Three-Year Outcomes in Kidney Transplant Patients Randomized to Steroid-Free Immunosuppression or Steroid Withdrawal, with Enteric-Coated Mycophenolate Sodium and Cyclosporine: The Infinity Study

Table 2

Immunosuppression at months 6 and 36.

	Month 6			Month 36
	Steroid avoidance (𝑛=70)	Steroid withdrawal (𝑛=61)	𝑃 value	Steroid avoidance (𝑛=70)	Steroid withdrawal (𝑛=61)	𝑃 value
Oral steroids, 𝑛/𝑁 (%)	19/70 (27.1)	34/61 (55.7)	0.001	22/68 (32.4)	30/58 (51.7)	0.028
Dose of oral steroids (mg/day)
Mean ± SD	8.8±1.7	9.6±5.9	0.529	6.2±2.2	5.9±3.2	0.206
Median (range)	10.0 (5.0–10.0)	8.8 (2.5–30.0)		5.5 (1.3–10.0)	5.0 (2.5–20.0)
Cumulative dose of oral steroids from month 6 (mg)
Mean ± SD	—	—	—	2467.8±3496	3397.7±3290	0.058
Median (range)	—	—		0 (0–11400)	3710 (0–11995)
CsA, 𝑛/𝑁 (%)	70/70 (100.0)	61/61 (100.0)	—	60/68 (89.6)	45/58 (81.8)	0.333
Tacrolimus, 𝑛/𝑁 (%)	—	—		7/68 (10.4)	10/58 (18.2)
No calcineurin inhibitor, 𝑛/𝑁 (%)	—	—		1/68 (1.4)	3/58 (5.2)
EC-MPS, 𝑛/𝑁 (%)	70/70 (100.0)	60/61 (98.4)	0.466	59/68 (93.7)	51/58 (87.9)	0.369
EC-MPS dose (mg/day)
Mean ± SD	1309±303	1332±259	0.435	1226±335	1161±340	0.242
Median (range)	1440 (180–2160)	1440 (720–1440)		1440 (360–1440)	1440 (540–1440)
mTOR inhibitor 𝑛/𝑁 (%)	—	—	—	0/70	2/58 (3.5)	0.201
Azathioprine 𝑛/𝑁 (%)	—	—	—	2/68 (2.9)	3/58 (5.2)	0.661

CsA: cyclosporine; EC-MPS: enteric-coated mycophenolate sodium; mTOR: mammalian target of rapamycin; SD: standard deviation.
Percentages at month 36 are shown using the denominator of all patients with a functioning graft at month 36.