Belatacept shows durable benefit in kidney transplant patients

Reuters Health Information: Belatacept shows durable benefit in kidney transplant patients

Belatacept shows durable benefit in kidney transplant patients

Last Updated: 2015-05-08

By Megan Brooks

NEW YORK (Reuters Health) - Seven years after kidney transplant, patients who received an immunosuppressive regimen containing belatacept (Nulojix, Bristol-Myers Squibb) had a statistically significant 43% reduction in death or graft loss compared with those who received a standard cyclosporine-containing regimen.

The seven-year data from the BENEFIT trial also shows a statistically significant and sustained difference in renal function favoring belatacept over cyclosporine, with no new safety concerns.

Dr. Flavio Vincenti from the University of California, San Francisco, presented the data May 6 in a plenary session at the 2015 American Transplant Congress (ATC) in Philadelphia, Pennsylvania.

Belatacept is the first selective T-cell costimulation blocker approved by the U.S. Food and Drug Administration (FDA). It is indicated in combination with basiliximab induction, mycophenolate mofetil (MMF) and corticosteroids for prophylaxis of organ rejection only in adult Epstein-Barr Virus (EBV) seropositive patients receiving a kidney transplant.

The BENEFIT trial is a 36-month clinical study funded by Bristol-Myers Squibb with long-term follow-up through 84 months. The trial enrolled 666 adults receiving a kidney from a living or standard-criteria deceased donor. All patients received basiliximab induction, MMF and corticosteroids, with either belatacept or cyclosporine.

"At both five years and seven years, and for the first time since the introduction of cyclosporine in the early 80s, the new drug in the context of a multicenter randomized trial shows an impact on long-term outcome," Dr. Vincenti told Reuters Health by phone.

"At both five and seven years, patients treated with belatacept had a significant improvement in graft survival, that is, patients surviving with a functioning graft. At seven years, the hazard ratio for the two arms comparing belatacept with cyclosporine was 0.57, meaning that being on belatacept these patients had a 43% reduction in risk of graft loss," he noted.

"The other benefit of belatacept that has been previously reported is that there is continued preservation of the kidney function, the glomerular filtration rate, which is very important because one could speculate the better the kidney function at any single point the longer the kidney will survive, but also lower kidney function is associated with morbidity and cardiovascular disease," he said.

Dr. Vincenti said, "These data, I think, will put the beneficial impact of belatacept in perspective and I think some physicians at transplant centers will start to reappraise the use of belatacept. Very frequently we are more short-term minded but because we never expected a drug or regimen to improve long-term outcome, but now we have proof that it is feasible with belatacept."

Dr. David Cohen, medical director of the kidney and pancreas transplant program at Columbia University in New York, called the data "very impressive."

"Belatacept is definitely a valuable addition to our armamentarium," Dr. Cohen, who wasn't involved the study, told Reuters Health by phone.

He said he's seen belatacept being used in two different ways: Patients may be started on the drug from day one, or switched to it later if they have trouble with the standard drugs. "It's a good alternative to the standard drugs and for a lot of patients it's an excellent drug to start out with. We use it both ways here at Columbia," he told Reuters Health.

Dr. Cohen said belatacept "hasn't had a huge use in clinical transplant for no particular reason other than I think people are just set in their ways. There is an interesting issue in the field whereby it's been difficult for many companies to get new drugs out and used because we kind of rely on the drugs we are experienced with, but maybe we need to rethink some of that."

He added, "Patients in trials tend to do well and they are monitored quite carefully so how well that translates into the general community use is a little bit of an open question but there is no particular reason to believe that results with belatacept wouldn't be sustained."

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