Comparison of the long-term efficacy and safety of generic Tacrobell with original tacrolimus (Prograf) in kidney transplant recipients

Figures & data

Figure 1 Patient disposition.

Abbreviations: PGF, Prograf; TCB, Tacrobell.

Table 1 Demographic and clinical characteristics

Variable	PGF group (n=245)	TCB group (n=444)	P-value
Recipient
Age, year	39.8±10.1	45.8±11.2	<0.0001
Male sex, n (%)	157 (64.1)	258 (58.1)	0.1251
BMI, kg/m^2	22.7±3.5	22.7±3.4	0.9310
Cause of ESRD, n (%)			0.0483
Diabetes mellitus	21 (8.6)	63 (14.2)
IgA nephropathy	24 (9.8)	62 (14.0)
FSGS	6 (2.5)	5 (1.1)
Other glomerulonephritis	39 (15.9)	51 (11.5)
ADPCK	8 (3.3)	21 (4.7)
Others	8 (3.3)	18 (4.1)
Unknown	139 (56.7)	224 (50.5)
HBsAg+, n (%)	11 (4.5)	23 (5.2)	0.6888
Anti-HCV Ab+, n (%)	6 (2.5)	5 (1.1)	0.2113
CMV-, n (%)	1 (0.4)	0 (0)	0.3556
Dialysis duration, months	24.4 (5.1–65.3)	32.2 (2.8–72.7)	0.7710
Dialysis modality, n (%)			0.8886
Preemptive	23 (9.4)	66 (14.9)
Hemodialysis	175 (71.4)	308 (69.3)
CAPD	47 (19.2)	70 (15.8)
PRA >30%, n (%)	14 (5.7)	50 (11.3)	0.0163
Secondary KT, n (%)	22 (9)	36 (8.1)	0.6816
Donor
Age, year	40.7±12.5	44.0±12.7	0.0010
BMI, kg/m^2	23.5±3.0	23.4±3.6	0.5592
Relationship, n (%)			0.0004
Living	184 (75.1)	274 (61.7)
Deceased	61 (24.9)	170 (38.3)
No of HLA mismatches	3.9±1.5	3.3±1.5	<0.0001
Transplant
Cold ischemic time, min	59.0 (45.0–144.0)	100.0 (66.0–224.0)	<0.0001
Induction therapy, n (%)	76 (31.0)	433 (97.5)	<0.0001
Delayed graft function, n (%)	30 (12.2)	48 (10.8)	0.5696
Primary nonfunction, n (%)	4 (1.6)	4 (0.9)	0.4636
Acute rejection, n (%)	92 (37.6)	126 (28.4)	0.0132
Repeated acute rejection, n (%)	27 (11.0)	36 (8.1)	0.2042

Notes: Continuous variables are expressed as the mean ± standard deviation or median (interquartile range). Categorical variables are expressed as number (%).

Abbreviations: ADPCK, autosomal dominant polycystic kidney; BMI, body mass index; CAPD, continuous ambulatory peritoneal dialysis; CMV, cytomegalovirus; ESRD, end-stage renal disease; FSGS, focal segmental glomerulosclerosis; HBsAg, hepatitis B surface antigen; HCV, hepatitis C virus; HLA, human leukocyte antigen; KT, kidney transplant; min, minutes; PGF, Prograf; PRA, panel reactive antibody; TCB, Tacrobell.

Figure 2 Five-year graft survival rates.

Notes: The solid line indicates graft survival in the TCB group patients; the broken line indicates graft survival in the PGF group patients. The 5-year graft survival rate was 92% for patients in PGF and 97% for patients in TCB, but the difference was not significant (P=0.1857) after adjusting for other risk factors. A significant noninferiority (with a margin of 0.2) of TCB was observed compared to PGF (HR: 0.58; 95% CI: 0–1.14).
Abbreviations: CI, confidence interval; HR, hazard ratio; PGF, Prograf; TCB, Tacrobell.

Figure 3 Five-year patient survival rates.

Notes: The solid line indicates survival of patients in the TCB group; the broken line indicates survival of patients in the PGF group. The 5-year patient survival rate was 96% for patients in the PGF group and 97% for patients in the TCB group (Figure 3), but the difference was not significant (P=0.7143) after adjusting for other risk factors. A significant noninferiority (with a margin of 1) of TCB was observed compared to PGF (HR 0.83; 95% CI: 0–1.95).
Abbreviations: CI, confidence interval; HR, hazard ration; PGF, Prograf; TCB, Tacrobell.

Figure 4 Five-year acute rejection-free graft survival rates.

Notes: The solid line indicates acute rejection-free graft survival in the TCB group; the broken line indicates acute rejection-free graft survival in the PGF group. The 5-year acute rejection-free graft survival rate was not significantly different between the groups (TCB 67%, PGF 68.8%; P=0.6286).
Abbreviations: PGF, Prograf; TCB, Tacrobell.

Table 2 Long-term adverse events

Adverse event	PGF group (n=245)	TCB group (n=444)	P-value
Cardiovascular events, n (%)	6 (2.5)	4 (0.9)	0.1793
Cerebrovascular events, n (%)	7 (2.9)	7 (1.6)	0.2703
Malignancy, n (%)	6 (2.5)	9 (2.0)	0.7870
NODAT, n (%)	28 (11.4)	49 (11.1)	0.9000
Infection events, n (% of total infection events)			0.3060
UTI	46 (13.6)	85 (17.5)
Pneumonia	19 (5.6)	29 (6.0)
PJP	2 (0.6)	0 (0.0)
CMV infection	139 (41.0)	204 (41.9)
Others	133 (39.2)	169 (34.7)

Abbreviations: CMV, cytomegalovirus; NODAT, new-onset diabetes after transplantation; PGF, Prograf; PJP, Pneumocystis jiroveci pneumonia; TCB, Tacrobell; UTI, urinary tract infection.