Comparing Efficacy and Safety of Telitacicept and Belimumab in Lupus Nephritis: A Retrospective Multicenter Cohort Study.

Yipeng Liu56 enrolled

Overview

The objective of this observational study is to compare the efficacy and safety of telitacicept and belimumab in the treatment of lupus nephritis in patients aged 18-65 years with lupus nephritis. The main question it aims to answer is: What are the response rates of the two drugs for the main renal therapy in the lupus nephritis population? Which drug has better efficacy and safety? This study is a retrospective study. The participants will not receive any treatment.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Lupus Nephritis Belimumab

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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; * Urine protein quantification ≥ 1g/d, or urine PCR ≥ 1g/g, or qualitative urine protein test in urine routine ≥ 1+; * Patients who have been using telitacicept 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 those who are about to become pregnant in the near future, or lactating women; * Participants who are simultaneously participating in other clinical studies; * Patients who have received telitacicept or belimumab treatment for less than 12 weeks.

Locations (1)

Qianfoshan Hospital

Jinan, Shandong, China

Outcomes

Primary Outcomes

The response rate for major kidney treatments

1. 24-hour urine PCR ≤ 0.7 g/g (70 mg/mmol); 2. eGFR decline does not exceed 20% of the baseline or is ≥ 60 ml/min/1.73 m2; 3. No rescue treatment was adopted due to treatment failure.

Time frame: From baseline to the end of 1-year treatment period

Secondary Outcomes

Complete renal response rate

1. 24-hour urine PCR \< 0.5 g/g (50 mg/mmol); 2. Renal function is stable or has improved (by no more than 10%-15% compared to the baseline).

Time frame: From baseline to the end of 1-year treatment period

Data from ClinicalTrials.gov

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