A novel treatment allows kidney transplant in previously inoperable patients who had decades on dialysis. The Vall d’Hebron Hospital, in Barcelona, is the center that has treated the first patient in Europe who has been treated with this drug, called imlifidase, and which has subsequently been successfully transplanted. “It’s a big change after 35 years on dialysis. This is a beam of hope for patients like me”, he said this Thursday Miguel Angel, the patient. “Now I have a life without dialysis, with freedom and I feel better than before”, this man assured 54 years old who had been on dialysis since 1984. Miguel Ángel underwent two unsuccessful transplant attempts: in 1991 and 1996. Now, he says, his life is different.
“Now I have a life without dialysis, with freedom and I feel better than before,” says Miguel Ángel, the 54-year-old transplanted patient three months ago
The case of this patient, who was transplanted three months ago, is included within a phase three clinical study which seeks to demonstrate the efficacy of imlifidase. It is expected that it will soon be approved by the European Medicines Agency (EMA). The drug is indicated for people with a hyperactivated immune system and that is why they cannot be transplanted.
Imlifidase “improves quality of life and is cheaper than dialysis,” as pointed out by the doctor Oriol Bestard, Head of the Vall d’Hebron Nephrology and Renal Transplant Service. Bestard estimates that around a few 150 Catalans. “In Catalonia there are a thousand people on the waiting list for a kidney transplant, but between 10% and 15% of them they cannot be transplanted,” he said.
In people with an overactive immune system there is a excess antibodies in the blood against most of the antigens of the human leukocyte antigen (HLA) system of the population, which is expressed by the cells of the different tissues of the organism and marks if an organ can be compatible for a specific patient. Therefore, in the event of a transplant, a rejection of the organ in a rapid and practically irreversible way. That is why these patients have a extremely low probability of finding a donor compatible.
Imlifidase, which is introduced intravenously, could be a therapeutic alternative for patients with end-stage kidney disease
What this new drug, introduced by intravenously, is to eliminate the antibodies and that is why it could be a effective therapeutic alternative for patients with a end-stage kidney disease, who are destined to stay on dialysis for many years. “This treatment is about a molecule that removes antibodies and this offers a new possibility: for a time of five or six days after treatment, we can accept an offer [de órgano] and go to the operating room. The effect of the drug is immediate and lasts five or six days,” Bestard explained. The drug can only be put once in the patient, since afterwards “the body generates antibodies against this molecule”.
According to this doctor, the effect of this treatment can be “beneficial” also for many other diseases. “There are studies in different diseases outside of transplantation. And this option is also being considered as rescue from rejection, that is, in patients who develop a acute transplant rejection has said.
Kidney transplant is the treatment of choice for patients with end-stage kidney disease. The transplanted organ has a median survival of around 15 years and therefore, especially in the younger patients, many times a new transplant will be necessary in the future.
Saving the lives of these patients requires a very high level of specialization, as well as great multidisciplinary coordination
“In those cases where there has already been a previous transplant, especially if it has been lost through chronic rejection, or in women with previous pregnancies that have allowed contact with biological material from other individuals, the patient’s immune system is more activated than usual and this generates a repertoire of specific antibodies that persist over time [la llamada memoria inmunológica]. This can cause a rejection very quickly if the patient is transplanted with an organ that expresses previously recognized HLA antigens”, said the Head of Nephrology at Vall d’Hebron.
However, there are patients with such high levels of antibodies that, despite being prioritized at regional and state level to receive organs, They can’t find a compatible one. No drug, until the arrival of imlifidase, had been effective in receiving the transplant. Previous studies in the United States and Sweden conducted with this treatment in small groups of patients have shown positive results up to three years later of the surgery.
Saving the lives of these patients requires a level of specialization of the teams very high, as well as a great multidisciplinary coordination between nephrologists, immunologists, urologists, transplant coordinator and a highly specialized nursing team. “This type of patients are quite complex also from the surgical point of view, since they have a biological age that does not generally represent the chronological for having spent so many years on dialysis,” he said for his part Enric Trilla, Head of the Urology Service of the hospital. That is why it requires a lot “surgical experience” in the field of transplantation.