Ruxolutinib in Steroid Refractory Graft Versus Host Disease (SR-GVHD): Systemic Literature Review

Background: Graft versus host disease (GVHD) is a main cause of morbidity and mortality in patients having undergone allogeneic hematopoietic stem cell transplantation (HSCT). About 30-40% of patients have steroid‐refractory GVHD (SR‐GVHD) after the first‐line use of high doses of corticosteroids with a poor prognosis .Ruxolitinib is a promising treatment for SR-GVHD. However, data regarding optimum dosing, response rates and associated adverse events are scarce. Herein, we provide the first systemic review of literature for the use ruxolutinib in GVHD. Methods: A Medline (PubMed), google scholar, OVID and Cochrane Database of Systematic Reviews search using key words "Ruxolutinib and GVHD", "Ruxolutinib and SR-GVHD" was undertaken in June 2019. Only peer reviewed databases were searched and search was restricted to human studies of acute and chronic GVHD only. Results: 16 publications, as listed in Table 1. Only one was a prospective trial, all others were retrospective studies, case series (5), and case reports (2). Overall response, ranged 45% - 100%, complete response was noted in 5.2% -80% patients. Time to response was variable from 1-12 weeks. Cytopenias and infectious complications were frequently reported with dose reduction or interruptions needed in most studies. Maintained responses were reported in a small proportion after ruxolutinib discontinuation. Conclusion Ruxolutinib has promising efficacy in SR-GVHD , however cytopenias and infectious complications reported frequently mandate close monitoring. Results of ongoing prospective trials could provide answers for optimum dosing and response assessment, and management of related adverse events. Table Disclosures No relevant conflicts of interest to declare.

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Adverse events in second- and third-line treatments for acute and chronic graft-versus-host disease: systematic review

Therapeutic Advances in Hematology ◽

10.1177/2040620720977039 ◽

2020 ◽

Vol 11 ◽

pp. 204062072097703

Author(s):

Vladica M. Velickovic ◽

Emily McIlwaine ◽

Rongrong Zhang ◽

Tim Spelman

Keyword(s):

Systematic Review ◽

Adverse Events ◽

Graft Versus Host Disease ◽

Chronic Gvhd ◽

Hematopoietic Stem ◽

Host Disease ◽

Pharmaceutical Management ◽

Graft Versus Host ◽

Increased Risk ◽

Third Line

Background: Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is associated with an increased risk of graft- versus-host disease (GvHD), a strong prognostic predictor of early mortality within the first 2 years following allo-HSCT. The objective of this study was to describe the harm outcomes reported among patients receiving second- and third-line treatment as part of the management for GvHD via a systematic literature review. Methods: A total of 34 studies met the systematic review inclusion criteria, reporting adverse events (AEs) across 12 different second- and third-line therapies. Results: A total of 14 studies reported AEs across nine different therapies used in the treatment of acute GvHD (aGvHD), 17 studies reported AEs of eight different treatments for chronic GvHD (cGvHD) and 3 reported a mixed population. Infections were the AE reported most widely, followed by haematologic events and laboratory abnormalities. Reported infections per patient were lower under extracorporeal photopheresis (ECP) for aGvHD (0.267 infections per patient over 6 months) relative to any of the therapies studied (ranging from 0.853 infections per patient per 6 months under etanercept up to 1.998 infections per patient on inolimomab). Conclusion: The reported incidence of infectious AEs in aGvHD and grade 3–5 AEs in cGvHD was lower on ECP compared with pharmaceutical management.

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Graft-Versus Host Disease Prophylaxis with Postransplantation Bendamustine in Refractory Leaukemia Patients

Blood ◽

10.1182/blood-2019-125570 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 5746-5746

Author(s):

Ivan S Moiseev ◽

Sergey N. Bondarenko ◽

Elena I Darskaya ◽

Aleksandr Alyanski ◽

Evgeniya Borzenkova ◽

...

