ReviewClinical rheumatology2025
The importance of developing reproducible primary endpoints for clinical trials in systemic lupus erythematosus.
Review in Clinical rheumatology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Lessons Learnt from the Belimumab Trials in Systemic Lupus Erythematosus.International journal of molecular sciences · 2025Review
- Systemic Lupus Erythematosus: Ophthalmological Safety Considerations of Emerging and Conventional Therapeutic Agents.International journal of molecular sciences · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
objectiveTo evaluate the current usage of reproducible primary endpoints and tools for assessing treatment response for clinical trials for systemic lupus erythematosus (SLE), and emphasize the need for developing standardized, reproducible endpoints in this context.
methodA comprehensive review of Phase II and III SLE biologic trials from the past 15 years was conducted using PubMed and ClinicalTrials.gov. The analysis focused on clinical trial endpoints, disease activity indices, and the evolution of primary endpoints. Key measurement tools, including the British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA), the Systemic Lupus Erythematosus Responder Index (SRI), and the Systemic Lupus Activity Measure-Revised (SLAM-R), were examined.
resultsThe SRI emerged as the most commonly used composite measure for phase II/III clinical trial endpoints, with over 60% of ongoing trials employing SRI (4) as the primary endpoint. BICLA, derived from the British Isles Lupus Assessment Group (BILAG) index, was also frequently used but demonstrated notable differences from SRI in its approach. Our analysis underscores the ongoing need for more effective tools to assess disease activity and treatment response in SLE trials.
conclusionsThe selection of optimal primary endpoints is vital for SLE clinical trials due to the disease's heterogeneity and the variability in treatment responses. Currently, different primary endpoints are employed depending on the specific focus of clinical trials. While the SRI is widely used in phase II/III trials, the standardized efficacy measures are critical to enhancing the design and outcomes of future SLE clinical trials. Key points • Selecting optimal primary endpoints is crucial for SLE clinical trials. • Challenges in SLE treatment response assessment include patient heterogeneity and inconsistent disease activity evaluation. • BICLA and SRI are commonly used as primary endpoints but have notable differences. • There is an urgent need for better tools to assess disease activity and response in SLE clinical trials.
Indexed as
Identifiers
39579266What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.