Clinical Outcomes of subcutaneous immunotherapy in Patients with primary immunodeficiency

Andres Flores; L. Vargas; L. Torres

doi:10.5281/zenodo.22812500

Authors

Andres Flores Division of Allergy and Immunotherapy, Oder Academy of Clinical Immunology Author https://orcid.org/6456-3261-4857-1280
L. Vargas Department of Clinical Immunology, Jordan Institute for Advanced Allergy and Immunotherapy Author https://orcid.org/4927-4676-4694-5233
L. Torres Department of Clinical Allergy and Immunotherapy, Narmada Research Center for Allergy and Immunotherapy Author https://orcid.org/9505-0840-2897-1318

DOI:

https://doi.org/10.5281/zenodo.22812500

Keywords:

Subcutaneous immunoglobulin, Primary immunodeficiency, Immunoglobulin replacement therapy, Trough IgG

Abstract

Patients with primary immunodeficiency (PID) depend on lifelong immunoglobulin replacement to prevent infection, and subcutaneous immunoglobulin (SCIG) has become a leading alternative to intravenous therapy. This review synthesizes clinical outcomes evidence for subcutaneous immunotherapy in PID, covering infection control, trough IgG attainment, adverse events, adherence, and quality of life. Across randomized, cohort, and pivotal-trial evidence, SCIG achieved infection control equivalent to intravenous therapy at dose-adjusted equivalence, with more stable trough IgG, fewer systemic adverse events, and consistently improved quality of life after transition to home-based self-infusion. Individualized trough targets further reduced pneumonia incidence beyond fixed thresholds. Subcutaneous immunotherapy is supported as a preferred first-line replacement strategy for most patients with primary immunodeficiency.

References

Fried AJ, Bonilla FA. (2009) Pathogenesis, diagnosis, and management of primary antibody deficiencies and infections. Clinical Microbiology Reviews, 22(3): 396-414. DOI: 10.1128/CMR.00001-09

Bonilla FA, Khan DA, Ballas ZK, et al. (2015) Practice parameter for the diagnosis and management of primary immunodeficiency. Journal of Allergy and Clinical Immunology, 136(5): 1186-1205. DOI: 10.1016/j.jaci.2015.04.049

Gardulf A, Andersen V, Bjorkander J, et al. (1995) Subcutaneous immunoglobulin replacement in patients with primary antibody deficiencies: safety and costs. Lancet, 345(8946): 365-369. DOI: 10.1016/S0140-6736(95)90346-1

Berger M. (2004) Subcutaneous immunoglobulin replacement in primary immunodeficiencies. Clinical Immunology, 112(1): 1-7. DOI: 10.1016/j.clim.2004.02.010

Berger M. (2008) Subcutaneous administration of IgG. Immunology and Allergy Clinics of North America, 28(4): 779-802.

Misbah SA, Chapel HM. (2009) Subcutaneous immunoglobulin: opportunities and outlook. Clinical and Experimental Immunology, 158(Suppl 1): 51-54. DOI: 10.1111/j.1365-2249.2009.04027.x

Chapel HM, Spickett GP, Ericson D, Engl W, Eibl MM, Bjorkander J. (2000) The comparison of the efficacy and safety of intravenous versus subcutaneous immunoglobulin replacement therapy. Journal of Clinical Immunology, 20(2): 94-100. DOI: 10.1023/A:1006678312925

Gardulf A, Nicolay U, Asensio O, et al. (2006) Rapid subcutaneous IgG replacement therapy is effective and safe in children and adults with primary immunodeficiencies--a prospective, multi-national study. Journal of Clinical Immunology, 26(2): 177-185. DOI: 10.1007/s10875-006-9002-x

Berger M, Pinciaro PJ; Hizentra Study Group. (2010) Safety, efficacy, and pharmacokinetics of Hizentra, a new 20% immunoglobulin preparation for subcutaneous administration. Journal of Clinical Immunology, 30(3): 321-329. DOI: 10.1007/s10875-010-9387-4

Wasserman RL, Melamed I, Stein MR, et al. (2012) Recombinant human hyaluronidase-facilitated subcutaneous infusion of human immunoglobulins for primary immunodeficiency. Journal of Allergy and Clinical Immunology, 130(4): 951-957. DOI: 10.1016/j.jaci.2012.06.021

Suez D, Stein M, Gupta S, et al. (2019) Efficacy, safety, and pharmacokinetics of a novel human immune globulin subcutaneous, 20%: a phase 2/3 study in Europe and the United States. Journal of Clinical Immunology, 39(7): 633-642. DOI: 10.1007/s10875-019-00659-8

Borte M, Pac M, Serban M, et al. (2011) Efficacy and safety of Hizentra in children and adolescents with primary immunodeficiencies. Journal of Clinical Immunology, 31(6): 952-961. DOI: 10.1007/s10875-011-9603-x

Orange JS, Grossman WJ, Navickis RJ, Wilkes MM. (2010) Impact of trough IgG on pneumonia incidence in primary immunodeficiency: A meta-analysis of clinical studies. Clinical Immunology, 137(1): 21-30. DOI: 10.1016/j.clim.2010.06.012

Abolhassani H, Sadaghiani MS, Aghamohammadi A, Ochs HD, Rezaei N. (2012) Home-based subcutaneous immunoglobulin versus hospital-based intravenous immunoglobulin in treatment of primary antibody deficiencies: systematic review and meta-analysis. Journal of Clinical Immunology, 32(6): 1180-1192. DOI: 10.1007/s10875-012-9720-1

