PMID- 24981039
OWN - NLM
STAT- MEDLINE
DCOM- 20150615
LR  - 20211021
IS  - 1573-2592 (Electronic)
IS  - 0271-9142 (Print)
IS  - 0271-9142 (Linking)
VI  - 34
IP  - 7
DP  - 2014 Oct
TI  - Clinical experience with an L-proline-stabilized 10 %intravenous immunoglobulin 
      (Privigen(R)): real-life effectiveness and tolerability.
PG  - 804-12
LID - 10.1007/s10875-014-0070-z [doi]
AB  - PURPOSE: This retrospective study evaluated the effectiveness and tolerability in 
      clinical practice of an L-proline-stabilized 10 % intravenous immunoglobulin 
      (IVIG; Privigen(R)) in patients with primary (PID) or secondary immunodeficiency 
      (SID). METHODS: Patients from 6 centers in Europe and the US were treated with 
      individually determined regimens of Privigen(R) for >/=3 months. Serum immunoglobulin 
      G (IgG) trough levels, annualized rates of infection, hospitalization and 
      antibiotics use, and the incidence of adverse events (AEs) were analyzed. 
      RESULTS: Of 72 patients, three infants with severe combined immunodeficiency 
      (SCID) were analyzed separately. The remaining 69 patients (52.2 % male; median 
      age 38 years [range: 0.1-90.0]) with PID (82.6 %) or SID (17.4 %) received a mean 
      (+/-standard deviation) Privigen(R) dose of 532 +/- 250 mg/kg/month resulting in trough 
      serum IgG levels of 407-1,581 mg/dL (median: 954 mg/dL). Ten patients (14.5 %) 
      experienced 11 serious bacterial infections over 22.0 +/- 15.0 months of treatment 
      (0.087 events/patient/year, upper one-sided 99 % confidence interval: 0.170), the 
      most common being pneumonia (11.6 %). The rates for any infection and 
      hospitalization were 1.082 events/patient/year and 3.63 days/patient/year, 
      respectively. Two patients with severe disease accounted for 303 of 460 hospital 
      days. Across all 72 patients, 13 (18.1 %) patients experienced AEs, including 10 
      (13.9 %) patients with AEs at least possibly related to Privigen(R), including 
      headache (8.3 %), fever, and chills (2.8 % each). No related serious AEs were 
      reported. One infant with SCID died due to severe viral infection. CONCLUSIONS: 
      Despite the heterogeneous population, effectiveness and tolerability of Privigen(R) 
      in clinical practice closely matched those reported in clinical studies.
FAU - Dorsey, Morna J
AU  - Dorsey MJ
AD  - Department of Pediatrics, University of California, San Francisco, CA, USA, 
      Morna.Dorsey@ucsf.edu.
FAU - Ho, Viet
AU  - Ho V
FAU - Mabudian, Mohsen
AU  - Mabudian M
FAU - Soler-Palacin, Pere
AU  - Soler-Palacin P
FAU - Dominguez-Pinilla, Nerea
AU  - Dominguez-Pinilla N
FAU - Rishi, Radha
AU  - Rishi R
FAU - Rishi, Rahul
AU  - Rishi R
FAU - Wong, Duane
AU  - Wong D
FAU - Rojavin, Mikhail
AU  - Rojavin M
FAU - Hubsch, Alphonse
AU  - Hubsch A
FAU - Berger, Melvin
AU  - Berger M
LA  - eng
PT  - Evaluation Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20140701
PL  - Netherlands
TA  - J Clin Immunol
JT  - Journal of clinical immunology
JID - 8102137
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Immunoglobulins, Intravenous)
RN  - 9DLQ4CIU6V (Proline)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anti-Bacterial Agents/*therapeutic use
MH  - Child
MH  - Child, Preschool
MH  - Europe
MH  - Female
MH  - Headache/etiology
MH  - Hospitalization
MH  - Humans
MH  - Immunoglobulins, Intravenous/*administration & dosage/adverse effects/chemistry
MH  - Immunologic Deficiency Syndromes/complications/immunology/*therapy
MH  - Infant
MH  - Infections/etiology/immunology/*therapy
MH  - Male
MH  - Middle Aged
MH  - Practice Patterns, Physicians'
MH  - Proline/chemistry
MH  - Protein Stability
MH  - Retrospective Studies
MH  - United States
MH  - Young Adult
PMC - PMC4165870
EDAT- 2014/07/02 06:00
MHDA- 2015/06/16 06:00
PMCR- 2014/07/01
CRDT- 2014/07/02 06:00
PHST- 2014/04/01 00:00 [received]
PHST- 2014/05/08 00:00 [accepted]
PHST- 2014/07/02 06:00 [entrez]
PHST- 2014/07/02 06:00 [pubmed]
PHST- 2015/06/16 06:00 [medline]
PHST- 2014/07/01 00:00 [pmc-release]
AID - 70 [pii]
AID - 10.1007/s10875-014-0070-z [doi]
PST - ppublish
SO  - J Clin Immunol. 2014 Oct;34(7):804-12. doi: 10.1007/s10875-014-0070-z. Epub 2014 
      Jul 1.