Lupus & antiphospholipid syndrome
A Phase 3 Trial of Telitacicept for Systemic Lupus Erythematosus
Primary result · Modified SRI-4 responseResult — go to the resultAdjusted difference 34.5 percentage points 95% CI 24.3–44.7Authors' conclusion
In this 52-week trial involving participants with active SLE who were receiving background therapy, the incidence of a clinical response was higher with telitacicept than with placebo. However, the incidence of upper respiratory infections, reduced immunoglobulin levels, and injection-site reactions was also higher with telitacicept.
Study context
- Population
- Adults with active systemic lupus erythematosus (SLE), China433 screened
- Participants
- 335 adults
- Comparison
- Telitacicept 160 mg SC once weekly for 52 weeks vs placebo, plus standard therapy
- Telitaciceptn = 167
- Placebon = 168reference
- Primary endpoint
- Modified SRI-4 response (≥4-point reduction in SELENA-SLEDAI, no new BILAG disease activity, no worsening in PGA)
- Follow-up
- Week 52
Methodological detailsphase 3, placebo-controlled, 1:1 randomisation
- Phase 3
- Placebo-controlled
- 1:1 randomisation
Primary result
Modified SRI-4 response
Adjusted difference
34.5 percentage points
95% CI 24.3–44.7
P < 0.001
By group
As reported in the abstract
Further findings
| Outcome | Telitacicept | Placebo | Difference (percentage points) (95% CI) | |
|---|---|---|---|---|
| ≥4-point reduction from baseline in SELENA-SLEDAI | 70.1% | 40.5% | 29.6 (13.1–46.1) | |
| −200204060Difference, percentage points (linear scale) |
Safety
Treatment-related adverse events (investigator-assessed)
Upper respiratory tract infection (related)
Reduced serum IgG level (related)
Reduced serum IgM level (related)
Injection-site reactions (related)
Original publication
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