PMID- 25761372
OWN - NLM
STAT- MEDLINE
DCOM- 20151117
LR  - 20240323
IS  - 1365-2249 (Electronic)
IS  - 0009-9104 (Print)
IS  - 0009-9104 (Linking)
VI  - 181
IP  - 3
DP  - 2015 Sep
TI  - Efficacy and tolerability of 16% subcutaneous immunoglobulin compared with 20% 
      subcutaneous immunoglobulin in primary antibody deficiency.
PG  - 441-50
LID - 10.1111/cei.12623 [doi]
AB  - Multiple subcutaneous immunoglobulin (SCIG) products are available to treat 
      primary antibody deficiency (PAD). The efficacy and tolerability of 16% SCIG 
      (Vivaglobin((R)) ) was compared with 20% SCIG (Hizentra((R)) ) in PAD subjects. The 
      study was a prospective, single-centre, open-label study of PAD subjects 
      transitioning Vivaglobin to equivalent Hizentra doses, rounded to the nearest 
      vial size. Comparisons included immunoglobulin (Ig)G levels; tetanus, varicella 
      and Streptococcus pneumoniae titres; adverse events (AEs), annual infection rate 
      and quality of life during 8 weeks of Vivaglobin and 24 weeks of Hizentra. 
      Thirty-two subjects (aged 2-75 years) participated. Rounding to the nearest 
      Hizentra vial size resulted in a 12.8% (+/- 2.9%) increase in SCIG dose. Median 
      immunoglobulin (Ig)G level following 8 weeks of Vivaglobin was similar to 24 
      weeks of Hizentra (1050 versus 1035 mg/dl, respectively; P = 0.77). Both products 
      had similar protective titres to tetanus, varicella and serotypes of S. 
      pneumoniae, which were variable but well above protective levels. After 12 weeks 
      of Hizentra, subjects reported fewer local site reactions compared with 
      Vivaglobin. Switching products resulted in increased systemic AEs in some 
      subjects but, overall, not significantly higher than during Vivaglobin treatment. 
      Average infusion time decreased from 104.7 min (3.3 sites) with Vivaglobin to 
      70.7 min (2.2 sites) with Hizentra (P = 0.0005). Acute serious bacterial 
      infections were similar. Treatment satisfaction was superior with Hizentra. 
      Hizentra and Vivaglobin have similar pharmacokinetics and efficacy. Although 
      transition to a different SCIG product initially increased AEs, Hizentra is well 
      tolerated and can be infused more rapidly and with fewer sites compared to 
      Vivaglobin.
CI  - (c) 2015 British Society for Immunology.
FAU - Niebur, H B
AU  - Niebur HB
AD  - Division of Allergy, Immunology and Rheumatology, Department of Pediatrics, 
      University of South Florida, St Petersburg, FL, USA.
FAU - Duff, C M
AU  - Duff CM
AD  - Division of Allergy, Immunology and Rheumatology, Department of Pediatrics, 
      University of South Florida, St Petersburg, FL, USA.
FAU - Shear, G F
AU  - Shear GF
AD  - Division of Allergy, Immunology and Rheumatology, Department of Pediatrics, 
      University of South Florida, St Petersburg, FL, USA.
FAU - Nguyen, D
AU  - Nguyen D
AD  - Division of Allergy, Immunology and Rheumatology, Department of Pediatrics, 
      University of South Florida, St Petersburg, FL, USA.
FAU - Alberdi, T K
AU  - Alberdi TK
AD  - Division of Allergy, Immunology and Rheumatology, Department of Pediatrics, 
      University of South Florida, St Petersburg, FL, USA.
FAU - Dorsey, M J
AU  - Dorsey MJ
AD  - Division of Allergy, Immunology and Rheumatology, Department of Pediatrics, 
      University of South Florida, St Petersburg, FL, USA.
FAU - Sleasman, J W
AU  - Sleasman JW
AD  - Division of Allergy, Immunology and Rheumatology, Department of Pediatrics, 
      University of South Florida, St Petersburg, FL, USA.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
DEP - 20150707
PL  - England
TA  - Clin Exp Immunol
JT  - Clinical and experimental immunology
JID - 0057202
RN  - 0 (Hizentra)
RN  - 0 (Immunoglobulin G)
RN  - 0 (Immunoglobulins)
RN  - 0 (Vivaglobin)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Bacterial Infections/immunology/*prevention & control
MH  - Child
MH  - Child, Preschool
MH  - Dose-Response Relationship, Drug
MH  - Edema/chemically induced
MH  - Female
MH  - Fever/chemically induced
MH  - Headache/chemically induced
MH  - Humans
MH  - Immunoglobulin G/administration & dosage/adverse 
      effects/immunology/metabolism/therapeutic use
MH  - Immunoglobulins/administration & dosage/adverse effects/*therapeutic use
MH  - Immunologic Deficiency Syndromes/*drug therapy/immunology
MH  - Infusions, Subcutaneous
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Quality of Life
MH  - Surveys and Questionnaires
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC4557380
OTO - NOTNLM
OT  - Hizentra
OT  - IVIG
OT  - IgG
OT  - Vivaglobin
OT  - antibody deficiency
OT  - immunodeficiency
OT  - pneumococcal titres
OT  - quality of life
OT  - subcutaneous immunoglobulin
OT  - varicella
EDAT- 2015/03/13 06:00
MHDA- 2015/11/18 06:00
PMCR- 2016/09/01
CRDT- 2015/03/13 06:00
PHST- 2015/02/25 00:00 [accepted]
PHST- 2015/03/13 06:00 [entrez]
PHST- 2015/03/13 06:00 [pubmed]
PHST- 2015/11/18 06:00 [medline]
PHST- 2016/09/01 00:00 [pmc-release]
AID - 10.1111/cei.12623 [doi]
PST - ppublish
SO  - Clin Exp Immunol. 2015 Sep;181(3):441-50. doi: 10.1111/cei.12623. Epub 2015 Jul 
      7.