Bioavailability of IgG administered by the subcutaneous route

Journal of Clinical Immunology

Volumn 33, Issue 5, 2013, Pages 984-990

  Berger, Melvin ^a   Jolles, Stephen ^b   Orange, Jordan S ^c   Sleasman, John W ^d  

^a CSL Behring LLC   (United States)

^b UNIVERSITY HOSPITAL OF WALES   (United Kingdom)

^c BAYLOR COLLEGE OF MEDICINE   (United States)

^d UNIVERSITY OF SOUTH FLORIDA   (United States)

Author keywords

bioavailability; IgG dose adjustments; intravenous IgG (IVIG); Subcutaneous IgG (SCIG)

Indexed keywords

GAMMANORM; HUMAN IMMUNOGLOBULIN; IMMUNOGLOBULIN; IMMUNOGLOBULIN G; UNCLASSIFIED DRUG;

AREA UNDER THE CURVE; ARTICLE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DOSAGE FORM COMPARISON; DRUG DOSE INCREASE; DRUG SUBSTITUTION; HUMAN; LICENSING; META ANALYSIS (TOPIC); PRIORITY JOURNAL; STEADY STATE;

ADOLESCENT; ADULT; AGED; AREA UNDER CURVE; BIOLOGICAL AVAILABILITY; CHILD; HUMANS; IMMUNOGLOBULIN G; INJECTIONS, SUBCUTANEOUS; MIDDLE AGED; YOUNG ADULT;

EID: 84879200850     PISSN: 02719142     EISSN: 15732592     Source Type: Journal    
DOI: 10.1007/s10875-013-9876-3     Document Type: Article

References (25)

