Multivariable regression analysis for OS and NRM after the initiation of second line therapy for acute GVHD
| . | . | OS . | NRM . | ||||
|---|---|---|---|---|---|---|---|
| HR . | 95% CI . | P value . | HR . | 95% CI . | P value . | ||
| Age (y) | ≤60 vs >60 | 1.28 | (0.79-2.06) | .32 | 1.21 | (0.71-2.06) | .48 |
| Sex | Male vs female | 1.17 | (0.75-1.83) | .49 | 1.09 | (0.67-1.77) | .74 |
| Indication for HCT | AML/MDS vs other | 0.95 | (0.61-1.48) | .82 | 1.07 | (0.66-1.74) | .79 |
| Donor type | Unrelated vs related | 1.32 | (0.81-2.16) | .26 | 1.19 | (0.70-2.02) | .53 |
| HLA match | Mismatched vs matched | 0.77 | (0.33-1.77) | .54 | 0.82 | (0.33-2.05) | .68 |
| Stem cell source | Peripheral blood vs BM | 1.16 | (0.65-2.08) | .62 | 1.14 | (0.62-2.11) | .67 |
| Stem cell source | Cord blood vs BM | 2.12 | (0.61-7.37) | .24 | 2.46 | (0.68-8.95) | .17 |
| Conditioning regimen intensity | Reduced-intensity vs myeloablative | 1.02 | (0.63-1.64) | .94 | 1.09 | (0.66-1.82) | .74 |
| GVHD prophylaxis | Non-CNI-based vs CNI-based | 0.90 | (0.42-1.93) | .78 | 0.89 | (0.40-2.00) | .78 |
| Median days from steroids to second line therapy | <14 d vs ≥14 d | 1.33 | (0.86-2.05) | .19 | 1.46 | (0.90-2.36) | .13 |
| GVHD Grade at second line therapy | 3 to 4 vs 0 to 2 | 2.02 | (1.2-3.37) | .0078 | 2.23 | (1.24-3.99) | .007 |
| MAP at second line therapy | High vs low | 3.36 | (2.05-5.50) | <.0001 | 3.00 | (1.74-5.16) | <.0001 |
| Second line treatment | Ruxolitinib vs no ruxolitinib | 0.56 | (0.34-0.90) | .017 | 0.54 | (0.31-0.94) | .03 |
| Bilirubin level (mg/dL) at second line therapy∗ | 2 to 3.9 vs <2 | 2.31 | (1.05-5.08) | .038 | 2.11 | (0.93-4.82) | .08 |
| ≥4 vs <2 | 2.48 | (1.19-5.14) | .015 | 2.30 | (1.08-4.9) | .03 | |
| Year of systemic GVHD therapy | 2019 to 2021 vs 2016 to 2018 | 1.53 | (0.95-2.45) | .08 | 1.38 | (0.82-2.31) | .22 |
| Day 28 response† | CR/PR vs no response | 0.55 | (0.34-0.91) | .02 | 0.38 | (0.21-0.66) | .0007 |
| . | . | OS . | NRM . | ||||
|---|---|---|---|---|---|---|---|
| HR . | 95% CI . | P value . | HR . | 95% CI . | P value . | ||
| Age (y) | ≤60 vs >60 | 1.28 | (0.79-2.06) | .32 | 1.21 | (0.71-2.06) | .48 |
| Sex | Male vs female | 1.17 | (0.75-1.83) | .49 | 1.09 | (0.67-1.77) | .74 |
| Indication for HCT | AML/MDS vs other | 0.95 | (0.61-1.48) | .82 | 1.07 | (0.66-1.74) | .79 |
| Donor type | Unrelated vs related | 1.32 | (0.81-2.16) | .26 | 1.19 | (0.70-2.02) | .53 |
| HLA match | Mismatched vs matched | 0.77 | (0.33-1.77) | .54 | 0.82 | (0.33-2.05) | .68 |
| Stem cell source | Peripheral blood vs BM | 1.16 | (0.65-2.08) | .62 | 1.14 | (0.62-2.11) | .67 |
| Stem cell source | Cord blood vs BM | 2.12 | (0.61-7.37) | .24 | 2.46 | (0.68-8.95) | .17 |
| Conditioning regimen intensity | Reduced-intensity vs myeloablative | 1.02 | (0.63-1.64) | .94 | 1.09 | (0.66-1.82) | .74 |
| GVHD prophylaxis | Non-CNI-based vs CNI-based | 0.90 | (0.42-1.93) | .78 | 0.89 | (0.40-2.00) | .78 |
| Median days from steroids to second line therapy | <14 d vs ≥14 d | 1.33 | (0.86-2.05) | .19 | 1.46 | (0.90-2.36) | .13 |
| GVHD Grade at second line therapy | 3 to 4 vs 0 to 2 | 2.02 | (1.2-3.37) | .0078 | 2.23 | (1.24-3.99) | .007 |
| MAP at second line therapy | High vs low | 3.36 | (2.05-5.50) | <.0001 | 3.00 | (1.74-5.16) | <.0001 |
| Second line treatment | Ruxolitinib vs no ruxolitinib | 0.56 | (0.34-0.90) | .017 | 0.54 | (0.31-0.94) | .03 |
| Bilirubin level (mg/dL) at second line therapy∗ | 2 to 3.9 vs <2 | 2.31 | (1.05-5.08) | .038 | 2.11 | (0.93-4.82) | .08 |
| ≥4 vs <2 | 2.48 | (1.19-5.14) | .015 | 2.30 | (1.08-4.9) | .03 | |
| Year of systemic GVHD therapy | 2019 to 2021 vs 2016 to 2018 | 1.53 | (0.95-2.45) | .08 | 1.38 | (0.82-2.31) | .22 |
| Day 28 response† | CR/PR vs no response | 0.55 | (0.34-0.91) | .02 | 0.38 | (0.21-0.66) | .0007 |
Bold values indicate statistical significance P < 0.05.
BM, bone marrow; CI, confidence interval; CNI, calcineurin inhibitor; HLA, human leukocyte antigen; HR, hazard ratio; MDS, myelodysplastic syndrome.
Due to collinearity between MAP and bilirubin levels, 2 multivariable models were performed: 1 includes MAP and the other includes bilirubin level.
D28 response was treated as a time-dependent variable.