Transitioning subcutaneous immunoglobulin 20% therapies in patients with primary and secondary immunodeficiencies: Canadian real-world study
Abstract Background Real-world data on transitioning to Immune Globulin Subcutaneous (Human) 20% solution (Ig20Gly) are limited. This study aimed to assess infusion parameters and experience of patients with primary (PID) or secondary immunodeficiencies (SID) transitioning to Ig20Gly in clinical pra...
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| Format: | Article |
| Language: | English |
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BMC
2022-08-01
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| Series: | Allergy, Asthma & Clinical Immunology |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13223-022-00709-8 |
| _version_ | 1797795631222226944 |
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| author | Paul K. Keith Juthaporn Cowan Amin Kanani Harold Kim Gina Lacuesta Jason K. Lee Jie Chen Michelle Park André Gladiator |
| author_facet | Paul K. Keith Juthaporn Cowan Amin Kanani Harold Kim Gina Lacuesta Jason K. Lee Jie Chen Michelle Park André Gladiator |
| author_sort | Paul K. Keith |
| collection | DOAJ |
| description | Abstract Background Real-world data on transitioning to Immune Globulin Subcutaneous (Human) 20% solution (Ig20Gly) are limited. This study aimed to assess infusion parameters and experience of patients with primary (PID) or secondary immunodeficiencies (SID) transitioning to Ig20Gly in clinical practice in Canada. Methods Patients with PID or SID who received subcutaneous immunoglobulin (SCIG) for ≥ 3 months before transitioning to Ig20Gly were eligible for this multicenter (n = 6), phase 4, non-interventional, prospective, single-arm study. Ig20Gly infusion parameters, dosing, and adverse events were collected from patient medical records at Ig20Gly initiation and 3, 6, and 12 months post-initiation. Patient satisfaction and quality of life were assessed 12 months post-initiation using validated questionnaires. Results The study included 125 patients (PID, n = 60; SID, n = 64; PID + SID, n = 1). Median volume per infusion was 30.0 ml at initiation, and 40.0 ml at 6 and 12 months post-initiation. Most patients administered Ig20Gly weekly and used two infusion sites (primarily abdomen). At each time point, median infusion duration was ≤ 1 h. At 12 months, 61% of infusions were administered via a pump and 39% manually. Headache and infusion-site reactions were the most reported adverse events of interest. Patients expressed overall satisfaction with Ig20Gly at 12 months post-initiation, with all respondents indicating they would like to continue Ig20Gly. Conclusions This study provides a detailed description of Ig20Gly infusion parameters, tolerability, and quality of life in clinical practice among patients with PID or SID switching to Ig20Gly from another SCIG and confirms the feasibility of infusing Ig20Gly via pump or manual administration. Trial registration NCT03716700, Registered 31 August 2018, https://clinicaltrials.gov/ct2/show/NCT03716700 |
| first_indexed | 2024-03-13T03:20:55Z |
| format | Article |
| id | doaj.art-2ab03b8bf43043f5bba67a9574e29253 |
| institution | Directory Open Access Journal |
| issn | 1710-1492 |
| language | English |
| last_indexed | 2024-03-13T03:20:55Z |
| publishDate | 2022-08-01 |
| publisher | BMC |
| record_format | Article |
| series | Allergy, Asthma & Clinical Immunology |
| spelling | doaj.art-2ab03b8bf43043f5bba67a9574e292532023-06-25T11:20:04ZengBMCAllergy, Asthma & Clinical Immunology1710-14922022-08-0118111110.1186/s13223-022-00709-8Transitioning subcutaneous immunoglobulin 20% therapies in patients with primary and secondary immunodeficiencies: Canadian real-world studyPaul K. Keith0Juthaporn Cowan1Amin Kanani2Harold Kim3Gina Lacuesta4Jason K. Lee5Jie Chen6Michelle Park7André Gladiator8Division of Clinical Immunology and Allergy, Department of Medicine, McMaster UniversityDivision of Infectious Diseases, Department of Medicine; Department of Biochemistry, Microbiology, and Immunology; Centre for Infection, Immunity and Inflammation, University of Ottawa, The Ottawa Hospital Research InstituteDivision