Delivery of subcutaneous immunoglobulin by rapid “push” infusion for primary immunodeficiency patients in Manitoba: a retrospective review

Allergy, Asthma & Clinical Immunology - Tập 16 - Trang 1-9 - 2020
Graham Walter1, Chrystyna Kalicinsky1,2, Richard Warrington1,2, Marianne Miguel3, Jeannette Reyes2, Tamar S. Rubin3,4
1Department of Internal Medicine, University of Manitoba, Winnipeg, Canada
2Section of Allergy and Clinical Immunology, University of Manitoba, Winnipeg, Canada
3Section of Pediatric Allergy and Clinical Immunology, University of Manitoba, Winnipeg, Canada
4Department of Pediatrics and Child Health, University of Manitoba, Winnipeg, Canada

Tóm tắt

Both intravenous and subcutaneous human immune globin G (IgG) replacement (IVIG and SCIG, respectively) reduce severe infection and increase serum IgG levels in primary immune deficiency disorder (PIDD) patients who require replacement. SCIG can be administered either with the aid of an infusion pump, or by patients or caregivers themselves, using butterfly needles and a syringe (“SCIG push”). SCIG offers advantages over IVIG, including higher steady state IgG levels, improved patient quality of life indicators, and decreased cost to the healthcare system, and for these reasons, SCIG has been increasingly used in Manitoba starting in 2007. We sought to determine the effectiveness of SCIG push in our local adult PIDD population. We conducted a retrospective chart review of all adult patients enrolled in the SCIG push program in Manitoba, Canada from its inception in November 2007 through September 2018. We included patients who were naïve to IgG replacement prior to SCIG, and those who had received IVIG immediately prior. We collected data regarding serum IgG levels, antibiotic prescriptions, hospital admissions, and adverse events during a pre-defined period prior to and following SCIG initiation. Statistical significance was determined via two-tailed t-test. 62 patients met inclusion criteria, of whom 35 were on IVIG prior and 27 were IgG replacement naïve. SCIG push resulted in an increase in serum IgG levels in those naïve to IgG replacement, as well as in those who received IVIG prior. SCIG push also resulted in a statistically significant reduction in number of antibiotic prescriptions filled in the naïve subgroup, and no significant change in antibiotics filled in the IVIG prior group. 8/62 PIDD patients (12.9%) left the SCIG program during our review period for varying reasons, including side-effects. In a real-life setting, in the Manitoba adult PIDD population, SCIG push is an effective method of preventing severe infections, with most patients preferring to continue this therapy once initiated.

