Characteristics of the cohort stratified by GVHD severity and infliximab use
Variable . | Cohort . | No and nonsevere GVHD . | Severe GVHD . | Non-infliximab recipients . | Infliximab recipients . |
|---|---|---|---|---|---|
| No. of patients | 264 | 211 | 53 | 42 | 11 |
| Median age, y (range) | 44 (18-66) | 44 (18-66) | 46 (20-62) | 46 (23-60) | 47 (20-62) |
| Transplant type, % | |||||
| Myeloablative | 74.6 | 76.3 | 67.9 | 73.8 | 45.4 |
| Nonmyeloablative | 25.4 | 23.7 | 32.1 | 26.2 | 54.6 |
| HLA matching, % | |||||
| Matched-related | 49.6 | 53.6 | 34.0 | 40.4 | 9.1 |
| Matched-unrelated | 35.6 | 31.3 | 52.8‡ | 47.6 | 72.7 |
| Mismatched-related | 4.6 | 5.7 | 0 | — | — |
| Mismatched-unrelated | 10.2 | 9.4 | 13.2 | 11.9 | 18.2 |
| Stem cell source, % | |||||
| Bone marrow | 62.1 | 62.1 | 62.3 | 66.7 | 45.4 |
| Peripheral blood | 37.9 | 37.9 | 37.7 | 33.3 | 54.6 |
| Conditioning regimen, % | |||||
| Myeloablative | |||||
| Cyclophosphamide and TBI | 70.8 | 72.5 | 64.1 | 69.0 | 45.4 |
| Other | 3.8 | 3.8 | 3.8 | 4.8 | — |
| Nonmyeloablative | |||||
| Busulfan and fludarabine | 25.4 | 23.7 | 32.1 | 26.2 | 54.6 |
| Risk group, % | |||||
| Low | 30.3 | 30.8 | 28.3 | 31.0 | 18.2 |
| High | 69.7 | 69.2 | 71.7 | 69.0 | 81.8 |
| CMV serology of donor/recipient, % | |||||
| D-/R- | 46.3 | 46.3 | 46.2 | 43.9 | 54.5 |
| D-/R+ | 15.7 | 16.7 | 11.5 | 9.8 | 18.2 |
| D+/R- | 20.8 | 21.2 | 19.2 | 19.5 | 18.2 |
| D+/R+ | 17.2 | 15.8 | 23.1 | 26.8 | 9.1 |
| GVHD prophylaxis, % | |||||
| Methotrexate | 53.8 | 54.0 | 52.8 | 54.8 | 45.4 |
| Cyclosporine | 45.8 | 45.0 | 49.1 | 47.6 | 54.6 |
| Tacrolimus | 40.5 | 39.3 | 45.3 | 45.2 | 45.4 |
| Sirolimus | 16.3 | 15.6 | 18.9 | 19.1 | 18.2 |
| MMF | 4.9 | 4.7 | 5.7 | 2.4 | 18.2 |
| T-cell manipulation | 18.6 | 20.4 | 11.3 | 14.3 | 0 |
| Corticosteroids | 37.9 | 35.1 | 49.1 | 42.9 | 72.7 |
| GVHD treatment, %* | |||||
| Corticosteroids | — | — | 100 | 100 | 100 |
| Cyclosporine | — | — | 54.7 | 52.5 | 63.6 |
| Tacrolimus | — | — | 64.2 | 61.9 | 72.7 |
| Sirolimus | — | — | 20.8 | 14.3 | 45.4 |
| MMF | — | — | 52.8 | 47.6 | 72.7 |
| Daclizumab | — | — | 54.7 | 47.6 | 81.8 |
| Organ-specific GVHD grade III or IV, %* | |||||
| Gastrointestinal | — | — | 35.9 | 21.4 | 90.9§ |
| Cutaneous | — | — | 43.4 | 42.9 | 45.4 |
| Hepatic | — | — | 39.6 | 42.9 | 27.3 |
| Median cumulative prednisone-equivalents, mg/kg (IQR)* | — | — | 112.9 (71.0-146.4) | 111.2 (57.2-150.9) | 132.5 (98.0-146.1) |
| Empiric antifungal use, %*† | |||||
| Amphotericin B | — | — | 69.8 | 69.1 | 72.7 |
| Fluconazole | — | — | 60.4 | 54.8 | 81.8 |
| Total patient-days | 83 244 | 69 992 | 13 252 | 11 448 | 1804 |
| Median follow-up, d (IQR) | 252 (121-493) | 269 (137-507) | 196 (103-363)‡ | 219 (87-401) | 143 (121-198) |
| Median survival, d (95% CI) | 397 (276-871 +) | 503 (366-871 +) | 196 (143-336)‡ | 224 (144-871 +) | 143 (121-198)§ |
Variable . | Cohort . | No and nonsevere GVHD . | Severe GVHD . | Non-infliximab recipients . | Infliximab recipients . |
|---|---|---|---|---|---|
| No. of patients | 264 | 211 | 53 | 42 | 11 |
| Median age, y (range) | 44 (18-66) | 44 (18-66) | 46 (20-62) | 46 (23-60) | 47 (20-62) |
| Transplant type, % | |||||
