Correlation of the NIH and Vienna Skin Scores with Provider and Patient-Reported Skin Changes in Chronic Graft-Versus-Host Disease (GVHD).
Authors: Jacobsohn David , Chai Xiaoyu , Kurland Brenda , Arai Sally , Arora Mukta , Cutler Corey , Jagasia Madan , Pavletic Steven Z. , Vogelsang Georgia , Lee Stephanie J. , Flowers Mary E.D. 
Published: October 2019

Abstract
Abstract 2256
Poster Board II-233
Correlation of the NIH and Vienna Skin scores with provider and patient-reported skin changes in chronic graft-versus-host disease (GVHD)
In 2007 we began a multi-center, prospective, observational study of patients diagnosed with chronic GVHD (cGVHD) by National Institute of Health (NIH) Consensus Conference criteria. A major objective is to develop sensitive and valid organ-specific criteria for cGVHD activity to document clinically meaningful changes in clinical trials. This preliminary analysis evaluated the NIH skin tool and the Vienna Skin scale (VS) for their ability to quantify the type and extent of skin involvement, and for their correlation with provider and patient perceptions of change in the skin.

Methods:
Patients ≥ age 2 diagnosed with cGVHD within 3 years after allogeneic hematopoietic cell transplantation requiring systemic treatment were eligible. Providers and patients complete multiple cGVHD assessment tools at study entry and every 3-6 months. The NIH scale grades 8 body regions according to the percent of body surface area (BSA) involvement by 3 manifestations: 1) erythematous rash, 2) moveable sclerosis, and 3) non-moveable sclerosis, with possible values of 0-100% total BSA for each manifestation. The VS scores each of 10 body regions with percentage involvement of 4 types of skin manifestations: 1 = hypo/hyperpigmentation, erythematous rash, 2 = lichenoid plaque, thickening, able to move, 3 = thickened, limited motion, pinchable, 4 = hidebound, unable to move or pinch. For areas scored as 3 or 4, concurrent fraction involved with erythema is also recorded. Regional scores are summed for a Vienna Skin Total (VST) score of 0-50. At follow-up visits patients and providers rated change in skin involvement as improved, stable, or worse. Proportional odds regression was used to predict improved, stable and worse rates using the difference in NIH subscales or VST since the last visit (change scores). Predictive ability for each scale was summarized using the c index of concordance.

Results:
Of the 229 participants as of 4/30/09, 61% were males, the median age was 52 years (2-79) and median time from transplant to study entry was 393 days (91-1233). Table 1 shows the scores on the two scales for patients with any skin involvement at baseline (n=161, 70%). At 168 follow-up visits with NIH and VS data, skin GVHD was rated by the providers as improved, stable, or worse in 43%, 48%, and 9%, respectively. Both tools appeared to predict subjective change with the c index of concordance of 0.76 for NIH and 0.71 for VS. Compared to providers, patients were more likely to rate the skin as improved (56%), and less likely to report stable (38%) or worse (6%). The same differences (VST, and NIH erythema and non-moveable sclerosis) were still significant predictors of patients' subjective change. Concordance (c index) and parameter estimates (odds ratios) were attenuated compared to models of provider ratings.Results of the 4 models are summarized in Table 2.

Conclusions:
Skin involvement is frequent in cGVHD. Both NIH and VS scores are associated with provider- and patient-reported changes in skin severity. These results suggest that the NIH and VS tools are quantitative measures that are sensitive to provider and patient-perceived skin changes over time. Data from additional patients with a broader range of skin severity and longer follow up are needed to better define the roles of these scales as endpoints in clinical trials.

Disclosures:
Jagasia: Genzyme: Research Funding.