Table 1 Characteristics of the patients at baselinea

From: Ruxolitinib plus steroids for acute graft versus host disease: a multicenter, randomized, phase 3 trial

Characteristic

No. (%)

 

Ruxolitinib/steroids (n = 99)

Steroids only (n = 99)

Age, median (range), y

35.0 (14.0–65.0)

34.0 (14.0–64.0)

Male

65 (65.7)

67 (67.7)

Weight, median (range), kg

64.0 (42.8–98.1)

67.0 (42.2–118.0)

Body-mass index, median (range), kg/m2

22.5 (16.0–32.8)

23.3 (15.0–38.5)

Diagnosis of underlying malignant disease

 Acute myelogenous leukemia

54 (54.5)

40 (40.4)

 Acute lymphoid leukemia

28 (28.3)

34 (34.3)

 Myelodysplastic syndrome

5 (5.1)

11 (11.1)

 Chronic myelogenous leukemia

1 (1.0)

2 (2.0)

 Non-Hodgkin lymphoma

5 (5.1)

3 (3.0)

 Other acute leukemia

2 (2.0)

5 (5.1)

 Other leukemia

4 (4.0)

4 (4.0)

Disease Risk Index

 low

15 (15.2)

11 (11.1)

 Intermediate

46 (46.5)

48 (48.5)

 High

32 (32.3)

33 (33.3)

 Very High

5 (5.1)

6 (6.1)

 missing

1 (1.0)

1 (1.0)

HCT-CI

 0

59 (59.6)

47 (47.5)

 1

22 (22.2)

40 (40.4)

 2

9 (9.1)

5 (5.1)

 3

5 (5.1)

3 (3.0)

 4

2 (2.0)

3 (3.0)

 5

1 (1.0)

0 (0.0)

 missing

1 (1.0)

1 (1.0)

Time from diagnosis to HCT, median (range), d

169 (12–859)

212 (14–625)

Time from HCT to screening, median(range), d

25 (17–89)

25 (15–77)

Conditioning regimen

 Modified Bu/Cy

85 (85.9)

85 (85.9)

 Bu/Flu

8 (8.1)

10 (10.1)

 Modified TBI/Cy

6 (6.1)

4 (4.0)

Donor’s age, median (range), y

37 (14.0–63.0)

34 (8.0–57.0)

Donor-recipient ABO match

 Match

56 (56.6)

56 (56.6)

 Major mismatch

21 (21.2)

19 (19.2)

 Minor mismatch

17 (17.2)

18 (18.2)

 Bidirectional mismatch

5 (5.1)

6 (6.1)

Donor-recipient gender match

 Female to male

24 (24.5)

19 (19.2)

 Female to female

9 (9.1)

9 (9.1)

 Male to female

26 (26.3)

23 (23.2)

 Male to male

40 (40.4)

48 (48.5)

Graft

 MNCs, median (range), ×108/kg

10.7 (2.8–28.0)

10.3 (2.3–32.7)

 CD34+, median (range), ×106/kg

4.9 (0.8–11.8)

4.9 (0.9–20.0)

Source of graft

 Matched sibling donor

12 (12.1)

10 (10.1)

 Haploidentical donor

76 (76.8)

78 (78.8)

 Unrelated donor

11 (11.1)

11 (11.1)

Cytomegalovirus positive at HCT

99 (100)

99 (100)

Donor cytomegalovirus positive at HCT

99 (100)

99 (100)

Overall aGVHD grade at baselineb

 Grade II

86 (86.9)

88 (88.9)

 Grade III

10 (10.1)

6 (6.1)

 Grade IV

3 (3.0)

5 (5.1)

aGVHD organ involvement at baseline

 Skin

63 (63.6)

72 (72.7)

 Liver

6 (6.1)

7 (7.1)

 Lower GI

24 (24.2)

30 (30.3)

Biomarker risk at baselineb

 Intermediate

55 (55.6)

55 (55.6)

 High

44 (44.4)

44 (44.4)

Overall aGVHD risk

 Minnesota high and biomarker high

13 (13.1)

11 (11.1)

 Minnesota standard and biomarker high

31 (31.3)

33 (33.3)

 Minnesota standard and biomarker intermediate

55 (55.6)

55 (55.6)

Coadministrations of antifungal drugs

 Voriconazole

83 (83.8)

82 (82.8)

 Posaconazole

8 (8.1)

7 (7.1)

 Caspofungin

8 (8.1)

10 (10.1)

  1. aGVHD acute graft versus host disease, Bu busulfan, Cy cyclophosphamide, Flu fludarabine, GI gastrointestinal tract, HCT hematopoietic stem cell transplant, HCT-CI hematopoietic cell transplant -comorbidity index, MNC mononuclear cells, TBI total body irradiation
  2. aData are presented as number (percentage) of patients unless otherwise indicated
  3. bBaseline defined as the last acute GVHD assessment prior to or on randomization date +3 days, but no later than the treatment start date