Czech Hizentra Noninterventional Study With Rapid Push: Efficacy, Safety, Tolerability, and Convenience of Therapy With 20% Subcutaneous Immunoglobulin

Milota, Tomáš; Bloomfield, Markéta; Králíčková, Pavlína; Jílek, Dalibor; Novak, Vitezslav; Litzman, Jiří; Posová, Helena; Mrazova, Lucie; Poloniova, Jana; Průcha, M; Rozsíval, P; Rauschova, Vlasta; Philipp, Gunnar; Šedivá, Anna

doi:10.1016/j.clinthera.2019.08.013

Cited by 5 publications

(8 citation statements)

References 18 publications

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“…In fact, many contemporary studies suggest an added benefit of SCIG push overand-above pump SCIG-including a 2013 retrospective analysis by Shapiro of 173 patients encompassing 1140 hospital visits and approximately 72,000 infusions [18]. This study demonstrated consistently higher serum IgG levels and lower dosing times with push administration, as was previously described [15][16][17][18][19][20]. A multi-centre randomized controlled trial by Gardulf et al in 2006 demonstrated that of 60 PIDD patients followed longitudinally on SCIG push, only 8 (13.3%) prematurely discontinued therapy -1 was lost to follow-up due to travel out of the country, 1 suffered a suspected systemic reaction, 2 withdrew consent for unknown reasons, 1 suffered moderate localized reactions, 1 was unable to obtain satisfactory IgG levels, and 2 were removed due to protocol violation (history of anaphylaxis to IVIG and renal failure) [3].…”

Section: Introductionsupporting

confidence: 69%

“…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) [15,16]. The push method has been increasingly studied and validated in sites through the United States, Europe, and Canada [17][18][19][20]. In fact, many contemporary studies suggest an added benefit of SCIG push overand-above pump SCIG-including a 2013 retrospective analysis by Shapiro of 173 patients encompassing 1140 hospital visits and approximately 72,000 infusions [18].…”

Section: Introductionmentioning

confidence: 99%

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

Walter

Kalicinsky

Warrington

et al. 2020

Allergy Asthma Clin Immunol

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Background: 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. Methods: 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. Results: 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. Conclusions: 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.

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Section: Introductionsupporting

confidence: 69%

Section: Introductionmentioning

confidence: 99%

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

Walter

Kalicinsky

Warrington

et al. 2020

Allergy Asthma Clin Immunol

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“…To the best of our knowledge, this is the first prospective clinical study to evaluate subcutaneous IgPro20 manual push E, number of events; Inf, infusions; n, number of patients; TEAE, treatment-emergent adverse event a One patient with a documented medical history of depression had a severe, unrelated serious TEAE (suicide attempt) that led to study discontinuation after administering 5 of 8 planned infusions at the 1.0-mL/min rate infusion parameters, as most previous prospective studies of IgPro20 have used infusion pumps [4,27] or have not specifically assessed infusion flow rates [8]. The tolerability of IgPro20 manual push flow rates of 0.5 to 2.0 mL/min in specific patient subgroups (e.g., young [≤ 17 years] and underweight [BMI ≤ 18 kg/m 2 ] patients) is of particular interest, since age and weight may impact tolerability.…”

Section: Discussionmentioning

confidence: 99%

“…SCIG has conventionally been administered using infusion pumps, but more recently manual push (also known as rapid push) administration using a syringe and butterfly needle has emerged as an alternative method [6][7][8]. Infusions of 20% SCIG products generally deliver up to 25 mL per injection site, depending on patient age and weight.…”

Section: Introductionmentioning

confidence: 99%

“…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%

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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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Immunoglobulin Replacement Therapy Versus Antibiotic Prophylaxis as Treatment for Incomplete Primary Antibody Deficiency

et al. 2020

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Background Patients with an IgG subclass deficiency (IgSD) ± specific polysaccharide antibody deficiency (SPAD) often present with recurrent infections. Previous retrospective studies have shown that prophylactic antibiotics (PA) and immunoglobulin replacement therapy (IRT) can both be effective in preventing these infections; however, this has not been confirmed in a prospective study. Objective To compare the efficacy of PA and IRT in a randomized crossover trial. Methods A total of 64 patients (55 adults and 9 children) were randomized (2:2) between two treatment arms. Treatment arm A began with 12 months of PA, and treatment arm B began with 12 months of IRT. After a 3-month bridging period with cotrimoxazole, the treatment was switched to 12 months of IRT and PA, respectively. The efficacy (measured by the incidence of infections) and proportion of related adverse events in the two arms were compared. Results The overall efficacy of the two regimens did not differ (p = 0.58, two-sided Wilcoxon signed-rank test). A smaller proportion of patients suffered a related adverse event while using PA (26.8% vs. 60.3%, p < 0.0003, chi-squared test). Patients with persistent infections while using PA suffered fewer infections per year after switching to IRT (2.63 vs. 0.64, p < 0.01). Conclusion We found comparable efficacy of IRT and PA in patients with IgSD ± SPAD. Patients with persistent infections during treatment with PA had less infections after switching to IRT. Clinical Implication Given the costs and associated side-effects of IRT, it should be reserved for patients with persistent infections despite treatment with PA.

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Czech Hizentra Noninterventional Study With Rapid Push: Efficacy, Safety, Tolerability, and Convenience of Therapy With 20% Subcutaneous Immunoglobulin

Cited by 5 publications

References 18 publications

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

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

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

Immunoglobulin Replacement Therapy Versus Antibiotic Prophylaxis as Treatment for Incomplete Primary Antibody Deficiency

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