Efficacy and Safety of Telitacicept in Primary Sjögren’s Syndrome: A Randomized, Double-blind, Placebo-controlled, Phase 2 Trial

Dong Xu¹, Shangzhu Zhang¹, Cibo Huang², Chenghui Huang³, Li Qin⁴, Xiaomei Li⁵, Meiqing Chen⁶, Xiumei Liu⁷, Yi Liu⁸, Zhijun Li⁹, Jiankang Hu¹⁰, Chunde Bao¹¹, wei Wei¹², Jing Tian¹³, Xinwang Duan¹⁴, Jianmin Fang¹⁵ and Xiaofeng Zeng¹⁶, ¹Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China, ²Beijing Hospital, Beijing, China, ³The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China, ⁴Huzhou Third Municipal Hospital, Huzhou, China, ⁵Anhui Provincial Hospital, Hefei, China, ⁶The First Affiliated Hospital of Xiamen University, Xiamen, China, ⁷The First Hospital of Shanxi Medical University, Taiyuan, China, ⁸West China Hospital of Sichuan University, Chengdu, China, ⁹The First Affiliated Hospital of Bengbu Medical College, Bengbu, China, ¹⁰Jiangxi Pingxiang People’s Hospital, Shanghai, China, ¹¹Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China, ¹²Tianjin Medical University General Hospital, Tianjin, China, ¹³Second Xiangya Hospital of Central South University, Changsha, China, ¹⁴The Second Affiliated Hospital of Nanchang University, Nanchang, China, ¹⁵Shanghai Tongji Hospital, Shanghai, China, ¹⁶Department of Rheumatology, Peking Union Medical College Hospital (PUMCH), Chinese Academy of Medical Sciences National Clinical Research Center for Dermatologic and Immunologic Diseases (NCRC-DID), Beijing, China

Meeting: ACR Convergence 2022

Keywords: Biologicals, clinical trial, Disease Activity, Sjögren's syndrome

Session Information

Date: Monday, November 14, 2022

Title: Sjögren's Syndrome – Basic and Clinical Science Poster

Session Type: Poster Session D

Session Time: 1:00PM-3:00PM

Background/Purpose: To evaluate the efficacy and safety of telitacicept in adult patients with primary Sjögren’s syndrome (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 endpoint was the change from baseline in the ESSDAI at week 24. Safety was monitored.

Results: 42 patients were enrolled and randomized (n=14 per group). Thirty patients who completed their 24 weeks visit were included in the per-protocol set (PPS) (telitacicept 240 mg, n=8; telitacicept, 160 mg; n=12; placebo, n=10).

Administration of telitacicept 160 mg resulted in a significant reduction in ESSDAI score from baseline to week 12 and week 24 compared with placebo in FAS and PPS populations (p< 0.05); telitacicept 240 mg resulted in a significant reduction in ESSDAI score from baseline to week 24 compared with placebo in the PPS population and week 12 in the FAS population (p< 0.05).

Significantly greater reductions from baseline in MFI-20 to weeks 12 and 24 were observed in patients in the telitacicept group (p< 0.05).

Telitacicept induced significant reductions in serum Ig levels at each visit throughout the 24 weeks. No serious adverse events were observed in the telitacicept treating group.

Conclusion: Telitacicept showed clinical benefits and good safety in the treatment of pSS.

Trial Profile

Changes from baseline in ESSDAI by visit (Mean±SE). ESSDAI: EULAR Sjögren’s Syndrome Disease Activity Index.

Percentage change from baseline in immunoglobulins, C3, C4, CD19⁺ B cells, CD4⁺ T cells and CD8⁺ T cells by visit (FAS, Mean±SE)

Disclosures: D. Xu, None; S. Zhang, None; C. Huang, None; C. Huang, None; L. Qin, None; X. Li, None; M. Chen, None; X. Liu, None; Y. Liu, None; Z. Li, None; J. Hu, None; C. Bao, None; w. Wei, None; J. Tian, None; X. Duan, None; J. Fang, RemeGen Co, LTD.; X. Zeng, None.

To cite this abstract in AMA style:

Xu D, Zhang S, Huang C, Huang C, Qin L, Li X, Chen M, Liu X, Liu Y, Li Z, Hu J, Bao C, Wei w, Tian J, Duan X, Fang J, Zeng X. Efficacy and Safety of Telitacicept in Primary Sjögren’s Syndrome: A Randomized, Double-blind, Placebo-controlled, Phase 2 Trial [abstract]. Arthritis Rheumatol. 2022; 74 (suppl 9). https://acrabstracts.org/abstract/efficacy-and-safety-of-telitacicept-in-primary-sjogrens-syndrome-a-randomized-double-blind-placebo-controlled-phase-2-trial/. Accessed .

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