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• W4366173614 abstract "TIS is a composite score proposed as a primary efficacy measure in DM clinical trials. We hypothesize that TIS may not adequately capture skin improvement in DM, as it does not include any direct measure of skin activity and may use redundant components. We also hypothesize that a new composite outcome, named Dermatomyositis Outcomes for Muscle and Skin (DMOMS), which includes components of TIS and a skin-specific outcome, is better suited to capture improvements in DM disease activity. DMOMS includes improvement from baseline in Manual Muscle Test (MMT), Physician’s Global Assessment (PGA), and Patient’s Global Assessment (PtGA), all scored as in TIS except a 50% increase in weight for PtGA. It also includes the Cutaneous Dermatomyositis Disease Area and Severity Index-Activity (CDASI-A) score, weighted the same as MMT. To compare efficacy of scores, data from a Phase 3 trial of lenabasum in DM were evaluated (Baseline vs Week 52). Pearson’s correlation assessed for redundancy (r>0.8). PGA and Extramuscular Global Assessment in TIS score were redundant (r=0.827). Subjects with a 10-point improvement in MMT or 11-point improvement in CDASI-A score at Week 52 (N=96) were considered responders (R). Mean (SD) TIS and DMOMS scores were compared for R and non-responders (NR) using Student’s t-test. CDASI-A R (n=36) vs NR (n=60) had mean TIS of 47 (13) vs 30 (18), p<0.001 and DMOMS of 64 (16) vs 29 (22), p<0.001. MMT R (n=27) vs NR (n=69) had a mean TIS of 49 (15) vs 31 (17), p<0.001 and DMOMS of 66 (18) vs 32 (23), p<0.001. Compared to TIS, DMOMS is a simpler composite score without redundant components (4 components vs 6). It provides about twice the treatment effect for R vs NR in both muscle and skin without any increase in score in NR and assigns greater weight to PtGA. DMOMS may be better suited to detect treatment effect in DM clinical trials that include patients with all DM phenotypes, even with a smaller sample size." @default.
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• W4366173614 date "2023-05-01" @default.
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• W4366173614 title "521 The total improvement score (TIS) in a phase 3 clinical trial for dermatomyositis (DM): Room for improvement?" @default.
• W4366173614 doi "https://doi.org/10.1016/j.jid.2023.03.527" @default.
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