Lupus & antiphospholipid syndrome
Identification of biomarkers to stratify response to B-cell-targeted therapies in systemic lupus erythematosus: an exploratory analysis of a randomised controlled trial
Primary result · Major clinical responseResult — go to the resultBetween-group difference 13 % 95% CI −15 to 38Authors' conclusion
This exploratory study revealed the presence of distinct molecular networks associated with renal and mucocutaneous involvement, and response to B-cell-targeted therapies
Study context
- Population
- Patients with systemic lupus erythematosus (SLE) recruited to the 52-week BEAT-LUPUS trial44 analysed
- Participants
- 52 patients
- Comparison
- Rituximab plus belimumab vs rituximab plus placebo
- Belimumabn = 21
- Placebon = 23reference
- Primary endpoint
- Biomarkers associated with major clinical response
- Follow-up
- 52 weeks
Methodological detailsmachine learning and conventional statistics, Recruited between Feb 2, 2017, and March 28, 2019
- Machine learning and conventional statistics
- Recruited between Feb 2, 2017, and March 28, 2019
Primary result
Major clinical response
Between-group difference
13 %
95% CI −15 to 38
Events by treatment group
Belimumabvs Placebo
between-group difference 13 % (95% CI −15 to 38)
As reported in the abstract
Further findings
| Outcome | Between-group difference (%) (95% CI) | |
|---|---|---|
| Major clinical response in patients with elevated baseline serum IgA2 anti-dsDNA antibody (subgroup) | 48 (10–70) | |
| −50050100Difference, % (linear scale) |
Serum IgA2 anti-dsDNA antibody concentrations among major clinical responders
- Significantly decreased from baseline only in the belimumab group
Associations with organ involvement
- Serum IgA2 anti-dsDNA associated with active renal disease
- Serum IgA1 anti-dsDNA and IFN-α associated with mucocutaneous disease activity but did not predict response to B-cell targeted therapy
High baseline serum IL-6
- Less likely to have a major clinical response, irrespective of therapy
Original publication
Identification of biomarkers to stratify response to B-cell-targeted therapies in systemic lupus erythematosus: an exploratory analysis of a randomised controlled trial. Lancet Rheumatol. Published 28 November 2022. doi:10.
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