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
Abstract: OP0137 (2023)
Authors: L. Wang et al.
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).
In a double-blind, randomized, placebo-controlled, phase 3 trial, Telitacicept was studied in 335 active SLE patients who were receiving stable standard therapy with positive ANA/anti-dsDNA and a SELENA-SLEDAI score ≥8. Patients were randomized 1:1 to receive telitacicept 160 mg or placebo subcutaneously weekly for 52 weeks.
A significantly greater proportion of patients receiving telitacicept 160 mg achieved the primary endpoint (SRI4 response). Greater proportions of subjects in telitacicept 160 mg group also had improvement in SELENA-SLEDAI and PGA. Rapid and sustained increases of C3 and C4 and reductions of serum immunoglobulins were observed following telitacicept. Incidences of TEAEs and infections were comparable between the two groups. A greater proportion of patients receiving placebo had SAEs and serious infections compared with telitacicept 160 mg.
Telitacicept 160 mg demonstrated clinical benefits and a favorable safety profile in SLE patients, underscoring the importance of B-cell stimulation in the pathogenesis of SLE. Telitacicept will likely enrich our therapeutic armamentarium in the near future.