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 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://ichgcp.net/clinical-trials-registry/NCT03716700.

Keywords: Ig20Gly; Immunoglobulin replacement therapy; Primary immunodeficiency diseases; Real-world; Secondary immunodeficiency diseases; Subcutaneous immunoglobulin.

Conflict of interest statement

PKK has received personal fees from Novartis, Aralez Pharmaceuticals, Pediapharm, AstraZeneca, Shire, CSL Behring, Kaleo, Merck, GlaxoSmithKline, Mylan, ALK, Sanofi, and Stallergenes and grants from AstraZeneca, CSL Behring, Genentech, and Shire. JCo has received research funding not related to this study from CSL Behring, Grifols, and Octapharma. She has received speaker fees from Octapharma, GSK, EMD Serono, and Alexion Pharma. She has received educational funding from Takeda. AK has received personal fees from Novartis, Aralez Pharmaceuticals, Pediapharm, Takeda, CSL Behring, and Mylan. He has received grants from Genentech and Takeda. HK has been on speakers’ bureaus and/or advisory boards for ALK, AstraZeneca, Aralez, CSL Behring, Kaleo, Merck, Mylan, Novartis, Pediapharm, Sanofi, and Shire. He has received research funding from AstraZeneca, Shire, and Novartis. GL has participated in research with Takeda. She has received speaker fees from Takeda, CSL Behring, Novartis, AstraZeneca, and Mylan. She has participated in advisory boards for Takeda, CSL Behring, Octapharma, Sanofi, GSK, and AstraZeneca; and was sponsored to attend international meetings with Shire/Takeda, AstraZeneca, and GSK. JKL has received speaker fees from ALK, Paladin, Novartis, AstraZeneca, Sanofi, Astellas, GSK, Takeda, Merck, CSL Behring, Omega, Sanofi Genzyme, Mylan, Meda, Pediapharm, Aralez, Paladin, Pfizer, and Stallergenes. He has received grants and research funding from Immunodeficiency Canada, AstraZeneca, ALK, Aralez, Paladin, Novartis, Sanofi, CSL Behring, GSK, Pediapharm, Stallergenes, Roche-Genentech, PPD, Shire, Takeda, Trudell Medical, Bausch and Lomb, and Regeneron. He has participated in advisory boards for GSK, Novartis, AstraZeneca, Merck, CSL Behring, Teva, Sanofi Genzyme, Mylan, ALK, Meda, Pediapharm, Paladin, Regeneron, AbbVie, and Genentech. He has been a consultant for GSK, AstraZeneca, Novartis, Regeneron, and Sanofi Genzyme. JCh and MP are employees of Takeda Development Center Americas, Inc. and are Takeda shareholders. AG is an employee of Takeda Pharmaceuticals International AG and a Takeda shareholder.

© 2022. The Author(s).

Figures

Fig. 1

Study design and assessments. a Time from Ig20Gly initiation. Cohort 1 transitioned to Ig20Gly at study enrollment; Cohort 2 transitioned to Ig20Gly approximately 6 months prior to enrollment; and Cohort 3 transitioned to Ig20Gly approximately 12 months prior to enrollment. Ig20Gly, Immune Globulin Subcutaneous (Human) 20% solution; IgG, immunoglobulin G; SCIG, subcutaneous immunoglobulin

Fig. 2

Site of infusion (over the observation period)

Fig. 3

Patient satisfaction with aspects of Ig20Gly administration (assessed using the Treatment Preference Questionnaire). n = 101 patients. a n = 100 patients. Ig20Gly, Immune Globulin Subcutaneous (Human) 20% solution