Oral chronic graft-vs.-host disease characterization using the NIH scale.

Area of Science:

• Hematology
• Immunology
• Oncology

Background:

• Chronic graft-vs-host disease (cGVHD) is a significant complication following allogeneic hematopoietic stem cell transplantation (alloHSCT).
• Oral cGVHD presents with diverse symptoms including mucosal, salivary, and sclerotic changes, often leading to pain and reduced quality of life.

Purpose of the Study:

• To characterize demographic, clinical, and laboratory markers associated with oral cGVHD in alloHSCT patients.
• To propose a reproducible and clinically meaningful measure for diagnosing oral cGVHD.

Main Methods:

• A cross-sectional study involving 187 alloHSCT patients was conducted at the NIH (ClinicalTrials.gov #NCT00331968).
• The 15-point NIH cGVHD clinician assessment scale was utilized to evaluate oral cGVHD.
• Multivariable logistic regression analysis identified predictive factors for oral cGVHD.

Main Results:

• Oral cGVHD was diagnosed in 44 patients.
• Oral cGVHD correlated with quiescent or de novo cGVHD onset, increased cGVHD severity, lower albumin levels, and higher total complement levels.
• Significant associations were found with increased mouth pain, oral ulcer bother, and food-related discomfort (p < 0.0001).

Conclusions:

• A cut-off score of >2 on the NIH scale is proposed as a reproducible definition for clinically significant oral cGVHD.
• This proposed measure can aid in clinical settings, serve as an eligibility criterion for clinical trials, or function as a trial endpoint.
• Predictive modeling using albumin, mouth pain, and total complement demonstrated high accuracy in identifying oral cGVHD.