RecruitingNCT06458972

Safety and Efficacy of Telitacicept in the Treatment of Systemic Lupus Erythematosus (SLE)

Safety and Efficacy of Telitacicept in the Treatment of Systemic Lupus Erythematosus (SLE) in the Real World: a Multicenter Retrospective Study


Sponsor

Tongji Hospital

Enrollment

139 participants

Start Date

Jan 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

Systemic lupus erythematosus (SLE) is a highly specific autoimmune disease that involves multiple systems due to abnormal immune activation. It is a classical diffuse connective tissue disease with autoimmune inflammation as its prominent manifestation. B cells are the core of systemic lupus erythematosus (SLE) pathogenesis. B Lymphocyte Stimulator (BLyS, also called BAFF) and A Proliferation-Inducing Ligand (APRIL) are signals for B cell maturation. B Lymphocyte Stimulator (BLyS) participates in promoting the development and maturation of B cells, while A Proliferation-Inducing Ligand (APRIL) participates in promoting the activation of mature B cells and the secretion of antibodies by plasma cells. Telitacicept is composed of the extracellular specific soluble portion of Transmembrane Activator and Calcium-modulating Cyclophilin Ligand (CAML) Interactor (TACI) and the Fragment crystallizable (Fc) segment of human Immunoglobulin G1 (IgG1). It is the only globally approved dual-target biological agent for the treatment of systemic lupus erythematosus (SLE) , blocking B Lymphocyte Stimulator (BLyS) and A Proliferation-Inducing Ligand (APRIL), hindering the development and activation of B cells, and the production of antibodies, comprehensively inhibiting the maturation, proliferation, and differentiation of B cells at different stages. In this study, the investigators will explore the adherence and influencing factors of telitacicept in systemic lupus erythematosus (SLE) patients, its effectiveness, and safety, providing a stronger basis for clinical management of systemic lupus erythematosus (SLE) patients.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria3

  • Age ≥ 18 years old, not exceeding 70 years old (including 70 years old);
  • Patients diagnosed with systemic lupus erythematosus (SLE) according to 2019 American College of Rheumatology/European League Against Rheumatism (2019ACR/EULAR) international classification diagnostic criteria;
  • Accepting the treatment of telitacicept.

Exclusion Criteria5

  • Subjects who meet any of the following criteria should be excluded from this study:
  • Patients with other rheumatic immune system diseases;
  • Patients in the active stage of acute and chronic infections;
  • Patients using other biologics;
  • Patients with wasting diseases such as malignant tumors

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Locations(1)

Tongji Hospital

Wuhan, Hubei, China

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NCT06458972


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