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Hematology›Condition·Updated Jul 11, 2026·v1

Graft-Versus-Host Disease

Graft-versus-host disease (GVHD) is a major complication of allogeneic hematopoietic cell transplantation, caused by donor T-cell recognition of recipient tissues. The disease manifests as acute (skin rash, GI symptoms, hepatitis) or chronic (lichenoid/sclerotic skin changes, sicca, bronchiolitis obliterans) syndromes. Management begins with corticosteroids; steroid-refractory disease requires targeted therapy with ruxolitinib (REACH2/3), belumosudil, or axatilimab. Prevention with post-transplant cyclophosphamide or anti-thymocyte globulin has dramatically reduced incidence. Prognosis is poor without effective treatment; biomarker-based risk stratification (Ann Arbor score, MAGIC composite) guides therapy intensity. Multidisciplinary care including surveillance for infections, pulmonary function monitoring, and supportive care is essential for long-term outcomes.

High Evidence515 references·9,993 words·40 min read·v1
GVHDgraft-versus-host diseasehematopoietic cell transplantationallogeneic transplantsteroid-refractory GVHDruxolitinibpost-transplant cyclophosphamidebronchiolitis obliteransAnn Arbor scoreMAGIC score

Quick Reference

RxDrug of choiceAcute GVHD first-line: Methylprednisolone 2 mg/kg/day IV (or prednisone equivalent). Steroid-refractory acute GVHD: Ruxolitinib 10 mg PO BID. Chronic GVHD first-line: Prednisone 1 mg/kg/day + calcineurin inhibitor. Steroid-refractory chronic GVHD: Ruxolitinib 10 mg PO BID (EBMT 2024 strong recommendation).
AltAlternativesAcute GVHD: Begelomab, ECP, ATG, MSCs. Chronic GVHD: Belumosudil 200 mg PO daily, axatilimab 0.3 mg/kg IV q2wk, ibrutinib 420 mg PO daily, ECP.
⊘AvoidMycophenolate mofetil in pregnancy (teratogenic). Non-dihydropyridine CCBs (diltiazem, verapamil), exacerbate GVHD. Antibiotics with anaerobic coverage (piperacillin-tazobactam, carbapenems), increase aGVHD risk. Avoid live vaccines in active GVHD or ongoing immunosuppression.
DxTest of choiceBiopsy of affected organ (skin, GI tract, liver) for histologic confirmation. MAGIC composite score (clinical + ST2, TNFR1, Reg3α) for risk stratification. PFTs with DLCO for cGVHD lung involvement. Chimerism analysis for engraftment monitoring.
ScKey scoreAnn Arbor GVHD score (TNFR1, ST2, Reg3α), predicts 6-month nonrelapse mortality: 8% (score 1), 27% (score 2), 46% (score 3). NIH global severity score for cGVHD (mild/moderate/severe), predicts survival. MAGIC composite score for aGVHD risk stratification.
→When to referSteroid-refractory GVHD, suspected bronchiolitis obliterans, need for second-line therapy, cellular therapy, or clinical trial enrollment. Multidisciplinary referral to transplant center, pulmonology, ophthalmology, dermatology, and rehabilitation as indicated.
GVHD is a common and potentially fatal complication of allogeneic HCT. Early diagnosis and prompt initiation of corticosteroids are critical. Steroid refractoriness requires transition to ruxolitinib (REACH2/3). Prevention with PTCy or ATG has significantly reduced incidence. Multidisciplinary supportive care and surveillance for infections and late complications are essential.
Graft-versus-host disease (GVHD) is a systemic inflammatory and fibrotic syndrome caused by donor-derived T cells recognizing recipient tissues as foreign after allogeneic hematopoietic cell transplantation (HCT). It is the leading cause of nonrelapse mortality after HCT, affecting 13-48% of patients with acute GVHD (grade II-IV) and 32-69% of survivors with chronic GVHD. Management requires early recognition of skin, gastrointestinal, and liver involvement, rapid initiation of systemic corticosteroids, and escalation to targeted therapies (ruxolitinib, belumosudil, axatilimab) for steroid-refractory disease. Prevention with post-transplant cyclophosphamide or anti-thymocyte globulin has dramatically reduced incidence, and a multidisciplinary approach to surveillance and supportive care is essential for long-term outcomes.

