Table 2.
CGVHD patient demographics
| 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).