| Myeloablative | 74.6 | 76.3 | 67.9 | 73.8 | 45.4 |
| Nonmyeloablative | 25.4 | 23.7 | 32.1 | 26.2 | 54.6 |
| HLA matching, % | |||||
| Matched-related | 49.6 | 53.6 | 34.0 | 40.4 | 9.1 |
| Matched-unrelated | 35.6 | 31.3 | 52.8‡ | 47.6 | 72.7 |
| Mismatched-related | 4.6 | 5.7 | 0 | — | — |
| Mismatched-unrelated | 10.2 | 9.4 | 13.2 | 11.9 | 18.2 |
| Stem cell source, % | |||||
| Bone marrow | 62.1 | 62.1 | 62.3 | 66.7 | 45.4 |
| Peripheral blood | 37.9 | 37.9 | 37.7 | 33.3 | 54.6 |
| Conditioning regimen, % | |||||
| Myeloablative | |||||
| Cyclophosphamide and TBI | 70.8 | 72.5 | 64.1 | 69.0 | 45.4 |
| Other | 3.8 | 3.8 | 3.8 | 4.8 | — |
| Nonmyeloablative | |||||
| Busulfan and fludarabine | 25.4 | 23.7 | 32.1 | 26.2 | 54.6 |
| Risk group, % | |||||
| Low | 30.3 | 30.8 | 28.3 | 31.0 | 18.2 |
| High | 69.7 | 69.2 | 71.7 | 69.0 | 81.8 |
| CMV serology of donor/recipient, % | |||||
| D-/R- | 46.3 | 46.3 | 46.2 | 43.9 | 54.5 |
| D-/R+ | 15.7 | 16.7 | 11.5 | 9.8 | 18.2 |
| D+/R- | 20.8 | 21.2 | 19.2 | 19.5 | 18.2 |
| D+/R+ | 17.2 | 15.8 | 23.1 | 26.8 | 9.1 |
| GVHD prophylaxis, % | |||||
| Methotrexate | 53.8 | 54.0 | 52.8 | 54.8 | 45.4 |
| Cyclosporine | 45.8 | 45.0 | 49.1 | 47.6 | 54.6 |
| Tacrolimus | 40.5 | 39.3 | 45.3 | 45.2 | 45.4 |
| Sirolimus | 16.3 | 15.6 | 18.9 | 19.1 | 18.2 |
| MMF | 4.9 | 4.7 | 5.7 | 2.4 | 18.2 |
| T-cell manipulation | 18.6 | 20.4 | 11.3 | 14.3 | 0 |
| Corticosteroids | 37.9 | 35.1 | 49.1 | 42.9 | 72.7 |
| GVHD treatment, %* | |||||
| Corticosteroids | — | — | 100 | 100 | 100 |
| Cyclosporine | — | — | 54.7 | 52.5 | 63.6 |
| Tacrolimus | — | — | 64.2 | 61.9 | 72.7 |
| Sirolimus | — | — | 20.8 | 14.3 | 45.4 |
| MMF | — | — | 52.8 | 47.6 | 72.7 |
| Daclizumab | — | — | 54.7 | 47.6 | 81.8 |
| Organ-specific GVHD grade III or IV, %* | |||||
| Gastrointestinal | — | — | 35.9 | 21.4 | 90.9§ |
| Cutaneous | — | — | 43.4 | 42.9 | 45.4 |
| Hepatic | — | — | 39.6 | 42.9 | 27.3 |
| Median cumulative prednisone-equivalents, mg/kg (IQR)* | — | — | 112.9 (71.0-146.4) | 111.2 (57.2-150.9) | 132.5 (98.0-146.1) |
| Empiric antifungal use, %*† | |||||
| Amphotericin B | — | — | 69.8 | 69.1 | 72.7 |
| Fluconazole | — | — | 60.4 | 54.8 | 81.8 |
| Total patient-days | 83 244 | 69 992 | 13 252 | 11 448 | 1804 |
| Median follow-up, d (IQR) | 252 (121-493) | 269 (137-507) | 196 (103-363)‡ | 219 (87-401) | 143 (121-198) |
| Median survival, d (95% CI) | 397 (276-871 +) | 503 (366-871 +) | 196 (143-336)‡ | 224 (144-871 +) | 143 (121-198)§ |
Abbreviations and some variables are explained in Table 1. — indicates calculation not applicable.
Only treatment for patients with severe GVHD is shown. Percentages do not add up to 100% because patients received multiple simultaneous or sequential interventions; some patients were switched from one calcineurin to another due to drug adverse effects.
Prescription of antifungals at any point after transplantation or onset of GVHD before a diagnosis of probable or proven IFI was documented as empiric use.
Two-sided P < .05 when compared with patients in the cohort who had no or nonsevere GVHD.
Two-sided P < .05 when compared with patients with severe GVHD who did not receive infliximab.