A novel composite measure detected up to twice the treatment effect in dermatomyositis compared with the standard Total Improvement Score, offering greater sensitivity for skin and muscle disease activity, according to a recent study.
Researchers developed and evaluated the Dermatomyositis Outcomes for Muscle and Skin (DMOMS), a novel composite measure addressing the limitations of the Total Improvement Score (TIS) in assessing dermatomyositis (DM) disease activity. Their findings, published in the Journal of Investigative Dermatology, leveraged data from the phase III trial of lenabasum to assess the sensitivity of DMOMS compared with TIS in capturing treatment effects on both skin and muscle disease activity.
The study included 174 participants meeting the Bohan and Peter or American College of Rheumatology/European League Against Rheumatism classification criteria for DM, with 87% having classic DM. The cohort had a mean age of 51.9 (12.2) years, 82% were female, and 75% self-identified as White. Baseline measures of disease activity included manual muscle testing (MMT, mean = 133.3 ± 15.5), CDASI-A (23.4 ± 12.85), PGA (5.5 ± 1.67), and PtGA (5.1 ± 2.43).
The DMOMS score integrated TIS components with CDASI-A while removing redundant measures such as Extramuscular Global Assessment and muscle enzymes. Equal weight was assigned to MMT and CDASI-A, with increased emphasis on PtGA to better capture patient-reported outcomes. Scores were collected at baseline and at weeks 16, 28, 40, and 52.
The researchers demonstrated that DMOMS provided significantly greater sensitivity in detecting treatment effects compared with TIS, noted lead study author Rachita Pandya, of the Corporal Micheal J. Crescenz Veterans Affairs Medical Center and the Department of Dermatology at the University of Pennsylvania, and her colleagues. Among the responders, DMOMS scores ranged from 25.9 to 40.0 points, depending on the time point, whereas TIS scores ranged from 17.6 to 21.7 points (P < .05). Among skin responders, DMOMS showed an improvement of 50.4 to 62.5 points vs 38.6 to 46.7 points with TIS. Among muscle responders, DMOMS scores ranged from 47.8 to 65.3 points compared with 39.6 to 48.8 points for TIS. Nonresponders had comparable scores between the two measures, indicating DMOMS's capacity to detect meaningful improvement in active disease.
The researchers concluded that DMOMS may be a more sensitive and clinically meaningful composite measure than TIS, particularly for assessing skin-predominant disease activity. Its implementation in future clinical trials may enhance the detection of treatment effects across diverse patient phenotypes in DM.
Full disclosures can be found in the published study.
