Such discoveries are vital in an era of skyrocketing health care costs and debate over health reform, said lead investigator Alan C. Farney, M.D., Ph.D., an associate professor of surgery in the Department of General Surgery, Transplantation Services.
“I think it’s very important that the public consider cost, and that they ask their doctors if there are alternatives for them that are less expensive,” he said. “Why should we use one drug or intervention over another that is equally effective and a fraction of the cost?”
For the study, published recently in the journal Transplantation, researchers looked at the two most common drugs used for induction immunosuppression therapy with kidney and pancreas transplants:
? alemtuzumab, a newer drug that costs about $1,000 per single-dose treatment and is marketed under the name CampathTM; and
? rabbit antithymocyte globulin, which costs about four times more for its multidose treatment than alemtuzumab, and is marketed under the name ThymoglobulinTM.
Both drugs destroy the cells that cause organ rejection during induction immunosuppression therapy – a short-term, early treatment meant to rapidly lower the immune system to prevent rejection until the patient begins taking daily drugs to suppress the immune system.
Though more expensive, rabbit antithymocyte globulin has generally been more commonly prescribed than alemtuzumab at Wake Forest Baptist and other transplant centers because there has been a concern that the newer drug would suppress the immune system too much and lead to infections or cancer, Farney said.
“We want to avoid acute rejection, but we also don’t want to pay a price when we’re trying to do that by leaving the patient over-immunosuppressed,” he said. “We were being cautious, but this study reveals that, through at least two years of follow up, both drugs are equally effective and safe.”
In the study of 222 patients receiving either kidney transplants alone, simultaneous kidney-pancreas transplants, or pancreas-after-kidney transplants, researchers found that both drugs showed similar survival rates for the patients (96 percent), the transplanted kidneys (89 percent) and the transplanted pancreases (90 percent). The drugs also had similar infection rates.
From Feb. 1, 2005, to Sept. 1, 2007, transplant patients participating in the study received either alemtuzumab or rabbit antithymocyte globulin, followed by the same course of maintenance drugs. Both groups included patients who varied in age, race, gender and risk – a unique approach with clinical studies, which usually look at a group with similar characteristics.
The researchers wanted to design this study – one of the largest single-institution trials for transplantation drugs – to reflect the actual demographics of the Medical Center’s transplant patients, Farney said. Transplantation Services at Wake Forest University Baptist Medical Center performs more than 150 kidney and pancreas transplants each year.
“It represents who we really transplant at Wake Forest Baptist,” Farney said. “Other trials are so exclusive that you don’t know what the true results are for most people.”
As a result of the study, the Wake Forest Baptist Transplant Program has adopted the newer drug as part of its standard anti-rejection protocol for kidney and pancreas transplantation, Farney said.
Co-investigators, all from the Medical Center, are William Doares, Pharm.D., M.A.Ed., Jeffrey Rogers, M.D., Rajinder Singh, M.D., Erica Hartmann, M.D., Lois Hart, Elizabeth Ashcraft, Amber Reeves-Daniel, D.O., Michael Gautreaux, Ph.D., Samy S. Iskandar, M.BB.Ch., Ph.D., Phillip Moore, M.D., Patricia L. Adams, M.D., and Robert J. Stratta, M.D.
The researchers continue to track the study participants annually to determine the long-term outcomes for both drugs.
Wake Forest University Baptist Medical Center (www.wfubmc.edu) is an academic health system comprised of North Carolina Baptist Hospital, Brenner Children’s Hospital, Wake Forest University Physicians, and Wake Forest University Health Sciences, which operates the university’s School of Medicine and Piedmont Triad Research Park. The system comprises 1,056 acute care, rehabilitation and long-term care beds and has been ranked as one of “America’s Best Hospitals” by U.S. News & World Report since 1993. Wake Forest Baptist is ranked 32nd in the nation by America’s Top Doctors for the number of its doctors considered best by their peers. The institution ranks in the top third in funding by the National Institutes of Health and fourth in the Southeast in revenues from its licensed intellectual property.