Table 4.
Response determination for chronic GVHD clinical trials based on clinician assessments
| Organ | Complete Response | Partial Response | Progression |
|---|---|---|---|
| Skin | NIH Skin Score 0 after previous involvement | Decrease in NIH Skin Score by 1 or more points | Increase in NIH Skin Score by 1 or more points, except 0 to 1 |
| Eyes | NIH Eye Score 0 after previous involvement | Decrease in NIH Eye Score by 1 or more points | Increase in NIH Eye Score by 1 or more points, except 0 to 1 |
| Mouth | NIH Modified Oral Mucosa Rating Score 0 after previous involvement | Decrease in NIH Modified Oral Mucosa Rating Score of 2 or more points | Increase in NIH Modified Oral Mucosa Rating Score of 2 or more points |
| Esophagus | NIH Esophagus Score 0 after previous involvement | Decrease in NIH Esophagus Score by 1 or more points | Increase in NIH Esophagus Score by 1 or more points, except 0 to 1 |
| Upper GI | NIH Upper GI Score 0 after previous involvement | Decrease in NIH Upper GI Score by 1 or more points | Increase in NIH Upper GI Score by 1 or more points, except 0 to 1 |
| Lower GI | NIH Lower GI Score 0 after previous involvement | Decrease in NIH Lower GI Score by 1 or more points | Increase in NIH Lower GI Score by 1 or more points, except from 0 to 1 |
| Liver | Normal ALT, alkaline phosphatase, and Total bilirubin after previous elevation of one or more | Decrease by 50% | Increase by 2x ULN |
| Lungs | -Normal %FEV1 after previous involvement -If PFTs not available, NIH Lung Symptom Score 0 after previous involvement |
-Increase by 10% predicted absolute value of %FEV1 -If PFTs not available, decrease in NIH Lung Symptom Score by 1 or more points |
-Decrease by 10% predicted absolute value of %FEV1 -If PFTs not available, increase in NIH Lung Symptom Score by 1 or more points, except 0 to 1 |
| Joints and Fascia | Both NIH Joint and Fascia Score 0 and P-ROM score 25 after previous involvement by at least one measure | Decrease in NIH Joint and Fascia Score by 1 or more points or increase in P-ROM score by 1 point for any site | Increase in NIH Joint and Fascia Score by 1 or more points or decrease in P-ROM score by 1 point for any site |
| Global | Clinician overall severity score 0 | Clinician overall severity score decreases by 2 or more points on a 0–10 scale | Clinician overall severity score increases by 2 or more points on a 0–10 scale |