Keyword(s):

Graft Versus Host Disease ◽

Chronic Gvhd ◽

Immunosuppressive Agents ◽

Single Agent ◽

Median Number ◽

Infectious Complications ◽

Hematopoietic Stem ◽

Host Disease ◽

Graft Versus Host ◽

Gvhd Prophylaxis

Background There was a limited improvement in the results of allogeneic hematopoietic stem cell transplantation (HSCT) in refractory leukemia over the last decades. The major reason of poor results is the relapse of the underlying malignancy. Thus the technologies to augment graft-versus-leukemia (GVL) effect is required for this group of patients. The preclinical study by Stokes et al. (British Journal of Haematology, 2016) indicated prolonged survival in the leukemia mouse model with substitution of posttransplantation cyclophosphamide (PTCy) with bendamustine (PTBenda). Also a small study evaluated the combination of PTCy and PTBenda in young patients and children (Katsanis E et al., 2018). We conducted the prospective study of postransplantation bendamustine as graft-versus-host-disease prophylaxis. Methods Single-center prospective dose-ranging de-escalation study (NCT02799147) evaluated safety and efficacy of PTBenda as GVHD prophylaxis. PTbenda was administered in doses 140, 100 and 70 mg/kg on days +3,+4. Myeloablative conditioning with fludarabine and busulfan was performed. First patients enrolled received single-agent PTbenda and subsequent- combination with other immunosuppressive agents. Inclusion criteria were acute myeloblstic (AML) or lymphoblstic leukemia (ALL) refractory to at least one induction course of chemotherapy or target therapy and more than 5% clonal blasts in the bone marrow. Twenty three patients were enrolled, 7 in the 140 mg/kg cohort, 10 in 100 mg/kg and 6 in 70 mg/kg, including 18 with AML and 5 with ALL. 35% of patients had primary refractory disease, and the rest - second or subsequent relapses, 61% had high-risk cytogenetics, 35% - complex karyotype, 17% - secondary AML, 30% - extramedulary disease. Median number of induction courses was 2 and 39% received target antibodies. Median number of blasts at transplant was 18% (range 6-97%). Two patients had matched related donor (MRD), 15 - unrelated (MUD), 6- haploidentical. Results Median follow-up was 10 months. The 140 mg/kg cohort was closed prematurely due to severe infectious complications. Ninety one percent of patients engrafted. Median time to engraftment was 16 days. Among the engrafted patients CR rate was 95%, and 67% had MRD(-) status. Relapse was documented in 10% of patients with CR. We have observed that PTBena induces a specific cytokine-release syndrome (CRC) with fever, vasculitis-like skin rush, oral mucositis, enteritis, hepatitis and pancreatitis. CNS signs, hypotension and respiratory failure were observed only in a few patients. CRC was observed in 78% of patients, including grade 1-2 in 17%, grade 3 in 26%, grade 4 in 22% and grade 5 in 3 patients. Median level of ferritin during CRC was 15 000 ng/ml and IL-6 levels were also increased (74 vs 8 ng/ml, p=0.036). Tocilizumab was administered to 13 patients and 10 responded. Classical grade II-IV GVHD was observed in 39% of pts and 60% of long-term survivors developed severe chronic GVHD. Non-relapse mortality was 48% with CRC, infectious complications and chronic GVHD as major causes. 1-year overall survival was 35%. Conclusion PTbenda even as a single agent has a significant potential to prevent acute, but not chronic GVHD. Moreover GVHD prophylaxis with PTbenda is a completely novel approach to induction of GVL, but optimal combination of immunosuppressive agents and supportive care should be determined to control the CRC and chronic GVHD. The optimal dosing regimen of PTbenda will be determined after enrollment in the last cohort will be completed. Figure Disclosures Moiseev: Novartis: Consultancy, Honoraria, Other: Travel grants, Speakers Bureau; MSD: Other: Travel grants; Celgene: Consultancy, Other: Travel grants; BMS: Other: Travel grants; Takeda: Other: Travel grants; Pfizer: Other: Travel grants. OffLabel Disclosure: Bendamustine used for graft-versus-host disease prophylaxis.

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New and emerging therapies for acute and chronic graft versus host disease

Therapeutic Advances in Hematology ◽

10.1177/2040620717741860 ◽

2017 ◽

Vol 9 (1) ◽

pp. 21-46 ◽

Cited By ~ 38

Author(s):

LaQuisa Hill ◽

Amin Alousi ◽

Partow Kebriaei ◽

Rohtesh Mehta ◽

Katayoun Rezvani ◽

...

