A matched cohort pharmacoepidemiological analysis of steroid free immunosuppression in renal transplantation.

BACKGROUND

This longitudinal, sequential, matched closed-cohort design pharmacoepidemiological analysis examined the influence of maintenance steroid therapy in 380 first graft recipients after renal transplantation under conditions of normal clinical practice.

METHODS

Nonexposed (steroid avoidance, n=190) and exposed (steroid treated, n=190) cohorts were matched 1:1 for key demographic factors, including donor source (living or deceased), diabetic status, panel reactive antibody level, recipient age (by decade), and sex.

RESULTS

Cohorts were comparable for all variables except median human leukocyte antigen mismatch (4 vs. 3, P=0.03), use of tacrolimus (90.0% vs. 59.5%, P<or=0.0001), and of basiliximab (94.7% vs. 57.4%, P<or=0.0001), which were higher in the nonexposed cohort. Estimated glomerular filtration rate (mL/min/1.73 m) was comparable at 1 year (median: 58.1 vs. 58.3, P=0.92) and 2 years (median: 55.5 vs. 58.0, P=0.97) in nonexposed and in exposed cohorts (P=0.97). There was no difference in Kaplan-Meier estimates of biopsy-proven acute rejection (14.8% vs. 17.0%; hazard ratio: 0.88, P=0.60) or of 2-year death censored graft failure (4.7% vs. 3.2%; P=0.44) between nonexposed or exposed cohorts. Median total cholesterol (4.6 vs. 5.0 mmol/L, P=0.0002), low-density lipoprotein (2.6 vs. 2.8 mmol/L, P=0.005), high-density lipoprotein levels (1.1 vs. 1.3, P=0.0001), and median weight change from baseline (-1.7 vs. +1.0 kg, P=0.001) were significantly lower in the nonexposed cohort. Forty-five patients (29%) in the nonexposed cohort commenced steroid therapy, principally for graft dysfunction or acute rejection.

CONCLUSION

In summary, steroid avoidance did not negatively impact 2-year graft function, biopsy-proven acute rejection rate, or short-term graft survival and offers clinical benefits, which weigh in the decision regarding maintenance therapy.