- In the results of China Phase III clinical trial announced at the 2025 ACR, Telitacicept demonstrated statistically significant and clinically meaningful improvements in ESSDAI [EULAR (European League Against Rheumatism) Sjögren's Syndrome Disease Activity Index] compared to placebo.
- Telitacicept met the primary endpoint and all key secondary endpoints. Patients in Telitacicept groups showed significant improvement in disease activity compared to the placebo group.
- Approximately 71.8% of patients receiving Telitacicept 160mg achieved an ESSDAI reduction of =3 points at 24 weeks, compared to 19.3% in the placebo group. The efficacy was sustained up to 48 weeks, with a favorable safety profile.
YANTAI, China, Oct. 14, 2025 /PRNewswire/ -- On October 14, RemeGen (688331.SH/09995.HK) announced that the results of the Phase III clinical study of Telitacicept for Sjögren's Syndrome in China have been published in an abstract on the 2025 ACR website. The study met its primary endpoint of change from baseline in ESSDAI at week 24, as well as all key secondary endpoints, with the telitacicept 160mg dose achieving highly significant p values (p<0.0001) for every endpoint at week 24 and 48 compared to placebo. The results will be presented in late-breaking poster session at the American College of Rheumatology (ACR) Convergence 2025 on October 28, 2025 from 10:30am to 12:30pm CT in Chicago, Illinois.
The China Phase III trial was a randomized, double-blind, placebo-controlled trial in patients with active, anti-SSA-positive primary Sjögren's disease. A total of 381 patients were randomized to receive weekly subcutaneous injections of telitacicept 160mg, telitacicept 80mg, or placebo for 48 weeks, in addition to standard therapy. During weeks 24-48, participants with inadequate response to treatment in the placebo group could switch to telitacicept 160mg or telitacicept 80mg at a ratio of 1:1 under blind conditions.
The primary endpoint of the study was change from baseline in ESSDAI (EULAR Sjögren's Syndrome Disease Activity Index) at week 24, with secondary endpoints including changes in ESSDAI and ESSPRI (EULAR Sjögren's Syndrome Patient Reported Index) at 12, 24, 36, and 48 weeks, as well as the proportion of patients achieving clinically meaningful improvements (=3-point decrease in ESSDAI and achievement of low disease activity [ESSDAI <5]) at 24 and 48 weeks.
Key Findings from the 48-Week Results
- Mean change in ESSDAI: At week 24, -4.4 (160mg), -3.0 (80mg), and -0.6 (placebo); at week 48, -4.6 (160mg), -3.2 (80mg), and -0.4 (placebo), demonstrating durable, dose-dependent improvement in systemic disease activity.
- Mean change in ESSPRI: At week 24, -1.88 (160mg), -1.31 (80mg), and -0.36 (placebo); at week 48, -2.56 (160mg), -1.74 (80mg), and -0.41 (placebo), showing sustained symptomatic benefit in dryness, fatigue, and pain.
- =3-point ESSDAI improvement: At week 24, 71.8% (160mg), 47.1% (80mg), and 19.3% (placebo); at week 48, 73.0% (160 mg), 49.1% (80mg), and 16.5% (placebo).
- Participants with ESSDAI <5 (low disease activity): At week 24, 49.6% (160mg), 28.8% (80mg), and 10.9% (placebo); at week 48, 55.0% (160mg), 32.7% (80mg), and 12.2% (placebo).
- Participants with =1-point or =15% ESSPRI reduction (significant improvement): At week 24, 86.2% (160mg), 63.0% (80mg), and 32.2% (placebo); at week 48, 89.1% (160mg), 75.4% (80mg), and 33.3% (placebo).
- Telitacicept demonstrated a favorable safety profile for the treatment of Sjögren's Syndrome and consistent with prior studies across other autoimmune indications, including systemic lupus erythematosus, rheumatoid arthritis, myasthenia gravis, and IgA nephropathy. No new safety signals were observed. Most adverse events were mild to moderate in severity.
Sjögren's Syndrome is a chronic inflammatory autoimmune disease characterized primarily by lymphocyte infiltration and damage to exocrine glands. Patients not only suffer from symptoms like dry mouth and dry eyes due to exocrine gland damage but also experience extraglandular manifestations such as arthritis, myalgia, skin rashes, and multi-system visceral damage that may severely impacting their quality of life in the long term. Currently, global treatment options for this disease are limited to symptom control. Lacking effective and systematic disease-modifying therapies, Sjögren's Syndrome represents a significant unmet clinical need.
Telitacicept is a global first-in-class recombinant B-lymphocyte stimulator (BLyS) / A Proliferation-Inducing Ligand (APRIL) dual-target fusion protein independently developed by RemeGen. Previously, Telitacicept for Sjögren's Syndrome indication received Fast Track designation from the US FDA and was approved to conduct Phase III clinical trials in the United States. On September 19, the Biologic License Application for Sjögren's Syndrome in China was accepted by the Center for Drug Evaluation (CDE), making it the first biologic drug globally to file for market approval for the disease.
SOURCE RemeGen Co., Ltd