Keyword(s):

Graft Versus Host Disease ◽

Chronic Gvhd ◽

Significant Proportion ◽

Unmet Need ◽

Treatment Strategies ◽

Infectious Complications ◽

Hematopoietic Stem ◽

Host Disease ◽

Graft Versus Host ◽

Emerging Therapies

Graft versus host disease (GVHD) remains a major cause of morbidity and mortality following allogeneic hematopoietic stem-cell transplantation (HSCT). Despite the use of prophylactic GVHD regimens, a significant proportion of transplant recipients will develop acute or chronic GVHD following HSCT. Corticosteroids are standard first-line therapy, but are only effective in roughly half of all cases with ~50% of patients going on to develop steroid-refractory disease, which increases the risk of nonrelapse mortality. While progress has been made with improvements in survival outcomes over time, corticosteroids are associated with significant toxicities, and many currently available salvage therapies are associated with increased immunosuppression, infectious complications, and potential loss of the graft versus leukemia (GVL) effect. Thus, there is an unmet need for development of newer treatment strategies for both acute and chronic GVHD to improve long-term post-transplant outcomes and quality of life for HSCT recipients. Here, we provide a concise review of major emerging therapies currently being studied in the treatment of acute and chronic GVHD.

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Ruxolitinib As a Salvage Therapy for Acute and Chronic Graft-versus-Host Disease in Children and Young Adults: a single institution experience.

10.1101/2021.10.29.21265670 ◽

2021 ◽

Author(s):

Melissa Mavers ◽

Edna Klinger ◽

David C Shyr ◽

Ami J Shah ◽

Alice Bertaina ◽

...

Keyword(s):

Young Adult ◽

Graft Versus Host Disease ◽

Salvage Therapy ◽

Chronic Gvhd ◽

Janus Kinase ◽

Adult Patients ◽

Close Monitoring ◽

Host Disease ◽

Graft Versus Host ◽

Steroid Refractory

Background Ruxolitinib, a Janus kinase (JAK)-1/JAK-2 inhibitor that reduces T-cell activation and proliferation leading to a potent anti-inflammatory effect, was recently approved to treat steroid-refractory acute graft-versus-host disease (aGvHD) and is under study for chronic GvHD (cGvHD). However, there are few reports on its use in pediatric and young adult patients with GvHD. Methods We retrospectively report our single center experience with ruxolitinib in 15 patients aged 11-29 years: 5 patients with steroid refractory/steroid dependent aGvHD and 10 patients with cGvHD who had failed at least one systemic therapy. Results In the aGvHD group, ruxolitinib led to an overall response rate (ORR) of 40% at day 28 and 80% with longer follow-up (complete response, CR 60%), with a median of 21 days (5-74) to achieve a response. In the cGvHD group (9 evaluable patients), we observed an ORR of 67% and a CR of 22%, with a median of 78 days (35-180) to achieve a response. Adverse events included cytopenias, gastrointestinal symptoms, infections, and an allergic reaction attributable to ruxolitinib. Conclusions Overall, our results show that ruxolitinib is an effective salvage therapy for severe GvHD in pediatric and young adult patients. The toxicities noted warrant adequate antimicrobial prophylaxis and close monitoring of blood counts.

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Mast Cell Involvement in Fibrosis in Chronic Graft-Versus-Host Disease

International Journal of Molecular Sciences ◽

10.3390/ijms22052385 ◽

2021 ◽

Vol 22 (5) ◽

pp. 2385

Author(s):

Ethan Strattan ◽

Gerhard Carl Hildebrandt

Keyword(s):

Wound Healing ◽

Mast Cell ◽

Mast Cells ◽

Graft Versus Host Disease ◽

Chronic Gvhd ◽

Fibrotic Disease ◽

Acute Leukemias ◽

Hematopoietic Stem ◽

Host Disease ◽

Graft Versus Host

Allogeneic hematopoietic stem cell transplantation (HSCT) is most commonly a treatment for inborn defects of hematopoiesis or acute leukemias. Widespread use of HSCT, a potentially curative therapy, is hampered by onset of graft-versus-host disease (GVHD), classified as either acute or chronic GVHD. While the pathology of acute GVHD is better understood, factors driving GVHD at the cellular and molecular level are less clear. Mast cells are an arm of the immune system that are known for atopic disease. However, studies have demonstrated that they can play important roles in tissue homeostasis and wound healing, and mast cell dysregulation can lead to fibrotic disease. Interestingly, in chronic GVHD, aberrant wound healing mechanisms lead to pathological fibrosis, but the cellular etiology driving this is not well-understood, although some studies have implicated mast cells. Given this novel role, we here review the literature for studies of mast cell involvement in the context of chronic GVHD. While there are few publications on this topic, the papers excellently characterized a niche for mast cells in chronic GVHD. These findings may be extended to other fibrosing diseases in order to better target mast cells or their mediators for treatment of fibrotic disease.

