In a new study, researchers identified eight disease activity domains for further development into the new Treatment Response Measure for Systemic Lupus Erythematosus (TRM-SLE), a clinical trial outcome assessment (COA) for systemic lupus erythematosus (SLE) randomized controlled trials (RCTs). RCTs have sparked challenges due to the complex process of measuring changes in disease activity in response to lupus treatment. Existing COAs that have been used to measure treatment responses in SLE have produced inconsistent outcomes.
The two-round modified Delphi study considered both patient and clinician perspectives on domain importance, and factors influencing domain utility. TRM-SLE taskforce members nominated domains based on two online surveys and could choose domains from the SLE Disease Activity Index (SLEDAI) as a starting point or suggest new ones. After stage 2, eight domains of active SLE were identified, including alopecia, arthritis, hemolytic anemia, nephritis, mucosal ulcers, rash, serositis and thrombocytopenia. These domains reached a consensus on appropriateness, representation and measurability in clinical trials.
Innovative methods for assessing significant treatment impacts on disease activity in SLE clinical trials are critically needed to enhance understanding of new therapies’ effectiveness and facilitate their regulatory approval for both adult and childhood-onset SLE. This research is critical in further developing and improving SLE trial clarity and effectiveness. Learn more about Lupus clinical trials.
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