title: Clinical experience with an L-proline–stabilized 10 %intravenous immunoglobulin (Privigen®): real-life effectiveness and tolerability.
abstract: OBJECTIVE
  This retrospective study evaluated the effectiveness and tolerability in clinical practice of an L-proline-stabilized 10 % intravenous immunoglobulin (IVIG; Privigen®) 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® 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® 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®, 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® in clinical practice closely matched those reported in clinical studies.
authors: Department of Pediatrics, University of California, San Francisco, CA, USA, Morna.Dorsey@ucsf.edu.
authors: Morna J
authors: MJ
authors: Dorsey
authors: Viet
authors: V
authors: Ho
authors: Mohsen
authors: M
authors: Mabudian
authors: Pere
authors: P
authors: Soler-Palacín
authors: Nerea
authors: N
authors: Domínguez-Pinilla
authors: Radha
authors: R
authors: Rishi
authors: Rahul
authors: R
authors: Rishi
authors: Duane
authors: D
authors: Wong
authors: Mikhail
authors: M
authors: Rojavin
authors: Alphonse
authors: A
authors: Hubsch
authors: Melvin
authors: M
authors: Berger
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D005060:Europe; D005260:Female; D006261:Headache / Q000209:etiology; D006760:Hospitalization; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry; D007153:Immunologic Deficiency Syndromes / Q000150:complications / Q000276:immunology / Q000628:therapy*; D007223:Infant; D007239:Infections / Q000209:etiology / Q000276:immunology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010818:Practice Patterns, Physicians'; D011392:Proline / Q000737:chemistry; D055550:Protein Stability; D012189:Retrospective Studies; D014481:United States; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D016756:Immunoglobulins, Intravenous; D011392:Proline