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.

NCT07053137 | Active Not Recruiting

• 1 other identifier: YXLL-KY-2025(101)
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Belimumab; Efficacy and Safety; Systemic Lupus Erythematosus; Telitacicept

Outcome Measures

Primary Outcomes (1)

• The percentage of patients with a Systemic Lupus Erythematosus Response Index-4 (SRI-4) response

  1. The SELENA-SLEDAI score decreased by ≥ 4 points compared to the baseline; 2. And there were no new BILAG-assessed grade A organs or ≤ 2 new BILAG-assessed grade B organs compared to the baseline; 3. And the overall physician assessment (PGA) did not deteriorate (an increase of \< 0.30 points compared to the baseline).

  From baseline to the end of 1-year treatment period

Secondary Outcomes (3)

• Proportion of Participants with Stable SLEDAI and PGA Scores

  From baseline to the end of 1-year treatment period

• The proportion of participants in the study who had their hormone dosage reduced

  From baseline to the end of 1-year treatment period

• The time of recurrence occurrence

  From baseline to the end of 1-year treatment period

Study Arms (2)

The Belimumab group

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

The Telitacicept group

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The inclusion period is from March 1, 2021 to March 1, 2024. Patients who visited the First Affiliated Hospital of Shandong University Medical University, the Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Wuhan University People's Hospital, and the Department of Nephrology of Capital Medical University Affiliated Beijing Friendship Hospital for clinical diagnosis of systemic lupus erythematosus were included.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Friendship Hospital: collaborator
• Yipeng Liu: lead
• Affiliated Hospital of Shandong University of Traditional Chinese Medicine: collaborator
• Renmin Hospital of Wuhan University: collaborator

Study Sites (1)

Qianfoshan Hospital

Jinan, Shandong, 250000, China

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: July 8, 2025
• Study Start: November 30, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: February 2, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)