Lupus & antiphospholipid syndrome
Selection of indicators reporting response rate in pharmaceutical trials for systemic lupus erythematosus: preference and relative sensitivity
Authors' conclusion
The impressionable efficacy discrimination ability of indicators highlights the importance of flexibility and comprehensiveness when choosing primary outcome(s).
Study context
- Population
- Pharmacological intervention-controlled SLE randomised clinical trials (RCTs)33 RCTs
- Comparison
- Eight commonly used indicators reporting response rate in SLE RCTs
- Outcome
- Relative discrimination of indicators reporting response rate
Methodological detailsBayesian hierarchical linear mixed model
- Bayesian hierarchical linear mixed model
Pooled result
As reported in the abstract
Relative discrimination of response indicators
- SLEDAI-4 and SRI-4 considered the best recommended indicators reporting response rate to discriminate pharmacological efficacy
- Indicator preference altered by disease severity, drug class and trial outcome; SLEDAI-4 robust in discriminating ability for most interventions
- BICLA showed efficacy in trials covering all-severity patients and in non-biologic RCTs
- BILAG response and PGA response more cautious in evaluating disease changes
- Serious adverse event often applied to evaluate safety and tolerability rather than efficacy
Original publication
Selection of indicators reporting response rate in pharmaceutical trials for systemic lupus erythematosus: preference and relative sensitivity. Lupus Sci Med. Published 5 October 2023. doi:10.
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