Belatacept (trade name: Nulojix) has been approved in Germany since June 2011 for use in adults who have had a kidney transplant. It is used in combination with other drugs to try to prevent the body from rejecting the donor organ.
People who have received a donor kidney need to use medication for the rest of their life to suppress their body's immune system. The medication is taken to try to stop the donor kidney from being rejected. A fully functional immune system would attack the new organ as it would any other foreign object.
Belatacept is given through an intravenous drip (infusion). The treatment takes 30 minutes and starts the day after the transplant. Belatacept is then given on days 5, 14, and 28. After the first two months, it is given every four weeks. Belatacept is used in combination with corticosteroids and a mycophenolic acid (antiobiotic).
The standard treatment after a kidney transplant is cyclosporine A. It is also combined with two additional drugs (corticosteroids and a mycophenolic acid).
In 2015, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) tested how belatacept compares with cyclosporine A. In order to compare the two drugs, IQWiG found two suitable studies. Data from a total of about 800 people were evaluated. Patients were monitored for up to seven years after the transplant. About half of them had received a combination of drugs including a belatacept infusion, the other half had a combination of drugs including cyclosporine A tablets.
The two studies differed in the criteria used for selecting donor organs to transplant: In the first study, the kidneys came from donors who were selected using standard criteria (standard criteria donors, or SCDs). About half the organs came from living donors, and the other half from deceased donors (for example, traffic accident victims).
In the second study, donors were selected using extended criteria (extended criteria donors, or ECDs). Only organs from deceased donors were transplanted, including donors over the age of 60.
What are the advantages of belatacept?
Death or rejection of donor organ:
When looking at data from both studies concerning these two events, there were differences between patients who were given an SCD organ and those who received an ECD organ.
In patients with an SCD organ, there was weak evidence of an advantage for belatacept: About 13 out of 100 patients who were given belatacept rejected the organ or died within the study duration of about 7 years. This was the case for about 22 out of 100 people who had treatment with cyclosporine A.
Belatacept didn't have any advantages over cyclosporine A in patients with an ECD organ.
Kidney failure due to advanced chronic kidney disease:
The studies suggested that kidney failure was less common in people who took belatacept than it was in those who took cyclosporine A, regardless of whether they had received an ECD or SCD organ.
Severe side effects:
Concerning severe side effects, there was weak evidence that belatacept had an an advantage in patients with an SCD organ: 71 out of 100 of them had a severe side effect within the 7-year study duration. This was the case in 80 out of 100 patients in the comparison group who took cyclosporine A. Looking only at the results of the participants from Europe, the advantage was greater: 75 out of 100 of the participants who used belatacept had a severe side effect during the same period, compared to about 93 out of 100 participants who used cyclosporine A.
In the other group with an ECD organ, belatacept was not found to have an advantage over cyclosporine A in terms of severe side effects..
Where was there no difference?
- Cardiovascular disease: The comparative studies did not find any differences between the treatment groups in terms of frequency of cardiovascular disease.
- Complications and secondary diseases: The IQWiG researchers looked for differences regarding medical conditions that can occur after a transplant, such as diabetes, infections or tumors. These complications are sometimes caused by drug-induced weakening of the immune system. But there was no difference between belatacept and cyclosporine A here.
What remains unanswered?
Health-related quality of life: No differences were apparent within the first three years following transplantation. The manufacturer did not provide any suitable data concerning longer periods of time. This means it is not possible to determine how belatacept compares with cyclosporine A in terms of long-term quality of life.
Termination of treatment due to side effects: The manufacturer did not provide any data regarding how many people discontinued treatment due to side effects either.
This information summarizes the main results of reviews produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The reviews were commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of these reviews and the hearings received, the G-BA passed a resolution on the added benefit of belatacept (Nulojix).
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Belatacept – Benefit assessment according to § 35a Social Code Book V. Dossier assessment A15-25. Cologne: IQWiG. October 13, 2015.
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Belatacept (Addendum to Commission A15-25). Dossier assessment A15-51. Cologne: IQWiG. December 10, 2015.
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