Lupus & antiphospholipid syndrome
Telitacicept in patients with active systemic lupus erythematosus: results of a phase 2b, randomised, double-blind, placebo-controlled trial
Authors' conclusion
All telitacicept groups showed a significantly higher proportion of patients achieving an SRI-4 response than the placebo group at week 48, and all doses were well tolerated.
Study context
- Population
- Adults with active systemic lupus erythematosus (SLE), 29 hospitals in China
- Participants
- 249 adults
- Comparison
- Subcutaneous telitacicept 80 mg, 160 mg or 240 mg once weekly vs placebo, in addition to standard therapy
- Telitacicept 240 mgn = 62
- Telitacicept 160 mgn = 63
- Telitacicept 80 mgn = 62
- Placebon = 62reference
- Primary endpoint
- Proportion achieving SRI-4 response
- Follow-up
- Week 48
Methodological detailsphase 2b, double-blind, placebo-controlled, 1:1:1:1 randomisation, multicentre (29 hospitals)
- Phase 2b
- Double-blind
- Placebo-controlled
- 1:1:1:1 randomisation
- Multicentre (29 hospitals)
Primary result
As reported in the abstract
SRI-4 response
Telitacicept 240 mg vs Placebo: P < 0.001 · Telitacicept 160 mg vs Placebo: P < 0.001 · Telitacicept 80 mg vs Placebo: P < 0.001
Secondary outcomes
≥4-point SLEDAI reduction, no PGA worsening, GC dose reduction (240 mg)
- Significant treatment responses in the 240 mg group
Safety
Adverse events and serious adverse events
- Incidence similar between telitacicept and placebo; telitacicept well tolerated
Original publication
Telitacicept in patients with active systemic lupus erythematosus: results of a phase 2b, randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. Published 12 March 2024. doi:10.
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