EFFICACY AND SAFETY OF TELITACICEPT, A NOVEL BLYS/APRIL DUAL INHIBITOR, IN PATIENTS WITH PRIMARY SJÖGREN’S SYNDROME: A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED 24-WEEK STUDY
Abstract: OP0142 (2023)
Authors: D. Xu et al.
Telitacicept (TACI-Fc fusion protein), 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 SLE was tested in a phase 2 study in 42 patients with active (ESSDAI score ≥5) primary Sjögren’s syndrome (pSS).
Patients were randomized to 3 treatment arms: placebo (N=14), telitacicept 160 mg (N=14) and telitacicept 240 mg (N=14). Study drugs were administered subcutaneously weekly for 24 weeks. Statistically significant improvements were observed for the ESSDAI score both at week 12 and week 24 (primary endpoint) in both telitacicept groups. The side effect profile of telitacicept was favourable.
To the knowledge of the author, this is one of a few studies demonstrating a clinical benefit of a DMARD in patients with pSS. The findings of this small study must be validated in a larger clinical trial. Telitacicept may also become an interesting drug for SLE patients with secondary Sjögren’s syndrome.