Perez EE, Orange JS, Bonilla F, et al. (2017) Update on the use of immunoglobulin in human disease: A review of evidence. Journal of Allergy and Clinical Immunology, 139(3S): S1-S46. DOI: 10.1016/j.jaci.2016.09.023

Quinti I, Soresina A, Guerra A, et al. (2011) Effectiveness of immunoglobulin replacement therapy on clinical outcome in patients with primary antibody deficiencies: results from a multicenter prospective cohort study. Journal of Clinical Immunology, 31(3): 315-322. DOI: 10.1007/s10875-011-9511-0

Bonagura VR, Marchlewski R, Cox A, Rosenthal DW. (2008) Biologic IgG level in primary immunodeficiency disease: the IgG level that protects against recurrent infection. Journal of Allergy and Clinical Immunology, 122(1): 210-212. DOI: 10.1016/j.jaci.2008.04.044

Jolles S, Bernatowska E, de Gracia J, et al. (2011) Efficacy and safety of Hizentra in patients with primary immunodeficiency after a dose-equivalent switch from intravenous or subcutaneous replacement therapy. Clinical Immunology, 141(1): 90-102. DOI: 10.1016/j.clim.2011.06.002

Wasserman RL, Melamed I, Kobayashi RH, et al. (2016) Long-term tolerability, safety, and efficacy of recombinant human hyaluronidase-facilitated subcutaneous infusion of human immunoglobulin for primary immunodeficiency. Journal of Clinical Immunology, 36(6): 571-582. DOI: 10.1007/s10875-016-0298-x

Ballow M. (2008) Immunoglobulin therapy: methods of delivery. Journal of Allergy and Clinical Immunology, 122(3): 430-436. DOI: 10.1016/j.jaci.2008.06.032

Shapiro RS. (2010) Subcutaneous immunoglobulin therapy given by subcutaneous rapid push vs infusion pump: a retrospective analysis. Journal of Clinical Immunology, 30(2): 301-307. DOI: 10.1007/s10875-009-9352-2

Gardulf A, Nicolay U, Math D, et al. (2004) Children and adults with primary antibody deficiencies gain quality of life by subcutaneous IgG self-infusions at home. Journal of Allergy and Clinical Immunology, 114(4): 936-942. DOI: 10.1016/j.jaci.2004.06.053

Nicolay U, Kiessling P, Berger M, et al. (2006) Health-related quality of life and treatment satisfaction in North American patients with primary immunedeficiency diseases receiving subcutaneous IgG self-infusions at home. Journal of Clinical Immunology, 26(1): 65-72. DOI: 10.1007/s10875-006-8905-x

Resnick ES, Moshier EL, Godbold JH, Cunningham-Rundles C. (2012) Morbidity and mortality in common variable immune deficiency over 4 decades. Blood, 119(7): 1650-1657. DOI: 10.1182/blood-2011-09-377945

Lucas M, Lee M, Lortan J, Lopez-Granados E, Misbah S, Chapel H. (2010) Infection outcomes in patients with common variable immunodeficiency disorders: relationship to immunoglobulin therapy over 22 years. Journal of Allergy and Clinical Immunology, 125(6): 1354-1360. DOI: 10.1016/j.jaci.2010.02.040

Busse PJ, Razvi S, Cunningham-Rundles C. (2002) Efficacy of intravenous immunoglobulin in the prevention of pneumonia in patients with common variable immunodeficiency. Journal of Allergy and Clinical Immunology, 109(6): 1001-1004. DOI: 10.1067/mai.2002.124999

Wood P, Stanworth S, Burton J, et al. (2007) Recognition, clinical diagnosis and management of patients with primary antibody deficiencies: a systematic review. Clinical and Experimental Immunology, 149(3): 410-423. DOI: 10.1111/j.1365-2249.2007.03432.x

Orange JS, Hossny EM, Weiler CR, et al. (2006) Use of intravenous immunoglobulin in human disease: a review of evidence by members of the Primary Immunodeficiency Committee of the American Academy of Allergy, Asthma and Immunology. Journal of Allergy and Clinical Immunology, 117(4 Suppl): S525-S553. DOI: 10.1016/j.jaci.2006.01.015

Cunningham-Rundles C. (2010) How I treat common variable immune deficiency. Blood, 116(1): 7-15. DOI: 10.1182/blood-2010-01-254417

Wasserman RL. (2014) Overview of recombinant human hyaluronidase facilitated subcutaneous immunoglobulin therapy. Immunotherapy, 6(5): 553-567. DOI: 10.2217/imt.14.34

Berger M. (2008) Principles of and advances in immunoglobulin replacement therapy for primary immunodeficiency. Immunology and Allergy Clinics of North America, 28(2): 413-437.

Berger M, Murphy E, Riley P, Bergman GE; Vivaglobin Investigator Team. (2010) Improved quality of life, immunoglobulin G levels, and infection rates in patients with primary immunodeficiency diseases during self-treatment with subcutaneous immunoglobulin G. Southern Medical Journal, 103(9): 856-863. DOI: 10.1097/SMJ.0b013e3181eba6ea

Clinical Outcomes of subcutaneous immunotherapy in Patients with primary immunodeficiency

Authors

DOI:

Keywords:

Abstract

References

Downloads

Published

Issue

Section

License