Subcutaneous Gammanorm® by pump or rapid push infusion: Impact of the device on quality of life in adult patients with primary immunodeficiencies

Klaus Warnatz; Stephen Jolles; Carlo Agostini; Fabrizio Vianello; Michael Borte; Claire Bethune; Sofia Grigoriadou; Alex Richter; Rashmi Jain; David M Lowe; Constance Katelaris; Cinzia Milito; Matthew C Cook

doi:10.1016/j.clim.2022.108938

Subcutaneous Gammanorm® by pump or rapid push infusion: Impact of the device on quality of life in adult patients with primary immunodeficiencies

Clin Immunol. 2022 Mar:236:108938. doi: 10.1016/j.clim.2022.108938. Epub 2022 Feb 1.

Authors

Affiliations

¹ Dept. of Rheumatology and Clinical Immunology, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany; Center for Chronic Immunodeficiency (CCI), Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany. Electronic address: klaus.warnatz@uniklinik-freiburg.de.
² Immunodeficiency Centre for Wales, University Hospital of Wales, Cardiff CF14 4XW, UK.
³ Hematology and Clinical Immunology Unit, Dept of Medicine, University of Padua, Veneto 35122, Italy.
⁴ Immuno Deficiency Center Leipzig (IDCL), Klinikum St. Georg, 04129 Leipzig, Germany.
⁵ Dept of Immunology and Allergy, University Hospital Plymouth NHS Trust, Plymouth PL6 8DH, UK.
⁶ Immunology Dept, Barts Health NHS Trust, The Royal London Hospital, London E1 2ES, UK.
⁷ Dept of Immunology, University Hospitals Birmingham NHS Foundation Trust, Birmingham B15 2TH, UK.
⁸ Dept of Clinical Immunology, The John Radcliffe Hospital, Oxford OX3 9DU, UK.
⁹ Dept of Immunology, Royal Free London and UCL Institute of Immunity and Transplantation, Royal Free Campus, London NW3 2QG, UK.
¹⁰ Dept of Medicine, Immunology and Allergy, Campbelltown Hospital, Campbelltown, NSW 2560, Australia.
¹¹ Dept of Molecular Medicine, "Sapienza" University of Rome, Lazio 00185, Italy.
¹² Dept of Immunology, Canberra Hospital and Centre for Personalised Immunology, John Curtin School of Medical Research, Australian National University, Canberra 2601, Australia.

PMID: 35121105
DOI: 10.1016/j.clim.2022.108938

Abstract

Many patients with immunodeficiencies require lifelong immunoglobulin replacement therapy (IgRT). In a multicenter, randomized, open-label, crossover, non-inferiority 3-month-trial, we compared the impact of the subcutaneous immunoglobulin Gammanorm® administered via pump or syringe (rapid push). Primary endpoint was the life quality index (LQI), secondary endpoints were QoL (SF36v2), satisfaction (TSQM-11), disease and treatment burden (PRISM), incidence of infections and adverse events (AE), treatment costs, and IgG levels. 28/30 patients completed the study. Most of the endpoints were comparable. Drug administrations with rapid push were more frequent, but reduced total time expenditure and some costs. Of the TSQM-11/LQI/SF36 components only "treatment interference with daily activities" was superior with pump and two QoL domains with rapid push. Both delivery devices showed favorable safety. Rapid push was preferred by 34.5% of patients. It proved to be an efficacious and cost-effective alternative to pumps adding to patient choice and increasing flexibility during long-term IgRT.

Keywords: Immunoglobulin replacement therapy; Primary immunodeficiency; Quality of life; Rapid push; Self-treatment.

Publication types

Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Humans
Immunization, Passive
Immunoglobulin G
Immunologic Deficiency Syndromes* / therapy
Infusions, Subcutaneous
Quality of Life*

Substances

Immunoglobulin G