of Allergy and Clinical Immunology, Department of Medicine, St. Paul’s Hospital, University of British ColumbiaDivision of Clinical Immunology and Allergy, Department of Medicine, McMaster UniversityDepartment of Medicine, Dalhousie UniversityChair of Toronto Allergists and Evidence Based Medical EducatorTakeda Development Center Americas, Inc.Takeda Development Center Americas, Inc.Glattpark-Opfikon , Takeda Pharmaceuticals International AGAbstract Background Real-world data on transitioning to Immune Globulin Subcutaneous (Human) 20% solution (Ig20Gly) are limited. This study aimed to assess infusion parameters and experience of patients with primary (PID) or secondary immunodeficiencies (SID) transitioning to Ig20Gly in clinical practice in Canada. Methods Patients with PID or SID who received subcutaneous immunoglobulin (SCIG) for ≥ 3 months before transitioning to Ig20Gly were eligible for this multicenter (n = 6), phase 4, non-interventional, prospective, single-arm study. Ig20Gly infusion parameters, dosing, and adverse events were collected from patient medical records at Ig20Gly initiation and 3, 6, and 12 months post-initiation. Patient satisfaction and quality of life were assessed 12 months post-initiation using validated questionnaires. Results The study included 125 patients (PID, n = 60; SID, n = 64; PID + SID, n = 1). Median volume per infusion was 30.0 ml at initiation, and 40.0 ml at 6 and 12 months post-initiation. Most patients administered Ig20Gly weekly and used two infusion sites (primarily abdomen). At each time point, median infusion duration was ≤ 1 h. At 12 months, 61% of infusions were administered via a pump and 39% manually. Headache and infusion-site reactions were the most reported adverse events of interest. Patients expressed overall satisfaction with Ig20Gly at 12 months post-initiation, with all respondents indicating they would like to continue Ig20Gly. Conclusions This study provides a detailed description of Ig20Gly infusion parameters, tolerability, and quality of life in clinical practice among patients with PID or SID switching to Ig20Gly from another SCIG and confirms the feasibility of infusing Ig20Gly via pump or manual administration. Trial registration NCT03716700, Registered 31 August 2018, https://clinicaltrials.gov/ct2/show/NCT03716700https://doi.org/10.1186/s13223-022-00709-8Ig20GlyImmunoglobulin replacement therapyPrimary immunodeficiency diseasesSecondary immunodeficiency diseasesReal-worldSubcutaneous immunoglobulin |
| spellingShingle | Paul K. Keith Juthaporn Cowan Amin Kanani Harold Kim Gina Lacuesta Jason K. Lee Jie Chen Michelle Park André Gladiator Transitioning subcutaneous immunoglobulin 20% therapies in patients with primary and secondary immunodeficiencies: Canadian real-world study Allergy, Asthma & Clinical Immunology Ig20Gly Immunoglobulin replacement therapy Primary immunodeficiency diseases Secondary immunodeficiency diseases Real-world Subcutaneous immunoglobulin |
| title | Transitioning subcutaneous immunoglobulin 20% therapies in patients with primary and secondary immunodeficiencies: Canadian real-world study |
| title_full | Transitioning subcutaneous immunoglobulin 20% therapies in patients with primary and secondary immunodeficiencies: Canadian real-world study |
| title_fullStr | Transitioning subcutaneous immunoglobulin 20% therapies in patients with primary and secondary immunodeficiencies: Canadian real-world study |
| title_full_unstemmed | Transitioning subcutaneous immunoglobulin 20% therapies in patients with primary and secondary immunodeficiencies: Canadian real-world study |
| title_short | Transitioning subcutaneous immunoglobulin 20% therapies in patients with primary and secondary immunodeficiencies: Canadian real-world study |
| title_sort | transitioning subcutaneous immunoglobulin 20 therapies in patients with primary and secondary immunodeficiencies canadian real world study |
| topic | Ig20Gly Immunoglobulin replacement therapy Primary immunodeficiency diseases Secondary immunodeficiency diseases Real-world Subcutaneous immunoglobulin |
| url | https://doi.org/10.1186/s13223-022-00709-8 |
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