Skin response using NIH consensus criteria vs Hopkins scale in a phase II study for steroid-refractory chronic GVHD

Area of Science:

• Hematology
• Immunology
• Dermatology

Background:

• Standardized response criteria are lacking for chronic graft-versus-host disease (GVHD) research.
• The National Institutes of Health (NIH) proposed criteria that require validation.
• Chronic GVHD treatment research faces challenges due to measurement inconsistencies.

Purpose of the Study:

• To compare the NIH and Hopkins scales for evaluating cutaneous responses in chronic GVHD.
• To assess the predictive value of each scale for treatment response.
• To identify challenges in quantifying GVHD manifestations, particularly sclerosis.

Main Methods:

• Prospective collection of percent body-surface-area (BSA) involvement for rash, superficial sclerosis, and deep sclerosis during a pentostatin trial.
• Comparison of cutaneous response assessments using the NIH and Hopkins scales.
• Analysis of agreement rates between the two scales for overall and domain-specific responses.

Main Results:

• Both scales showed similar overall response rates (80% agreement).
• Domain-specific response rates differed, with lower agreement for fasciitis/non-moveable sclerosis (64%).
• The Hopkins scale, incorporating skin softening, was more predictive of early response than the NIH scale's BSA focus, especially for sclerosis.

Conclusions:

• Disparities in sclerosis measurement highlight quantification difficulties.
• The Hopkins scale's focus on skin softening may be valuable for early detection of treatment activity in chronic GVHD.
• Further validation of the NIH scale is necessary to ensure clinical utility and predictive power.