ReviewEULAR rheumatology open2026
Lupus trials and tribulations: are outcome measures the problem?
Review in EULAR rheumatology open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Many randomised clinical trials in systemic lupus erythematosus have failed, and the manner in which they have failed is of concern. In lupus, phase III trials have a higher risk of failing than phase II trials-going against the expected gradient and against logic, because phase III trials are preferentially based on successful rather than on failed phase II trials. In addition, there have been puzzling discrepancies between different outcomes within individual trials as well as between the same outcomes in different trials. Therefore, it has been suggested that outcome measures are to blame for the difficulties in achieving trial successes in lupus. Additional concerns regarding clinical trial outcomes deal with their complexity and lack of clinical applicability; and the most widely used trial outcomes, SRI-4 (systemic lupus response index [based on four points improvement]) and BICLA (British Isles Lupus Assessment Group-Based Composite Lupus Assessment), are at odds with current therapeutic thinking, which is less concerned with change and more with the disease state that is achieved (treating to target). A number of suggestions have been made, and concrete initiatives launched, to address these issues, and these may change the way in which clinical trials will be done in the future. Meanwhile, it is worth mentioning that a large number of phase III trials are currently underway; their outcomes may yet again change the way we approach clinical trial outcomes in lupus.
Identifiers
What 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.