Table 2.
Patient demographicsa | Median (range) | Number of patients (%) |
---|---|---|
Age | 45 (18–67) | |
Gender | ||
Male | 23 (49%) | |
Female | 24 (51%) | |
Months from transplant | 40 (6–170) | |
Duration of cGVHD (months) | 25 (1–161) | |
Donor source | ||
Related | 29 (62%) | |
Unrelated | 18 (38%) | |
Cell source | ||
Bone marrow | 13 (27%) | |
Peripheral blood | 34 (72%) | |
Acute GVHD | 31 (66%) | |
CGVHD onset | ||
Progressive | 19 (40%) | |
Quiescent | 12 (26%) | |
de novo | 16 (34%) | |
Global NIH scoreb | ||
Mild | 1 (2%) | |
Moderate | 16 (34%) | |
Severe | 30 (63%) | |
Number of organs involved | 5 (1–8) | |
Eyes | 42 (89%) | |
Genital tract (female) | 13 (28%) | |
GI tract | 24 (51%) | |
Joint fascia | 28 (60%) | |
Liver | 21 (45%) | |
Lungs | 30 (64%) | |
Mouth | 34 (72%) | |
Skinc | 39 (83%) | |
Erythema (% BSA) | (0.45–80) | 30 (65%) |
Dermal sclerosis (% BSA) | (0.18–62.1) | 25 (53%) |
Deep sclerosis (% BSA) | (0.45–66.6) | 22 (47%) |
Total NIH score | 7 (2–13) | |
Systemic immunosuppressiond | ||
None | 8 (17%) | |
Mild | 3 (6%) | |
Moderate | 14 (30%) | |
High | 22 (47%) | |
Number of prior systemic regimens | 3 (0–8) |
Abbreviations: BSA, body surface area; cGVHD, chronic graft versus host disease; GI, gastrointestinal.
These patients constitute a series of patients whose Treg subpopulations were assessed in comparison with normal controls on day of entry into the protocol. Any patients in Table 1 have been excluded.
cGVHD severity was characterized as mild (only one or two organs (except lung) affected, with a maximum score of 1 in any organs), moderate (lungs with a maximum score of 1, at least one organ with a score of 2, or three or more organs with a maximum score of 1) or severe (a score of 3 in any organ, or a lung score of 2 or 3).
These categories are not mutually exclusive. Some patients were scored as having areas of erythema, as well as dermal and/or deep sclerosis.
Immunosuppression categories: none, mild (single-agent prednisone <0.5mg/kg per day), moderate (prednisone ⩾0.5 mg/kg per day and/or any single agent per modality), high (two or more agents per modalities±prednisone ⩾0.5 mg/kg per day).