Keymeulen et al. 10.1073/pnas.0608141103. |
Table 3. Characteristics of recipients with and without graft function during PT month 2
| C-peptide >0.5 ng/ml |
| |
| Yes (n = 16) | No (n = 6) | P value |
Recipient characteristics before transplant |
|
|
|
Age (yrs) | 43 (40-50) | 42 (36-46) | 0,68 |
Body weight (kg) | 69 (65-76) | 70 (61-73) | 0,88 |
BMI (kg/m2) | 24,7 (22,4-26,1) | 22,8 (21,3-24,0) | 0,27 |
Diabetes |
|
|
|
Age at clinical onset (yrs) | 18 (12-23) | 17 (11-24) | 0,94 |
HbA1c (%) | 7,6 (6,9-8,0) | 7,8 (7,1-8,2) | 0,58 |
Insulin dose (IU/kg/d) | 0,6 (0,5-0,7) | 0,8 (0,6-0,9) | 0,26 |
Positivity for |
|
|
|
ICA | 6/16 | 1/6 | 0,61 |
GADA | 8/16 | 4/6 | 0,64 |
IA2-A | 7/16 | 2/6 | 1,00 |
I(A)A | 15/16 | 4/6 | 0,16 |
Grafts |
|
|
|
b cell number (106/kg BW) | 3,1 (2,3 - 3,9) | 1,4 (1,3 - 1,8) | 0,002 |
Immune suppression |
|
|
|
ATG dose (mg/kg) | 24 (22-25) | 24 (22-24) | 0,76 |
MMF (gr/d) | 2000 (2000-2000) | 2000 (1625-2000) | 0,08 |
Tacrolimus trough (ng/ml)* | 9 (8-10) | 7 (6-10) | 0,35 |
CD3+ (/mm3)* | 181 (150-226) | 204 (144-252) | 0,76 |
CD4/CD8* | 0,54 (0,37-0,61) | 0,61 (0,52-0,72) | 0,25 |
CD19+ (/mm3)* | 182 (165-331) | 305 (254-416) | 0,10 |
Data represent median (IQR). Difference in b cell number remains significant at the 5% level after Bonferroni correction (on the basis of 18 tests performed).
*Median of all measurements during PT month 2
Table 4. Adverse events (grades 2, 3, and 4) during PT year 1
PT month | 0-3 | 3-6 | 6-9 | 9-12 | ||||
Recipients with events | n | % | n | % | n | % | n | % |
Gastrointestinal |
|
|
|
|
|
|
|
|
Pyrosis | 9 | 37 | 3 | 12 | 3 | 13 | 0 | 0 |
Vomiting | 2 | 8 | 0 | 0 | 0 | 0 | 0 | 0 |
Esophagitis | 1 | 4 | 1 | 4 | 0 | 0 | 0 | 0 |
Acute Diarrhea | 1 | 4 | 0 | 0 | 0 | 0 | 1a | 4 |
CMV hepatitis | 1 | 4 | 0 | 0 | 0 | 0 | 0 | 0 |
Apthous Mouth Ulcer | 0 | 0 | 4 | 17 | 0 | 0 | 0 | 0 |
Neurologic |
|
|
|
|
|
|
|
|
Insomnia | 2 | 8 | 2 | 8 | 3 | 13 | 1 | 4 |
Depression | 2 | 8 | 2 | 8 | 1 | 4 | 1 | 4 |
Tacrolimus Neuropathy | 0 | 0 | 0 | 0 | 1a | 4 | 0 | 0 |
Constitutional |
|
|
|
|
|
|
|
|
Asthenia | 4 | 16 | 1 | 4 | 0 | 0 | 1 | 4 |
Loss of Bodyweight | 2 | 8 | 6 | 25 | 6 | 26 | 6 | 26 |
Respiratory |
|
|
|
|
|
|
|
|
Rhinits | 3 | 12 | 2 | 8 | 1 | 4 | 3 | 13 |
Bronchitis | 2 | 8 | 2 | 8 | 2 | 8 | 4 | 17 |
Skin |
|
|
|
|
|
|
|
|
Ungual Infection | 2 | 8 | 1 | 4 | 0 | 0 | 1 | 4 |
Acné/folliculitis | 0 | 0 | 1 | 4 | 1 | 4 | 4 | 17 |
Laboratory |
|
|
|
|
|
|
|
|
Anemia | 18e | 75 | 5 | 20 | 2 | 8 | 2a | 8 |
Leucopenia | 17d | 70 | 12b,f | 50 | 4b | 17 | 6 | 26 |
Increase in ALT | 8c | 33 | 0 | 0 | 0 | 0 | 0 | 0 |
Adverse events were graded with the National Cancer Institute Common Terminology Criteria system version 3.0 (32).
Number of adverse events that is not grade 2 (moderate) is shown in superscript letters: Grade 3 in 1 patient (a), 2 patients (b), 3 patients (c), 5 patients (d), and 6 patients (e); grade 4 in 1 patient (f).