Belatacept is based on research into the molecular basis of immune tolerance. Its precursor, CTLA4Ig, was first shown to induce transplant tolerance in research conducted by Bluestone. Animal studies at Emory University by Larsen and preliminary clinical studies by Vincenti also contributed to the development of belatacept as an effective co-stimulatory blocker.
In the phase II study reported in NEJM, 218 patients were randomized to receive cyclosporine or either a less-intensive or more-intensive course of belatacept. All patients received several other drugs that are included in standard post-transplant therapy. At the end of six months, the rates of acute rejection were similar in all patient groups (six to seven percent for belatacept versus eight percent for cyclosporine). Acute rejection usually can be reversed, and study results showed that all patients retained their transplanted kidneys except for one in the intensive belatacept group and one in the cyclosporine group.
After 12 months of post-transplant treatment, the researchers used glomular filtration rate (GFR) -- a measure of the kidney's ability to filter waste -- as an indicator of how well transplanted kidneys were functioning. The GFR was significantly higher at 12 months for patients receiving both the intensive and less intensive belatacept regimens compared to cyclosporine patients. Another indicator of kidney health, chronic allograft nephropathy (scarring of the kidney), also was lower at 12 months among patients receiving either of the belatacept regimens.
Patients in all treatment groups had comparable total cholesterol levels and comparable blood pressure levels at 12 months. However, 53 percent of cyclosporine patients required lipid-lowering medications compared to 32-36 percent of belatacept patients. More than half of cyclosporine treated patients nee
Source:University of California - San Francisco