Lupus & antiphospholipid syndrome
Obexelimab in Systemic Lupus Erythematosus With Exploration of Response Based on Gene Pathway Co‐Expression Patterns: A Double‐Blind, Randomized, Placebo‐Controlled, Phase 2 Trial
Authors' conclusion
Although the primary endpoint was not reached, secondary analysis showed time to LOI was significantly increased in obexelimab-treated patients, and analysis of patient subsets defined by gene expression patterns at baseline suggests a responding subpopulation.
Study context
- Population
- Patients with active, non-organ-threatening systemic lupus erythematosus (SLE) whose disease activity improved after screening corticosteroid injections with immunosuppressants withdrawnrandomised
- Participants
- 104 patients
- Comparison
- Obexelimab 5 mg/kg IV every 2 weeks vs placebo, until week 32 or loss of improvement
- Primary endpoint
- Proportion of patients reaching week 32 without loss of improvement (LOI)
- Follow-up
- Week 32
Methodological detailsdouble-blind, placebo-controlled, phase 2, 1:1 randomisation
- Double-blind
- Placebo-controlled
- Phase 2
- 1:1 randomisation
Primary result
As reported in the abstract
Reached week 32 without LOI
P = 0.183
Further findings
| Outcome | HR | P value |
|---|---|---|
| Time to LOIObexelimab vs Placebo · efficacy-evaluable population | 0.53 | P = 0.025 |
| Time to LOIObexelimab vs Placebo · intention-to-treat population | 0.59 | P = 0.062 |
B cells in obexelimab-treated patients
- B cells decreased ≈50%
Safety
- Obexelimab associated with infusion reactions but generally safe and well-tolerated
Original publication
Obexelimab in Systemic Lupus Erythematosus With Exploration of Response Based on Gene Pathway Co‐Expression Patterns: A Double‐Blind, Randomized, Placebo‐Controlled, Phase 2 Trial. Arthritis Rheumatol. Published 29 November 2023. doi:10.
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