- The development of donor specific antibodies (DSA) can lead to graft rejection and thus to a greatly increased mortality risk
- To date no convincing therapy concept for treatment of DSA after lung transplantation available
- Relative reduction in mortality by more than 70 % after Pentaglobin® therapy after one year
- Four years of data on Pentaglobin® therapy show promise for long-term therapy success
DREIEICH, Germany I May 29, 2018 I In lung transplantation donor specific antibodies (DSA) increase the risk of mortality, and acute and chronic graft rejection. About 20-30% of all lung transplantation patients develop DSA. To date no standard treatment in lung transplantation is established. In a recently published study conducted in Hanover Medical School, Germany, it was shown that the survival rate of patients treated with Pentaglobin® (IgM-enriched immunoglobulin) with early DSA development after lung transplantation has been significantly increased.1, 2
In the Pentaglobin® group (128 patients) the survival rate of 94% after one year was comparable to patients without DSA (452 patients) and much higher than in the historic therapeutic plasma exchange group (57 patients with DSA development) with a survival rate of 79%. The relative mortality rate after one year was reduced more than 70%.
“IgM-enriched immunoglobulin eliminates the mortality risk caused by DSA after lung transplantation. Data from four years, which has now been published, show that there are no significant differences in the treated patient population, which previously had donor specific antibodies, compared to patients, who did not develop donor specific antibodies”, stated Professor Dr Gregor Warnecke, principal investigator for the study.
The particular importance of Pentaglobin® therapy is evident in an indirect comparison with similar data from a French study, in which the patient population was treated with standard immunoglobulins. Despite standard immunoglobulin administration, the DSA-positive patients had a much lower survival rate than patients without DSA (41% vs. 70% after 5 years).3
Biotest is the sole manufacturer of IgM-enriched immunoglobulin worldwide. These promising results indicate a breakthrough in organ rejection therapy and support the Pentaglobin® approach to transplantation. Promising data on Pentaglobin® therapy after heart transplantation is available.
1 Ius et al (2018). Preemptive treatment of early donor specific antibodies with IgA- and IgM-enriched intravenous human immunoglobulins in lung transplantation, Am J Transplant.,
2 Ius et al (2016). IgM-Enriched Human Intravenous Immunoglobulin-Based Treatment of Patients With Early Donor Specific Anti-HLA Antibodies After Lung Transplantation, Transplantation. 100(12): 2682–2692.
3 Le Pavec, J. et al. De-novo donor-specific anti-HLA antibodies 30 days after lung transplantation are associated with a worse outcome. J Heart Lung Transplant 35, 1067–1077 (2016).
About Pentaglobin®
Pentaglobin® is the first and only IgM-enriched immunoglobulin preparation for intravenous use. Pentaglobin® significantly increases the survival rate of patients with severe bacterial infections and acts against a broad spectrum of bacterial pathogens. Pentaglobin’s® mode of action, is both anti-bacterial by fast neutralization of bacterial endo- and exotoxins and anti-inflammatory by scavenging excessively activated complement factors. Pentaglobin® is licensed in several countries, mainly for the treatment of severe bacterial infections in combination with antibiotics.
About Biotest
Biotest is a provider of plasma proteins and biological drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology and intensive medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumins based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. In addition Biotest develops monoclonal antibodies in the indications of cancer of plasma cells and systemic lupus erythematosus which are produced by recombinant technologies. Biotest has more than 1,600 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.
SOURCE: Biotest
Post Views: 21
- The development of donor specific antibodies (DSA) can lead to graft rejection and thus to a greatly increased mortality risk
- To date no convincing therapy concept for treatment of DSA after lung transplantation available
- Relative reduction in mortality by more than 70 % after Pentaglobin® therapy after one year
- Four years of data on Pentaglobin® therapy show promise for long-term therapy success
DREIEICH, Germany I May 29, 2018 I In lung transplantation donor specific antibodies (DSA) increase the risk of mortality, and acute and chronic graft rejection. About 20-30% of all lung transplantation patients develop DSA. To date no standard treatment in lung transplantation is established. In a recently published study conducted in Hanover Medical School, Germany, it was shown that the survival rate of patients treated with Pentaglobin® (IgM-enriched immunoglobulin) with early DSA development after lung transplantation has been significantly increased.1, 2
In the Pentaglobin® group (128 patients) the survival rate of 94% after one year was comparable to patients without DSA (452 patients) and much higher than in the historic therapeutic plasma exchange group (57 patients with DSA development) with a survival rate of 79%. The relative mortality rate after one year was reduced more than 70%.
“IgM-enriched immunoglobulin eliminates the mortality risk caused by DSA after lung transplantation. Data from four years, which has now been published, show that there are no significant differences in the treated patient population, which previously had donor specific antibodies, compared to patients, who did not develop donor specific antibodies”, stated Professor Dr Gregor Warnecke, principal investigator for the study.
The particular importance of Pentaglobin® therapy is evident in an indirect comparison with similar data from a French study, in which the patient population was treated with standard immunoglobulins. Despite standard immunoglobulin administration, the DSA-positive patients had a much lower survival rate than patients without DSA (41% vs. 70% after 5 years).3
Biotest is the sole manufacturer of IgM-enriched immunoglobulin worldwide. These promising results indicate a breakthrough in organ rejection therapy and support the Pentaglobin® approach to transplantation. Promising data on Pentaglobin® therapy after heart transplantation is available.
1 Ius et al (2018). Preemptive treatment of early donor specific antibodies with IgA- and IgM-enriched intravenous human immunoglobulins in lung transplantation, Am J Transplant.,
2 Ius et al (2016). IgM-Enriched Human Intravenous Immunoglobulin-Based Treatment of Patients With Early Donor Specific Anti-HLA Antibodies After Lung Transplantation, Transplantation. 100(12): 2682–2692.
3 Le Pavec, J. et al. De-novo donor-specific anti-HLA antibodies 30 days after lung transplantation are associated with a worse outcome. J Heart Lung Transplant 35, 1067–1077 (2016).
About Pentaglobin®
Pentaglobin® is the first and only IgM-enriched immunoglobulin preparation for intravenous use. Pentaglobin® significantly increases the survival rate of patients with severe bacterial infections and acts against a broad spectrum of bacterial pathogens. Pentaglobin’s® mode of action, is both anti-bacterial by fast neutralization of bacterial endo- and exotoxins and anti-inflammatory by scavenging excessively activated complement factors. Pentaglobin® is licensed in several countries, mainly for the treatment of severe bacterial infections in combination with antibiotics.
About Biotest
Biotest is a provider of plasma proteins and biological drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology and intensive medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumins based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. In addition Biotest develops monoclonal antibodies in the indications of cancer of plasma cells and systemic lupus erythematosus which are produced by recombinant technologies. Biotest has more than 1,600 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.
SOURCE: Biotest
Post Views: 21