Tài liệu tham khảo

Chapel HM, Spickett GP, Ericson D, Engl W, Eibl MM, Bjorkander J. The comparison of the efficacy and safety of intravenous versus subcutaneous immunoglobulin replacement therapy. J Clin Immunol. 2000;20(2):94–100. Gaspar J, Gerritsen B, Jones A. Immunoglobulin replacement treatment by rapid subcutaneous infusion. Arch Dis Child. 1998;79(1):48–51. 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 Clin Immunol. 2006;26(2):177–85. Shehata N, Palda VA, Meyer RM, Blydt-Hansen TD, Campbell P, Cardella C, et al. The use of immunoglobulin therapy for patients undergoing solid organ transplantation: an evidence-based practice guideline. Transfus Med Rev. 2010;24(SUPPL. 1):S7–27. https://doi.org/10.1016/j.tmrv.2009.09.010. Hooper JA. The history and evolution of immunoglobulin products and their clinical indications. LymphoSign J. 2015;2(4):181–94. Radinsky S, Bonagura VR. Subcutaneous immunoglobulin infusion as an alternative to intravenous immunoglobulin [5]. J Allergy Clin Immunol. 2003;112(3):630–3. Haddad E, Berger M, Wang ECY, 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. Koterba AP, Stein MR. Initiation of immunoglobulin therapy by subcutaneous administration in immunodeficiency patients naive to replacement therapy. Allergy Asthma Clin Immunol. 2014;10(1):1–4. Bonilla FA. Pharmacokinetics of immunoglobulin administered via intravenous or subcutaneous routes. Immunol Allergy Clin N Am. 2008;28(4):803–19. Gardulf A, Nicolay U, Math D, Asensio O, Bernatowska E, Böck 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(4):936–42. Nicolay U, Kiessling P, Berger M, Gupta S, Yel L, Roifman CM, 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(1):65–72. Vultaggio A, Azzari C, Milito C, Finocchi A, Toppino C, Spadaro G, et al. Subcutaneous immunoglobulin replacement therapy in patients with primary immunodeficiency in routine clinical practice: The VISPO Prospective Multicenter Study. Clin Drug Investig. 2015;35(3):179–85. Strickland S (Nova SPBCP, Keseji T, Paolone E, Daine M, Wile G. IVIG and SCIG Utilization in the Atlantic Provinces in FY 2016/17. 2017. http://www.cdha.nshealth.ca/system/files/sites/documents/20180104-ivig-scig-utilization-atlantic-provinces-fy-2016-17.pdf. Martin A, Lavoie L, Goetghebeur M, Schellenberg R. Economic benefits of subcutaneous rapid push versus intravenous immunoglobulin infusion therapy in adult patients with primary immune deficiency. Transfus Med. 2013;23(1):55–60. Shapiro RS. Subcutaneous immunoglobulin: rapid push vs. infusion pump in pediatrics. Pediatr Allergy Immunol. 2013;24(1):49–53. Shapiro R. Subcutaneous immunoglobulin therapy by rapid push is preferred to infusion by pump: a retrospective analysis. J Clin Immunol. 2010;30(2):301–7. Shapiro R. Subcutaneous immunoglobulin (16 or 20%) therapy in obese patients with primary immunodeficiency: a retrospective analysis of administration by infusion pump or subcutaneous rapid push. Clin Exp Immunol. 2013;173(2):365–71. Shapiro RS. Subcutaneous immunoglobulin therapy given by subcutaneous rapid push vs infusion pump: a retrospective analysis. Ann Allergy Asthma Immunol. 2013;111(1):51–5. Milota T, Bloomfield M, Kralickova P, Jilek D, Novak V, Litzman J, et al. Czech Hizentra noninterventional study with rapid push: efficacy, safety, tolerability, and convenience of therapy with 20% subcutaneous immunoglobulin. Clin Ther. 2019;41(11):2231–8. Misbah S, Sturzenegger MH, Borte M, Shapiro RS, Wasserman RL, Berger M, et al. Subcutaneous immunoglobulin: opportunities and outlook. Clin Exp Immunol. 2009;158(SUPPL. 1):51–9. Center for Biologics Evaluation and Research. Vivaglobin. U.S. Food and Drug Administration. https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/vivaglobin. Accessed Nov 9 2019. Hizentra. Hizentra Prescribing Information. https://www.hizentra.com/prescribing-information. Cuvitru. https://www.cuvitru.com/. Accessed Nov 9 2019. Bonilla FA, Khan DA, Ballas ZK, Chinen J, Frank MM, Hsu JT, et al. Practice parameter for the diagnosis and management of primary immunodeficiency. J Allergy Clin Immunol. 2014;136(5):1186–205. https://doi.org/10.1016/j.jaci.2015.04.049. Ochs HD, Gupta S, Kiessling P, Nicolay U, Berger M. Safety and efficacy of self-administered subcutaneous immunoglobulin in patients with primary immunodeficiency diseases. J Clin Immunol. 2006;26(3):265–73. Song J, Zhang L, Li Y, Quan S, Liang Y, Zeng L, et al. 20% subcutaneous immunoglobulin for patients with primary immunodeficiency diseases: a systematic review. Int Immunopharmacol. 2015;25(2):457–64. Rn AG, Hammarström L, Gustafson R, Nyström T, Smith CIE, Gustafson R, et al. Subcutaneous immunoglobulin replacement in patients with primary antibody deficiencies: safety and costs. Lancet. 