Prospective open‐label study of pharmacokinetics, efficacy and safety of a new 10% liquid intravenous immunoglobulin in patients with hypo‐ or agammaglobulinemia

Björkander, Janne; Nikoskelainen, J; Leibl, Heinz; Lanbeck, Peter; Wallvik, Jonas; Lumio, JT; Braconier, Jean Henrik; Pavlova, B. G.; Birthistle, K.; Engl, Werner; Walter, Simone; Ehrlich, H. J.

doi:10.1111/j.1423-0410.2006.00764.x

Cited by 50 publications

(37 citation statements)

References 28 publications

(23 reference statements)

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“…This may change when the next generation of 10% liquid IVIGs enters the market in the coming years [7]. Our analysis was able to distinguish between individual products, but the IMS Health hospital disease database did not contain information about the reasons for prescribing specific products.…”

Section: Discussionmentioning

confidence: 99%

The Use of Intravenous Immunoglobulins in Belgium

Simoens

2010

Int Arch Allergy Immunol

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Background: In light of the limited supply of intravenous immunoglobulins, it is important to strive for their appropriate use. Off-label use needs to be discouraged because of the limited supply of intravenous immunoglobulins, their unproven effectiveness in many conditions, their high costs, and the risk of adverse effects. This study aims to document the use of intravenous immunoglobulins in registered and off-label conditions in Belgian hospitals. Methods: Data were derived from the IMS Health hospital disease database. For each condition, this database generated figures about the number of patients and the reimbursement value in 2007. Data were provided at the level of individual products. Results: In 2007, intravenous immunoglobulins were administered to 9,629 patients, amounting to a reimbursement value of EUR 33.5 million (or 17% of Belgian hospital drug expenditure). Around 50–60% of intravenous immunoglobulin use was associated with registered conditions and around 40–50% with off-label use, depending on how use was measured. Off-label use occurred in unspecified conditions, surgery, orthopedics and oncology. There was limited use in myasthenia gravis. The market was dominated by Multigam and Sandoglobuline, each of which made up 45–50% of intravenous immunoglobulin use. Conclusions: In addition to their use in registered conditions, intravenous immunoglobulins are used off-label in other conditions in Belgium. A number of options are proposed to discourage off-label use in light of the limited supply of intravenous immunoglobulins, their unproven effectiveness in many conditions, their high cost, and the risk of adverse effects.

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Section: Discussionmentioning

confidence: 99%

The Use of Intravenous Immunoglobulins in Belgium

Simoens

2010

Int Arch Allergy Immunol

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“…The dosing regimen for 10% IVIg ready-to-use solution is highly patient-dependent but, with the assumption of one infusion every 3 weeks [4,5], each patient will require 17 infusions per year. Therefore, one can estimate a yearly cost saving per patient of €1010·14.…”

Section: Pharmacoeconomic Datamentioning

confidence: 99%

“…It contains no added sugar, sodium or preservatives [9], and formulation at low pH reduces aggregate formation and IgG dimerization during storage, which are potentially associated with adverse events [10]. The 10% ready-to-use IVIg solution can be infused at a maximum infusion rate of 8 ml/kg/h [5].…”

Section: Introductionmentioning

confidence: 99%

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A 10% ready-to-use intravenous human immunoglobulin offers potential economic advantages over a lyophilized product in the treatment of primary immunodeficiency

Kallenberg

2007

Clinical and Experimental Immunology

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SummaryIntravenous immunoglobulin (IVIg) replacement therapy is the standard of care for patients with primary humoral immunodeficiencies. This study evaluated differences in infusion time between a 10% IVIg ready-to-use solution and a 6% IVIg lyophilized product and addressed potential cost implications. After receiving in-hospital treatment with 6% IVIg lyophilized solution for at least 6 months, 14 patients with humoral immunodeficiency without anti-IgA antibodies received five successive infusions with 10% IVIg ready-to-use solution. Data on infusion times were collected during the last two infusions of each IVIg product when maximum infusion rates had been reached. The median infusion time was reduced from 104·4 min with the 6% IVIg lyophilized solution to 51·0 min with the 10% IVIg ready-to-use solution (51% reduction), with corresponding median maximum infusion rates of 4·1 ml/kg/h and 5·9 ml/kg/h, respectively. Median gammaglobulin (IgG) trough levels were 7·1 g/l for the 6% IVIg lyophilized solution and 7·9 g/l for the 10% IVIg ready-to-use solution. Fewer adverse events were observed after infusing with 10% IVIg ready-to-use solution compared with 6% IVIg lyophilized preparation. We conclude that the 10% IVIg ready-to-use solution was well tolerated by most patients and reduced the median infusion time by 51% compared with a 6% lyophilized preparation of IVIg. The reduced bed occupancy and nursing time associated with a reduced infusion time, together with the elimination of a reconstitution step, were estimated to provide a cost-saving of €59·42 per patient per infusion. Thus, this product has the potential to reduce overall costs of IVIg treatment. Reduced infusion time is also likely to improve patients' quality of life.

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“…It is developed by Baxter Healthcare Corporation. This sugar-free glycine-stabilized formulation is a ready-to-use IVIG [51]. …”

Section: Specific Ivig Productsmentioning

confidence: 99%

Immunoglobulin Replacement Therapy: A Twenty-Year Review and Current Update

Saeedian

Randhawa

2014

Int Arch Allergy Immunol

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Objective: The expansion of immunoglobulin replacement to multiple disease entities marks a decade-long advancement in immune therapy. Parallel to its extension, the characteristics and composition of immunoglobulin products have diversified. The aim of this study was to summarize a 20-year comprehensive literature review of currently commercially available immunoglobulin products, particularly examining individual product properties in a comparative format. Data Sources/Study Selections: The literature review was performed using PubMed and Ovid, screening a time span of 2 decades. Both authors reviewed the obtained articles for acceptable quality, and the selection was narrowed down based on criteria for randomized clinical and therapeutic trials. Results: Product-specific characteristics in terms of purification strategy, stabilizers, composition, and viral inactivation were found among the immunoglobulin products investigated. Such differing characteristics manifest in their variable clinical safety and efficacy as assessed by the comparative product analysis. In subgroups of patients, subcutaneous immunoglobulin therapy may be an alternative to intravenous immunoglobulin (IVIG) therapy with an equal efficacy and a lower number of systemic adverse events. Conclusion: Only few comprehensive clinical synopses are available to clearly demonstrate the differences in IVIG products despite the widespread clinical use of the therapy. This review defines significant characteristics of individual immunoglobulin products, noting important differences in product development and application and allowing informed clinical decisions to match a product with patients' risk factors and comorbidity. This balanced approach to gammaglobulin replacement therapy is imperative to produce the highest clinical efficacy and lowest number of adverse events.

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Prospective open‐label study of pharmacokinetics, efficacy and safety of a new 10% liquid intravenous immunoglobulin in patients with hypo‐ or agammaglobulinemia

Abstract: The new 10% liquid immunoglobulin preparation was well tolerated and shown to have an excellent pharmacokinetic, efficacy and safety profile. The liquid formulation provides convenience to patients and healthcare professionals.

Cited by 50 publications

References 28 publications

The Use of Intravenous Immunoglobulins in Belgium

The Use of Intravenous Immunoglobulins in Belgium

A 10% ready-to-use intravenous human immunoglobulin offers potential economic advantages over a lyophilized product in the treatment of primary immunodeficiency

Immunoglobulin Replacement Therapy: A Twenty-Year Review and Current Update

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