Long-Term Infectious and Noninfectious Outcomes of Monthly Alemtuzumab as a Calcineurin Inhibitor- and Steroid-Free Regimen for Pancreas Transplant Recipients
Table 3
Infection, rejection, graft failure, cancer, and mortality outcomes among pancreas transplant recipients receiving the standard induction and maintenance therapies vs. those with extended alemtuzumab exposure.
Outcomesa
Standard induction and maintenance therapy n = 159
Extended alemtuzumab exposure n = 179 (%)
value
Unadjusted HR (95% CI)
value
Adjusted HRb (95% CI)
value
All infectionsc
140 (88.1)
169 (94.4)
0.06
1.33 (1.06–1.66)
0.01
1.41 (1.11–1.79)
0.01
Bacteriac
135 (84.9)
166 (92.7)
0.03
1.33 (1.05–1.67)
0.02
1.37 (1.07–1.76)
0.01
Gram positive
116 (73.0)
143 (79.9)
0.17
C difficile
21 (13.2)
33 (18.4)
0.25
Gram negative
67 (42.1)
88 (49.2)
0.24
Mycobacteria
1 (0.6)
6 (3.4)
0.17
Fungic
42 (26.4)
77 (43.0)
0.002
1.86 (1.28–2.71)
<0.01
1.84 (1.24–2.74)
<0.01
Aspergillus spp.
2 (1.3)
6 (3.4)
0.37
Candida spp.
27 (17.0)
55 (30.7)
0.005
Other
21 (13.2)
32 (17.9)
0.30
Non-CMV virusesc
44 (27.7)
59 (33.1)
0.35
1.29 (0.87–1.91)
0.20
1.24 (0.82–1.86)
0.31
HSV/VZV
24 (15.1)
40 (22.3)
0.12
Respiratory viruses
10 (6.3)
5 (2.8)
0.19
BKV
5 (3.1)
7 (3.9)
0.93
Other non-CMV virusesc
18 (11.3)
16 (8.9)
0.59
CMV
22 (13.8)
51 (28.5)
0.002
2.29 (1.39–3.77)
<0.01
1.95 (1.16–3.26)
0.01
Other infectionse
5 (3.1)
12 (6.7)
0.21
ACR
45 (28.3)
89 (49.7)
<0.001
2.09 (1.46–2.99)
<0.01
2.29 (1.57–3.33)
<0.01
Pancreas allograft failure
88 (55.3)
85 (47.5)
0.18
0.88 (0.65–1.18)
0.39
0.84 (0.61–1.15)
0.28
PAK
42 (26.4)
38 (21.2)
0.32
PTA
29 (16.2)
34 (21.4)
0.97
SPK
17 (10.7)
13 (7.3)
0.36
Kidney allograft failuref
15 (31.9)
22 (46.8)
0.14
Kidney function of all recipientsg
Creatinine (mean ± SD)h
1.52 ± 1.33
1.49 ± 0.89
0.89
Dialysis within one year of transplant
7 (4.5)
4 (2.3)
0.43
Cancer
46 (28.9)
54 (30.2)
0.89
1.40 (0.72–2.72)
0.32
1.34 (0.67–2.66)
0.41
Skin cancer
32 (20.1)
42 (23.5)
0.54
1.33 (0.84–2.10)
0.23
1.24 (0.76–2)
0.39
Death
49 (30.8)
72 (40.2)
0.09
1.38 (0.96–1.98)
0.08
1.31 (0.89–1.92)
0.17
aFirst event. bAdjusted for patients’ age, gender, pancreatic duct drainage, and CMV serostatus. cEach unique patient may have more than one infection. dHuman papillomavirus, viral meningitis or encephalitis, hepatitis C virus, gastrointestinal viruses, and EBV. eNot specified. fOf 47 patients in each group who received SPK. gData available for 157/159 in the standard induction and maintenance therapy group, 174/179 in the extended alemtuzumab group. hExcluding those who had to go on dialysis within one year of transplant. ACR: acute cellular rejection; BKV: BK virus; CI: confidence interval; HR: hazard ratio; HSV/VZV: herpes simplex virus/varicella zoster virus; PAK: pancreas after kidney transplant; PTA: pancreas transplant alone; SD, standard deviation; SPK: simultaneous pancreas and kidney transplant.
