Telitacicept reveals positive efficacy data in Chinese patients with Sjögren’s disease

Telitacicept, a recombinant fusion protein that simultaneously inhibits B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL), showed significant improvements in disease activity scores versus placebo in patients with Sjögren’s disease in China, with injection-site reactions reported as the most common adverse event.

Dr Dong Xu (Peking Union Medical College Hospital, China) presented results from a randomised, double-blind, placebo-controlled, phase 3 study (NCT05673993), conducted in multiple sites in China. Participants were eligible if they were aged 18-70 years, met the 2016 ACR/EULAR classification criteria for Sjögren’s disease, were anti-SSA (Ro) antibody-positive, and had an EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score ≥5. Randomisation was carried out to subcutaneous telitacicept 80 mg once weekly, 160 mg once weekly, or placebo for 48 weeks. Participants in the placebo group who had an inadequate response after week 24 were allowed to switch to telitacicept in a 1:1, blinded re-randomisation. The primary efficacy endpoint was the change from baseline in ESSDAI score at week 24. A total of 381 participants were enrolled.

Participants treated with telitacicept had greater reductions from baseline in ESSDAI scores at week 24 compared with placebo, corresponding to a least-squares mean difference versus placebo of -3.8 (95% CI -4.6 to -3.0; P<0.0001) for telitacicept 160 mg and -2.4 (95% CI -3.2 to -1.6; P<0.0001) for telitacicept 80 mg. Participants who switched from placebo to telitacicept after week 24 also showed clinical improvement; however, the difference compared with the continuous telitacicept groups remained significant through week 48.

The most commonly reported adverse events with telitacicept included injection-site reaction, upper respiratory tract infections, urinary tract infection, cough, and abnormal hepatic function.

The authors concluded that telitacicept met the study's primary efficacy endpoint. “Compared with placebo, both telitacicept 160 mg and 80 mg demonstrated consistent improvement in clinical symptoms through 48 weeks with a favourable safety profile. Greater improvements were observed in the telitacicept 160 mg group,” said Dr Xu.

1. Xu D, et al. Efficacy and safety of telitacicept in patients with Sjögren’s disease: Results from a multicenter, randomized, double-blind, placebo-controlled, phase 3 clinical study. ACR Convergence, 24–29 October 2025, Chicago, IL, USA.

Medical writing support was provided by Mihai Surducan, PhD.

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Posted on 30 October 202530 October 2025