J Clin Med Res

Journal of Clinical Medicine Research, ISSN 1918-3003 print, 1918-3011 online, Open Access

Article copyright, the authors; Journal compilation copyright, J Clin Med Res and Elmer Press Inc

Journal website https://jocmr.elmerjournals.com

Original Article

Volume 17, Number 12, December 2025, pages 698-707

Ruxolitinib Plus Extracorporeal Photopheresis for Steroid-Refractory Acute and Chronic Graft-Versus-Host Disease

**Table 1.** Patient, Disease, and Transplant Characteristics
Variable	Ruxo + ECP arm	Ruxo alone arm	P-value
AA: aplastic anemia; ATG: antithymoglobulin; BM: bone marrow; CB: cord blood; CNI: calcineurin; CR: complete remission; ECP: extracorporeal photopheresis; FA: Fanconi anemia; GvHD: graft-versus-host disease; HCT: hematopoietic cell transplantation; NoCR: non-remission; PBSCs: peripheral blood stem cells; PID: primary immunodeficiency; PTCy: post-transplant cyclophosphamide; RIC: reduced-intensity conditioning; RTC: reduced-toxicity conditioning; Ruxo: ruxolitinib.
Total patients (n, %)	31 (100%)	37 (100)	0.086
Age (years), median and range			0.444
Adult	34 (18 - 62)	28 (18 - 59)
Pediatric	13 (2 - 17)	11.5 (6 - 17)
Adult (n, %)	22 (71%)	25 (67%)	0.760
Pediatric (n, %)	9 (29%)	12 (33)
Male (n, %)	19 (61%)	24 (65%)	0.454
Female (n, %)	12 (39%)	13 (35%)
Primary disease, n (%)			0.454
Acute myeloid leukemia (AML)	9 (29%)	14 (38%)
Acute lymphoid leukemia (ALL)	9 (29%)	8 (22%)
Myelodysplastic syndrome (MDS)	5 (16%)	2 (5.5%)
Myeloproliferative neoplasms (MPN)	2 (7%)	2 (5.5%)
Lymphoma	5 (16%)	6 (16%)
Nonmalignant (PID/AA/FA/thalassemia)	1 (3%)	5 (13%)
CR of primary disease at HCT, n (%)	23 (74%)	30 (81%)	0.454
PR/VGPR, n (%)	8 (26%)	7 (19%)
Allo-HCT first, n (%)	31 (100%)	37 (100%)	0.454
Donor type, n (%)			0.454
Matched related (MRD)	22 (71%)	27 (73%)
Mismatch relative (MMR)	9 (29%)	9 (24%)
CBT	0	1 (3%)
Graft source			0.454
PBSC	31 (100%)	34 (92%)
BM	0	2 (5.4%)
CB	0	1 (2.6%)
Myeloablative	18	23	0.358
RIC-RTC	13	14
GvHD prophylaxis therapy, n (%)			0.098
CNI-based +/-ATG	29 (93%)	37 (100%)
PTCy-based+/-ATGATG	4 (13%)	0

Table 1. Patient, Disease, and Transplant Characteristics

Variable

Ruxo + ECP arm

Ruxo alone arm

P-value

AA: aplastic anemia; ATG: antithymoglobulin; BM: bone marrow; CB: cord blood; CNI: calcineurin; CR: complete remission; ECP: extracorporeal photopheresis; FA: Fanconi anemia; GvHD: graft-versus-host disease; HCT: hematopoietic cell transplantation; NoCR: non-remission; PBSCs: peripheral blood stem cells; PID: primary immunodeficiency; PTCy: post-transplant cyclophosphamide; RIC: reduced-intensity conditioning; RTC: reduced-toxicity conditioning; Ruxo: ruxolitinib.

Total patients (n, %)

31 (100%)

37 (100)

0.086

Age (years), median and range

0.444

Adult

34 (18 - 62)

28 (18 - 59)

Pediatric

13 (2 - 17)

11.5 (6 - 17)

Adult (n, %)

22 (71%)

25 (67%)

0.760

Pediatric (n, %)

9 (29%)

12 (33)

Male (n, %)

19 (61%)

24 (65%)

0.454

Female (n, %)

12 (39%)

13 (35%)

Primary disease, n (%)

0.454

Acute myeloid leukemia (AML)

9 (29%)

14 (38%)

Acute lymphoid leukemia (ALL)

9 (29%)

8 (22%)

Myelodysplastic syndrome (MDS)

5 (16%)

2 (5.5%)

Myeloproliferative neoplasms (MPN)

