Soliris Reduces Risk of Relapse, Kidney Transplant Loss, Study Finds

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by Patricia Inacio PhD |

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Soliris (eculizumab), given as a treatment or as a preventive measure, reduces disease relapse and kidney transplant loss in people with atypical hemolytic uremic syndrome (aHUS), according to a Brazilian retrospective study.

Researchers emphasized the need, in low- to medium-income countries, to provide greater access to Soliris and similar therapies at a lower cost.

The study, “Thrombotic microangiopathy after kidney transplantation: Analysis of the Brazilian Atypical Hemolytic Uremic Syndrome cohort,” was published in the journal Plos One.

aHUS is a rare disorder characterized by the formation of blood clots in small blood vessels, a condition called thrombotic microangiopathy (TMA), which causes damage to the kidneys and may lead to kidney failure.

Kidney transplant has the potential to restore kidney function loss, but it is also associated with a high risk of disease relapse.

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Currently, the mainstay approach to avoid disease relapse and kidney transplant failure is treatment with Alexion’s Soliris, an approved therapy that targets the complement system — a part of the immune system that is overactive in people with aHUS. Specifically, Soliris works by binding to C5, a specific component of the complement cascade.

“However, due to the high cost of this medication, especially in middle-income countries, the evaluation of its effectiveness is extremely important,” the researchers wrote.

In this study, researchers in Brazil conducted a retrospective analysis of 38 aHUS patients, with a median age of 30, who were followed at six centers. Each of the 24 women and 14 men had received a kidney transplant; more than half (68%) received their new kidney from a deceased donor.

Patients were divided into three groups according to their treatment: one group received Soliris following kidney transplant, due to TMA recurrence; another included those who took Soliris as a preventive therapy (prophylaxis); and the last group included individuals who did not receive Soliris or any other complement inhibitor.

The study’s main goal was to assess the proportion of patients having a relapse leading to transplant loss. Additional goals included evaluating the number of individuals who developed transplant rejection, as well as the number of deaths.

Of the 38 patients, 10 received Soliris as a preventive therapy and 17 as a regular treatment. The other 11 received no treatment with complement inhibitors. Ten patients received Soliris alongside plasma exchange, a treatment that involves replacing a person’s plasma — the noncellular part of blood.

Analyses showed that 91% of the patients who did not receive any complement inhibitor had a relapse leading to transplant loss. Transplant loss was less in both groups of patients given Soliris, occurring in only one person in each group. In both cases, researchers noted that a delay in the administration of Soliris could have been the cause of the transplant loss.

Acute transplant rejection was significantly higher in patients who did not receive Soliris (67%) compared with those given the medication prophylactically (0%) or as a treatment (35%).

Transplant loss due to TMA at 1,000 days of follow-up was seen in 7.6% of patients in the Soliris treatment group and in 10% of those in the prophylactic group, compared with 86.4% of those in the no-treatment group.

The likelihood for patients to survive over 1,000 days was 100% in the prophylactic group, 70% in therapeutic group, and 40% in the no-treatment group. Causes of death in the treatment group included hemorrhagic shock and septic shock, while in the no-treatment group the cause was disease relapse.

Overall, these results reinforce “the need of eculizumab use for treatment of aHUS kidney transplant patients,” the researchers wrote.

“Cost optimization analysis and the early access to C5 inhibitors are suggested, especially in low-medium income countries,” they wrote.