On October 16, 2025, the rheumatology team led by Chief Physician Zhang Fengchun at PUMCH published the phase 3 clinical trial results of telitacicept—a novel biological agent independently developed in China—in the internationally authoritative The New England Journal of Medicine (NEJM, IF: 78.5). The study demonstrated the efficacy and safety of telitacicept in Chinese patients with systemic lupus erythematosus (SLE), providing important clinical evidence for its use in combination therapy for SLE. Telitacicept is expected to offer a new treatment option for SLE and other autoimmune diseases in which humoral immunity plays a significant role. This represents an important contribution by the Chinese medical community to SLE patients worldwide.

SLE predominantly affects women of childbearing age and commonly involves multiple organs and systems. The disease is chronic, prone to relapse, and difficult to cure. Currently, treatment options with approved indications are very limited. Even after treatment with existing regimens, some patients still experience adverse outcomes such as poor disease control, target organ damage, and various complications, which severely impact their quality of life and even lifespan.

B lymphocytes are the primary source of autoantibodies and important antigen-presenting cells, playing a crucial role in the pathogenesis of SLE. B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL) are important factors in the differentiation, survival, maturation, and antibody secretion processes of B lymphocytes. Telitacicept is a biological agent independently developed in China that targets B lymphocytes by simultaneously binding to both BLyS and APRIL, thereby blocking B lymphocyte maturation.

This study was a phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial that enrolled 335 adult SLE patients with moderate or higher disease activity despite standard therapy from 42 research centers. Patients were randomly assigned in a 1:1 ratio to receive either telitacicept (160 mg) or placebo by subcutaneous injection, in addition to standard therapy.

▲ Study data

Results showed that at week 52, the response rates on the modified SRI-4 were 67.1% in the telitacicept group and 32.7% in the placebo group, with a significant difference between the two (P<0.001). Moreover, from week 4 through the end of the 52-week follow-up period, the response rate on SRI-4 in the telitacicept group was consistently higher than in the placebo group, demonstrating the stability of telitacicept's therapeutic advantage.

Safety assessment showed that adverse events primarily included infections (upper respiratory tract infection: 31.7% in the telitacicept group vs. 19.0% in the placebo group), a reduced immunoglobulin level (15.6% in the telitacicept group vs. 1.2% in the placebo group), and injection-site reactions (12.6% in the telitacicept group vs. 0.6% in the placebo group), similar to other marketed B lymphocyte-targeted biological agents and subcutaneously administered drugs. Regarding the incidence of serious adverse events, particularly trial-related ones, the telitacicept group was not higher than the placebo group, demonstrating acceptable safety.

Under the leadership and guidance of Chief Physician Zhang Fengchun, the phase 1, 2a, 2b, and 3 clinical trials of this drug were completed over more than ten years.

Chief Physician Wang Li from the Department of Rheumatology at PUMCH is the first author, and Chief Physician Zhang Fengchun is the corresponding author. Professor Ronald van Vollenhoven from Amsterdam University Medical Center is both first and corresponding author. Professor Fang Jianmin from Tongji University is a corresponding author.

Written by and pictures courtesy of the Department of Rheumatology

Edited by Fu Tanping and Chen Xiao

Chief editor Duan Wenli

Supervised by Wu Peixin