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Acute and chronic graft versus host disease after hematopoietic stem cell transplant

JBMTCT ◽

10.46765/2675-374x.2020v1n1p53-66 ◽

2020 ◽

Vol 1 (1) ◽

pp. 53-66

Author(s):

Vaneuza A. M. Funke ◽

Maria Claudia Rodrigues Moreira ◽

Afonso Celso Vigorito

Keyword(s):

Stem Cell ◽

Hematopoietic Stem Cell ◽

Graft Versus Host Disease ◽

Acute Gvhd ◽

Chronic Gvhd ◽

Cell Transplant ◽

Primary Therapy ◽

Hematopoietic Stem ◽

Host Disease ◽

Graft Versus Host

Graft versus host disease is one of the main complications of Hematopoietic stem cell, involving about 50% to 80% of the patients. Acute GVHD clinical manifestations and therapy is discussed, as well as new NIH criteria for the diagnosis and classification of chronic GVHD. Therapy for both refractory chronic and acute GVHD is an important field of discussion once there is no superiority for the majority of the agents after primary therapy has failed. Hence, this review is meant to be a useful tool of consultation for clinicians who are dealing with this complex complication.

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Successful and Safe Treatment of Intestinal Graft-Versus-Host Disease (GvHD) with Pooled-Donor Full Ecosystem Microbiota Biotherapeutics

Blood ◽

10.1182/blood-2019-125540 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 1993-1993

Author(s):

Florent Malard ◽

Faezeh Legrand ◽

Jérôme Cornillon ◽

Amandine Le Bourgeois ◽

Jean-Baptiste Mear ◽

...

Keyword(s):

