Quantitative Evidence of Wear-Off Effect at the End of the Intravenous IgG (IVIG) Dosing Cycle in Primary Immunodeficiency

Journal of Clinical Immunology

Volumn 36, Issue 3, 2016, Pages 210-219

  Rojavin, Mikhail A ^a   Hubsch, Alphonse ^b   Lawo, John Philip ^c  

^a CSL Behring LLC   (United States)

^b CSL Behring AG   (Switzerland)

^c CSL BEHRING GMBH   (Germany)

Author keywords

end dose effect; Immunoglobulin replacement therapy; ivig; primary immunodeficiency; scig; wear off; well being

Indexed keywords

HUMAN IMMUNOGLOBULIN; IMMUNOGLOBULIN; IMMUNOGLOBULIN G;

ADULT; ADVERSE OUTCOME; ARTICLE; BRONCHIECTASIS; DOSE RESPONSE; DRUG EFFICACY; FATIGUE; FEMALE; HOSPITALIZATION; HUMAN; IMMUNE DEFICIENCY; IMMUNOTHERAPY; INFECTION RISK; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; RHINOPHARYNGITIS; SINUSITIS; TREATMENT OUTCOME; UPPER RESPIRATORY TRACT INFECTION; WELLBEING; ADOLESCENT; AGED; BLOOD; CHILD; CLINICAL TRIAL; DRUG RESISTANCE; IMMUNOLOGIC DEFICIENCY SYNDROMES; IMMUNOLOGY; MIDDLE AGED; PATHOPHYSIOLOGY; PRESCHOOL CHILD; QUALITY OF LIFE; SUBCUTANEOUS DRUG ADMINISTRATION;

ADOLESCENT; ADULT; AGED; CHILD; CHILD, PRESCHOOL; DRUG RESISTANCE; FEMALE; HUMANS; IMMUNOGLOBULIN G; IMMUNOGLOBULINS, INTRAVENOUS; IMMUNOLOGIC DEFICIENCY SYNDROMES; INFUSIONS, SUBCUTANEOUS; MALE; MIDDLE AGED; QUALITY OF LIFE; TREATMENT OUTCOME;

EID: 84961133226     PISSN: 02719142     EISSN: 15732592     Source Type: Journal    
DOI: 10.1007/s10875-016-0243-z     Document Type: Article

References (24)

1. Buckley RH. Primary immunodeficiency diseases due to defects in lymphocytes. N Engl J Med. 2000;343(18):1313–24.
2. Buckley RH, Schiff RI. The use of intravenous immune globulin in immunodeficiency diseases. N Engl J Med. 1991;325(2):110–7.
3. Wood P, Stanworth S, Burton J, Jones A, Peckham DG, Green T, et al. Recognition, clinical diagnosis and management of patients with primary antibody deficiencies: a systematic review. Clin Exp Immunol. 2007;149(3):410–23.
4. Stein MR, Nelson RP, Church JA, Wasserman RL, Borte M, Vermylen C, et al. Safety and efficacy of privigen, a novel 10 % liquid immunoglobulin preparation for intravenous use, in patients with primary immunodeficiencies. J Clin Immunol. 2009;29(1):137–44.
5. Wasserman RL, Melamed I, Nelson, RP Jr., Knutsen AP, Fasano MB, Stein MR, et al. Pharmacokinetics of subcutaneous IgPro20 in patients with primary immunodeficiency. Clin Pharmacokinet 2011;50(6):405–414
6. Alyanakian MA, Bernatowska E, Scherrmann JM, Aucouturier P, Poplavsky JL. Pharmacokinetics of total immunoglobulin G and immunoglobulin G subclasses in patients undergoing replacement therapy for primary immunodeficiency syndromes. Vox Sang. 2003;84(3):188–92.
7. Mankarious S, Lee M, Fischer S, Pyun KH, Ochs HD, Oxelius VA, et al. The half-lives of IgG subclasses and specific antibodies in patients with primary immunodeficiency who are receiving intravenously administered immunoglobulin. J Lab Clin Med. 1988;112(5):634–40.
8. Ochs HD, Pinciaro PJ. Octagam 5 %, an intravenous IgG product, is efficacious and well tolerated in subjects with primary immunodeficiency diseases. J Clin Immunol. 2004;24(3):309–14.
9. Berger M Subcutaneous administration of IgG. Immunol Allergy Clin N Am. 2008;28(4):779–802 viii.
10. Jolles S, Orange JS, Gardulf A, Stein MR, Shapiro R, Borte M, et al. Current treatment options with immunoglobulin G for the individualisation of care in patients with primary immunodeficiency disease. Clin Exp Immunol. 2015;179(2):146–60.
11. Wasserman RL. Overview of recombinant human hyaluronidase-facilitated subcutaneous infusion of IgG in primary immunodeficiencies. Immunotherapy. 2014;6(5):553–67.
12. Wasserman RL, Melamed I, Stein MR, Gupta S, Puck J, Engl W, et al. Recombinant human hyaluronidase-facilitated subcutaneous infusion of human immunoglobulins for primary immunodeficiency. J Allergy Clin Immunol. 2012;130(4):951–7 e11.
13. Immune Deficiency Foundation. Treatment experiences and preferences of patients with primary immune deficiency diseases: first national survey. Immune Deficiency Foundation, Towson, MD, USA. 2003 [online] Available at: http://primaryimmune.org/about-primary-immunodeficiency-diseases/idf-publications?aid=1266&pid=275&sa=1. Accessed 25 June 2015.
14. FDA Guidance for Industry. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. 2009 http://www.fda.gov/downloads/Drugs/Guidances/UCM193282.pdf. Accessed 18 June 2015.
15. Pan W Akaike's information criterion in generalized estimating equations. Biometrics. 2001;57(1):120–5.
16. Lessler J, Reich NG, Brookmeyer R, Perl TM, Nelson KE, Cummings DA. Incubation periods of acute respiratory viral infections: a systematic review. Lancet Infect Dis. 2009;9(5):291–300.
17. 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(1):210–2.
18. Gonzalez-Quintela A, Alende R, Gude F, Campos J, Rey J, Meijide LM, et al. Serum levels of immunoglobulins (IgG, IgA, IgM) in a general adult population and their relationship with alcohol consumption, smoking and common metabolic abnormalities. Clin Exp Immunol. 2008;151(1):42–50.
19. Rose ME, Lang DM. Evaluating and managing hypogammaglobulinemia. Cleve Clin J Med. 2006;73(2):133-7, 40, 43-4.
20. Ballow M, Notarangelo L, Grimbacher B, Cunningham-Rundles C, Stein M, Helbert M, et al. Immunodeficiencies. Clin Exp Immunol. 2009;158(Suppl 1):14–22.
21. Bertorini TE, Nance AM, Horner LH, Greene W, Gelfand MS, Jaster JH. Complications of intravenous gammaglobulin in neuromuscular and other diseases. Muscle Nerve. 1996;19(3):388–91.
22. Berger M Subcutaneous IgG in neurologic diseases. Immunotherapy. 2014;6(1):71–83.
23. Dacci P, Riva N, Scarlato M, Andresen I, Schmidt D, Comi G, et al. Subcutaneous immunoglobulin therapy for the treatment of multifocal motor neuropathy: a case report. Neurol Sci. 2010;31(6):829–31.
24. Jolles S, Sleasman JW. Subcutaneous immunoglobulin replacement therapy with hizentra, the first 20 % SCIG preparation: a practical approach. Adv Ther. 2011;28(7):521–33.