2016, Number 3
<< Back Next >>
Rev Cubana Hematol Inmunol Hemoter 2016; 32 (3)
Treatment with subcutaneous immunoglobulin G in patients with primary immunodeficiencies: preliminary results of cuban multicenter study
Macías-Abraham C, Sánchez SM, Insua AC, García NMC, Hernández FG, Arce HA, Merlín LJC, Martínez TR
Language: Spanish
References: 35
Page: 364-374
PDF size: 92.54 Kb.
ABSTRACT
Introduction: Previous studies have shown that infusion of subcutaneous (SC)
Immunoglobulin G (IgG) shows similar efficacy to intravenous IgG (IV) to prevent
infections in IgG deficiency of primary immunodeficiencies (PID) patients and this
treatment is safe and well tolerated.
Objective: To evaluate the safety and effectiveness of treatment with SC IgG in a
group of PID patients demonstrated deficient IgG, IgG pretreated with EV.
Methods: This is the first multicenter study of SC (Gammanorm, Octhapharma)
versus Intravenous (Intacglobín, national production) replacement therapy in PID
patients in Cuba, 6 patients were included; 3 children and 3 adults, from different
institutions in the country. SCIgG dose was similar to the previous month's overall
dose of IgG IV, 4 doses divided, with a range of 108mg/ kg (range 100-200)
administered weekly for 36 weeks.
Results: Patients who were not receiving treatment IgG IV with serum IgG levels
greatly diminished reached normal values according to age range. In the patients who
had treatment IgG IV in the week before the study, serum IgG levels were increased
or superior to 7g/L. All the patients decreased the frequency and severity of
infections, the infection rate of 1.7 infections / subject / year during the
administration of IV IgG decreased to 0.5 during the infusion period of SC IgG
infections and responded very well to treatment. All patients maintained the
administration of SCIgG at home with a good answer.
Conclusions: The SCIgG replacement therapy in PID patients is well tolerated and
effective therapeutic alternative for patients with PID.
REFERENCES
Stiehm ER, Ochs HD, Winkelstein JA. Immunologic disorders: General considerations. Filadelfia: WB Saunders; 2004. p. 289-35.
Notarangelo LD, Fisher A,Geha MD. Primary immunodeficiencies: 2009 update. J Allergy ClinImmunol. 2009; 124:1161-78.
Notarangelo LD. Primaryimmunodeficiencies. J Clin Immunol. 2010;125(suppl 2):S182-94.
Chapel H. Classification of primary immunodeficiency diseases by the International Union of Immunological Societies (IUIS). Expert Committee on Primary Immunodeficiency 2011. Clin Exp Immunol 2012;168(1):58-9.doi: 10.1111/j.1365- 2249.2012.04561.x.
Kobrynski L. Subcutaneous immunoglobulin therapy: a new option for patients with primary immunodeficiency diseases. Biologics. 2012;6:277-87. doi: 10.2147/BTT.S25188
Berger M, Cupps TR, Fauci AS. Immunoglobulin replacement therapy by slow subcutaneous infusions. Ann Intern Med.1980;93:55-6.
Berger M. Subcutaneous Administration of IgG. Immunol Allergy Clin N Am. 2008;28:779-802.
Orange JS, Grossman WJ, Navickis RJ, Wilkes MM. Impact of trough IgG on pneumonia incidence in primary immunodeficiency: A meta-analysis of clinical studies. ClinImmunol. 2010;137(1):21-30.
Bezrodnik L, Gómez A, Regairaz L, Díaz D, Seminario G, Moreira I, et al. Subcutaneous IgG Replacement Therapy by Push in 32 Patients with Primary Immunodeficiency Diseases in Argentine. Clin Exp Pharmacol.2014(4):148. doi: 10.4172/2161-1459.1000148
BholeMailin V,Burton J, Chapel H. Self-infusion Programmes for Immunoglobulin Replacement at Home: Feasibility, Safety and Efficacy. Immunol Allergy Clin N Am. 2008;28:821-32.
Maroto Hernando M, Soler Palacin P, NaldaM, Oliveras Arenas M, Español Boren T, Figueras Nadal C. Gammaglobulina subctutánea en inmunodeficiencia común variable. Primera experiencia en España. An Pediatr (Barc).2009;70(2):111-9. doi: 10.1016/j.anpedi.2008.11.011.
Ochs HD, Gupta S, Kiessling P, Nicolay U, Berger M. Safety and efficacy ofselfadministered subcutaneous immunoglobulin in patients with primary immunodeficiency diseases. J Clin Immunol. 2006;26:265-73.
Chapel HM, Spickett GP, Ericson D, et al. The comparison of the efficacy and safety of intravenous versus subcutaneous immunoglobulin replacement therapy. J Clin Immunol. 2000;20:94-100.
Borte M, Bernatowska E, Ochs HD, Roifman CM. Efficacy and safety of homebased subcutaneous immunoglobulin replacement therapy in pediatric patients with primary immunodeficiencies. Clin Exper Immunol. 2011;1-8.
Gardulf A, Hansen S, Johansson K. Rapid subcutaneous IgG replacement therapy in children and adults-20 years of clinical experience. VII Meeting of the Spanish group for Primary Immunodeficiencies. Inmunología 2005;24(4):392-5.
