N Engl J Med

Investigational agent demonstrates efficacy in SLE, phase 3 trial finds

October 22, 2025

Study details: This randomized, double-blind, placebo-controlled phase 3 trial (NCT04082416) enrolled 335 adults with active systemic lupus erythematosus (SLE) in China. Participants received SC telitacicept 160 mg or placebo weekly for 52 weeks, in addition to standard therapy. Primary endpoint was the proportion achieving a response on the modified SLE Responder Index 4 (SRI-4) at week 52, defined by ≥4-point reduction in SELENA-SLEDAI, no new BILAG A/multiple B scores, and no worsening in Physician’s Global Assessment.

Results: At week 52, 67.1% of telitacicept-treated patients achieved SRI-4 response vs. 32.7% with placebo (adjusted difference, 34.5 percentage points; 95% confidence interval, 24.3–44.7; P<0.001). A ≥4-point SELENA-SLEDAI reduction occurred in 70.1% of the telitacicept group vs. 40.5% in the placebo. Adverse events were more frequent with telitacicept (74.9% vs. 50.0%), notably upper respiratory tract infections, reduced IgG/IgM, and injection-site reactions.

Clinical impact: Telitacicept significantly improved disease activity in patients with active SLE, suggesting that dual targeting of BLyS and APRIL may be a viable strategy for patients inadequately controlled on current therapies. Monitoring for immunosuppression-related adverse effects is warranted.

Source:

van Vollenhoven RF, et al; 18C010 Trial Investigators. (2025, October 16). N Engl J Med. A Phase 3 Trial of Telitacicept for Systemic Lupus Erythematosus. https://pubmed.ncbi.nlm.nih.gov/41092329/