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Belatacept after a kidney transplant: Minor added benefit for certain patients
Date:11/9/2012

Belatacept (trade name Nulojix) has been approved since June 2011 to prevent a rejection reaction of the body to the donor organ (transplant) in adults who have received a kidney transplant. The Institute for Quality and Efficiency in Health Care (IQWiG) has examined the added benefit of the drug pursuant to the "Act on the Reform of the Market for Medicinal Products" (AMNOG).

The assessment showed an indication of a minor added benefit of belatacept in adults with transplants from donors who had been selected according to the so-called standard criteria. Serious side effects such as urinary tract infections or pneumonia occurred less frequently in these patients and they also discontinued treatment due to side effects less often.

In patients who received transplants from donors who had been selected according to extended criteria (in this case, only deceased donors, who could also have been older and could have had certain accompanying diseases), no relevant differences could be found between the treatment with belatacept or with the comparator therapy, cyclosporine A. That means an added benefit of belatacept is not proven for these patients.

Belatacept in comparison with cyclosporine A

The immunosuppressant belatacept suppresses the immune system and thereby the natural defence reaction of the body to foreign tissue. Immunosuppressive drugs have to be taken long-term after a transplant in order to prevent the donor kidney being rejected after transplantation.

The appropriate comparator therapy used for the early benefit assessment was cyclosporine A. Both belatacept and cyclosporine A are given in combination with corticosteroids and a mycophenolic acid. Belatacept is given as an infusion (intravenously) into the bloodstream, whereas cyclosporine A is administered as a tablet.

Different donor characteristics

In both of the studies that were part of the approval of the drug and
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Contact: Dr. Anna-Sabine Ernst
presse@iqwig.de
0049-221-356-85153
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

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