Blocking Cytokine Promoting B-Lymphocyte Activity with Telitacicept to Manage Systemic Lupus Erythematosus
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Reviewed & Translated by Dat Tien Nguyen, B.A, ScM.
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Posted on October 31st, 2025
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Systemic lupus erythematosus is an autoimmune disease driven by B-lymphocyte. There are many available therapies for the condition; however, their effectiveness and safety profile are not optimal. Cytokines such as B-lymphocyte stimulator (BLyS) and APRIL are important for the pathogenesis of lupus. With funding from RemeGen, a study was conducted to assess the usage of Telitacicept, an cytokine-targeting agent, in managing lupus.
The phase 3 clinical study was conducted in China, and it included 335 participants. More than 90% of the participants were female, and their average age was around 35 years old. These participants were diagnosed with systemic lupus erythematosus using the criteria set by the American College of Rheumatology. On average, these patients had been living with the disease for around 7 years, and around two-third of them had renal lesions. These patients had been previously treated with a combination of glucocorticoid, immunosuppresive medication, and antimalrial agents.
The patients were randomly assigned to be treated subcutaneously with either placebo or telitacicept with a weekly dose of 160 mg. Telitacicept is a fusion protein that contains the extracelullar binding domain for both the BLyS and APRIL cytokines. Both of these cytokines are important modulating agents for the development and function of B-cells. Thus, blocking their interaction with B-cells can reduce autoantibodies production.
After 52 weeks, the researchers found that telitacicpet was 34.5% more effective at managing lupus symptoms than placebo. As a result, patients treated with telitacicept required less glucocorticoids. This clinical improvement can be explained by significant reduction in B-cell population and antibody production. However, this reduction in humoral immune response might have increased the susceptibility of patients treated with telitacicept to infectious disease, with the frequency of upper respiratory tract infection significantly higher.
The phase 3 clinical study was conducted in China, and it included 335 participants. More than 90% of the participants were female, and their average age was around 35 years old. These participants were diagnosed with systemic lupus erythematosus using the criteria set by the American College of Rheumatology. On average, these patients had been living with the disease for around 7 years, and around two-third of them had renal lesions. These patients had been previously treated with a combination of glucocorticoid, immunosuppresive medication, and antimalrial agents.
The patients were randomly assigned to be treated subcutaneously with either placebo or telitacicept with a weekly dose of 160 mg. Telitacicept is a fusion protein that contains the extracelullar binding domain for both the BLyS and APRIL cytokines. Both of these cytokines are important modulating agents for the development and function of B-cells. Thus, blocking their interaction with B-cells can reduce autoantibodies production.
After 52 weeks, the researchers found that telitacicpet was 34.5% more effective at managing lupus symptoms than placebo. As a result, patients treated with telitacicept required less glucocorticoids. This clinical improvement can be explained by significant reduction in B-cell population and antibody production. However, this reduction in humoral immune response might have increased the susceptibility of patients treated with telitacicept to infectious disease, with the frequency of upper respiratory tract infection significantly higher.