Background/Purpose: The FDA encourages clearance of skin findings as a primary outcome of clinical trials for inflammatory skin conditions. However, some DM patients retain signs of inflammation and damage despite having an acceptable quality of life. The current standardized quality of life instruments, Skindex-29 and Dermatology Life Quality Index, are shown to correlate with Cutaneous Dermatomyositis Activity and Severity Index activity scores and have been validated for use in clinical trials. However, Skindex-29 and Dermatology Life Quality Index scores have not been examined in patients with mild disease (Cutaneous Dermatomyositis Activity and Severity Index activity score≤14), who may have an acceptable quality of life despite their cutaneous manifestations

Methods: This is a retrospective review of 171 patients enrolled in a prospective longitudinal database for DM. We evaluated the correlation of individual Skindex-29 and Dermatology Life Quality Index scores vs. the Cutaneous Dermatomyositis Activity and Severity Index activity scores in patients with DM skin disease. A linear model was fitted to determine the “Cutaneous Dermatomyositis Activity and Severity Index cut-off value”, which is the lowest Cutaneous Dermatomyositis Activity and Severity Index activity score at which the instrument correlates well with quality of life.

Results: The Dermatology Life Quality Index had the lowest Cutaneous Dermatomyositis Activity and Severity Index cut-off value at 3, compared to the other Skindex-29 subscales (Emotions, 9; Functioning, 7; Symptoms, 6). Below these Cutaneous Dermatomyositis Activity and Severity Index values, the Skindex-29 and Dermatology Life Quality Index are not shown to directly correlate with cutaneous disease activity, and further improvement in Cutaneous Dermatomyositis Activity and Severity Index activity score does not lead to further improvement in quality of life.

Conclusion:

Our findings suggest that quality of life is not directly affected by the minimal cutaneous disease activity below these Cutaneous Dermatomyositis Activity and Severity Index cut-off values and therefore total clearance of skin findings may be irrelevant as a meaningful outcome for patients. Additionally, the linear correlation of Cutaneous Dermatomyositis Activity and Severity Index with quality of life until the cut-off values suggests that changes in Cutaneous Dermatomyositis Activity and Severity Index scores are relevant over the spectrum of disease activity above these cut-offs. The results of this study should encourage design of trials that reach a meaningful endpoint in terms of quality of life for patients.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/examining-cutaneous-disease-activity-as-an-outcome-measure-for-clinical-trials-in-dermatomyositis/