The following is a summary of “Efficacy and safety of telitacicept in primary Sjögren’s syndrome: a randomized, double-blind, placebo-controlled, phase 2 trial,” published in the March 2024 issue of Rheumatology by Xu et al.
Researchers conducted a retrospective study to assess the effectiveness and safety of telitacicept in adult patients diagnosed with primary Sjögren’s syndrome (pSS) through a phase II randomized, double-blind placebo-controlled trial.
They randomized patients diagnosed with pSS, positive anti-SSA antibody, and an ESSDAI score of ≥5 into three groups in a 1:1:1 ratio. These groups received either weekly subcutaneous doses of telitacicept at 240 mg, 160 mg, or a placebo over a period of 24 weeks. The primary objective assessed was the change in ESSDAI scmenores from baseline to week 24. Safety parameters were closely monitored throughout the trial.
The results showed that among the 42 patients enrolled and randomized (n = 14 per group), administration of telitacicept 160 mg led to a notable reduction in ESSDAI score from baseline to week 24 compared with placebo (P< 0.05). The placebo-adjusted least-squares mean change from baseline was –4.3 (95% CI –7.0, –1.6; P=0.002). The mean change of ESSDAI in the telitacicept 240 mg group was –2.7 (–5.6–0.1), with no statistically significant difference compared to the placebo group (P=0.056). Both telitacicept groups exhibited significant decreases in MFI-20 and serum immunoglobulins at week 24 compared with placebo (P<0.05). Notably, no serious adverse events were observed in the telitacicept-treated group.
Investigators concluded that Telitacicept appears to be a safe and effective treatment for pSS.
Source: academic.oup.com/rheumatology/article/63/3/698/7218326?searchresult=1