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.

Comparing Efficacy and Safety of Telitacicept and Belimumab in Systemic Lupus Erythematosus: A Retrospective Multicenter Cohort Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07053137

Enrollment

180

Registered

2025-07-08

Start date

2025-11-30

Completion date

2026-03-31

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Belimumab, Efficacy and Safety, Systemic Lupus Erythematosus, Telitacicept

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
The percentage of patients with a Systemic Lupus Erythematosus Response Index-4 (SRI-4) response	From baseline to the end of 1-year treatment period	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).

Secondary

Measure	Time frame	Description
Proportion of Participants with Stable SLEDAI and PGA Scores	From baseline to the end of 1-year treatment period	The percentage of study participants whose SLEDAI score decreased by at least 4 points and whose PGA did not worsen.
The proportion of participants in the study who had their hormone dosage reduced	From baseline to the end of 1-year treatment period	The ratio of study participants whose prednisone dose was reduced by ≥25% or ≤7.5 mg/day compared to the baseline at 44-48 weeks.
The time of recurrence occurrence	From baseline to the end of 1-year treatment period	The time of the first recurrence or the first severe recurrence.

Countries

China

Outcome results