Baseline demographics and disease characteristics
| Characteristic . | Total . | Newly diagnosed BOS (cohort A) . | Established BOS (cohort B) . | P value . |
|---|---|---|---|---|
| Number of participants | 49 | 36 | 13 | |
| Median age, y (range) | 63 (21-71) | 64 (30-77) | 60 (21-71) | .37 |
| Sex, n (%) | .53 | |||
| Female | 22 (45) | 15 (42) | 7 (54) | |
| Male | 27 (55) | 21 (58) | 6 (46) | |
| Ethnicity, n (%) | .32 | |||
| Hispanic | 4 (8) | 3 (8) | 1 (8) | |
| Non-Hispanic | 34 (69) | 23 (64) | 11 (85) | |
| Unknown | 11 (22) | 10 (28) | 1 (8) | |
| Race, n (%) | .89 | |||
| White | 42 (86) | 30 (83) | 12 (92) | |
| Asian | 1 (2) | 1 (3) | 0 (0) | |
| American Indian or Alaskan Native | 1 (2) | 1 (3) | 0 (0) | |
| >1 race | 1 (2) | 1 (3) | 0 (0) | |
| Unknown | 4 (8) | 3 (8) | 1 (8) | |
| Maximum chronic GVHD severity before enrollment, n (%) | .53 | |||
| Moderate | 27 (55) | 21 (58) | 6 (46) | |
| Severe | 22 (45) | 15 (42) | 7 (54) | |
| Median number of organs with GVHD involvement at enrollment (range) | 3 (1-6) | 3 (1-6) | 3 (1-6) | .92 |
| Median time from BOS diagnosis to start of ruxolitinib, mo (range) | 1.4 (0.1-111.7) | 0.9 (0.1-4.9) | 14.6 (6.7-111.7) | NA |
| BOS classification, n (%) | 1.00 | |||
| Atypical phenotype criteria | 16 (33) | 12 (33) | 4 (31) | |
| NIH diagnostic criteria | 33 (67) | 24 (67) | 9 (69) | |
| NIH lung score at enrollment, n (%) | .67 | |||
| Mild (%FEV1 60%-79%) | 15 (31) | 12 (33) | 3 (23) | |
| Moderate (%FEV1 41%-59%) | 26 (53) | 19 (53) | 7 (54) | |
| Severe (%FEV1 <40%) | 8 (16) | 5 (14) | 3 (23) | |
| Receiving systemic corticosteroids at enrollment, n (%) | .50 | |||
| Yes | 34 (73) | 26 (72) | 8 (62) | |
| No | 13 (27) | 10 (28) | 5 (38) | |
| Median daily dose of prednisone at enrollment (range)∗ | 25 (5-80) | 40 (5-80) | 10 (5-30) | .017 |
| Receiving inhaled therapies at enrollment, n (%) | .71 | |||
| Yes | 39 (80) | 28 (78) | 11 (85) | |
| No | 10 (20) | 8 (22) | 2 (15) | |
| Use of supplemental oxygen at enrollment, n (%) | .22 | |||
| Yes | 9 (18) | 5 (14) | 4 (31) | |
| No | 40 (82) | 31 (86) | 9 (69) |
| Characteristic . | Total . | Newly diagnosed BOS (cohort A) . | Established BOS (cohort B) . | P value . |
|---|---|---|---|---|
| Number of participants | 49 | 36 | 13 | |
| Median age, y (range) | 63 (21-71) | 64 (30-77) | 60 (21-71) | .37 |
| Sex, n (%) | .53 | |||
| Female | 22 (45) | 15 (42) | 7 (54) | |
| Male | 27 (55) | 21 (58) | 6 (46) | |
| Ethnicity, n (%) | .32 | |||
| Hispanic | 4 (8) | 3 (8) | 1 (8) | |
| Non-Hispanic | 34 (69) | 23 (64) | 11 (85) | |
| Unknown | 11 (22) | 10 (28) | 1 (8) | |
| Race, n (%) | .89 | |||
| White | 42 (86) | 30 (83) | 12 (92) | |
| Asian | 1 (2) | 1 (3) | 0 (0) | |
| American Indian or Alaskan Native | 1 (2) | 1 (3) | 0 (0) | |
| >1 race | 1 (2) | 1 (3) | 0 (0) | |
| Unknown | 4 (8) | 3 (8) | 1 (8) | |
| Maximum chronic GVHD severity before enrollment, n (%) | .53 | |||
| Moderate | 27 (55) | 21 (58) | 6 (46) | |
| Severe | 22 (45) | 15 (42) | 7 (54) | |
| Median number of organs with GVHD involvement at enrollment (range) | 3 (1-6) | 3 (1-6) | 3 (1-6) | .92 |
| Median time from BOS diagnosis to start of ruxolitinib, mo (range) | 1.4 (0.1-111.7) | 0.9 (0.1-4.9) | 14.6 (6.7-111.7) | NA |
| BOS classification, n (%) | 1.00 | |||
| Atypical phenotype criteria | 16 (33) | 12 (33) | 4 (31) | |
| NIH diagnostic criteria | 33 (67) | 24 (67) | 9 (69) | |
| NIH lung score at enrollment, n (%) | .67 | |||
| Mild (%FEV1 60%-79%) | 15 (31) | 12 (33) | 3 (23) | |
| Moderate (%FEV1 41%-59%) | 26 (53) | 19 (53) | 7 (54) | |
| Severe (%FEV1 <40%) | 8 (16) | 5 (14) | 3 (23) | |
| Receiving systemic corticosteroids at enrollment, n (%) | .50 | |||
| Yes | 34 (73) | 26 (72) | 8 (62) | |
| No | 13 (27) | 10 (28) | 5 (38) | |
| Median daily dose of prednisone at enrollment (range)∗ | 25 (5-80) | 40 (5-80) | 10 (5-30) | .017 |
| Receiving inhaled therapies at enrollment, n (%) | .71 | |||
| Yes | 39 (80) | 28 (78) | 11 (85) | |
| No | 10 (20) | 8 (22) | 2 (15) | |
| Use of supplemental oxygen at enrollment, n (%) | .22 | |||
| Yes | 9 (18) | 5 (14) | 4 (31) | |
| No | 40 (82) | 31 (86) | 9 (69) |
NA, not applicable.
For participants receiving systemic corticosteroids at enrollment.