“Experiences of the burden of treatment”—Patient reports of facilitated subcutaneous immunoglobulin treatment in adults with immunodeficiency

Petersson, Christina; Fust, Ramona; Hagstedt, Carina; Wågström, Per; Nilsdotter-Augustinsson, Åsa

doi:10.1111/jocn.14580

Cited by 13 publications

(12 citation statements)

References 23 publications

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“…Here we aimed to achieve a trough IgG level of >5.0 g/L ( 20 ) that optimally reduced infection rates in the particular patient and was preferably within the reference range of the local laboratory (i.e., 7.0–12.0 g/L). In assessing patient's needs, we also took into account their subjective overall well-being and symptoms related to wear-off effect and fatigue ( 21 ).…”

Section: Methodsmentioning

confidence: 99%

Facilitated Subcutaneous Immunoglobulin Replacement Therapy in Clinical Practice: A Two Center, Long-Term Retrospective Observation in Adults With Primary Immunodeficiencies

et al. 2020

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Facilitated subcutaneous immunoglobulin (fSCIG) replacement therapy is the latest method of IgG administration; however, real-life data are limited. We retrospectively analyzed the everyday experience of fSCIG administration, particularly, the method used to switch from intravenous immunoglobulin (IVIG) or subcutaneous immunoglobulin (SCIG) to fSCIG and the dosing modifications required. Of the 39 adult patients with primary immunodeficiency (PID) who received fSCIG, 34 remained on the therapy at the end of the study. The median observation time was 18 (range, 3–24) months. Two patients were IgG-treatment-naïve; 23 had previously received IVIG and 14 had received SCIG. In 25 cases, a non-ramp-up dosing mode was used to switch to fSCIG (including two half-monthly doses given biweekly in 14 cases, and full monthly doses given in 11 cases), a ramp-up mode was used in six cases; other methods were used in eight cases. The median IgG trough level at baseline was 7.9 g/L ( n = 38), 7.9 g/L ( n = 32) at Month 6, 9.0 g/L ( n = 30) at Month 12, 8.6 g/L ( n = 22) at Month 18, and 9.0 g/L ( n = 11) at Month 24. No serious bacterial infections or hospitalizations due to PID complications occurred. At the end of the study, 24 patients (71%) received fSCIG every 4 weeks, six (18%) received fSCIG every 3 weeks, and four (12%) received fSCIG biweekly. In conclusion, our study provides real-life evidence of clinical efficacy of personalized fSCIG treatment when switching from prior immunoglobulin replacement using various switching modes and dosing frequencies.

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Section: Methodsmentioning

confidence: 99%

Facilitated Subcutaneous Immunoglobulin Replacement Therapy in Clinical Practice: A Two Center, Long-Term Retrospective Observation in Adults With Primary Immunodeficiencies

et al. 2020

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“…However, these studies do not routinely investigate infusion parameters that are higher than those used conventionally, which may reduce the time needed for injection and the number of injection sites. The latter two characteristics reflect patients' preferences on SCIG and lead to a better health-related quality of life for patients with PID (16,17). A high, stable health-related quality of life is important both as a separate goal, especially in PID patients who need life-long IgG replacement therapy, and as a means of increasing patients' treatment compliance (31).…”

Section: Discussionmentioning

confidence: 99%

“…However, higher infusion volumes (60 mL per injection site) and flow rates (>60 mL/h per injection site) of 20% SCIG products have been demonstrated to be well tolerated in both pediatric and adult patients, as well as in obese adults (9)(10)(11)15). Higher infusion paremeters of SCIG products are important because, in general, patients on SCIG replacement therapy tend to prefer shorter infusion times (achievable with higher flow rates) and fewer needle sticks per infusion (requiring higher volume per individual injection site) (16,17).…”

Section: Introductionmentioning

confidence: 99%

Study design of a prospective, open-label study comparing increased infusion parameters of a 20% subcutaneous immunoglobulin (IgPro20) in patients with primary immunodeficiency

