Telitacicept shows promise in systemic lupus erythematosus

Telitacicept, a novel fusion protein that neutralizes signals of B lymphocyte stimulator and a proliferation-inducing ligand, is safe and helps improve the symptoms of systemic lupus erythematosus (SLE), as shown in a phase IIb study.

The study included 249 adult patients with active SLE who were recruited from several hospitals across China. These patients were randomly assigned to receive subcutaneous telitacicept at 80 mg (n=62), 160 mg (n=63), or 240 mg (n=62), or placebo (n=62). Treatment was given once weekly and in addition to standard therapy.

The primary endpoint was the proportion of patients achieving an SLE Responder Index 4 (SRI-4) response at week 48. This endpoint occurred with significantly greater frequency in the telitacicept arms than in the placebo arm. SRI-4 response rates at week 48 were 75.8 percent with 240 mg telitacicept, 68.3 percent with 160 mg, 71.0 percent with 80 mg, and 33.9 percent with placebo (p<0.001 for all).

Furthermore, telitacicept was associated with substantial improvements in secondary endpoints, such as a ≥4-point reduction on the Systemic Lupus Erythematosus Disease Activity Index, a lack of Physician’s Global Assessment score worsening, and a glucocorticoid dose reduction in the 240-mg arm.

In terms of safety, telitacicept was well tolerated. The frequency of adverse events and serious adverse events did not significantly differ between the telitacicept and placebo arms.