Pathogen safety of human C1 esterase inhibitor concentrate

Gröner, Albrecht; Nowak, Thomas; Schäfer, Wolfram

doi:10.1111/j.1537-2995.2012.03590.x

Cited by 35 publications

(29 citation statements)

References 27 publications

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“…The risk of allergic reactions is negligible. Modern pdC1-INH use has not been associated with transmission of hepatitis B or C or human immunodeficiency viruses [29,87,88]. …”

Section: Therapy Of Hae-1/2mentioning

confidence: 99%

WAO Guideline for the Management of Hereditary Angioedema

Craig

Pürsün

Bork

et al. 2012

World Allergy Organization Journal

292

428

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Hereditary Angioedema (HAE) is a rare disease and for this reason proper diagnosis and appropriate therapy are often unknown or not available for physicians and other health care providers. For this reason we convened a group of specialists that focus upon HAE from around the world to develop not only a consensus on diagnosis and management of HAE, but to also provide evidence based grades, strength of evidence and classification for the consensus. Since both consensus and evidence grading were adhered to the document meets criteria as a guideline. The outcome of the guideline is to improve diagnosis and management of patients with HAE throughout the world and to help initiate uniform care and availability of therapies to all with the diagnosis no matter where the residence of the individual with HAE exists.

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“…The risk of allergic reactions is negligible. Modern pdC1-INH use has not been associated with transmission of hepatitis B or C or human immunodeficiency viruses [29,87,88]. …”

Section: Therapy Of Hae-1/2mentioning

confidence: 99%

WAO Guideline for the Management of Hereditary Angioedema

Craig

Pürsün

Bork

et al. 2012

World Allergy Organization Journal

292

428

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“…In addition to the dedicated virus reduction steps pasteurization and hydrophobic interaction chromatography, a nanofiltration process has recently been introduced in the manufacturing of Berinert and obtained regulatory approval for the treatment of acute attacks and self-administration in both adult and pediatric patients by European health authorities and in adults and adolescents by the Food and Drug Administration. 7 Berinert was also recently approved for short-term prophylaxis (pre-procedure prevention) in the European Union. The new proposed abbreviation for the plasma-derived, pasteurized, nanofiltered product is pnfC1-INH.…”

mentioning

confidence: 99%

Treatment with C1-esterase inhibitor concentrate in type I or II hereditary angioedema: A systematic literature review

Bork

Steffensen²,

Machnig³

2013

allergy asthma proc

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Hereditary angioedema (HAE) due to C1 esterase inhibitor (HAE-C1-INH) deficiency is a rare genetic disorder presenting with recurrent episodes of skin swellings, abdominal pain attacks, and potentially fatal laryngeal edema. This study was designed to review the efficacy and safety of pasteurized, human, plasma-derived C1-INH concentrate for the treatment of patients with HAE-C1-INH. A systematic search of electronic databases up to December 2011 was performed without language or date restrictions. Two reviewers completed the study selection using predefined inclusion criteria, tabulated, and analyzed the data. The data were inappropriate for meta-analysis; thus, a qualitative synthesis was performed. We identified 89 studies (≍2000 patients) that investigated C1-INH. Replacement therapy with C1-INH significantly shortened time to onset of symptom relief in HAE attacks compared with placebo in a randomized controlled trial, and similar improvements were consistently reported in observational and descriptive studies, accompanied by improvements in patients' quality of life. C1-INH has been shown to be effective for patients receiving home therapy and short- and long-term prophylaxis. Treatment with C1-INH was generally well tolerated. Administration of C1-INH was not associated with transmission of viruses or development of autoantibodies irrespective of treatment duration. This research provides additional confirmation of the efficacy of C1-INH in the treatment and prevention of HAE attacks. C1-INH is generally safe and well tolerated and has an excellent safety record for over 25 years of clinical use.

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“…One such barrier is a lack of consistent training in self‐administration, and the perception that IV injections are difficult to master . Although there are concerns that the self‐administration of C1 inhibitor therapy may increase the risk of infection, there has been no evidence to support this …”

Section: Discussionmentioning

confidence: 99%

An analysis of the teaching of intravenous self-administration in patients with hereditary angio-oedema

Mühlberg¹,

Ettl²,

Magerl

2016

Clin Exp Dermatol

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C1 inhibitor self-administration for the treatment of HAE allows patients to quickly treat attacks at home, potentially reducing attack severity. The results also demonstrate the benefit of self-administered routine prevention therapy in a real-world patient population. Self-administered therapy potentially allows patients to gain greater control over their attacks, resulting in a reduction in healthcare utilization.

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Pathogen safety of human C1 esterase inhibitor concentrate

Abstract: The pathogen reduction capacity demonstrated here indicates that the manufacturing process of the C1-INH Berinert is highly effective for reducing enveloped and nonenveloped viruses and prion proteins.

Cited by 35 publications

References 27 publications

WAO Guideline for the Management of Hereditary Angioedema

WAO Guideline for the Management of Hereditary Angioedema

Treatment with C1-esterase inhibitor concentrate in type I or II hereditary angioedema: A systematic literature review

An analysis of the teaching of intravenous self-administration in patients with hereditary angio-oedema

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