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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

139 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Systemic Lupus Erythematosus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

Subjects who meet any of the following criteria should be excluded from this study:

1. Patients with other rheumatic immune system diseases;
2. Patients in the active stage of acute and chronic infections;
3. Patients using other biologics;
4. Patients with wasting diseases such as malignant tumors

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No