Efficacy and safety of telitacicept in primary Sjögren’s syndrome: a randomized, double-blind, placebo-controlled, phase 2 trial

医学 安慰剂 内科学 不利影响 临床终点 随机对照试验 临床试验 胃肠病学 安慰剂组 双盲 外科 病理 替代医学
作者
Dong Xu,Jianmin Fang,Shangzhu Zhang,Cibo Huang,Chenghui Huang,Qin Li,Xiaomei Li,Meiqing Chen,Xiumei Liu,Yi Liu,Zhijun Li,Jiankang Hu,Chunde Bao,Wei Wei,Jing Tian,Xinwang Duan,Xiaofeng Zeng
出处
期刊:Rheumatology [Oxford University Press]
卷期号:63 (3): 698-705 被引量:36
标识
DOI:10.1093/rheumatology/kead265
摘要

Abstract Objective To evaluate the efficacy and safety of telitacicept in adult patients with primary SS (pSS) in a phase II randomized double-blind placebo-controlled trial. Methods Patients with pSS with positive anti-SSA antibody and ESSDAI ≥ 5 were randomly assigned, in a 1:1:1 ratio, to receive weekly subcutaneous telitacicept 240 mg, 160 mg, or placebo for 24 weeks. The primary end point was the change from baseline in the ESSDAI at week 24. Safety was monitored. Results A total of 42 patients were enrolled and randomized (n = 14 per group). Administration of telitacicept 160 mg resulted in a significant 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). While, mean change of ESSDAI in telitacicept 240 mg was –2.7(–5.6–0.1) with no statistical difference when compared that in placebo group (P = 0.056). In addition, MFI-20 and serum immunoglobulins decreased significantly (P < 0.05) at week 24 in both telitacicept groups compared with placebo. No serious adverse events were observed in the telitacicept treating group. Conclusion Telitacicept showed clinical benefits and good tolerance and safety in the treatment of pSS. Trial registration ClinicalTrials.gov, https://clinicaltrials.gov, NCT04078386
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