Gardulf A, Nicolay U, Asensio O, Bernatowska E, Böck A, Carvalho BC, et al. Rapid Subcutaneous IgG Replacement Therapy is Effective and Safe in Children and Adults with Primary Immunodeficiencies-A Prospective, Multi-National Study. J ClinImmunol. 2006.26: 177-85.
Shapiro R. Subcutaneous immunoglobulin therapy by rapid push is preferred to infusion by pump: a retrospective analysis. J Clin Immunol. 2010;30:301-7.
Conley MF, Notarangelo LD, Etzioni A. Diagnostic criteria for primary immunodeficiencies. Representing PAGID (Pan American Group for Immunodeficiency) and ESID (European Society for Immuno deficiencies). Clin Immunol. 1999;93:190-7.
Orange J. Clinical Update in Immunoglobulin Therapy for Primary Immunodeficiency Diseases. Clinical Focus on Primary Immunodeficiencies. 2011;14:1-9.
Gaspar J, Gerritsen B, Jones A. Immunoglobulin replacement treatment by rapid subcutaneous infusion. Arch Dis Child. 1998;79:48-51.
Björkander J, Chapel H, Spickett G. Comparison of the efficacy and safety of immunoglobulin given subcutaneously versus intravenous immunoglobulin in the prevention of infection in patients with primary antibody deficiency syndromes. MolImmunol. 1998;35:11-2.
Berger M. Subcutaneous immunoglobulin replacement in primary immunodeficiencies. Clin Immunol. 2004;112:1-7.
Shah SN, Todoric K, Tarrant TK. Improved outcomes on subcutaneous IgG in patients with humoral immunodeficiency and co-morbid bowel disease. Clin Case Rep Rev.2015;1(7):151-52 doi: 10.15761/CCRR.1000149.
Bonagura VR.Dose and outcomes in primary immunodeficiency disorders. Clin Exp Immunol. 2014 Dec;178 Suppl 1:7-9. doi: 10.1111/cei.12492.
Gardulf A, Nicolay U,Math D, Asensio O, Bernatowska E, Bock A, et al. Children and adults with primary antibody deficiencies gain quality of life by subcutaneous IgG self-infusions at home. J Allergy Clin Immunol. 2004;114:936-42.
Nicolay U, Kiessling P, BergerM,GuptaS, Yel L, RoifmanCM, et al. Health related quality of life and treatment satisfaction in north american patients with primary immunodeficiency diseases receiving subcutaneous IgG self-infusions at home. J Clin Immunol. 2006;26:65-72.
Varni JW, Seid M, Rode CA. The PedsQL: measurement model for the pediatric quality of life inventory. Med Care. 1999 Feb;37(2):126-39.
Vilagut G, Ferrer M, Rajmil L, Rebollo P, Permanyer-Miralda G, Quintana JM, et al. El cuestionario de salud SF-36 español: una década de experiencia y nuevos desarrollos. GacSanit.2005;19(2):135-50.
Koterba AP, Stein MR. Initiation of immunoglobulin therapy by subcutaneous administration in immunodeficiency patients naive to replacement therapy. Allergy Asthma Clin Immunol. 2014;10:63-7.
Hagan JB, Fasano MB, Spector S, Wasserman RL, Melamed I, Rojavin MA, et al. Efficacy and safety of a new 20% immunoglobulin preparation for subcutaneous administration, IgPro20, in patients with primary immunodeficiency. J ClinImmunol. 2010;30(5):734-45. doi:10.1007/s10875-010-9423-4.
Fadeyi M, Pharm D, Tran T. Calculating the Dose of Subcutaneous Immunoglobulin for Primary Immunodeficiency Disease in Patients Switched From Intravenous to Subcutaneous Immunoglobulin Without the Use of a Dose-Adjustment Coefficient.PT 2013;38(12):768-70.
Jolles S, Bernatowska E, de Gracia J, Borte M, Cristea V, Peter HH, et al. Efficacy and safety of Hizentra((R)) in patients with primary immunodeficiency after a doseequivalent switch from intravenous or subcutaneous replacement therapy. ClinImmunol. 2011;141(1):90-102. doi:10.1016/j.clim.2011.06.002.
Jiang F, Torgerson TR, Ayars AG. Health-related quality of life in patients with primary immunodeficiency disease. Allergy Asthma Clin Immunol. 2015 Sep 29;11:27. doi: 10.1186/s13223-015-0092-y.
Haddad E, Berger M, Wang EC, Jones CA, Bexon M, Baggish JS. Higher doses of subcutaneous IgG reduce resource utilization in patients with primary immunodeficiency. J Clin Immunol.2012;32(2):281-9. doi:10.1007/s10875-011- 9631-6.
Bezrodnik L, Gómez Raccio A, Belardinelli G, Regairaz L, Díaz Ballve D, Seminario G, et al. Comparative Study of Subcutaneous Versus Intravenous IgG Replacement Therapy in Pediatric Patients with Primary Immunodeficiency Diseases: A Multicenter Study in Argentina. J Clin Immunol. 2013;33(7):1216-22. doi: 10.007/s10875-013- 9916-z.