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Clinician-reported outcome measures in lupus trials: a problem worth solving
Kathryn Connelly1, Vera Golder1, Rangi Kandane-Rathnayake2
1School of Clinical Sciences, Monash University, Clayton, VIC 3168, Australia; Department of Rheumatology, Monash Health, Monash University, Clayton, VIC 3168, Australia.
The Lancet. Rheumatology
|January 30, 2024
Summary
Systemic lupus erythematosus (SLE) clinical trials face challenges due to patient diversity. This study reviews current outcome measures and proposes improvements for future SLE therapeutic development.
Area of Science:
- Rheumatology
- Clinical Trial Design
- Drug Development
Background:
- Systemic lupus erythematosus (SLE) presents a significant unmet clinical need.
- Patient heterogeneity complicates clinical trial efficacy assessments.
- Existing outcome measures for SLE trials have limitations.
Purpose of the Study:
- To critically evaluate current clinician-reported outcome measures in SLE clinical trials.
- To identify strengths and weaknesses of existing indices and composite assessments.
- To propose advancements in endpoint design for future SLE trials.
Main Methods:
- Review of existing SLE disease activity indices (e.g., SLEDAI, BILAG).
- Analysis of composite responder definitions (e.g., SRI, BICLA).
- Exploration of strengths and limitations of current assessment approaches.
Main Results:
- Individual indices and composite measures have notable drawbacks.
- Current approaches require further investigation for optimal use.
- There is a need for improved endpoint design in SLE trials.
Conclusions:
- Defining optimal clinical trial outcome measures for SLE is an ongoing research goal.
- Future analyses should investigate specific features of existing measures.
- Advancing endpoint design is crucial for improving SLE trial interpretability and success.
