Infections in secondary immunodeficiency patients treated with Privigen^® or Hizentra^®: a retrospective US administrative claims study in patients with hematological malignancies

References

• Chinen J, Shearer WT. Secondary immunodeficiencies, including HIV infection. J Allergy Clin Immunol. 2010;125(2 Suppl. 2):S195–S203.
   PubMed Web of Science ®Google Scholar
• Jolles S, Chapel H, Litzman J. When to initiate immunoglobulin replacement therapy (IGRT) in antibody deficiency: a practical approach. Clin Exp Immunol. 2017;188(3):333–341.
   PubMed Web of Science ®Google Scholar
• Hamblin A, Hamblin T. The immunodeficiency of chronic lymphocytic leukaemia. Br Med Bull. 2008;87:49–62.
   PubMed Web of Science ®Google Scholar
• Seppänen M. Immunoglobulin G treatment of secondary immunodeficiencies in the era of novel therapies. Clin Exp Immunol. 2014;178:10–13.
   PubMed Web of Science ®Google Scholar
• Casulo C, Maragulia J, Zelenetz AD. Incidence of hypogammaglobulinemia in patients receiving rituximab and the use of intravenous immunoglobulin for recurrent infections. Clin Lymphoma Myeloma Leuk. 2013;13(2):106–111.
   PubMed Web of Science ®Google Scholar
• Tete SM, Bijl M, Sahota SS, et al. Immune defects in the risk of infection and response to vaccination in monoclonal gammopathy of undetermined significance and multiple myeloma. Front Immunol. 2014;5:257.
   PubMed Web of Science ®Google Scholar
• IHME. Global burden of disease results tool; 2019. Available from: http://ghdx.healthdata.org/gbd-results-too
   Google Scholar
• Morrison VA. Infectious complications of chronic lymphocytic leukaemia: pathogenesis, spectrum of infection, preventive approaches. Best Pract Res Clin Haematol. 2010;23(1):145–153.
   PubMed Web of Science ®Google Scholar
• Dhalla F, Misbah SA. Secondary antibody deficiencies. Curr Opin Allergy Clin Immunol. 2015;15(6):505–513.
   PubMed Web of Science ®Google Scholar
• Oscier D, Dearden C, Eren E, et al. Guidelines on the diagnosis, investigation and management of chronic lymphocytic leukaemia. Br J Haematol. 2012;159:541.
   PubMed Web of Science ®Google Scholar
• Blimark C, Holmberg E, Mellqvist U-H, et al. Multiple myeloma and infections: a population-based study on 9253 multiple myeloma patients. Haematologica. 2015;100(1):107–113.
   PubMed Web of Science ®Google Scholar
• Ostrow S, Diggs CH, Sutherland J, et al. Causes of death in patients with non‐Hodgkin's lymphoma. Cancer. 1981;48(3):779–782.
   PubMed Web of Science ®Google Scholar
• Anderson D, Ali K, Blanchette V, et al. Guidelines on the use of intravenous immune globulin for hematologic conditions. Transfus Med Rev. 2007;21(2 Suppl. 1):S9–S56.
   PubMed Web of Science ®Google Scholar
• Čolović N, Bogdanović A, Čemerikić-Martinović V, et al. Prognostic significance of serum immunoglobulins in B-chronic lymphocytic leukemia. Arch Oncol. 2001;9:79–82.
   Google Scholar
• Snowden JA, Ahmedzai SH, Ashcroft J, et al. Guidelines for supportive care in multiple myeloma 2011. Br J Haematol. 2011;154(1):76–103.
   PubMed Web of Science ®Google Scholar
• Department of Health. Clinical guidelines for immunoglobulin use. 2nd ed. London: Department of Health; 2011.
   Google Scholar
• National Blood Authority. Criteria for the clinical use of intravenous immunoglobulin in Australia. 2nd ed. Australia: Canberra; 2012.
   Google Scholar
• European Medicines Agency. Guideline on core SmPC for human normal immunoglobulin for intravenous administration (IVIg). London; 2018.
   Google Scholar
• Perez EE, Orange JS, Bonilla F, et al. Update on the use of immunoglobulin in human disease: a review of evidence. J Allergy Clin Immunol. 2017;139(3S):S1–S46.
   PubMed Web of Science ®Google Scholar
• Jolles S, Michallet M, Agostini C, et al. Treating secondary antibody deficiency in patients with haematological malignancy: European Expert Consensus. Eur J Haematol. 2021;106(4):439–449.
   PubMed Web of Science ®Google Scholar
• Legendre P, Chahwan D, Marjanovic Z, et al. Utilization of intravenous or subcutaneous immunoglobulins in secondary immune deficiency (ULTIMATE): a retrospective multicenter study. Clin Immunol. 2020; 215:108419.
   PubMed Web of Science ®Google Scholar
• Breslow NE, Day NE. Statistical methods in cancer research. Volume I – the analysis of case-control studies. Lyon: International Agency for Research on Cancer; 1980;5–338.
   Google Scholar
• Vittinghoff E, Glidden DV, Shiboski SC, et al. Regression methods in biostatistics: linear, logistic, survival, and repeated measures models. New York: Springer; 2012.
