Drugdu.com expert's response:

Telitacicept, a novel fusion protein drug for the treatment of autoimmune diseases, has demonstrated its therapeutic efficacy in multiple clinical trials, as detailed below:

I. Main Therapeutic Indications and Effects

Systemic Lupus Erythematosus (SLE)

Telitacicept alleviates SLE symptoms by inhibiting the overactivation of B cells. Clinical trial data indicate that over 60% of patients using Telitacicept experienced significant improvement in their condition, specifically evident in the relief of skin, joint, and kidney symptoms.

A multicenter, randomized, double-blind, placebo-controlled pivotal clinical study showed that the 48-week response rate in the high-dose Telitacicept group was 79.2%, significantly higher than the 32.0% in the placebo control group.

Another nationwide multicenter, randomized, double-blind, placebo-controlled Phase IIb drug study showed that the Telitacicept 160mg dose group (the standard dose approved for marketing in China) had significantly higher response rates than the placebo group from Week 12 onwards, and the efficacy advantage persisted until Week 48.

Sjögren's Syndrome (pSS)

A Phase II randomized, double-blind, placebo-controlled clinical trial of Telitacicept in adult pSS patients showed that the Telitacicept treatment group significantly improved patients' ESSDAI scores and MFI-20 at Weeks 12 and 24, reduced immunoglobulin levels, and was well-tolerated with no serious adverse events occurring.

Rheumatoid Arthritis (RA)

A multicenter, randomized, double-blind, placebo-controlled Phase III clinical study of Telitacicept in RA patients with methotrexate-based treatment showed that Telitacicept significantly increased the ACR20 response rate among RA patients. The 24-week ACR20 response rate was 67.4%, and the 48-week ACR20 response rate continued to increase to 72.2%.

Telitacicept also significantly delayed joint structural damage in RA patients, significantly improved their inflammatory levels and physical function, and alleviated pain.

Myasthenia Gravis (MG)

Multiple studies have shown that Telitacicept is efficacious and well-tolerated in MG patients. After 12 weeks of treatment, most patients experienced significant improvements in clinical symptoms and quality of life, with a low and controllable incidence of adverse reactions.

II. Mechanism of Action

Telitacicept is a dual-target antibody fusion protein that targets both BLyS and APRIL, two cytokines crucial for the differentiation and maturation of B lymphocytes. Overexpression of these two factors is closely related to various B lymphocyte-associated autoimmune diseases. Telitacicept competitively binds to these factors, reducing autoimmune reactions and thereby lowering inflammatory responses and related symptoms.

III. Safety and Tolerability

Telitacicept demonstrates good safety. Most patients tolerate it well, with only a few patients experiencing mild adverse reactions such as respiratory infections, urinary tract infections, and injection site discomfort. These symptoms are usually manageable with symptomatic treatment and generally do not affect the treatment of the disease.

In conclusion, Telitacicept has demonstrated good efficacy and safety in the treatment of autoimmune diseases such as systemic lupus erythematosus, Sjögren's syndrome, rheumatoid arthritis, and myasthenia gravis. However, the therapeutic effect of the drug may vary among individuals, so it is advisable to consult a professional doctor before use and develop a suitable treatment plan based on individual circumstances.