Overview and Recommendations

Background

  • •GVHD is a systemic alloimmune syndrome that occurs when donor-derived immunocompetent T cells recognize recipient tissues as foreign after allogeneic HCT, leading to inflammatory and fibrotic damage in target organs including skin, tract, liver, lungs, and oral mucosa. It is the most important cause of nonrelapse morbidity and mortality after HCT, with untreated steroid-refractory acute GVHD carrying a median survival of approximately 6 months.
  • •Acute GVHD (aGVHD) typically presents within the first 100 days post-transplant with a classic triad of maculopapular rash (often starting on palms, soles, ears), secretory diarrhea, and cholestatic hepatitis. Chronic GVHD (cGVHD) develops after day 100 and resembles autoimmune disease with lichenoid skin changes, oral , sicca syndrome, fasciitis, and bronchiolitis obliterans.
  • •The 2014 NIH Consensus Classification replaced the arbitrary 100-day cutoff with a clinical phenotype-based system. Acute GVHD is divided into classic (≤100 days) and late acute (>100 days without chronic features). Chronic GVHD includes classic, overlap (concurrent acute symptoms), and progressive subtypes. The overlap subtype carries the worst prognosis, with a hazard ratio for nonrelapse mortality of 5.47 compared to classic cGVHD.
  • •The pathophysiology of aGVHD follows a three-phase cascade: (1) conditioning-induced tissue injury releasing DAMPs and cytokines (TNF, IL-1, IL-6) that activate host APCs; (2) donor T-cell activation, proliferation, and differentiation into Th1/Th17 effectors; (3) effector cell migration to target organs causing epithelial damage, particularly in the GI tract where intestinal stem cell and Paneth cell loss leads to barrier breakdown and microbial translocation. Chronic GVHD is driven by B-cell dysregulation (TLR7 hyperresponsiveness, autoantibody production), macrophage-driven fibrosis via CSF-1/CSF-1R signaling, and impaired regulatory T-cell function.
  • •Risk factors for GVHD include donor-recipient HLA disparity (mismatched unrelated donors carry 55% cGVHD disability at 3 years), donor clonal hematopoiesis (HR 2.4 for grade II-IV aGVHD), peripheral blood stem cell grafts (higher cGVHD risk than bone marrow), and conditioning intensity. The incidence of severe aGVHD has declined from 11% to 5% over the past decade due to improved prophylaxis with post-transplant (PTCy) and anti-thymocyte globulin (ATG).

Evaluation

  • •Suspect acute GVHD in any allogeneic HCT recipient within the first 100 days who presents with a new maculopapular rash, watery or bloody diarrhea, nausea/vomiting, or cholestatic jaundice. The rash typically begins on the palms, soles, ears, and face, then spreads to the trunk and extremities, pruritus is common. Gastrointestinal symptoms include anorexia, abdominal cramps, and stool volumes ≥1.0 L/day define higher-risk disease.
  • •Suspect chronic GVHD in any transplant survivor beyond day 100 with lichenoid or sclerotic skin changes, oral mucositis with lichenoid striae, dry eyes, dyspnea on exertion, or elevated liver enzymes (cholestatic pattern). The NIH consensus criteria require at least one diagnostic manifestation (e.g., skin sclerosis, oral , bronchiolitis obliterans) or one distinctive manifestation plus biopsy confirmation.
  • •Ask about the timing of symptom onset relative to transplant, prior GVHD history, recent immunosuppression adjustments, and exposure to medications that could mimic GVHD (e.g., drug reactions, infections). Inquire about sun exposure, which can trigger or exacerbate cutaneous GVHD. Also ask about fevers, night sweats, weight loss, and fatigue, these may indicate infection or relapse.
  • •Examine the skin thoroughly: assess body surface area involved (use the NIH skin scoring tool), note the morphology (erythematous macules/papules in aGVHD; poikiloderma, lichenoid plaques, or sclerotic changes in cGVHD). Palpate for skin thickening and joint mobility impairment. Examine the oral cavity for erythema, lichenoid striae, hyperkeratotic plaques, and mucoceles. Perform a Schirmer test for tear production. Auscultate the lungs for crackles or wheezes; a normal exam does not exclude bronchiolitis obliterans.
  • •Order a complete blood count, comprehensive metabolic panel (including bilirubin, alkaline phosphatase, ALT, AST, and albumin), and stool studies (culture, Clostridium difficile, viral PCR) to rule out infection. For suspected GI GVHD, consider upper endoscopy with biopsy of the stomach and duodenum and/or flexible sigmoidoscopy with biopsy, the histologic hallmark is apoptotic crypt epithelial cells. For suspected liver GVHD, liver biopsy may be needed to distinguish from veno-occlusive disease or drug-induced injury.
  • •Order pulmonary function tests (PFTs) with diffusion capacity for suspected cGVHD lung involvement. A decline in FEV1 of ≥10% from baseline is the hallmark of bronchiolitis obliterans syndrome (BOS). Forced vital capacity (FVC) <15 mL/kg predicts need for intubation. Perform high-resolution CT chest to evaluate for air trapping, mosaic attenuation, and bronchiectasis.
  • •Diagnostic criteria for acute GVHD are based on the MAGIC staging system: stage 0-4 for skin (percentage of body surface area), liver (bilirubin level), and GI (stool volume/consistency). Overall grade I-IV is determined by the combination of stages. The MAGIC composite score integrates clinical stage with serum biomarkers (ST2, TNFR1, Reg3α) to predict 6-month nonrelapse mortality, scores ≥0.290 identify high-risk patients.
  • •Diagnostic criteria for chronic GVHD follow the NIH consensus: mild (1-2 organs with score 1), moderate (≥3 organs score 1, or any organ score 2), or severe (any organ score 3). The NIH skin score uses a 4-point body surface area scale and a 3-point sclerosis scale. The global severity score predicts survival and guides therapy intensity.
  • •Also consider alternative diagnoses: drug reaction (e.g., to antibiotics, anticonvulsants), viral infection (CMV, HHV-6, EBV, adenovirus), bacterial or fungal infection, conditioning regimen toxicity (mucositis, hepatic veno-occlusive disease), and relapse of underlying malignancy. Over 40% of steroid courses for suspected GVHD are started for other causes, biopsy confirmation is essential when the diagnosis is uncertain.
  • •When evaluating for GVHD, assess severity using the Minnesota Risk Score (standard risk vs high risk based on organ involvement and severity) and the Ann Arbor biomarker score (TNFR1, ST2, Reg3α) if available. These tools stratify day 28 response and 6-month nonrelapse mortality. In chronic GVHD, the NIH global severity score and the presence of thrombocytopenia (<100 × 10⁹/L) or progressive onset are key prognostic factors.
  • •In all patients with suspected GVHD, check for CMV viremia (PCR) and consider bronchoalveolar lavage if pulmonary symptoms are present. Assess for iron overload with ferritin level if prior transfusions. Perform chimerism analysis on peripheral blood with cell subset separation (CD3+ T cells, CD33+ myeloid cells) to evaluate engraftment status and risk of graft failure or relapse.