   Google Scholar
• Langholz B, Goldstein L. Conditional logistic analysis of case-control studies with complex sampling. Biostatistics. 2001;2(1):63–84.
   PubMedGoogle Scholar
• Cameron AC. Regression analysis of count data. Cambridge: Cambridge University Press; 1998.
   Google Scholar
• Jones AM. Models for count data. London: Applied Health Economics; 2013.
   Google Scholar
• Vacca A, Melaccio A, Sportelli A, et al. Subcutaneous immunoglobulins in patients with multiple myeloma and secondary hypogammaglobulinemia: a randomized trial. Clin Immunol. 2018;191:110–115.
   PubMed Web of Science ®Google Scholar
• Na IK, Buckland M, Agostini C, et al. Current clinical practice and challenges in the management of secondary immunodeficiency in hematological malignancies. Eur J Haematol. 2019;102(6):447–456.
   PubMed Web of Science ®Google Scholar
• Patel SY, Carbone J, Jolles S. The expanding field of secondary antibody deficiency: causes, diagnosis, and management. Front Immunol. 2019;10:33.
   PubMed Web of Science ®Google Scholar
• Nucci M, Anaissie E. Infections in patients with multiple myeloma in the era of high-dose therapy and novel agents. Clin Infect Dis. 2009;49(8):1211–1225.
   PubMed Web of Science ®Google Scholar
• Orange JS, Grossman WJ, Navickis RJ, et al. Impact of trough IgG on pneumonia incidence in primary immunodeficiency: a meta-analysis of clinical studies. Clin Immunol. 2010;137(1):21–30.
   PubMed Web of Science ®Google Scholar
• 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(2):172–181.
   PubMed Web of Science ®Google Scholar
• Chapel H, Lee M, Hargreaves R, et al. Randomised trial of intravenous immunoglobulin as prophylaxis against infection in plateau-phase multiple myeloma. Lancet. 1994;343(8905):1059–1063.
   PubMed Web of Science ®Google Scholar
• Boughton B, Jackson N, Lim S, et al. Randomized trial of intravenous immunoglobulin prophylaxis for patients with chronic lymphocytic leukaemia and secondary hypogammaglobulinaemia. Clin Lab Haematol. 2008;17(1):75–80.
   Google Scholar
• Reiser M, Borte M, Huscher D, et al. Management of patients with malignancies and secondary immunodeficiencies treated with immunoglobulins in clinical practice: long-term data of the SIGNS study. Eur J Haematol. 2017;99(2):169–177.
   PubMed Web of Science ®Google Scholar
• Benbrahim O, Viallard J-F, Choquet S, et al. The use of octagam and gammanorm in immunodeficiency associated with hematological malignancies: a prospective study from 21 French Hematology Departments. Hematology. 2019;24(1):173–182.
   PubMed Web of Science ®Google Scholar
• Plath M, Slawik H, Reiser M, et al. Privigen® in secondary immunodeficiencies – interim analysis of a multicenter non-interventional study in Germany. Annual Meeting of the German, Austrian and Swiss Societies for Hematology and Medical Oncology; Basel; 2015.
   Google Scholar
• Spadaro G, Pecoraro A, De Renzo A, et al. Intravenous versus subcutaneous immunoglobulin replacement in secondary hypogammaglobulinemia. Clin Immunol. 2016;166–167:103–104.
   PubMed Web of Science ®Google Scholar
• Viallard J, Agape P, Barlogis V, et al. Treatment with Hizentra in patients with primary and secondary immunodeficiencies: a real-life, non-interventional trial. BMC Immunol. 2016;17(1):34.
   PubMed Web of Science ®Google Scholar
• Reiser M, Otremba B, Plath M, et al. Correlation between efficacy of the intravenous immunoglobulin preparation IgPro10 and IgG plasma concentrations achieved in secondary immunodeficiencies (SID) – results from a multicenter observation study. Poster ESID6-0592, Presented at ESID 2016. Barcelona, Spain; 2016.
   Google Scholar
• Ehlers H-U, Otremba BJ, Plath M, et al. Correlation between immunoglobulin dose and incidence of severe and serious infections in secondary immunodeficiencies. J Clin Oncol. 2017;35(15 Suppl.):e21686.
   Web of Science ®Google Scholar
• Mikhael J, Ismaila N, Cheung MC, et al. Treatment of multiple myeloma: ASCO and CCO joint clinical practice guideline. J Clin Oncol. 2019;37(14):1228–1263.
   PubMed Web of Science ®Google Scholar
• van de Donk NW, Moreau P, Plesner T, et al. Clinical efficacy and management of monoclonal antibodies targeting CD38 and SLAMF7 in multiple myeloma. Blood. 2016;127(6):681–695.
   PubMed Web of Science ®Google Scholar
• Wierda WG, Kipps TJ, Mayer J, et al. Ofatumumab as single-agent CD20 immunotherapy in fludarabine-refractory chronic lymphocytic leukemia. J Clin Oncol. 2010;28(10):1749–1755.
   PubMed Web of Science ®Google Scholar