Steroids have remained the mainstay of immunosuppression but their prolonged use is associated with a number of side effects. Recent data indicate that early elimination or steroid free regimens are feasible in renal transplant recipients (RTR), thereby reducing the side effects and improving compliance.
Methods: -A prospective open labeled controlled study to assess the safety and efficacy of steroid avoidance in RTR was initiated in our centre with the following inclusion criteria a) severe diabetes, b) ischemic heart disease, c) gross obesity and d) bone complications like osteoporosis or avascular necrosis. Exclusion criteria included high risk patients with, re- transplants, PRA of >20 or previous positive cross match. Primary end point was biopsy proven acute rejection. Total number studied was 40 with 20 in the steroid free group and 20 in the control group. In the steroid free group, all subjects other than those with no HLA mismatches received induction therapy with either antithymocyte globulin (ATG Fresenius) or interleukin 2 receptor antibody (IL2Rab) Basiliximax except one who received Campath1H. Steroids were given only for 5 days and then discontinued and the maintenance immunosuppression included a combination of mycophenolate mofetil (MMF) and Tacrolimus (Tac), n= 11; Rapamicin (Rapa) and Tac, n= 4 ; MMF and Cyclosporine A (CyA), n=3 ; and one case each of MMF and Rapa and Tac monotherapy (Campath1H induced patient). These subjects were compared to matched controls and were followed up for a median period of 8.8 months with a minimum of 3 months.
Results: Demographic details were comparable in both groups. Patient survival and graft survival were 100% in both groups. Biopsy proven ARE were 1 (5%) in the steroid group, compared to 3 (15%) in the control group with a mean serum creatinine of 118.8 umol/L and 108.2 umol/L respectively. Post transplant hypertension, higher number of antihypertensive medications, weight gain and post transplant diabetes mellitus were more common in the control group than the steroid free group. Steroid avoidance in selected patients using newer immunosuppressive protocols provides comparable graft survival, patient survival and rejection episodes and low incidence of steroid related morbidities. These results will be further verified as our study continues in larger number of patients with longer follow up evaluation.