Management

  • •Initiate systemic corticosteroids immediately for grade II-IV acute GVHD: 2 mg/kg/day IV (or prednisone equivalent 2 mg/kg/day PO). Assess response clinically at day 3-5. For grade II acute GVHD with isolated skin or upper GI involvement, a lower dose of 1 mg/kg/day may be considered per EBMT 2024 recommendations.
  • •For steroid-refractory acute GVHD (no response or progression after 3-5 days of corticosteroids), initiate 10 mg twice daily. The REACH2 trial demonstrated a 28-day overall response rate of 62% vs 39% with best available therapy (OR 2.64, NNT=4). Continue ruxolitinib until response, then taper as tolerated. Monitor for thrombocytopenia (33% grade ≥3), anemia, and infection.
  • •For steroid-refractory acute GVHD in patients who cannot tolerate ruxolitinib, consider 2.7 mg/m²/day IV on days 1-5, then days 10, 14, 17, 21, 24, 28 (pediatric dosing). Alternatively, extracorporeal photopheresis (ECP) or anti-thymocyte globulin (ATG) may be used. Mesenchymal stromal cells (MSCs) are approved in Japan and Canada for GI GVHD.
  • •For first-line systemic therapy of moderate-to-severe chronic GVHD, initiate 1 mg/kg/day (or equivalent) combined with a calcineurin inhibitor ( or ). Begin steroid taper after 2 weeks of stable response, reducing by 10-20% every 1-2 weeks, aiming for discontinuation by 6-9 months. For mild disease limited to skin or mouth, topical corticosteroids alone may suffice.
  • •For steroid-refractory or steroid-dependent chronic GVHD, initiate 10 mg twice daily (EBMT 2024 strong recommendation). The REACH3 trial showed week-24 overall response rate of 49.7% vs 25.6% (OR 2.99, NNT=4) and median failure-free survival >18.6 vs 5.7 months (HR 0.37). Grade 3-4 thrombocytopenia occurred in 15% and anemia in 13%.
  • •Alternative second-line agents for chronic GVHD: 200 mg once daily (ROCK2 inhibitor, overall response 74% in ROCKstar trial, median duration of response 54 weeks); 0.3 mg/kg IV every 2 weeks (CSF1R-blocking antibody, 74% ORR, 60% with ≥5-point Lee Symptom Scale reduction); 420 mg daily (67% ORR, FDA-approved after first-line failure). These are appropriate after ruxolitinib intolerance or failure.
  • •For GVHD prophylaxis in HLA-matched related or unrelated donor peripheral blood stem cell transplants, use post-transplant (PTCy) 50 mg/kg/day IV on days +3 and +4 combined with and mofetil. The BMT CTN 1703 trial showed 1-year GVHD-free, relapse-free survival (GRFS) of 52.7% vs 34.9% with tacrolimus/methotrexate (HR 0.64, NNT=6).
  • •For alternative prophylaxis, consider anti-thymocyte globulin (ATG) 4.5 mg/kg total dose (reduces 2-year cGVHD from 68.7% to 32.2%, NNT=3) or abatacept 10 mg/kg IV on days -1, +5, +14, +28 added to calcineurin inhibitor/methotrexate (reduces grade 3-4 aGVHD from 14.8% to 6.8% in 8/8 HLA-matched unrelated donors). For haploidentical transplantation, PTCy-based prophylaxis is standard.
  • •For maintenance therapy to prevent relapse after transplant (especially in FLT3-ITD AML), consider 400 mg twice daily starting day 30-60 post-transplant for 2 years. This reduces 5-year relapse from 33.9% to 15.0% (HR 0.33, NNT=5) and improves 5-year OS from 56.4% to 72.0% (HR 0.55). For high-risk MRD-negative AML, 5 mg/m² IV days 1-5 plus rhG-CSF 100 µg/m² SC days 0-5 every 4-6 weeks reduces 2-year relapse from 38.3% to 15.0% (HR 0.32, NNT=4).
  • •What NOT to do: Avoid non-dihydropyridine calcium channel blockers (diltiazem, verapamil), they exacerbate GVHD. Avoid antibiotics with anaerobic coverage (e.g., piperacillin-tazobactam, carbapenems) when possible, a meta-analysis showed increased acute GVHD incidence (RR 1.33) and a trend toward higher GVHD-related mortality (RR 1.65). Prefer for febrile neutropenia. Do not start steroids for grade I acute GVHD, it does not reduce progression to grade II-IV and increases infections.
  • •Monitor patients on systemic immunosuppression with weekly complete blood counts, liver and renal function tests, and therapeutic drug monitoring for calcineurin inhibitors (tacrolimus trough 5-15 ng/mL, cyclosporine trough 100-400 ng/mL). For patients on ruxolitinib, monitor platelets and hemoglobin weekly for the first month, then monthly. Check CMV PCR weekly during active GVHD treatment.
  • •When to refer: Refer to a transplant center for any patient with suspected steroid-refractory GVHD, for consideration of second-line therapy, cellular therapy (donor lymphocyte infusion, MSCs), or clinical trial enrollment. Refer to pulmonology for suspected bronchiolitis obliterans (FEV1 decline ≥10% from baseline). Refer to ophthalmology for sicca syndrome (Schirmer test, slit-lamp exam). Refer to dermatology for skin sclerosis or refractory cutaneous GVHD.
  • •Discharge criteria for acute GVHD: resolution of diarrhea to <500 mL/day, stable skin rash (improving), bilirubin <2 mg/dL, no need for IV fluids or parenteral nutrition, and ability to manage oral medications. Provide a steroid taper plan, instruct on sun protection, and arrange close follow-up with weekly lab monitoring. Educate patient on signs of infection (fever, new rash, diarrhea) and when to seek urgent care.

