Telitacicept promising with acceptable safety profile in patients with SLE: Phase 2 Trial
China: Findings from a phase 2b clinical trial showed the safety and effectiveness of novel fusion protein telitacicept in patients with active systemic lupus erythematosus (SLE). The findings were published online in the Annals of the Rheumatic Diseases.
This trial met the primary endpoint. 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.
"At 48 weeks, the primary endpoint of the SLE Responder Index 4 (SRI-4) response was met by 75.8% with 240 mg telitacicept, 68.3% with 160 mg, and 71.0% with 80 mg compared with 33.9% of patients in the placebo group," the researchers reported.
Despite the approval of biological therapies such as anifrolumab and belimumab for patients with SLE, still, there is an unmet medical need for therapies with more satisfactory safety and efficacy profiles. Studies have demonstrated an association between SLE disease activity and serum level of B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL). Telitacicept is a novel fusion protein that effectively inhibits both BLyS and APRIL.
Against the above background, Fengchun Zhang, Chinese Academy of Medical Sciences & Peking Union Medical College, China, and colleagues aimed to evaluate the safety and efficacy of telitacicept.
The study included 249 adult patients with active SLE from 29 hospitals in China. They were randomized on the ratio of 1:1:1:1 to receive subcutaneous telitacicept at 80 mg (n=62), 160 mg (n=63), 240 mg (n=62) or placebo (n=62) once weekly in addition to standard therapy.
The study's primary endpoint was the proportion of patients achieving an SRI-4 response at week 48. Missing data were imputed using the last observation carried forward method.
The researchers reported the following findings:
- At week 48, the proportion of patients achieving an SRI-4 response was 75.8% in the 240 mg telitacicept group, 68.3% in the 160 mg group, 71.0% in the 80 mg group and 33.9% in the placebo group.
- Significant treatment responses were observed in secondary endpoints, including 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 group.
- Telitacicept was well-tolerated, and the incidence of adverse events and serious adverse events was similar between the telitacicept and placebo groups.
Reference:
Wu D, Li J, Xu D, et alTelitacicept in patients with active systemic lupus erythematosus: results of a phase 2b, randomised, double-blind, placebo-controlled trialAnnals of the Rheumatic Diseases Published Online First: 21 December 2023. doi: 10.1136/ard-2023-224854
