ORR stratified by GVHD and patient characteristics
| . | Itacitinib (n = 70) . | Systemic corticosteroids (n = 140) . | P value . |
|---|---|---|---|
| GVHD characteristics | |||
| GVHD grade | |||
| Grade I | 11/12 (92%) | 19/25 (76%) | .39 |
| Grade II/III | 51/58 (90%) | 101/115 (88%) | 1 |
| Target organ involvement | |||
| LGI ± Other | 18/21 (86%) | 36/42 (86%) | 1 |
| Skin 1/2 ± UGI | 15/16 (94%) | 24/30 (80%) | .39 |
| Skin 3 ± UGI | 26/28 (93%) | 51/56 (91%) | 1 |
| UGI Only | 3/5 (60%) | 9/12 (75%) | .60 |
| Days between HCT and start of systemic treatment∗ | |||
| ≤40 | 23/26 (88%) | 73/85 (86%) | 1 |
| >40 | 39/44 (89%) | 47/55 (85%) | .77 |
| Patient characteristics | |||
| Age, y | |||
| <60 | 31/34 (91%) | 66/77 (86%) | .55 |
| ≥60 | 31/36 (86%) | 54/63 (86%) | 1 |
| Donor type | |||
| Related | 23/28 (82%) | 53/61 (87%) | .54 |
| Unrelated | 39/42 (93%) | 67/79 (85%) | .26 |
| Stem cell source | |||
| Bone marrow | 10/10 (100%) | 33/35 (94%) | 1 |
| Peripheral blood | 52/60 (87%) | 87/105 (83%) | .66 |
| HLA match | |||
| Matched | 44/50 (88%) | 77/90 (86%) | .80 |
| Mismatched | 4/5 (80%) | 15/17 (88%) | 1 |
| Haploidentical | 14/15 (93%) | 28/33 (85%) | .65 |
| Conditioning intensity | |||
| Myeloablative | 29/33 (88%) | 59/68 (87%) | 1 |
| Non-myeloablative/reduced intensity | 33/37 (89%) | 61/72 (85%) | .77 |
| GVHD prophylaxis | |||
| CNI based | 29/33 (88%) | 71/82 (87%) | 1 |
| Cyclophosphamide based | 32/35 (91%) | 47/55 (85%) | .52 |
| Other | 1/2 (50%) | 2/3 (67%) | 1 |
| . | Itacitinib (n = 70) . | Systemic corticosteroids (n = 140) . | P value . |
|---|---|---|---|
| GVHD characteristics | |||
| GVHD grade | |||
| Grade I | 11/12 (92%) | 19/25 (76%) | .39 |
| Grade II/III | 51/58 (90%) | 101/115 (88%) | 1 |
| Target organ involvement | |||
| LGI ± Other | 18/21 (86%) | 36/42 (86%) | 1 |
| Skin 1/2 ± UGI | 15/16 (94%) | 24/30 (80%) | .39 |
| Skin 3 ± UGI | 26/28 (93%) | 51/56 (91%) | 1 |
| UGI Only | 3/5 (60%) | 9/12 (75%) | .60 |
| Days between HCT and start of systemic treatment∗ | |||
| ≤40 | 23/26 (88%) | 73/85 (86%) | 1 |
| >40 | 39/44 (89%) | 47/55 (85%) | .77 |
| Patient characteristics | |||
| Age, y | |||
| <60 | 31/34 (91%) | 66/77 (86%) | .55 |
| ≥60 | 31/36 (86%) | 54/63 (86%) | 1 |
| Donor type | |||
| Related | 23/28 (82%) | 53/61 (87%) | .54 |
| Unrelated | 39/42 (93%) | 67/79 (85%) | .26 |
| Stem cell source | |||
| Bone marrow | 10/10 (100%) | 33/35 (94%) | 1 |
| Peripheral blood | 52/60 (87%) | 87/105 (83%) | .66 |
| HLA match | |||
| Matched | 44/50 (88%) | 77/90 (86%) | .80 |
| Mismatched | 4/5 (80%) | 15/17 (88%) | 1 |
| Haploidentical | 14/15 (93%) | 28/33 (85%) | .65 |
| Conditioning intensity | |||
| Myeloablative | 29/33 (88%) | 59/68 (87%) | 1 |
| Non-myeloablative/reduced intensity | 33/37 (89%) | 61/72 (85%) | .77 |
| GVHD prophylaxis | |||
| CNI based | 29/33 (88%) | 71/82 (87%) | 1 |
| Cyclophosphamide based | 32/35 (91%) | 47/55 (85%) | .52 |
| Other | 1/2 (50%) | 2/3 (67%) | 1 |
Denominators reflect the number of patients within each subgroup of each GVHD or patient characteristic. Numerators reflect the number of patients who had a complete response (CR) or partial response (PR) to treatment within each subgroup.
HCT, hematopoietic cell transplantation; LGI, lower gastrointestinal; UGI, upper gastrointestinal.
The median number of days from HCT to start of systemic treatment for the entire cohort (n = 210) was 40 days.