A Comparative Study of the Efficacy and Safety of Telitacicept and Belimumab in the Treatment of Systemic Lupus Erythematosus Involving Multiple Units, Based on Previous Data.

Yipeng Liu

Status: Active, not recruiting

Conditions: Telitacicept; Belimumab; Efficacy and Safety; Systemic Lupus Erythematosus

Study type: Observational

Funder types: Other

Identifiers

NCT07053137

YXLL-KY-2025(101)

Details and patient eligibility

About

The objective of this observational study is to compare the efficacy and safety of tixocutibine and belizumab in the treatment of systemic lupus erythematosus in patients aged 18-65 years with systemic lupus erythematosus. The main question it aims to answer is: In the overall population of systemic lupus erythematosus: What is the response rate (SRI-4) of the two drugs in treating systemic lupus erythematosus? Which drug has better efficacy and safety? This study is a retrospective study. The participants will not receive any treatment.

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;
• SELENA-SLEDAI score of at least 8 points (clinical symptoms of no less than 6 points, excluding positive anti-double-stranded DNA (anti-dsDNA) and low complement);
• Patients who have been using tofacitinib or belimumab for at least 12 weeks.

Exclusion criteria

• Having active central nervous system diseases;
• eGFR < 30 mL/min/1.73m², or undergoing hemodialysis or kidney transplantation;
• Pregnant women, or women planning to get pregnant in the near future while taking the medication, or lactating women;
• Participants who are simultaneously participating in other clinical studies;
• Patients who have received treatment with tixagrel or belimumab for less than 12 weeks.

Trial design

180 participants in 2 patient groups

The Belimumab group

Description:

The participants in the study had previously used belimumab as a therapeutic drug.

The Telitacicept group

Description:

The participants in the study had previously used telitacicept as a therapeutic drug.