Efficacy and safety of a new 20% immunoglobulin preparation for subcutaneous administration, IgPro20, in patients with primary immunodeficiency.
Subcutaneous human IgG (SCIG) therapy in primary immunodeficiency (PID) offers sustained IgG levels throughout the dosing cycle and fewer adverse events (AEs) compared to intravenous immunoglobulin (IVIG). A phase I study showed good local tolerability of IgPro20, a new 20% liquid SCIG stabilized with L-proline. A prospective, open-label, multicenter, single-arm, phase III study evaluated the efficacy and safety of IgPro20 in patients with PID over 15 months. Forty-nine patients (5-72 years) previously treated with IVIG received weekly subcutaneous infusions of IgPro20. The mean serum IgG level was 12.5 g/L. No serious bacterial infections were reported. There were 96 nonserious infections (rate 2.76/patient per year). The rate of days missed from work/school was 2.06/patient per year, and the rate of hospitalization was 0.2/patient per year. Ninety-nine percent of AEs were mild or moderate. No serious, IgPro20-related AEs were reported. IgPro20 effectively protected patients with PID against infections and maintained serum IgG levels without causing unexpected AEs.
Hagan
John B
JB
Division of Allergic Diseases, Mayo Clinic, 200 First St. S.W., Rochester, MN 55905, USA. hagan.john@mayo.edu
Fasano
Mary B
MB
Spector
Sheldon
S
Wasserman
Richard L
RL
Melamed
Isaac
I
Rojavin
Mikhail A
MA
Zenker
Othmar
O
Orange
Jordan S
JS
D000293:Adolescent; D000328:Adult; D000361:Agammaglobulinemia / Q000097:blood / Q000188:drug therapy / Q000276:immunology / Q000503:physiopathology; D000368:Aged; D001424:Bacterial Infections / Q000517:prevention & control; D002648:Child; D017074:Common Variable Immunodeficiency / Q000097:blood / Q000188:drug therapy* / Q000276:immunology / Q000503:physiopathology; D005260:Female; D040181:Genetic Diseases, X-Linked / Q000097:blood / Q000188:drug therapy / Q000276:immunology / Q000503:physiopathology; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D016756:Immunoglobulins, Intravenous / Q000627:therapeutic use; D007155:Immunologic Factors / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D055550:Protein Stability
D007074:Immunoglobulin G; D016756:Immunoglobulins, Intravenous; D007155:Immunologic Factors
Lancet. 1991 Jul 20;338(8760):162-6
1712881
Clin Immunol. 1999 Jul;92(1):34-48
10413651
Ann Intern Med. 2001 Aug 7;135(3):165-74
11487483
N Engl J Med. 2000 Nov 2;343(18):1313-24
11058677
J Pediatr. 1999 May;134(5):589-96
10228295
Pediatrics. 1996 Dec;98(6 Pt 1):1127-31
8951264
J Clin Immunol. 2006 May;26(3):265-73
16783465
J Clin Immunol. 2006 Mar;26(2):177-85
16758340
J Allergy Clin Immunol. 1998 Jun;101(6 Pt 1):848-9
9648714
Curr Opin Allergy Clin Immunol. 2006 Dec;6(6):434-42
17088648
J Clin Immunol. 2006 Jul;26(4):400-5
16783533
Immunol Allergy Clin North Am. 2008 Nov;28(4):779-802, viii
18940574
Lancet. 2008 Aug 9;372(9637):489-502
18692715
Clin Exp Immunol. 2003 Apr;132(1):9-15
12653830
Pediatr Infect Dis J. 1997 Jul;16(7):696-707
9239774
J Neurol. 2009 Mar;256(3):339-42
19253011
Int Immunopharmacol. 2004 Jun;4(6):745-53
15135316
J Clin Immunol. 2006 Jul;26(4):388-95
16705486
J Clin Immunol. 1983 Jul;3(3):285-6
6885970
Int Immunopharmacol. 2003 Sep;3(9):1325-33
12890430
Clin Immunol. 2002 Sep;104(3):237-41
12217333
J Allergy Clin Immunol. 2002 Jun;109(6):1001-4
12063531
J Allergy Clin Immunol. 2003 Oct;112(4):797-9
14564366
Biologicals. 2008 Jul;36(4):239-47
18337119
J Clin Immunol. 2009 Jan;29(1):137-44
18814020
Ann Allergy Asthma Immunol. 2007 Dec;99(6):567-70
18219840
J Clin Immunol. 2000 Mar;20(2):94-100
10821460
Lancet. 1995 Feb 11;345(8946):365-9
7845120
Immunol Allergy Clin North Am. 2008 May;28(2):413-37, x
18424340
Thromb Haemost. 2004 Apr;91(4):771-8
15045139
Clin Exp Immunol. 1999 Oct;118 Suppl 1:1-28
10540200