The Efficacy and Safety of an Immunosuppressive Regimen Including the Use of Mycophenolate Mofetil and an Interleukin-2 Monoclonal Antibody in Heart Transplant Patients

ABSTRACT

BACKGROUND AND OBJECTIVES: An immunosuppressive regimen including the use of mycophenolate mofetil (MMF) and an interleukin-2 monoclonal antibody (IL2mAb) has shown promise to prevent acute rejection after heart transplantation. There has been a lack of report on the evaluation of the efficacy and safety of this regimen in patients receiving heart transplants in Korea. SUBJECTS AND METHODS: From November 1992 to December 2003, 111 consecutive patients who had received heart transplants in our institute were classified into two groups: patients who received the immunosuppressive regimen with MMF and an IL2mAb (group A, n=51) and patients who did not receive the regimen (group B, n=60). We compared the clinical outcomes of patients in each group including the survival rate and the occurrence of acute rejection and infection at 24 months post transplantation. RESULTS: Both drugs were tolearated in all patients except in 5 patients who complained of gastrointestinal side effects due to MMF. Despite a longer ischemic time (137.4+/-54.6 vs. 92.3+/-25.8 hours, p<0.05) and a lower serum level of cyclosporine (212.3+/-66.8 vs. 259.1+/-62.1 ng/mL, p<0.05), the rate of treatment for acute rejection was lower in group A than in group B (16% vs. 53%, p<0.05). In addition, the median time to the first treatment for acute rejection was almost twice as long for group A as for group B (91 vs. 43 days, p<0.05). The 2-year survival rate and the incidence of major infection requiring hospitalization in both groups were 94% vs. 88% and 26% vs. 21%, respectively, which were not statistically different. CONCLUSION: An immunosuppressive regimen including the use of MMF and an IL2mAb is efficacious and safe as a prophylaxis against acute rejection without the increased risk of major infection in patients who have received heart transplants in Korea.