Intravenous gammaglobulin: pharmacology, clinical uses and mechanisms of action

Schiff, Richard I.

doi:10.1111/j.1399-3038.1994.tb00222.x

Cited by 30 publications

(27 citation statements)

References 204 publications

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“…These observations have been confirmed in controlled studies (Bussel et al 1983) and the use of high-dose IVIG to treat acute ITP is well-established (Schiff 1994).…”

Section: Immune Thrombocytopenic Purpura (Itp)supporting

confidence: 58%

“…A principal use of immunoglobulin is to provide antibodies against infectious organisms to patients who are unable to make antibodies (Schiff 1994). Such patients include those with primary antibody deficiencies as well as patients with age-related antibody deficiencies.…”

Section: Ivig For Antibody Deficienciesmentioning

confidence: 99%

“…Shown to be effective for post-exposure prophylaxis of measles and hepatitis A infections, ISG became the standard of care for patients with primary antibody deficiencies (Medical Research Council 1969;Schiff 1994). The standard dose was approximately 100-150 mg/kg.…”

Section: Antibodies Are Gamma Globulinsmentioning

confidence: 99%

“…Most studies have shown a significant benefit when immunodeficient patients are treated with doses of 300 mg/kg per month or more (Schiff 1994).…”

Section: Ivig In the United Statesmentioning

confidence: 99%

“…The standard dose was approximately 100-150 mg/kg. When children with measles infections were given ISG intravenously, they suffered from severe adverse reactions including fever, convulsions, restlessness, chills, and vasomotor collapse (Schiff 1994). Therefore, ISG administration was restricted to intramuscular or subcutaneous injection.…”

Section: Antibodies Are Gamma Globulinsmentioning

confidence: 99%

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The history and evolution of immunoglobulin products and their clinical indications

Hooper¹

2015

LymphoSign Journal

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The history of providing antibodies to treat diseases began in the 19th century with the discovery of tetanus and diphtheria toxins and the demonstration that immunity to tetanus and diphtheria infections could be transferred by immune sera. Characterization of the mediators of this immunity resulted in the discovery that antibodies are proteins that can be isolated and used to protect against infectious diseases. Development of a method to isolate antibodies from human plasma that could be safely injected into people initiated the development of human gamma globulin preparations to provide antibodies to patients with inherited antibody deficiencies. To overcome the limitations imposed by intramuscular injection of gamma globulin, intravenous gamma globulin preparations were developed that began to be used in a wide variety of clinical conditions. Thus the original clinical indication for infection prevention was expanded to several other indications that employ large doses to suppress inflammatory and autoimmune disorders. The most recent development in immunoglobulin therapy is the production of concentrated immune globulins for subcutaneous injection. Home infusions of subcutaneous immunoglobulin are increasingly used to treat immunodeficient patients and are being studied for other clinical applications.

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“…These observations have been confirmed in controlled studies (Bussel et al 1983) and the use of high-dose IVIG to treat acute ITP is well-established (Schiff 1994).…”

Section: Immune Thrombocytopenic Purpura (Itp)supporting

confidence: 58%

Section: Ivig For Antibody Deficienciesmentioning

confidence: 99%

Section: Antibodies Are Gamma Globulinsmentioning

confidence: 99%

“…Most studies have shown a significant benefit when immunodeficient patients are treated with doses of 300 mg/kg per month or more (Schiff 1994).…”

Section: Ivig In the United Statesmentioning

confidence: 99%

Section: Antibodies Are Gamma Globulinsmentioning

confidence: 99%

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The history and evolution of immunoglobulin products and their clinical indications

Hooper¹

2015

LymphoSign Journal

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Purification of intravenous immunoglobulin G from human plasma – aspects of yield and virus safety