Gut Microbiota ◽

Graft Versus Host Disease ◽

Hematopoietic Stem ◽

Host Disease ◽

Graft Versus Host ◽

Steroid Dependent ◽

Gi Symptoms ◽

Microbiota Diversity ◽

Steroid Refractory

Introduction Intestinal Graft-versus-Host Disease (GvHD), following allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT), comes with a high mortality rate and a reduced life-expectancy. In this context, failure to respond to steroid therapy is associated with an absence of further therapeutic options, thereby representing an unmet medical need. A marked reduction in gut microbiota diversity leading to loss of functions was strongly associated with reduced overall survival in GvHD, while a high gut microbiota diversity appears to be protective. Aiming at restoring microbiome functions, Fecal Microbiota Transfer proved to be a promising treatment modality in this challenging clinical situation, with recent studies reporting favorable results in steroid refractory-acute GVHD (SR-aGvHD) patients. Here we report on the use of "MaaT013", a standardized, pooled-donor, high-richness microbiota biotherapeutic, used to treat 8 patients with intestinal-predominant aGvHD. Patients and methods Eight allo-HSCT recipients with steroid-dependent or steroid-refractory gastrointestinal GvHD (classical aGVHD n=3, late-onset aGVHD n=2; aGvHD with overlap syndrome n=3) were treated with the MaaT013 biotherapeutic as part of a compassionate use program. These patients had previously received and failed 1 to 5 lines (median 2.5) of GvHD systemic treatments. MaaT013 microbiota biotherapeutics were provided as a pharmaceutical preparation to hospitals by the developer, "MaaT Pharma". Each patient received 1 to 3 doses (median: 3; total doses administered: 21) of MaaT013, a 150 mL bag, by enema (n=7) or nasogastric tube (n=1). GvHD response was evaluated 7 days after each administration and 28 days after the first dose. Prepared under Good Manufacturing Practices, MaaT013 biotherapeutics are characterized by a highly consistent richness of 455 +/- 3% Operational Taxonomic Units (OTUs) and an Inverse Simpson index greater than 20. Batch release specifications are based on potency (viability), identity (diversity), and purity (microbiological safety testing following regulatory guidelines and proportion of proinflammatory species), ensuring the desired consistency between batches. Results We observed 6/8 positive responses at D28 after first dosing, including 3 Complete Responses (CR), one Very Good Partial Response (VGPR), and 2 Partial Responses (PR). Considering the best GI response achieved, all (8/8) patients experienced at least a PR, with 3 CRs, 2 VGPRs and 3 PRs. The 3 patients with CR were still alive at last follow-up (60 to 192 days after last dosing; median: 115 days) and were able to taper and stop steroids and immunosuppressants without relapse of GI symptoms. Of note, among these 3 patients, mild mouth chronic GvHD symptoms persisted in one patient, and relapse of hematologic malignancy was observed in another patient. Among the 8 treated patients, 5 were still alive at last follow-up (60 to 232 days after last dosing; median: 125 days). The safety of the MaaT013 microbiota biotherapeutic was satisfactory in all patients. One patient developed a possibly related sepsis one day after the third MaaT013 administration. In the latter case, no pathogen was identified in blood cultures, and the patient recovered after a course of antibiotics. Conclusions We herein report for the first time the treatment of 8 patients with steroid-dependent or steroid-refractory intestinal aGvHD using a full ecosystem, standardized, pooled-donor, high-richness biotherapeutic. Overall, 3/8 patients attained a complete response following treatment with the off-the-shelf MaaT013 product, shown to be safe and effective in these immunocompromised patients with severe conditions, warranting further exploration of the full ecosystem microbiota restoration approach. Disclosures Malard: Sanofi: Honoraria; JAZZ pharmaceutical: Honoraria; Astellas: Honoraria; Therakos/Mallinckrodt: Honoraria; Keocyte: Honoraria; Janssen: Honoraria. Plantamura:MaaT Pharma: Employment. Carter:MaaT Pharma: Employment. Chevallier:Jazz Pharmaceuticals: Honoraria; Incyte: Consultancy, Honoraria; Daiichi Sankyo: Honoraria. Blaise:Pierre Fabre medicaments: Honoraria; Molmed: Consultancy, Honoraria; Jazz Pharmaceuticals: Honoraria; Sanofi: Honoraria. Mohty:Jazz Pharmaceuticals: Honoraria, Research Funding.

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Safety and efficacy of denileukin diftitox in patients with steroid-refractory acute graft-versus-host disease after allogeneic hematopoietic stem cell transplantation

Blood ◽

10.1182/blood-2004-01-0028 ◽

2004 ◽

Vol 104 (4) ◽

pp. 1224-1226 ◽

Cited By ~ 118

Author(s):

Vincent T. Ho ◽

David Zahrieh ◽

Ephraim Hochberg ◽

Eileen Micale ◽

Jesse Levin ◽

...

Keyword(s):

Graft Versus Host Disease ◽

Phase 1 ◽

Interleukin 2 ◽

Maximum Tolerated Dose ◽

Hematopoietic Stem ◽

Host Disease ◽

Graft Versus Host ◽

Denileukin Diftitox ◽

Steroid Refractory ◽

Acute Graft

Abstract Denileukin diftitox (Ontak), a recombinant protein composed of human interleukin 2 (IL-2) fused to diphtheria toxin, has selective cytotoxicity against activated lymphocytes expressing the high-affinity IL-2 receptor. We conducted a phase 1 study of denileukin diftitox in 30 patients with steroid refractory acute graft-versus-host disease (GVHD). Seven patients received 9 μg/kg intravenously on days 1 and 15; 18 received 9 μg/kg intravenously on days 1, 3, 5, 15, 17, and 19; and 5 received 9 μg/kg intravenously on days 1 to 5 and 15 to 19. Hepatic transaminase elevation was the dose-limiting toxicity (DLT), and dose level 2 was the maximum tolerated dose (MTD). Overall, 71% of patients responded with complete resolution (12 of 24; 50%) or partial resolution (5 of 24; 21%) of GVHD. Eight of 24 patients (33%) are alive at 6.3 to 24.6 months (median, 7.2 months). Denileukin diftitox is tolerable and has promising activity in steroid-refractory acute GVHD. (Blood. 2004;104:1224-1226)

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Chronic graft versus host disease is associated with long-term risk for pneumococcal infections in recipients of bone marrow transplants

Blood ◽

10.1182/blood.v95.12.3683 ◽

2000 ◽

Vol 95 (12) ◽

pp. 3683-3686 ◽

Cited By ~ 99

Author(s):

Samar Kulkarni ◽

Ray Powles ◽

Jennie Treleaven ◽

Unell Riley ◽

Seema Singhal ◽

...