1995;345(8946):365–9. Högy B, Keinecke HO, Borte M. Pharmacoeconomic evaluation of immunoglobulin treatment in patients with antibody deficiencies from the perspective of the German statutory health insurance. Eur J Health Econ. 2005;50:24–9. https://doi.org/10.1007/s10198-004-0250-5. Liu Z, Albon E, Hyde C. Department of Public Health and Epidemiology West Midlands Health Technology Assessment Group. 2006;(54). Haddad L, Perrinet M, Parent D, Leroy-Cotteau A, Toguyeni E, Condette-Wojtasik G, et al. Economic evaluation of at home subcutaneous and intravenous immunoglobulin substitution. Rev Med Intern. 2006;27(12):924–6. Beauté J, Levy P, Millet V, Debré M, Dudoit Y, Le Mignot L, et al. Economic evaluation of immunoglobulin replacement in patients with primary antibody deficiencies. Clin Exp Immunol. 2010;160(2):240–5. Ducruet T, Levasseur MC, Des Roches A, Kafal A, Dicaire R, Haddad E. Pharmacoeconomic advantages of subcutaneous versus intravenous immunoglobulin treatment in a Canadian pediatric center. J Allergy Clin Immunol. 2013;131(2):585–7. Statistics Canada 2016 Census of Population. Census Profile, 2016 Census—Manitoba and Canada. Statistics Canada Catalogue. 2017. p. no. 98-316-X2016001. https://www12.statcan.gc.ca/census-recensement/2016/dp-pd/prof/index.cfm?Lang=E. Accessed Feb 14 2020. Health M. Population report—part 2 population of Manitoba. 2017. https://www.gov.mb.ca/health/population/2017/index.html. Accessed Feb 14 2020. Kearns S, Kristofek L, Bolgar W, Seidu L, Kile S. Clinical profile, dosing, and quality-of-life outcomes in primary immune deficiency patients treated at home with immunoglobulin G: data from the IDEaL Patient Registry. J Manag Care Spec Pharm. 2017;23(4):400–6. Perez EE, Orange JS, Bonilla F, Chinen J, Chinn IK, Dorsey M, et al. Update on the use of immunoglobulin in human disease: a review of evidence. J Allergy Clin Immunol. 2017;139(3):S1–46. https://doi.org/10.1016/j.jaci.2016.09.023. Canessa C, Iacopelli J, Pecoraro A, Spadaro G, Matucci A, Milito C, et al. Shift from intravenous or 16% subcutaneous replacement therapy to 20% subcutaneous immunoglobulin in patients with primary antibody deficiencies. Int J Immunopathol Pharmacol. 2017;30(1):73–82. Gelfand EW, Ochs HD, Shearer WT. Controversies in IgG replacement therapy in patients with antibody deficiency diseases. J Allergy Clin Immunol. 2013;131(4):1001–5. https://doi.org/10.1016/j.jaci.2013.02.028. Buckley RH. Immunoglobulin G subclass deficiency: fact or fancy? Curr Allergy Asthma Rep. 2002;2(5):356–60. Abdou NI, Greenwell CA, Mehta R, Narra M, Hester JD, Halsey JF. Efficacy of intravenous gammaglobulin for immunoglobulin g subclass and/or antibody deficiency in adults. Int Arch Allergy Immunol. 2009;149(3):267–74. Abrahamian F, Agrawal S, Gupta S. Immunological and clinical profile of adult patients with selective immunoglobulin subclass deficiency: response to intravenous immunoglobulin therapy. Clin Exp Immunol. 2010;159(3):344–50. Olinder-Nielsen AM, Granert C, Forsberg P, Friman V, Vietorisz A, Björkander J. Immunoglobulin prophylaxis in 350 adults with IgG subclass deficiency and recurrent respiratory tract infections: a long-term follow-up. Scand J Infect Dis. 2007;39(1):44–50. Joud H, Nguyen AL, Constantine G, Kutac C, Syed MN, Orange JS, et al. Prophylactic antibiotics versus immunoglobulin replacement in specific antibody deficiency. J Clin Immunol. 2020;40(1):158–64. Espanol T, Prevot J, Drabwell J, Sondhi S, Olding L. Improving current immunoglobulin therapy for patients with primary immunodeficiency: quality of life and views on treatment. Patient Prefer Adherence. 2014;8:621–9. Pasquet M, Pellier I, Aladjidi N, Auvrignon A, Cherin P, Clerson P, et al. A cohort of french pediatric patients with primary immunodeficiencies: are patient preferences regarding replacement immunotherapy fulfilled in real-life conditions? Patient Prefer Adherence. 2017;11:1171–80. Mallick R, Jolles S, Kanegane H, Agbor-Tarh D, Rojavin M. Treatment satisfaction with subcutaneous immunoglobulin replacement therapy in patients with primary immunodeficiency: a pooled analysis of six Hizentra® studies. J Clin Immunol. 2018;38(8):886–97. Jolles S, Rojavin MA, Lawo JP, Nelson R, Wasserman RL, Borte M, et al. Long-term efficacy and safety of Hizentra® in patients with primary immunodeficiency in Japan, Europe, and the United States: a review of 7 phase 3 trials. J Clin Immunol. 2018;38(8):864–75. Ponsford M, Carne E, Kingdon C, Joyce C, Price C, Williams C, et al. Facilitated subcutaneous immunoglobulin (fSCIg) therapy—practical considerations. Clin Exp Immunol. 2015;182(3):302–13.