New immunosuppressant Certican addresses a key risk factor in late graft loss - First ever clinical data for an immunosuppressan

15-Apr-2002

Basel, Switzerland, – New clinical data on the investigational transplantation drug CerticanTM (everolimus), a proliferation inhibitor, presented at the International Society of Heart and Lung Transplantation (ISHLT) in Washington, demonstrate a significant reduction in acute rejection and graft vasculopathy (proliferation of smooth muscle cells in the intima – or innermost wall – of the graft vessels, leading to gradual thickening, vessel narrowing and restriction of blood supply). This is the first time that an immunosuppressant has been shown to significantly reduce vasculopathy.

"After one year vasculopathy is the most serious risk-factor for long-term graft loss," commented Professor Jon Kobashigawa MD, University of California, Los Angeles one of the investigators of the study. "Late graft loss is a critical issue, and one that traditional immunosuppressants have failed to control adequately. A major challenge in transplantation is to improve long-term graft survival," he added, "Our hope is that the benefit of reduced vasculopathy at 12 months will translate into long-term benefits."

In this international trial, 634 heart transplant patients (all receiving Neoral® - cyclosporin microemulsion - and steroids) were randomised to one of three groups: Certican at 1.5 mg/ day, Certican at 3.0 mg /day or to the standard add-on immunosuppressant therapy azathioprine at 1-3 mg/kg/day.

Acute rejection rates after 12 months were significantly lower (p<0.001) in patients receiving Certican at 3.0 mg/day (21.3%), than in patients on azathioprine at 1-3 mg/kg/ day (45.8%). In patients given Certican at 1.5mg/day the acute rejection rate was 30.6%, compared with 45.8% with azathioprine (p<0.001).

Of particular importance, 12 months data showed that the addition of Certican to the standard regimen significantly (p <0.05) lowered the incidence of graft vasculopathy compared with azathioprine. Vasculopathy was measured serially using a specialised, state- of-the-art intravascular ultrasound (IVUS) technique to measure the thickness of the intima of the vessel.

In addition to acute rejection rates and intimal thickening being significantly lower in the Certican group than in the azathioprine group, the study also showed a significant reduction (p<0.001) in the incidence of cytomegalovirus (CMV) infections, which is an important risk factor for the development of vasculopathy.

The investigators concluded that these attributes of Certican could conceivably have a major impact both on the health-related quality of life of heart and other transplant patients as well as on medical care resource utilisation - by decreasing morbidity, graft loss and costs of prolonged hospitalisation and/or re-transplantation.

This international trial is planned to run for another year.

https://www.bionity.com/en/news/10109/new-immunosuppressant-certican-addresses-a-key-risk-factor-in-late-graft-loss-first-ever-clinical-data-for-an-immunosuppressan.html