An immediate hypersensitivity reaction induced by PEGylated recombinant factor VIII

SummaryIn this open multicenter study the safety and efficacy of recombinant factor VIII (rFVIII) was assessed in 39 previously treated patients with hemophilia A (factor VIII basal activity ≤15%).Recombinant FVIII was administered for prophylaxis and treatment of bleeding episodes and for surgical procedures. A total of 3679 infusions of rFVIII were given. Efficacy of rFVIII as assessed by subjective evaluation of response to infusion and mean annual consumption of rFVIII was comparable to that of plasma derived FVIII concentrates. The incremental recovery of FVIII (2.4 ± 0,83%/IU/kg, 2.12 ± 0.61%/IU/kg, resp.) was within the expected range. No clinical significant FVIII inhibitor was detected in this trial. Five of 16 susceptible patients showed a seroconversion for parvovirus B19. However, the results are ambiguous in two cases and might be explained otherwise in one further case. Thus, in two patients a reliable seroconversion for parvovirus B19 was observed.

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Immediate hypersensitivity reaction followed by successful oral desensitization to ursodiol

Allergy Asthma & Clinical Immunology ◽

10.1186/s13223-021-00578-7 ◽

2021 ◽

Vol 17 (1) ◽

Author(s):

Erika Yue Lee ◽

Christine Song

Keyword(s):

Hypersensitivity Reaction ◽

Primary Biliary Cholangitis ◽

Line Treatment ◽

Second Line ◽

Immediate Hypersensitivity ◽

First Line ◽

Case Presentation ◽

Desensitization Protocol ◽

First Line Treatment ◽

Oral Desensitization

Abstract Background Immediate hypersensitivity reaction to ursodiol is rare and there is no previously published protocol on ursodiol desensitization. Case presentation A 59-year-old woman with primary biliary cholangitis (PBC) developed an immediate hypersensitivity reaction to ursodiol—the first-line treatment for PBC. When she switched to a second-line treatment, her PBC continued to progress. As such, she completed a novel 12-step desensitization protocol to oral ursodiol. She experienced recurrent pruritus after each dose following desensitization, which subsided after a month of being on daily ursodiol. Conclusion Immediate hypersensitivity reaction to ursodiol is uncommon. Our case demonstrated that this novel desensitization protocol to ursodiol could be safely implemented when alternative options are not available or have proven inferior in efficacy.

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Anti-apoptotic genes Aven and E1B-19K enhance performance of BHK cells engineered to express recombinant factor VIII in batch and low perfusion cell culture

Biotechnology and Bioengineering ◽

10.1002/bit.21479 ◽

2007 ◽

Vol 98 (4) ◽

pp. 825-841 ◽

Cited By ~ 31

Author(s):

Toey Nivitchanyong ◽

Amanda Martinez ◽

Adiba Ishaque ◽

John E. Murphy ◽

Konstantin Konstantinov ◽

...

Keyword(s):

Cell Culture ◽

Factor Viii ◽

Recombinant Factor Viii ◽

Perfusion Cell Culture ◽

Bhk Cells ◽

Apoptotic Genes

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Long‐term safety and efficacy of recombinant factor VIII Fc fusion protein (rFVIIIFc) in subjects with haemophilia A

Haemophilia ◽

10.1111/hae.12766 ◽

2015 ◽

Vol 22 (1) ◽

pp. 72-80 ◽

Cited By ~ 38

Author(s):

B. Nolan ◽

J. Mahlangu ◽

D. Perry ◽

G. Young ◽

R. Liesner ◽

...

Keyword(s):

Fusion Protein ◽

Factor Viii ◽

Recombinant Factor Viii ◽

Haemophilia A ◽

Safety And Efficacy ◽

Fc Fusion Protein

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Efficacy and inhibitor development in previously treated patients with haemophilia A switched to a B domain-deleted recombinant factor VIII - clarification of Kogenate inhibitor data.

British Journal of Haematology ◽

10.1111/j.1365-2141.2005.05551.x ◽

2005 ◽

Vol 130 (1) ◽

pp. 145-146

Author(s):

Peter Larson

Keyword(s):

Factor Viii ◽

Recombinant Factor Viii ◽

Haemophilia A ◽

Inhibitor Development ◽

Previously Treated Patients ◽

Previously Treated

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TT virus contaminates first-generation recombinant factor VIII concentrates

Blood ◽

10.1182/blood.v98.8.2571 ◽

2001 ◽

Vol 98 (8) ◽

pp. 2571-2573 ◽

Cited By ~ 27

Author(s):

Alberta Azzi ◽

Riccardo De Santis ◽

Massimo Morfini ◽

Krystyna Zakrzewska ◽

Roberto Musso ◽

...

Keyword(s):

Factor Viii ◽

First Generation ◽

Second Generation ◽

Human Albumin ◽

Factor Ix ◽

Recombinant Factor Viii ◽

Tt Virus ◽

Recombinant Product ◽

Before And After ◽

Factor Viii Concentrates

Abstract Recombinant factor VIII and factor IX concentrates, human-plasma–derived albumin, and samples from previously untreated patients with hemophilia were examined for the presence of TT virus (TTV) by using polymerase chain reaction testing. Blood samples from the patients were obtained prospectively before and every 3 to 6 months after therapy was begun. TTV was detected in 23.5% of the recombinant-product lots and 55.5% of the albumin lots tested. Only first-generation factor VIII recombinant concentrates stabilized with human albumin were positive for TTV, whereas all second-generation (human protein–free) concentrates were negative for the virus. In 59% of patients treated with either first- or second-generation recombinant factor concentrates, TTV infection developed at some point after the initial infusion. Infection with TTV in these patients before and after treatment did not appear to be clinically important. Thus, first-generation recombinant factor VIII concentrates may contain TTV and the source of the viral contamination may be human albumin.

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