Buchacher

Iberer

2006

Biotechnology Journal

110

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Plasma-derived intravenous immunoglobulin (IVIG) preparations have been successfully applied for the prophylactic prevention of infectious diseases in immunodeficient patients. In addition to its replacement therapy of primary and secondary antibody deficiencies, IVIG has found increased use in autoimmune and inflammatory diseases. IVIG has become the major plasma product on the global blood product market. The world wide consumption nearly tripled between 1992 and 2003, from 19.4 to 52.6 tons. Classical manufacturing processes of IVIG, but also new strategies for purification are discussed with respect to practicability and yield. Ethanol fractionation is still the basis for most IVIG processes, although isolation and purification of immunoglobulin G (IgG) by chromatography has gained ground. The efficiency of virus inactivation methods and virus removal techniques in terms of logarithmic reduction factors are analyzed, but also the IgG losses are taken into consideration. Some of these methods also have the ability to separate prions. High pathogen safety and high yields have become the dominant goals of the plasma fractionation industry.

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Anwendung polyvalenter intravenöser Immunglobuline in der Pädiatrie

Wahn

Eibl²,

Späth³

1999

Monatsschrift Kinderheilkunde

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Für die Behandlung mit Immunglobulinen gibt es bei einer Reihe von Erkrankungen aufgrund von vielen vorliegenden klinischen Studien absolute Indikationen. Bei anderen Krankheitsbildern liegen nur anekdotische Berichte vor, und es besteht eine gewisse Unsicherheit beim Umgang mit solchen Mitteilungen. Um bei der Wahl der Therapie eine mögliche Orientierung über vorliegende Daten zu geben, haben wir uns bemüht, auf diese Situation einzugehen, ohne dabei Anspruch auf Vollstän-digkeit zu erheben. Unsere Überlegungen sind nicht zuletzt in Anbetracht der Kostenentwicklung im Gesundheitswesen zu verstehen, da bei ärzt-lichen Maßnahmen auch kostenbewußtes Denken verlangt wird. Zu diesem Kostenbewußtsein haben die Kinderärzte seit vielen Jahren immer positive Beiträge geleistet, ohne daß dabei Abstriche an der Qualität der Therapie gemacht worden wären. In diesem Sinne ist der Versuch zu verstehen, die Indikationen für i.v.-Immunglobuline (IVIG) zu definieren und publizierte Studien kritisch zu werten. Damit sollen dem Pädiater Entscheidungshilfen für einen rationalen Einsatz der IVIG an die Hand gegeben werden. Bezüglich weiterer Details wird auf geeignete Übersichtsar-beiten verwiesen [2,[8][9][10], die die Kontroversen, die es beim Einsatz der Immunglobuline gibt, allerdings nur begrenzt wiedergeben. Die Kontroversen sind wohl am grellsten von einem amerikanischen Expertengremium mit einer sehr USA-spezifischen kritischen Wertung des Einsatzes von IVIG beleuchtet worden [7]. Um die Stellungnahme überschaubar zu halten, werden folgende Kriterien berück-sichtigt: State of the art-Anwendungen: Absolute IndikationenBei einigen Erkrankungen ist die Behandlung mit IVIG die Therapie der Wahl. In erster Linie sind hier die verschiedenen Formen des Antikörper-mangelsyndroms (AMS) zu nennen. Beim AMS ist zwar weltweit nie eine placebokontrollierte Studie durchgeführt worden, dennoch ist bei allen Experten die Indikation zur ausreichend dosierten regelmäßigen Substitution unbestritten. Der Verzicht auf Immunglobulinsubstitution, der im Rahmen einer placebokontrollierten Studie ja vorkommen würde, wäre ethisch nicht zu verantworten. Die Tatsache, daß die Kinderärzte ihre Patienten mit AMS inzwischen in gutem Zustand an Internisten überweisen können, ist unstrittig auf den regelmäßigen präventiven Einsatz von IVIG zurückzuführen, nicht auf den begleitend gelegentlich notwendigen Einsatz von Antibiotika.

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Intravenous gammaglobulin: pharmacology, clinical uses and mechanisms of action

Cited by 30 publications

References 204 publications

The history and evolution of immunoglobulin products and their clinical indications

The history and evolution of immunoglobulin products and their clinical indications

Purification of intravenous immunoglobulin G from human plasma – aspects of yield and virus safety

Anwendung polyvalenter intravenöser Immunglobuline in der Pädiatrie

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