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Toward Better Response Assessment of Cutaneous Chronic Graft-Versus-Host Disease: A Report from the National
Alina Markova1, Stephanie J Lee2, Badri Modi3
1Dermatology Service, Department of Medicine, Memorial Sloan Kettering Cancer, New York, New York; Weill Cornell Medicine, New York, New York.
Abstract:
The National Institutes of Health (NIH) chronic graft-versus-host disease (cGVHD) Consensus Project established response criteria that enabled clinical trials and facilitated regulatory approval of multiple therapies. Nonetheless, organ-specific assessments have limitations, particularly for severe sclerotic skin involvement. Cutaneous manifestations occur in approximately half of patients with chronic GVHD but are difficult to evaluate due to heterogeneous clinical features. To address these challenges, the NIH Consensus Skin Task Force convened from 2024 to 2025 to refine skin response measures for use in clinical trials. This report (1) summarizes current diagnosis and scoring of skin chronic GVHD, (2) reviews existing response assessments, (3) identifies gaps in their performance, (4) proposes refinements to the 2014 NIH skin response criteria, and (5) outlines future directions incorporating patient-reported outcomes, novel technologies, and biomarker research. Current NIH scoring relies on a 4-point body surface area (BSA) scale and a 3-point sclerosis features scale. While standardized, these measures have limited sensitivity to clinically meaningful change. Proposed refinements include: (1) separate BSA assessments for epidermal involvement and sclerotic features; (2) modification of sclerosis descriptors, with removal of impaired mobility and specification of GVHD-related ulceration, and addition of sclerosis-associated edema with or without erythema; and (3) replacement of the exploratory severity scale with two new clinician instruments. The Sclerosis Quality and Physical Signs scale (0 to 10) captures qualitative physical changes, while the Sclerosis Daily Function Impact scale (0 to 4) evaluates functional compromise. These proposed refinements aim to improve the accuracy, reproducibility, and clinical relevance of skin chronic GVHD assessments, strengthening trial endpoints and patient care.
Insights
New criteria improve skin assessments for chronic graft-versus-host disease (cGVHD). Refinements enhance accuracy and clinical relevance for clinical trials and patient care in this challenging condition.
Area of Science:
- Hematology
- Dermatology
- Clinical Trials
Background:
- Chronic graft-versus-host disease (cGVHD) affects approximately 50% of patients post-transplant, with cutaneous manifestations posing significant evaluation challenges.
- Existing National Institutes of Health (NIH) response criteria for skin cGVHD have limitations in sensitivity for detecting clinically meaningful changes, especially with severe sclerotic skin involvement.
Purpose of the Study:
- To refine existing NIH skin response criteria for chronic GVHD to improve accuracy, reproducibility, and clinical relevance in trial settings.
- To address the heterogeneity and difficulty in evaluating cutaneous manifestations of cGVHD, particularly sclerotic skin involvement.
Main Methods:
- The NIH Consensus Skin Task Force reviewed current diagnosis and scoring methods for skin cGVHD.
- Proposed refinements include separate body surface area (BSA) assessments for epidermal and sclerotic features, modified sclerosis descriptors, and introduction of new clinician-reported outcome instruments.
- New instruments include the Sclerosis Quality and Physical Signs (SQPS) scale and the Sclerosis Daily Function Impact (SDFI) scale.
Main Results:
- Current NIH scoring using BSA and sclerosis features scales lacks sensitivity to clinically meaningful changes.
- Proposed modifications aim to enhance the assessment of epidermal involvement and sclerotic features, including edema and ulceration.
- The new SQPS and SDFI scales are designed to capture qualitative physical changes and functional compromise more effectively.
Conclusions:
- The proposed refinements to the NIH skin response criteria are expected to improve the accuracy and clinical relevance of cGVHD assessments.
- These enhanced measures will strengthen endpoints in clinical trials and ultimately improve patient care for individuals with skin manifestations of cGVHD.
- Future directions involve incorporating patient-reported outcomes, novel technologies, and biomarker research into cGVHD skin assessments.