1. Aebersold P. Regulatory requirements for subcutaneous Ig for PID. In: Intravenous immunoglobulins in the 21st century: progress and challenges in efficacy, safety and paths to licensure. FDA workshop. 2005. http://www.fda.gov/downloads/BiologicsBloodVaccines/NewsEvents/ WorkshopsMeetingsConferences/TranscriptsMinutes/UCM054437.pdf. Accessed 8 Nov 2012.
2. Wang W, Wang EQ, Balthasar JP. Monoclonal antibody pharmacokinetics and pharmacodynamics. Clin Pharmacol Ther. 2008;84:548-58.
3. Berger M, Rojavin M, Kiessling P, Zenker O. Pharmacokinetics of subcutaneous immunoglobulin and their use in dosing of replacement therapy in patients with primary immunodeficiencies. Clin Immunol. 2011;139:133-41.
4. Wasserman RL, Melamed I, Nelson RP, et al. Pharmacokinetics of subcutaneous IgPro20 in patients with primary immunodeficiency. Clin Pharmacokinet. 2011;50:405-14.
5. Wasserman RL, Irani AM, Tracy J, et al. Pharmacokinetics and safety of subcutaneous immune globulin (human), 10 % caprylate/chromatography purified in patients with primary immunodeficiency disease. Clin Exp Immunol. 2010;161:518-26.
6. Wasserman RL, Melamed I, Kobrynski L, et al. Efficacy, safety, and pharmacokinetics of a 10 % liquid immune globulin preparation (GAMMAGARD LIQUID, 10 %) administered subcutaneously in subjects with primary immunodeficiency disease. J Clin Immunol. 2011;31:323-31.
7. Ochs HD, Gupta S, Kiessling P, Nicolay U, Berger M. Safety and efficacy of self-administered subcutaneous immunoglobulin in patients with primary immunodeficiency diseases. J Clin Immunol. 2006;26:265-73.
8. Hagan JB, Fasano MB, Spector S, et al. Efficacy and safety of a new 20 % immunoglobulin preparation for subcutaneous administration, IgPro20, in patients with primary immunodeficiency. J Clin Immunol. 2010;30:734-45.
9. Lucas M, Hugh-Jones K, Welby A, et al. Immunomodulatory therapy to achieve maximum efficacy: doses, monitoring, compliance, and self-infusion at home. J Clin Immunol. 2010;30 Suppl 1:S84-9.
10. Bonilla FA. Pharmacokinetics of immunoglobulin administered via intravenous or subcutaneous routes. Immunol Allergy Clin North Am. 2008;28:803-19. ix.
11. Hoffmann F, Grimbacher B, Thiel J, Peter HH, Belohradsky BH. Home-based subcutaneous immunoglobulin G replacement therapy under real-life conditions in children and adults with antibody deficiency. Eur J Med Res. 2010;15:238-45.
12. Gardulf A, Nicolay U, Asensio O, et al. Rapid subcutaneous IgG replacement therapy is effective and safe in children and adults with primary immunodeficiencies-a prospective, multi-national study. J Clin Immunol. 2006;26:177-85.
13. Orange JS, Grossman WJ, Navickis RJ, Wilkes MM. Impact of trough IgG on pneumonia incidence in primary immunodeficiency: a meta-analysis of clinical studies. Clin Immunol. 2010;137:21-30.
14. Orange JS, Belohradsky BH, Berger M, et al. Evaluation of correlation between dose and clinical outcomes in subcutaneous immunoglobulin replacement therapy. Clin Exp Immunol. 2012;169:172-81.
15. Jolles S, Bernatowska E, de Gracia J, et al. Efficacy and safety of Hizentra® in patients with primary immunodeficiency after a dose-equivalent switch from intravenous or subcutaneous replacement therapy. Clin Immunol. 2011;141:90-102.
16. Nguyen D, Dorsey T, Alberdi C, Duff J, Sleasman JW. Subcutaneous Hizentra® (20%) is better tolerated and shares similar efficacy compared to subcutaneous Vivaglobin® (16%). J Allergy Clin Immunol. 2012;129:AB15.
17. von Behring E. Serum therapy in therapeutics and medical science. Nobel lecture. 1901. http://nobelprize.org/nobel-prizes/medicine/laureates/1901/ behring-lecture.html. Accessed 27 Nov 2012.
18. Emu B, Luca D, Offutt C, et al. Safety, pharmacokinetics, and biologic activity of pateclizumab, a novel monoclonal antibody targeting lymphotoxin alpha: results of a phase I randomized, placebo-controlled trial. Arthritis Res Ther. 2012;14:R6.
19. Zhou H. Clinical pharmacokinetics of etanercept: a fully humanized soluble recombinant tumor necrosis factor receptor fusion protein. J Clin Pharmacol. 2005;45:490-7.
20. Abolhassani H, Sadaghiani MS, Aghamohammadi A, Ochs HD, Rezaei N. Home-based subcutaneous immunoglobulin versus hospital-based intravenous immunoglobulin in treatment of primary antibody deficiencies: systematic review and meta analysis. J Clin Immunol. 2012.
21. Desai SH, Chouksey A, Poll J, Berger M. A pilot study of equal doses of 10 % IGIV given intravenously or subcutaneously. J Allergy Clin Immunol. 2009;124:854-6.
22. Thepot S, Malphettes M, Gardeur A, et al. Immunoglobulin dosage and switch from intravenous to subcutaneous immunoglobulin replacement therapy in patients with primary hypogammaglobulinemia: decreasing dosage does not alter serum IgG levels. J Clin Immunol. 2010;30:602-6.
23. Berger M. Incidence of infection is inversely related to steady-state (trough) serum IgG level in studies of subcutaneous IgG in PIDD. J Clin Immunol. 2011;31:924-6.
24. Bonagura VR, Marchlewski R, Cox A, Rosenthal DW. Biologic IgG level in primary immunodeficiency disease: the IgG level that protects against recurrent infection. J Allergy Clin Immunol. 2008;122:210-2.
25. Lucas M, Lee M, Lortan J, et al. Infection outcomes in patients with common variable immunodeficiency disorders: relationship to immunoglobulin therapy over 22 years. J Allergy Clin Immunol. 2010;125:1354-60.