2 (7%)

2 (5.5%)

Lymphoma

5 (16%)

6 (16%)

Nonmalignant (PID/AA/FA/thalassemia)

1 (3%)

5 (13%)

CR of primary disease at HCT, n (%)

23 (74%)

30 (81%)

0.454

PR/VGPR, n (%)

8 (26%)

7 (19%)

Allo-HCT first, n (%)

31 (100%)

37 (100%)

0.454

Donor type, n (%)

0.454

Matched related (MRD)

22 (71%)

27 (73%)

Mismatch relative (MMR)

9 (29%)

9 (24%)

CBT

1 (3%)

Graft source

0.454

PBSC

31 (100%)

34 (92%)

2 (5.4%)

1 (2.6%)

Myeloablative

0.358

RIC-RTC

GvHD prophylaxis therapy, n (%)

0.098

CNI-based +/-ATG

29 (93%)

37 (100%)

PTCy-based+/-ATGATG

4 (13%)

**Table 2.** GvHD Characteristics in Both Arms
Variable	Ruxo + ECP (n = 31)	Ruxo alone (n = 37)	P value
aGvHD: acute graft-versus-host disease; cGvHD: chronic graft-versus-host disease; ECP: extracorporeal photopheresis; GvHD: graft-versus-host disease; Ruxo: ruxolitinib; SR: steroid-refractory.
aGvHD	27 (87%)	27 (73%)	0.229
Grade II-IV	25 (95.6%)	22 (81.5%)	0.420
Grade III-IV	18 (66.6%)	5 (18.5%)	0.007
Skin
Grade I	5 (18.5%)	0	0.051
Grade II	4 (15%)	8 (30%)	0.202
Grade III	5 (18.5%)	11 (41%)	0.077
Grade IV	2 (7%)	0	0.235
Gut
Grade I	1 (4%)	0	0.051
Grade II	2 (7%)	1 (4%)	0.202
Grade III	10 (37%)	4 (15%)	0.077
Grade IV	4 (15%)	2 (7%)	0.490
Liver
Grade I	0	0	0.050
Grade II	3 (11%)	1 (4%)	0.202
Grade III	0	2 (7%)	0.077
Grade IV	0	0	0.490
cGvHD	24 (77.4%)	26 (70%)	0.587
NIH score I	33%	2 (8%)	0.235
NIH score II + III	23 (96%)	24 (92%)	0.668
Percentage of patients progressed to cGvHD	20 (74%) (95% CI: 55-87%)	16 (59%) (95% CI: 41-76%)	0.387
Skin and subcutaneous tissue	8 (33%)	19 (73%)	0.002
Liver	11 (46%)	7 (27%)	0.386
Eyes	15 (63%)	19 (73%)	0.254
Mouth	17 (71%)	20 (77%)	0.371
Lung	10 (42%)	3 (11.5%)	0.053
others	2 (8%)	1 (4%)	-
Duration of Ruxo continued treatment, median days	222 (31 - 854)	341 (17 - 1,274)	0.046
Time from Ruxo and start of ECP treatment, median days	50
Type of SR-aGvHD
Progressive after 3 days or no improvement after 7 days	24 (77.5%)	17 (65%)	0.053
Inability to taper steroids < 0.5 mg/kg	7 (26%)	11 (42%)	0.2541

Table 2. GvHD Characteristics in Both Arms

Variable

Ruxo + ECP (n = 31)

Ruxo alone (n = 37)

P value

aGvHD: acute graft-versus-host disease; cGvHD: chronic graft-versus-host disease; ECP: extracorporeal photopheresis; GvHD: graft-versus-host disease; Ruxo: ruxolitinib; SR: steroid-refractory.

aGvHD

27 (87%)

27 (73%)

0.229

Grade II-IV

25 (95.6%)

22 (81.5%)

0.420

Grade III-IV

18 (66.6%)

5 (18.5%)

0.007

Skin

Grade I

5 (18.5%)

0.051

Grade II

4 (15%)

8 (30%)

0.202

Grade III

5 (18.5%)

11 (41%)

0.077

Grade IV

2 (7%)

0.235

Gut

Grade I

1 (4%)

0.051

Grade II

2 (7%)

1 (4%)

0.202

Grade III

10 (37%)

4 (15%)

0.077

Grade IV

4 (15%)

2 (7%)

0.490

Liver

Grade I

0.050

Grade II

3 (11%)

1 (4%)

0.202

Grade III

2 (7%)

0.077

Grade IV

0.490

cGvHD

24 (77.4%)

