Evaluating Important Change in Cutaneous Disease Activity as an Efficacy Measure for Clinical Trials in Dermatomyositis

Sarah Ahmed¹, Srita Chakka ², Rebecca Krain ³, Rui Feng ⁴ and Victoria Werth ⁵, ¹Department of Dermatology, University of Pennsylvania, Philadelphia, PA, Philadelphia, PA, ²Department of Dermatology, University of Pennsylvania, Philadelphia, PA, USA, Philadelphia, ³University of Pennsylvania, Philadelphia, PA, ⁴University of Pennsylvania, Philadelphia, ⁵Corporal Michael J. Crescenz VAMC, Philadelphia, PA, USA and Department of Dermatology, University of Pennsylvania, Philadelphia, PA, USA, Philadelphia, PA

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: clinical trials and Autoimmune Skin Disease, patient outcomes

Session Information

Date: Tuesday, November 12, 2019

Title: Patient Outcomes, Preferences, & Attitudes Poster II: Patient Preferences, Beliefs, & Experiences

Session Type: Poster Session (Tuesday)

Session Time: 9:00AM-11:00AM

Background/Purpose: The FDA uses near or total clearance in cutaneous disease in inflammatory skin conditions as an endpoint in clinical trials. However, patients may experience improvement in their quality of life (QoL) without achieving complete clearance of their skin disease. A previous study has shown that the Cutaneous Dermatomyositis Disease Area and Severity Index-Activity (CDASI-A) score correlates with the Symptoms and Emotions subscales of the Skindex-29, a skin specific measure of QoL, down to CDASI-A scores of 7 and 10, respectively. Our goal is to define an important change in disease activity, as measured by CDASI-A, that results in meaningful change in QoL in patients with dermatomyositis (DM).

Methods: In 103 patients seen in the outpatient Autoimmune Disease Clinic at the University of Pennsylvania, we assessed the percent change and actual change in CDASI-A needed to achieve a meaningful improvement in QoL using linear regression models.

Results: Comparing the Skindex-29 to the Dermatology Life Quality Index (DLQI), we found that meaningful improvement in the Symptoms and Emotions subscales of the Skindex-29 is 7.86 (P< .0001) and 10.29 (P< .0001) points, respectively. For patients with initial CDASI-A scores >14, a 40% change in CDASI-A between the first two visits suggests a meaningful change in the Skindex-29. In patients with moderate initial CDASI-A (15-26), the change in CDASI-A score needed to achieve a meaningful change in Symptoms and Emotions was 6 (P=.0002) and 7 (P=.0007), respectively. For initial CDASI-A scores in the severe range of 27-35, an improvement in CDASI-A by 11 (P=.0301) and 9 (P=.0212) points is needed to result in meaningful change in Symptoms and Emotions, respectively.

Conclusion: In patients with an initial CDASI-A of >14, a 40% change in CDASI-A can be used to indicate meaningful change in QoL in future DM trials.

Disclosure: S. Ahmed, None; S. Chakka, None; R. Krain, None; R. Feng, None; V. Werth, Biogen, 2, 5, Corbus Pharmaceuticals, 2, 9, University of Pennsylvania, 9.

To cite this abstract in AMA style:

Ahmed S, Chakka S, Krain R, Feng R, Werth V. Evaluating Important Change in Cutaneous Disease Activity as an Efficacy Measure for Clinical Trials in Dermatomyositis [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/evaluating-important-change-in-cutaneous-disease-activity-as-an-efficacy-measure-for-clinical-trials-in-dermatomyositis/. Accessed .

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