Board Review — High Yield

  • •MAGIC composite score, Integrates clinical stage with serum biomarkers (ST2, TNFR1, Reg3α) to predict 6-month nonrelapse mortality in acute GVHD; AUC 0.76.
  • •Ann Arbor GVHD score, Three-biomarker panel (ST2, TNFR1, Reg3α) stratifies 6-month NRM: 8% (score 1), 27% (score 2), 46% (score 3).
  • •Post-transplant cyclophosphamide (PTCy), 50 mg/kg/day on days +3 and +4; BMT CTN 1703 showed 1-year GRFS 52.7% vs 34.9% (NNT=6) compared to tacrolimus/methotrexate.
  • •REACH2 trial, Ruxolitinib 10 mg BID for steroid-refractory acute GVHD: day 28 ORR 62% vs 39% (OR 2.64, NNT=4).
  • •REACH3 trial, Ruxolitinib for steroid-refractory chronic GVHD: week 24 ORR 49.7% vs 25.6% (OR 2.99, NNT=4); median FFS >18.6 vs 5.7 months (HR 0.37).
  • •ROCKstar trial, Belumosudil 200 mg daily for chronic GVHD: ORR 74% (95% CI 62-84), median duration of response 54 weeks.
  • •AGAVE-201 trial, Axatilimab 0.3 mg/kg IV q2wk for chronic GVHD: ORR 74%, 60% with ≥5-point Lee Symptom Scale reduction.
  • •Anaerobic antibiotic coverage, Increases acute GVHD incidence (RR 1.33) and trend toward increased GVHD-related mortality (RR 1.65), avoid piperacillin-tazobactam and carbapenems.
  • •Sorafenib maintenance, For FLT3-ITD AML post-transplant: 400 mg BID starting day 30-60 reduces 5-year relapse from 33.9% to 15.0% (HR 0.33, NNT=5).
  • •Donor clonal hematopoiesis, Present in 18% of donors; increases risk of grade II-IV aGVHD (HR 2.4) and grade III-IV aGVHD (HR 3.8).

Deep Dive — Evidence Details

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