Prograf for steroid-free and cost-effective immunosuppression

VENICE (Italy) September 24 (PROTEXT/PRNewswire) - Theresults of several trials reported at the 11th Congress of theEuropean Society for Organ Transplantation in Venice suggest thatthe use of the cornerstone immunosuppressant Prograf(r)(tacrolimus) not only enables the successful management oftransplant recipients without the need for corticosteroid therapy- an all-important goal in transplantation - but also that it canbe more cost-effective than ciclosporin microemulsion.

Corticosteroids have been a key component of post-transplantimmunosuppressive regimens since the early days oftransplantation, but their use is associated with a myriad ofpotentially harmful side effects, including bonedemineralisation, diabetes mellitus and hyperlipidaemia. Asa result, many transplant centres are investigating thefeasibility of withdrawing or omitting corticosteroids fromimmunosuppressive regimens.

Several studies presented at the ESOT congress demonstratedthat immunosuppression with Prograf(r) permits the successfulwithdrawal or avoidance of corticosteroids, providing a number ofhealth-related benefits and without placing the transplantrecipient at increased risk of graft rejection. Indeed, the 3-year follow-up results of a European, multicentre study,presented by Professor Johannes van Hooff (Department of InternalMedicine, University Hospital Maastricht, Maastricht, theNetherlands), revealed that steroid-free immunosuppression withPrograf(r) plus mycophenolate mofetil (MMF) is feasible over thelong term. (1)

To achieve maximum effectiveness in terms of steroidavoidance after kidney or liver transplantation, Prograf(r) canbe combined with the anti-interleukin-2-receptor monoclonalantibody agents basiliximab and daclizumab, induction agentsadministered in the early post-transplantation period. (2-4) The6-month results of a randomised comparative study in 538 renaltransplant recipients showed important health benefits associatedwith a steroid-free regimen of daclizumab induction followed byPrograf(r)/MMF dual therapy. Good renal function was maintainedwithout any increase in acute rejection and the incidence of new-onset diabetes mellitus was less than 1%. (3) In livertransplantation, a steroid-free immunosuppressive regimen ofPrograf(r) monotherapy after daclizumab induction was associatedwith a lower incidence of diabetes mellitus and cytomegalovirusinfection compared with the same regimen but containing steroids.(4)

"There is a growing body of evidence that using Prograf(r) asthe primary immunosuppressant plus monoclonal antibody inductiontherapy does mean physicians can potentially avoid or withdrawsteroids," said Mr David Mayer (The Liver and Hepatobiliary Unit,Queen Elizabeth Hospital, Birmingham, UK). He added that this ispotentially very good news for patients, not just because of theimportant safety advantages, but also because anything thatimproves tolerability is likely to improve patient compliance -critical in preventing organ rejection.

Data were also presented that demonstrated that the costsassociated with kidney transplantation can be reduced (savingsper patient ranged from 583 to 9,919) by using Prograf(r) basedtherapy. A pharmacoeconomic analysis of a European, multicentre,direct, head-to-head comparison (557 patients) of Prograf(r) andciclosporin microemulsion-based regimens was conducted from ahospital perspective. To gain a reliable pan-European picture,the costs of treatment were calculated independently using localcost data from three countries - Italy, Spain and Germany. Inall three countries the cost advantages of Prograf(r) were due tolower hospitalisation costs, lower costs for concomitantimmunosuppressive medication, and a lower incidence of dialysis.(5)

Taken together, these data reinforce the position of Prograf(r) at the centre of successful immunosuppressive regimens inboth kidney and liver transplantation.

Fujisawa GmbH is a subsidiary of Fujisawa Pharmaceutical Co.,Ltd., based in Osaka, Japan. Fujisawa Pharmaceutical Co., Ltd. isamong the world's top 30 pharmaceutical companies and employsover 8000 people in Japan, Europe, North America and Asia. Sinceits launch of Prograf(r) in Japan in 1993, the first in theworld, Fujisawa has become one of the world's leading transplantand immunosuppression companies.

Fujisawa plans to maintain its commitment to transplantation,and is dedicated both to improving the results of solid-organtransplantation and to ensuring the health and quality of life ofpatients. Prograf(r) is currently available in nearly 70countries and forms the centrepiece of Fujisawa's continuinggrowth. Additional information on Fujisawa GmbH can be found onthe Company's Web site at www.fujisawaeurope.com.References

1. Van Hoof JP, et al. Long-term efficacy and safety ofsteroid-withdrawal in tacrolimus-treated patients: results of along-term follow-up study in renal transplant patients. Presentedat the 11th Congress of the European Society for OrganTransplantation, 20-24 September 2003, Venice, Italy. Abstract99.

2. Salmela K, et al. Steroid-free immunosuppression withtacrolimus/basiliximab and tacrolimus/MMF in renaltransplantation: a large, prospective, randomised, 6-month study.Presented at the 11th Congress of the European Society for OrganTransplantation, 20-24 September 2003, Venice, Italy. Abstract287.

3. Mourad G, et al. Immunosuppression without steroids:daclizumab/tacrolimus/MMF vs tacrolimus/MMF/steroids in renaltransplantation. Presented at the 11th Congress of the EuropeanSociety for Organ Transplantation, 20-24 September 2003, Venice,Italy. Abstract 12.

4. Mayer AD, et al. Steroid-free immunosuppression withtacrolimus after daclizumab induction: a multicentre,comparative, randomised study. Presented at the 11th Congress ofthe European Society for Organ Transplantation, 20-24 September2003, Venice, Italy. Abstract 97.

5. Vianello A, et al. Analysis of cost effectiveness ofimmunosuppression following kidney transplantation in threeEuropean countries. Presented at the 11th Congress of theEuropean Society for Organ Transplantation, 20-24 September 2003,Venice, Italy. Abstract 168.Abstract numbers obtained fromhttp://www.keycongress.com/congressi/esot2003/esot.htmContact:Marité OdeFujisawa GmbH, Munich, GermanyT: +49 89 45442249F: +49 89 434129media@fujisawa.de

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