Rojavin

Hofmann

Praus

2019

Preprint

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Background: Immunoglobulin G (IgG) replacement therapy can be administered subcutaneously (SCIG) using an infusion pump or by manual push. Both methods have shown similar serum IgG trough levels for the same total weekly/monthly dose as well as safety and tolerability profiles. The currently approved infusion parameters for the SCIG Hizentra® (IgPro20, CSL Behring, King of Prussia, PA, USA) in primary immunodeficiency (PID) in the United States are volumes of ≤25 mL and flow rates of ≤25 mL/h per injection site. Previously, clinical studies and case reports had demonstrated use of higher infusion parameters than those approved, but safety and tolerability of these have not been systematically evaluated. In the absence of regulatory guidance, we have developed a novel prospective clinical study applying forced upward titration design to evaluate the safety and tolerability of high infusion parameters of IgPro20 in PID patients using pump-assisted and manual push techniques (NCT03033745). Results: A total of 45 patients were planned for inclusion. Primary endpoints were defined as the proportion of patients successfully infusing certain infusion parameters (responder rate). The study included three cohorts (n=15 planned per group): 1) Pump-assisted Volume Cohort with weekly infusions at volumes of 25, 40 and 50 mL per injection site; 2) Pump-assisted Flow Rate Cohort with weekly infusions at flow rates of 25, 50, 75 and 100 mL/h per injection site, and 3) Manual Push Flow Rate Cohort with 2 to 7 infusions at flow rates 30, 60 and 120 mL/h per injection site. Each infusion parameter level was tested for 4 weeks, after which those who successfully infused at the current level (responders) were switched to the next level. Responder rate, safety and tolerability were assessed. Study results will be available in early 2020. Conclusions: This study applied a novel and rigorous prospective evaluation of individual safety and tolerability levels of pump-assisted and manual push SCIG at higher infusion parameters than currently approved in the United States and demonstrated their safety and tolerability.

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“…Furthermore, the EU has approved parameters for manual push infusion of IgPro20 up to 2.0 mL/min/site if patients tolerate initial loading doses at a rate of 0.5 mL/min/site [15]. Higher infusion flow rates allow for shorter infusion times, which is preferred by patients and caregivers [8,[16][17][18]. Infusion flow rates > 25 mL/h for 20% SCIG products have been investigated for both methods of SCIG administration but have not been systematically evaluated and compared [19][20][21][22][23][24][25].…”

Section: Introductionmentioning

confidence: 99%

Safety and Tolerability of Manual Push Administration of Subcutaneous IgPro20 at High Infusion Rates in Patients with Primary Immunodeficiency: Findings from the Manual Push Administration Cohort of the HILO Study

et al. 2020

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Purpose To evaluate the safety and tolerability of IgPro20 manual push (also known as rapid push) infusions at flow rates of 0.5–2.0 mL/min. Methods Patients with primary immunodeficiency (PID) with previous experience administering IgPro20 (Hizentra®, CSL Behring, King of Prussia, PA, USA) were enrolled in the Hizentra® Label Optimization (HILO) study (NCT03033745) and assigned to Pump-assisted Volume Cohort, Pump-assisted Flow Rate Cohort, or Manual Push Flow Rate Cohort; this report describes the latter. Patients administered IgPro20 via manual push at 0.5, 1.0, and 2.0 mL/min/site for 4 weeks each. Responder rates (percentage of patients who completed a predefined minimum number of infusions), safety outcomes, and serum immunoglobulin G (IgG) trough levels were evaluated. Results Sixteen patients were treated; 2 patients (12.5%) discontinued at the 1.0-mL/min level (unrelated to treatment). Responder rates were 100%, 100%, and 87.5% at 0.5-, 1.0-, and 2.0-mL/min flow rates, respectively. Mean weekly infusion duration decreased from 103–108 to 23–28 min at the 0.5- and 2.0-mL/min flow rates, respectively. Rates of treatment-related treatment-emergent adverse events (TEAEs) per infusion were 0.023, 0.082, and 0.025 for the 0.5-, 1.0-, and 2.0-mL/min flow rates, respectively. Most TEAEs were mild local reactions and tolerability (infusions without severe local reactions/total infusions) was 100% across flow rate levels. Serum IgG levels (mean [SD]) were similar at study start (9.36 [2.53] g/L) and end (9.58 [2.12] g/L). Conclusions Subcutaneous IgPro20 manual push infusions at flow rates up to 2.0 mL/min were well tolerated and reduced infusion time in treatment-experienced patients with PID. Trial Registration NCT03033745

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“Experiences of the burden of treatment”—Patient reports of facilitated subcutaneous immunoglobulin treatment in adults with immunodeficiency

Cited by 13 publications

References 23 publications

Facilitated Subcutaneous Immunoglobulin Replacement Therapy in Clinical Practice: A Two Center, Long-Term Retrospective Observation in Adults With Primary Immunodeficiencies

Facilitated Subcutaneous Immunoglobulin Replacement Therapy in Clinical Practice: A Two Center, Long-Term Retrospective Observation in Adults With Primary Immunodeficiencies

Study design of a prospective, open-label study comparing increased infusion parameters of a 20% subcutaneous immunoglobulin (IgPro20) in patients with primary immunodeficiency

Safety and Tolerability of Manual Push Administration of Subcutaneous IgPro20 at High Infusion Rates in Patients with Primary Immunodeficiency: Findings from the Manual Push Administration Cohort of the HILO Study

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