News Release

Leading immunosuppressant CellCept® significantly extends the lifespan of transplanted kidneys

Patients keep their kidneys for longer with CellCept

Peer-Reviewed Publication

Ketchum UK

The analysis showed that after three years treatment with CellCept + tacrolimus, kidney survival was 85.9% versus 80.3% with patients taking sirolimus + tacrolimus immunosuppressants. The outcome was even better for higher risk patients with a kidney survival rate of 74.5% vs 57.5%[i]. The new data were presented at the European Society for Organ Transplantation (ESOT), Geneva, Switzerland. Previous data have shown that CellCept gives a survival benefit when compared to older immunosuppressant drugs and now these new data demonstrate the survival benefit of CellCept combinations over the newer drug regimens.

Kidneys are the most commonly transplanted organs[ii]; for every kidney available there are four people waiting to receive one[iii]. After transplantation, people need to take a combination of immunosuppressant drugs for the rest of their lives to prevent the body rejecting the new organ. By preserving the transplanted organ with CellCept based combinations, doctors can help patients to keep their organs longer, thereby, reducing the burden on the already limited donor pool. One way to achieve this is by choosing combinations based on the low toxicity profile of CellCept, along with reduced doses of the more toxic immunosuppressant drugs to decrease the risk of losing the new kidney.

"We have learnt that the combination of cyclosporine/sirolimus is toxic to the kidney over time and as a result some doctors have switched to a sirolimus/tacrolimus combination, that was perceived to be less toxic," said Prof Herwig-Ulf Meier Kriesche, University of Florida, Gainesville, Fl, USA. "Now we have the data to show that this combination is just as damaging. These data, along with this latest analysis of patients on CellCept combinations, should help us make an evidence-based choice on how best to reduce the risk of toxicity, which we know is associated with some long-term immunosuppressant regimens," he added.

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Improved kidney survival

  • Data were analysed from 44,915 adult kidney transplant patients, discharged between 2000-2004, on a drug regimen including CellCept or rapamycin in place of cyclosporine. Superior graft survival was seen in all patient groups treated with CellCept + tacrolimus (p<0.001).

  • This significant effect was magnified for patients with high risk grafts*, that may show earlier susceptibility to nephrotoxic damage.

  • Additional data show that the two drug regimens have similar low acute rejection rates in the first year (11.5%-12.6%). As data show that three year survival rates were significantly different, it seems that these two parameters may not have a clinical correlation.

  • Data were drawn from US renal transplant recipients, 2000-2004.

  • *High risk graft recipient groups included deceased donor, expanded criteria donor and African American.

Roche in transplantation
Roche is strongly committed to improving the long-term outcomes of transplantation and enhancing the quality of life of transplant recipients. Roche has developed innovative therapies that improve graft and post-transplant health: CellCept is the cornerstone of low toxicity immunosuppressant therapies.

CellCept, the largest selling branded immunosuppressant in North America, offers both physicians and patients the possibility of an effective long-term immunosuppressant regimen with low toxicity. Zenapax prevents the acute rejection of the newly transplanted organ. Valcyte was developed for the prevention of cytomegalovirus, a dangerous viral infection associated with transplantation. In addition, Roche supports basic research in transplantation with its funding of the independent Roche Organ Transplantation Research Foundation (ROTRF), which directly supports innovative research projects attracting new researchers with novel scientific ideas to meet unmet medical needs in solid organ transplantation.

About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai.

References
[i] Schold JD, Fujita S, Srinivas TR, Kaplan B, Meier-Kriesche H-U. Evidence for worse renal allograft survival with the the rapa/fk versus mmf/fk combination. [OR-092] presented at European Society of Organ Transplantation (ESOT) 2005.

[ii] UK Transplant © 2004. About Transplants. [Accessed 27 September 2005]. Available from: http://www.uktransplant.org.uk/ukt/about_transplants/about_transplants.jsp

[iii] UK Transplant © 2004. Statistics. [Accessed 27 September 2005]. Available from: http://www.uktransplant.org.uk/ukt/statistics/transplant_activity_report/archive_activity_reports/pdf/ukt/tx_activity_report_2004_uk2_complete.pdf


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