Subcutaneous immunoglobulin for patients with antibody deficiency

Helbert, Matthew; Farragher, Alex

doi:10.12968/hmed.2007.68.4.206

Cited by 9 publications

(6 citation statements)

References 22 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…This steady level of exposure with lower peak levels and higher trough levels compared with iv administration is considered to be advantageous. The lower peak levels reduce the risk of severe headache and other systemic adverse events, whereas the higher trough levels provide more protection against breakthrough infections (19,22,23). Overall the adverse event data indicate that treatment with BT088 is well tolerated and safe after SC administration.…”

Section: Discussionmentioning

confidence: 98%

“…Regular SC dosing (generally weekly) at a level high enough to provide sufficient protection (and minimal injection volume) constitutes standard care in the related indication of normal immunoglobulin replacement therapy for patients who have a primary immunodeficiency and require life‐long protection. Home care has been successfully implemented in this setting (18,19), although injection volumes are larger in this indication (10–20 ml) than for HBIg prophylaxis (1–2 ml). The small injection volumes in our study (a single ml for 500 IU dose) were very well tolerated.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Efficacy and safety of subcutaneous human HBV-immunoglobulin (Zutectra®) in liver transplantation: an open, prospective, single-arm phase III study

Yahyazadeh

Beckebaum

Cicinnati

et al. 2011

Transplant International

View full text Add to dashboard Cite

Summary Hepatitis B re‐infection prophylaxis is crucial for graft and recipient survival for transplanted patients and is administered routinely after liver transplantation for hepatitis B. Aim of the current study was the investigation of efficacy, safety and feasibility of home‐treatment of a novel human hepatitis B immunoglobulin BT088 (Zutectra®) after weekly subcutaneous application in liver‐transplanted patients. A total of 23 patients (5 female, 18 male, median age 51 years) were enrolled and switched from monthly IV to weekly SC hepatitis B immunoglobulin administration. During a period of 18 weeks (optional 24 weeks) anti‐HBs levels, signs of re‐infection, adverse events and feasibility of self‐administration were studied. After 8 weeks of training patients showing good compliance and stable antibody titres were allowed to start self‐administration at home. All patients maintained a safety level of >100 U/l anti‐HBs. No failure was noted, no re‐infection occurred. A total of 10 treatment‐emergent events were assessed as related to study drug application (injection‐site haematoma, headache, abdominal pain, fatigue and haematuria). High numbers of self‐administration (287 vs. 122 by staff) demonstrated general feasibility of SC administration. Weekly subcutaneous administration of BT088 (Zutectra®– registered trade mark in the EU) is effective, safe and presents an easy‐to‐apply treatment option for combined hepatitis B virus re‐infection prophylaxis in liver transplant patients (Eudra CT Number: 2005‐003737‐40).

show abstract

Section: Discussionmentioning

confidence: 98%

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of subcutaneous human HBV-immunoglobulin (Zutectra®) in liver transplantation: an open, prospective, single-arm phase III study

Yahyazadeh

Beckebaum

Cicinnati

et al. 2011

Transplant International

View full text Add to dashboard Cite

show abstract

“…The disadvantages include frequent dosing because of the limited volume that can be administered at one time, slow build up of serum trough Ig levels, and patients' reliability if self-administered at home. Lastly, the use of SCIG is contra-indicated in patients with bleeding tendencies or in those with skin conditions that affect large areas of the body surface (Helbert and Farragher 2007).…”

Section: Introductionmentioning

confidence: 99%

Home gammaglobulin therapy: a patient survey of intravenous and subcutaneous options in Canada

ReidBrenda

PiresLinda

2014

LymphoSign Journal

View full text Add to dashboard Cite

Introduction: For close to half a century immunoglobulin replacement therapy has been the main therapy for patients unable to produce functioning antibodies. To date, both subcutaneous (SC) and intravenous delivery methods have been successful at effectively and safely replacing immunoglobulin. Home intravenous and SC therapy programs have been established and have gained attention, but the true motivation and frequency of switching from traditional hospital-based treatment to these alternatives remains unknown. This study aims to determine the willingness of patients in Canada to switch to a home-based gammaglobulin treatment program by quantifying related experiences and preferences.

show abstract

“…Immunoglobulin G (IgG) replacement therapy is widely used in the treatment of patients with infections associated with primary immunodeficiency (PI) diseases [1][2][3][4]. While intravenous (IV) infusion of immune globulin (IVIG) is a well-established approach, some patients (e.g., poor venous access, at risk of systemic adverse events [AEs]) may benefit from a subcutaneous (SC) route of administration [5,6].…”

Section: Introductionmentioning

confidence: 99%

A Multi‑Center, Open‑Label, Single‑Arm Trial to Evaluate the Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary Immunodeficiency

et al. 2022

View full text Add to dashboard Cite

Purpose The purpose of this phase 3 study was to evaluate the efficacy, pharmacokinetics (PK), and safety of Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%) in patients with primary immunodeficiency (PI). Methods Immunoglobulin treatment-experienced subjects with PI received 52 weeks of IGSC 20% given weekly at the same dose as the subject’s previous IgG regimen (DAF 1:1); the minimum dose was 100 mg/kg/week. The primary endpoint was serious bacterial infections (SBIs [null vs alternative hypothesis: SBI rate per person per year ≥ 1 vs < 1]). IgG subclasses and specific pathogen antibody levels were also measured. Results Sixty-one subjects (19 children [≤ 12 years], 10 adolescents [> 12–16 years], and 32 adults) were enrolled. The rate of SBIs per person per year was 0.017. The 1-sided 99% upper confidence limit was 0.036 (< 1), and the null hypothesis was rejected. The rate of hospitalization due to infection per person per year was 0.017 (2-sided 95% confidence interval: 0.008–0.033) overall. The mean trough total IgG concentrations were comparable to the previous IgG replacement regimen. The average of the individual mean trough ratios (IGSC 20%:previous regimen) was 1.078 (range: 0.83–1.54). The average steady-state mean trough IgG concentrations were 947.64 and 891.37 mg/dL, respectively. Seven subjects had serious treatment-emergent adverse events (TEAEs); none was drug-related. The rate of all TEAEs, including local infusion site reactions, during 3045 IGSC 20% infusions was 0.135. Most TEAEs were mild or moderate. Conclusions IGSC 20% demonstrated efficacy and good safety and tolerability in subjects with PI.

show abstract

Subcutaneous immunoglobulin for patients with antibody deficiency

Cited by 9 publications

References 22 publications

Efficacy and safety of subcutaneous human HBV-immunoglobulin (Zutectra®) in liver transplantation: an open, prospective, single-arm phase III study

Efficacy and safety of subcutaneous human HBV-immunoglobulin (Zutectra®) in liver transplantation: an open, prospective, single-arm phase III study

Home gammaglobulin therapy: a patient survey of intravenous and subcutaneous options in Canada

A Multi‑Center, Open‑Label, Single‑Arm Trial to Evaluate the Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary Immunodeficiency

Contact Info

Product

Resources

About