 mL/kg/h), translating 
      into a threefold decrease in mean infusion time. IgPro10 was well tolerated at a 
      flow rate of up to 12 mg/kg/min. Safety and tolerability findings were consistent 
      with previously reported studies in non-Japanese patients with PID.
FAU - Morio, Tomohiro
AU  - Morio T
AUID- ORCID: 0000-0002-9259-1025
AD  - Department of Pediatrics and Developmental Biology, Tokyo Medical and Dental 
      University, Tokyo, Japan. tmorio.ped@tmd.ac.jp.
FAU - Gotoh, Kenji
AU  - Gotoh K
AD  - Department of Pediatrics, Kurume University Hospital, Fukuoka, Japan.
FAU - Imagawa, Tomoyuki
AU  - Imagawa T
AD  - Department of Infectious Disease and Immunology, Kanagawa Children's Medical 
      Center, Yokohama, Japan.
FAU - Morita, Kimio
AU  - Morita K
AD  - Department of Internal Medicine, Dokkyo Medical University Saitama Medical 
      Center, Saitama, Japan.
FAU - Ohnishi, Hidenori
AU  - Ohnishi H
AD  - Department of Pediatrics, Gifu University Hospital, Gifu, Japan.
FAU - Yasui, Kozo
AU  - Yasui K
AD  - Department of Pediatrics, Hiroshima-City Hospital, Hiroshima, Japan.
FAU - Hofmann, Jutta
AU  - Hofmann J
AD  - CSL Behring AG, Bern, Switzerland.
FAU - Lawo, John Philip
AU  - Lawo JP
AD  - CSL Behring GmbH, Marburg, Germany.
FAU - Shebl, Amgad
AU  - Shebl A
AD  - CSL Behring GmbH, Marburg, Germany.
FAU - Rojavin, Mikhail A
AU  - Rojavin MA
AD  - CSL Behring LLC, King of Prussia, PA, USA.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
DEP - 20210318
PL  - Japan
TA  - Int J Hematol
JT  - International journal of hematology
JID - 9111627
RN  - 0 (Immunoglobulin G)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Asian People
MH  - Female
MH  - Humans
MH  - Immunoglobulin G/*administration & dosage/adverse effects
MH  - Japan
MH  - Male
MH  - Middle Aged
MH  - Primary Immunodeficiency Diseases/*drug therapy
MH  - Prospective Studies
MH  - *Registries
OTO - NOTNLM
OT  - IgPro10
OT  - Japan
OT  - Primary immunodeficiency
OT  - Safety
OT  - Tolerability
EDAT- 2021/03/20 06:00
MHDA- 2021/06/01 06:00
CRDT- 2021/03/19 07:39
PHST- 2020/09/29 00:00 [received]
PHST- 2021/02/18 00:00 [accepted]
PHST- 2021/02/08 00:00 [revised]
PHST- 2021/03/20 06:00 [pubmed]
PHST- 2021/06/01 06:00 [medline]
PHST- 2021/03/19 07:39 [entrez]
AID - 10.1007/s12185-021-03106-w [pii]
AID - 10.1007/s12185-021-03106-w [doi]
PST - ppublish
SO  - Int J Hematol. 2021 Jun;113(6):921-929. doi: 10.1007/s12185-021-03106-w. Epub 
      2021 Mar 18.