A Prospective Comparative Study Involving Multiple Units to Evaluate the Efficacy and Safety of Telitacicept and Belimumab in the Treatment of Systemic Lupus Erythematosus.

Yipeng Liu

Status: Not yet enrolling

Conditions: Systemic Lupus Erythematosus

Study type: Observational

Funder types: Other

Identifiers

NCT07069972

YXLL-KY-2025(106)

Details and patient eligibility

About

The objective of this observational study is to compare the efficacy and safety of telitacicept versus belimumab in systemic lupus erythematosus (SLE) patients aged 18-65 years. The primary questions it aims to answer are:

• In the overall SLE population: What are the SRI-4 response rates for both drugs?
• In the lupus nephritis subgroup: What are the major renal response rates for both drugs?

Participants will autonomously select their treatment regimen (add-on telitacicept or belimumab) based on:

• The patient's objective clinical condition at enrollment
• Physician's assessment
• Joint decision-making between physicians and patients/family members As an observational study, no active intervention will be implemented.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age range: 18 - 65 years old;
• Meets the revised SLE classification criteria of the American College of Rheumatology in 1997 or the SLE diagnostic classification criteria issued by EULAR/ACR in 2019;
• The SELENA-SLEDAI score is at least 8 points (clinical symptoms are no less than 6 points, excluding positive anti-double-stranded DNA (anti-dsDNA) and low complement);
• Has not responded well to hormone and/or immunosuppressant treatment, is intolerant or has recurrence, and is willing to accept tixocortinib/belimumab as a therapeutic drug.

Exclusion criteria

• Any of the following conditions exists: active central nervous system disease, severe active lupus nephritis, HIV infection, hepatitis B or C virus infection, low gamma globulinemia, liver dysfunction;
• eGFR < 30 mL/min/1.73m², or undergoing hemodialysis or kidney transplantation;
• Pregnant women, or women who are about to become pregnant in the near future, or lactating women;
• Participants who are simultaneously participating in other clinical studies;
• Within 1 year before randomization, received B-cell targeted therapy (including belimumab);
• During treatment, used traditional Chinese medicine with immunosuppressive effects (such as Tripterygium wilfordii, White Peony Root, etc.) in combination.

Trial design

180 participants in 4 patient groups

The Telitacicept group（the overall SLE population）

Description:

The participants in this group were diagnosed with SLE and were selected to use Telitacicept as the treatment drug.This study is an observational study and no active intervention is carried out.

The Belimumab group（the overall SLE population）

Description:

The participants in this group were diagnosed with SLE and were selected to receive belimumab as the treatment drug.This study is an observational study and no active intervention is carried out.

The Telitacicept group（the lupus nephritis subgroup）

Description:

The participants in this group were diagnosed with LN and were selected to receive telitacicept as the treatment drug.This study is an observational study and no active intervention is carried out.

The Belimumab group（the lupus nephritis subgroup）

Description:

The participants in this group were diagnosed with LN and were selected to receive belimumab as the treatment drug.This study is an observational study and no active intervention is carried out.