Patient and transplant characteristics
| . | Itacitinib (n = 70) . | Systemic corticosteroids (n = 140) . | P value∗ . |
|---|---|---|---|
| Age at BMT, median [range] | 60 [15-74] | 59 [12-79] | .72 |
| Indication for HCT, n (%) | .07 | ||
| Acute leukemia | 32 (46%) | 75 (54%) | |
| Lymphoma | 6 (9%) | 13 (9%) | |
| MDS/MPN | 29 (41%) | 38 (27%) | |
| Nonmalignant | 3 (4%) | 5 (4%) | |
| Other malignant† | 0 (0%) | 9 (6%) | |
| Donor type, n (%) | .66 | ||
| Related | 28 (40%) | 61 (44%) | |
| Unrelated | 42 (60%) | 79 (56%) | |
| Stem cell source, n (%) | .08 | ||
| Bone marrow | 10 (14%) | 35 (25%) | |
| Peripheral blood | 60 (86%) | 105 (75%) | |
| HLA match, n (%) | .50 | ||
| Matched | 50 (71%) | 90 (64%) | |
| Mismatched | 5 (8%) | 17 (12%) | |
| Haploidentical | 15 (21%) | 33 (24%) | |
| Conditioning intensity, n (%) | .88 | ||
| Myeloablative | 33 (47%) | 68 (49%) | |
| Non-myeloablative/reduced intensity | 37 (53%) | 72 (51%) | |
| GVHD serotherapy, n (%) | .19 | ||
| ATG | 9 (13%) | 29 (21%) | |
| No ATG | 61 (87%) | 111 (79%) | |
| GVHD prophylaxis, n (%) | .17 | ||
| CNI based | 33 (47%) | 82 (59%) | |
| Cyclophosphamide based | 35 (50%) | 55 (39%) | |
| T-cell depletion | 2 (3%) | 1 (1%) | |
| Sirolimus based | 0 (0%) | 2 (1%) | |
| GVHD grade, n (%) | .87 | ||
| Grade I | 12 (17%) | 25 (18%) | |
| Grade II | 55 (79%) | 111 (79%) | |
| Grade III | 3 (4%) | 4 (3%) | |
| Target organ involvement, n (%) | 1 | ||
| LGI ± other | 21 (30%) | 42 (30%) | |
| Skin 1/2 ± UGI | 16 (23%) | 30 (21%) | |
| Skin 3 ± UGI | 28 (40%) | 56 (40%) | |
| UGI only | 5 (7%) | 12 (9%) | |
| Histopathologic confirmation of GVHD | 35 (50%) | 54 (39%) | .14 |
| MAP median [range] | 0.064 [0.013-0.139] | 0.072 [0.020-0.140] | .08 |
| CMV-seropositive donor or recipient | .12 | ||
| Yes | 55 (79%) | 92 (66%) | |
| No | 15 (21%) | 47 (33%) | |
| N/A | 0 | 1 (1%) | |
| Topical corticosteroids, n (%) | .76 | ||
| Yes | 43 (61%) | 89 (64%) | |
| No | 27 (39%) | 51 (36%) |
| . | Itacitinib (n = 70) . | Systemic corticosteroids (n = 140) . | P value∗ . |
|---|---|---|---|
| Age at BMT, median [range] | 60 [15-74] | 59 [12-79] | .72 |
| Indication for HCT, n (%) | .07 | ||
| Acute leukemia | 32 (46%) | 75 (54%) | |
| Lymphoma | 6 (9%) | 13 (9%) | |
| MDS/MPN | 29 (41%) | 38 (27%) | |
| Nonmalignant | 3 (4%) | 5 (4%) | |
| Other malignant† | 0 (0%) | 9 (6%) | |
| Donor type, n (%) | .66 | ||
| Related | 28 (40%) | 61 (44%) | |
| Unrelated | 42 (60%) | 79 (56%) | |
| Stem cell source, n (%) | .08 | ||
| Bone marrow | 10 (14%) | 35 (25%) | |
| Peripheral blood | 60 (86%) | 105 (75%) | |
| HLA match, n (%) | .50 | ||
| Matched | 50 (71%) | 90 (64%) | |
| Mismatched | 5 (8%) | 17 (12%) | |
| Haploidentical | 15 (21%) | 33 (24%) | |
| Conditioning intensity, n (%) | .88 | ||
| Myeloablative | 33 (47%) | 68 (49%) | |
| Non-myeloablative/reduced intensity | 37 (53%) | 72 (51%) | |
| GVHD serotherapy, n (%) | .19 | ||
| ATG | 9 (13%) | 29 (21%) | |
| No ATG | 61 (87%) | 111 (79%) | |
| GVHD prophylaxis, n (%) | .17 | ||
| CNI based | 33 (47%) | 82 (59%) | |
| Cyclophosphamide based | 35 (50%) | 55 (39%) | |
| T-cell depletion | 2 (3%) | 1 (1%) | |
| Sirolimus based | 0 (0%) | 2 (1%) | |
| GVHD grade, n (%) | .87 | ||
| Grade I | 12 (17%) | 25 (18%) | |
| Grade II | 55 (79%) | 111 (79%) | |
| Grade III | 3 (4%) | 4 (3%) | |
| Target organ involvement, n (%) | 1 | ||
| LGI ± other | 21 (30%) | 42 (30%) | |
| Skin 1/2 ± UGI | 16 (23%) | 30 (21%) | |
| Skin 3 ± UGI | 28 (40%) | 56 (40%) | |
| UGI only | 5 (7%) | 12 (9%) | |
| Histopathologic confirmation of GVHD | 35 (50%) | 54 (39%) | .14 |
| MAP median [range] | 0.064 [0.013-0.139] | 0.072 [0.020-0.140] | .08 |
| CMV-seropositive donor or recipient | .12 | ||
| Yes | 55 (79%) | 92 (66%) | |
| No | 15 (21%) | 47 (33%) | |
| N/A | 0 | 1 (1%) | |
| Topical corticosteroids, n (%) | .76 | ||
| Yes | 43 (61%) | 89 (64%) | |
| No | 27 (39%) | 51 (36%) |
ATG, anti-thymocyte globulin; CNI, calcineurin inhibitor; CMV, cytomegalovirus; LGI, lower gastrointestinal; MAP, MAGIC algorithm probability; MDS, myelodysplastic syndrome; MPN, myeloproliferative neoplasm; N/A, not available; UGI, upper gastrointestinal.
P values were obtained from the Fisher exact test for categorical variables and the Wilcoxon test for continuous variables.
Other malignant: multiple myeloma (7), prolymphocytic leukemia (1), chronic lymphocytic leukemia (1).