26 (70%)

0.587

NIH score I

33%

2 (8%)

0.235

NIH score II + III

23 (96%)

24 (92%)

0.668

Percentage of patients progressed to cGvHD

20 (74%) (95% CI: 55-87%)

16 (59%) (95% CI: 41-76%)

0.387

Skin and subcutaneous tissue

8 (33%)

19 (73%)

0.002

Liver

11 (46%)

7 (27%)

0.386

Eyes

15 (63%)

19 (73%)

0.254

Mouth

17 (71%)

20 (77%)

0.371

Lung

10 (42%)

3 (11.5%)

0.053

others

2 (8%)

1 (4%)

Duration of Ruxo continued treatment, median days

222 (31 - 854)

341 (17 - 1,274)

0.046

Time from Ruxo and start of ECP treatment, median days

Type of SR-aGvHD

Progressive after 3 days or no improvement after 7 days

24 (77.5%)

17 (65%)

0.053

Inability to taper steroids < 0.5 mg/kg

7 (26%)

11 (42%)

0.2541

**Table 3.** Outcomes
Response category	Variable	Ruxo + ECP (n = 31)	Ruxo alone (n = 37)	P-value
aGvHD: acute GvHD; cGvHD: chronic GvHD; CI: cumulative incidence; CIR: cumulative incidence of relapse; CR: complete response; GFRS: graft-versus-host disease relapse-free survival; GvHD: graft-versus-host disease; NR: no response; NRM: non-relapse mortality; ORR: objective response; PR: partial response.
aGvHD at last encounter	ORR	18 (58%)	18 (49%)	0.02
	CR	12 (39%)	16 (43%)	0.19
	PR	6 (19%)	2 (6%)	0.03
	NR	13 (42%)	19 (51%)	0.002
	Steroid taper ≥ 50%	87%	93%	0.69
Gut aGvHD (n = 23; 20 grade III-IV) at last encounter		17 (74%)	6 (26%)	0.001
	ORR (n, %)	10 (59%)	0 (0%)	0.001
	NR (n, %)	7 (41%)	6 (100%)	0.506
cGvHD at last encounter	12 months	26% (95% CI: 22-64%)	55% (95% CI: 41.9-69%)	0.018
	3-year GFRS	100%	97%	0.481
	Ongoing immunosuppression	11 (35%)	16 (43%)	0.514
	NRM	19% (95% CI: 5-55%)	0%	0.006
	CIR at 1 year	6% (95% CI: 8-33%)	2% (95% CI: 2-13%)	> 0.5
Median follow-up		72 months (range: 54 - 71)	72 months (range: 54 - 71)	-
Primary disease status	CR	94%	97%	0.588
Patient status	Alive at last follow-up	78%	95%	0.068
Survival	3-year survival	70% (95% CI: 53-92%)	80% (95% CI: 65-78%)	0.327

Table 3. Outcomes

Response category

Variable

Ruxo + ECP (n = 31)

Ruxo alone (n = 37)

P-value

aGvHD: acute GvHD; cGvHD: chronic GvHD; CI: cumulative incidence; CIR: cumulative incidence of relapse; CR: complete response; GFRS: graft-versus-host disease relapse-free survival; GvHD: graft-versus-host disease; NR: no response; NRM: non-relapse mortality; ORR: objective response; PR: partial response.

aGvHD at last encounter

ORR

18 (58%)

18 (49%)

0.02

12 (39%)

16 (43%)

0.19

6 (19%)

2 (6%)

0.03

13 (42%)

19 (51%)

0.002

Steroid taper ≥ 50%

87%

93%

0.69

Gut aGvHD (n = 23; 20 grade III-IV) at last encounter

17 (74%)

6 (26%)

0.001

ORR (n, %)

10 (59%)

0 (0%)

0.001

NR (n, %)

7 (41%)

6 (100%)

0.506

cGvHD at last encounter

12 months

26% (95% CI: 22-64%)

55% (95% CI: 41.9-69%)

0.018

3-year GFRS

100%

97%

0.481

Ongoing immunosuppression

11 (35%)

16 (43%)

0.514

NRM

19% (95% CI: 5-55%)

0.006

CIR at 1 year

6% (95% CI: 8-33%)

2% (95% CI: 2-13%)

> 0.5

Median follow-up

72 months (range: 54 - 71)

Primary disease status

94%

97%

0.588

Patient status

Alive at last follow-up

78%

95%

0.068

Survival

3-year survival

70% (95% CI: 53-92%)

80% (95% CI: 65-78%)

0.327