Lupus & antiphospholipid syndrome
Measurement of haemolytic anaemia in a novel treatment response measure for SLE clinical trials
Authors' conclusion
Hb, with meaningful thresholds for entry and improvement, will be adopted to classify haemolytic anaemia treatment response in a novel multi-domain outcome measure for SLE clinical trials.
Study context
- Population
- International working group of 12 clinicians and 4 patients defining a haemolytic anaemia treatment response measure for SLE clinical trials12 clinicians and 4 patients
- Outcome
- Consensus haemolytic anaemia treatment response measure and thresholds
Methodological detailsinternational working group, online survey, nominal group technique
- International working group
- Online survey
- Nominal group technique
Recommendations
As reported in the abstract
- Response measure: Haemoglobin (Hb) improvement
- Entry threshold: Hb <100 g/L with laboratory confirmation of haemolysis
- Minimum clinically meaningful response: Hb improvement >20 g/L or Hb normalised with ongoing haemolysis
- Complete response: Hb normalised without haemolysis
- Domain scope (unanimous): immune-mediated haemolytic anaemia attributed to active lupus, impacting the patient and modifiable by therapy, incl. Coombs' positive autoimmune haemolytic anaemia and rarer subtypes
Further findings
Systematic literature review (SLR) of shortlisted laboratory measures
- Laboratory measures shortlisted
- 6
- Articles screened
- 1519
- Articles included
- 10
Original publication
Measurement of haemolytic anaemia in a novel treatment response measure for SLE clinical trials. Lupus Sci Med. Published 18 March 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →