OP0137 EFFICACY AND SAFETY OF TELITACICEPT, A NOVEL BLYS/APRIL DUAL INHIBITOR, IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS: A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED 52-WEEK STUDY

Background

Telitacicept (TACI-Fc fusion protein) is a novel BLyS (B-lymphocyte stimulator)/APRIL (a proliferation-inducing ligand) dual inhibitor, which has been approved in 2021 in China for the treatment of patients with active systemic lupus erythematosus (SLE)[1].

Objectives

Assess the efficacy and safety of telitacicept in SLE patients in a double-blind, randomized, placebo-controlled, phase 3 trial.

Methods

In this study, 335 active SLE patients who were receiving stable standard therapy with positive ANA/anti-dsDNA and a SELENA-SLEDAI score ≥8 were randomized 1:1 to receive telitacicept 160 mg (N=167) or placebo (N=168) subcutaneously weekly for 52 weeks. The primary endpoint was the response rate of SLE responder index 4 (SRI4) at Week 52. Key secondary endpoints included: SELENA-SLEDAI, PGA, immunological biomarkers including C3, C4, IgM, IgG, IgA and CD19⁺ B cells. Safety was assessed during the study.

Results

Baseline demographics and disease characteristics were comparable between the two groups. The primary endpoint at Week 52 was met, with significantly greater proportion of patients in telitacicept 160 mg group vs placebo group achieving SRI4 response (Table 1). SRI4 response was sustained in telitacicept 160 mg group up to Week 52 (Figure 1A). Significantly greater proportions of subjects in telitacicept 160 mg group had improvement in SELENA-SLEDAI and PGA (Table 1 & Figure 1B, 1C). Rapid and sustained increase of C3 and C4 (Figure 1G, 1H), and reduction of IgM, IgG, IgA and CD19⁺ B cells (Figure 1D, 1E, 1F, 1I) were observed following telitacicept treatment. Incidences of TEAEs and infections were comparable between the two groups. Most of TEAEs were mild to moderate in severity. A greater proportion of patients receiving placebo had SAEs and serious infections compared with telitacicept 160 mg. (Table 1).

Conclusion

This phase 3 trial met the primary endpoint. Telitacicept 160 mg showed good clinical benefits and a favorable safety profile in SLE patients.

Reference

[1]Dhillon S. Telitacicept: First Approval. Drugs. 2021 Sep;81(14):1671-1675.

Acknowledgements

The patients and their families who participated in this clinical trial.

Disclosure of Interests

Li Wang: None declared, JING LI: None declared, Dong Xu: None declared, Jianmin Fang Shareholder of: RemeGen Co., Ltd, Employee of: RemeGen Co., Ltd, Ronald van Vollenhoven: None declared, Fengchun Zhang: None declared.