Ruxolitinib add-on in corticosteroid-refractory graft-vs-host disease after allogeneic stem cell transplantation: Results from a retrospective study on 38 Chinese patients

Table 1 Baseline clinical characteristics of the patients with acute or chronic graft-vs-host disease treated with ruxolitinib

Parameter	aGVHD, n = 10	cGVHD, n = 28
Age in yr, median (range)	35 (19–55)	30 (14–55)
Sex, n (%)
Female	3 (30.0)	14 (50.0)
Male	7 (70.0)	14 (50.0)
Disease, n (%)
AML	5 (50.0)	11 (39.3)
ALL	2 (20.0)	8 (28.6)
CML	0 (0)	6 (21.4)
MDS	2 (20.0)	3 (10.7)
CMML	1 (10.0)	0 (0)
Donor type, n (%)
Matched related	8 (80.0)	15 (53.6)
Partially mismatched related	2 (20.0)	8 (28.6)
Unrelated	0 (0)	5 (17.9)
Types of transplantation, n (%)
PBSC	6 (60.0)	22 (78.6)
BM-HSC	2 (20.0)	1 (3.6)
PBSC + BM-HSC	2 (20.0)	5 (17.9)
Median number of infused nucleated cells as /kg	11.1 × 108	15.62 × 106
Median number of infused CD34+ cells as /kg	5.99 × 106	6.05 × 106
aGVHD of grade 3 or higher, n (%)	9 (90.0)	-
Moderate or severe cGVHD, n (%)	-	24 (85.7)
Multiple organ involvement, n (%)	3 (30.0)	22 (78.6)
Median number of immunosuppressive agents1	2	2
aGVHD stage 3–4 or cGVHD NIH 2–3, n (%)
Skin	5 (50.0)	19 (67.9)
Digestive tract	3 (30.0)	6 (21.4)
Liver	2 (20.0)	4 (14.3)
Eyes	-	12 (42.9)
Oral cavity	-	11 (39.3)
Lungs	-	6 (21.4)
Fascia	-	8 (28.6)

¹Before initiation of ruxolitinib therapy. aGVHD: Acute graft-vs-host disease; ALL: Acute lymphocytic leukemia; AML: Acute myeloid leukemia; BM-HSC: Bone marrow hematopoietic stem cell; cGVHD: Chronic graft-vs-host disease; CML: Chronic myeloid leukemia; CMML: Chronic myelomonocytic leukemia; MDS: Myelodysplastic syndrome; PBSC: Peripheral blood stem cell; NIH: National Institutes of Health.

Table 2 Response to treatment with ruxolitinib

Parameter	aGVHD, n = 10	cGVHD, n = 28
Overall response rate, n (%)	10 (100)	22 (82.1)
Median follow-up time in mo, median (range)	2.5 (1.5–4)	5 (1.5–10)
Time to best overall response in mo, median (range)	1.0 (0.5–2.5)	3.0 (1.0–9.5)
Time to best response for each organ system in d, median (range)
Skin	28 (14–28)	77 (7–147)
Digestive tract	25 (14–60)	259 (70–308)
Liver	32 (21–42)	42 (28–56)
Eye	-	112 (42–182)
Oral cavity	-	80 (28–168)
Lung	-	91 (49–140)
Fascia	-	91 (56–266)
Discontinuation of immunosuppressive agents after ruxolitinib, n (%)	8 (80.0)	21 (75.0)

aGVHD: Acute graft-vs-host disease; cGVHD: Chronic graft-vs-host disease.

Table 3 Adverse events during treatment with ruxolitinib, n (%)

Parameter	aGVHD, n = 10	cGVHD, n = 28
Activation of cytomegalovirus	3 (30.0)	0 (0)
Activation of Epstein-Barr virus	1 (10.0)	4 (14.3)
Infection with herpes-zoster virus	0 (0)	2 (7.1)
Relapse of malignant blood disease	1 (10.0)	3 (10.7)

aGVHD: Acute graft-vs-host disease; cGVHD: Chronic graft-vs-host disease.