Keyword(s):

Graft Versus Host Disease ◽

Chronic Gvhd ◽

Pneumococcal Infection ◽

Pneumococcal Infections ◽

Hematopoietic Stem ◽

Host Disease ◽

Graft Versus Host ◽

Increased Risk ◽

Penicillin Prophylaxis

Abstract Incidences of and risk factors for Streptococcus pneumoniaesepsis (SPS) after hematopoietic stem cell transplantation were analyzed in 1329 patients treated at a single center between 1973 and 1997. SPS developed in 31 patients a median of 10 months after transplantation (range, 3 to 187 months). The infection was fatal in 7 patients. The probability of SPS developing at 5 and 10 years was 4% and 6%, respectively. Age, sex, diagnosis, and graft versus host disease (GVHD) prophylaxis did not influence the development of SPS. Allogeneic transplantation (10-year probability, 7% vs 3% for nonallogeneic transplants; P = .03) and chronic GVHD (10-year probability, 14% vs 4%; P = .002) were associated with significantly higher risk for SPS. All the episodes of SPS were seen in patients who had undergone allograft or total body irradiation (TBI) (31 of 1202 vs 0 of 127;P = .07). Eight patients were taking regular penicillin prophylaxis at the time of SPS, whereas 23 were not taking any prophylaxis. None of the 7 patients with fatal infections was taking prophylaxis for Pneumococcus. Pneumococcal bacteremia was associated with higher incidences of mortality (6 of 15 vs 1 of 16;P = .04). We conclude that there is a significant long-term risk for pneumococcal infection in patients who have undergone allograft transplantation, especially those with chronic GVHD. Patients who have undergone autograft transplantation after TBI-containing regimens also appear to be at increased risk. These patients should receive lifelong pneumococcus prophylaxis. Consistent with increasing resistance to penicillin, penicillin prophylaxis does not universally prevent SPS, though it may protect against fatal infections. Further studies are required to determine the optimum prophylactic strategy in patients at risk.

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Methotrexate for the Treatment of Graft-versus-Host Disease after Allogeneic Hematopoietic Stem Cell Transplantation

Journal of Transplantation ◽

10.1155/2014/980301 ◽

2014 ◽

Vol 2014 ◽

pp. 1-10 ◽

Cited By ~ 5

Author(s):

Amr Nassar ◽

Ghada Elgohary ◽

Tusneem Elhassan ◽

Zubeir Nurgat ◽

Said Y. Mohamed ◽

...

Keyword(s):

Graft Versus Host Disease ◽

Chronic Gvhd ◽

Corticosteroid Treatment ◽

Complete Response ◽

Primary Treatment ◽

Lower Grade ◽

Hematopoietic Stem ◽

Host Disease ◽

Graft Versus Host ◽

Pooled Data

Glucocorticoids have been the primary treatment of graft-versus-host disease (GVHD) over the past decade. Complete responses to steroid therapy are usually expected in almost one-third of aGVHD cases and partial response is anticipated in another one-third of patients. However, for those patients not responding to corticosteroid treatment, there is no standard second-line therapy for acute or chronic GVHD. Methotrexate (MTX) for treatment of steroid refractory GVHD has been evaluated in a number of studies. Results from peer-reviewed original articles were identified and the pooled data analyzed. Despite several limitations in data collection and analysis, weekly administration of methotrexate at a median dose of 7.5 mg/m2seems to be safe with minimal toxicities in the context of both aGVHD and cGVHD treatments. The observed overall response (OR) in patients with aGVHD to MTX treatment in the published studies was 69.9%, with complete response (CR) in 59.2% and PR in 10.6%. In cGVHD the OR was 77.6%, with CR reported in 49.6% and PR in 28% of patients. Predictors of better responses were lower grade GVHD, cutaneous involvement, and isolated organ involvement. MTX as a steroid sparing agent might reduce long-term complications and improve the quality of life of GVHD affected individuals.

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