Safety and Efficacy of Telitacicept in the Treatment of Systemic Lupus Erythematosus (SLE)

Safety and Efficacy of Telitacicept in the Treatment of Systemic Lupus Erythematosus (SLE) in the Real World: a Multicenter Retrospective Study

Systemic lupus erythematosus (SLE) is a highly specific autoimmune disease that involves multiple systems due to abnormal immune activation. It is a classical diffuse connective tissue disease with autoimmune inflammation as its prominent manifestation. B cells are the core of systemic lupus erythematosus (SLE) pathogenesis. B Lymphocyte Stimulator (BLyS, also called BAFF) and A Proliferation-Inducing Ligand (APRIL) are signals for B cell maturation. B Lymphocyte Stimulator (BLyS) participates in promoting the development and maturation of B cells, while A Proliferation-Inducing Ligand (APRIL) participates in promoting the activation of mature B cells and the secretion of antibodies by plasma cells. Telitacicept is composed of the extracellular specific soluble portion of Transmembrane Activator and Calcium-modulating Cyclophilin Ligand (CAML) Interactor (TACI) and the Fragment crystallizable (Fc) segment of human Immunoglobulin G1 (IgG1). It is the only globally approved dual-target biological agent for the treatment of systemic lupus erythematosus (SLE) , blocking B Lymphocyte Stimulator (BLyS) and A Proliferation-Inducing Ligand (APRIL), hindering the development and activation of B cells, and the production of antibodies, comprehensively inhibiting the maturation, proliferation, and differentiation of B cells at different stages. In this study, the investigators will explore the adherence and influencing factors of telitacicept in systemic lupus erythematosus (SLE) patients, its effectiveness, and safety, providing a stronger basis for clinical management of systemic lupus erythematosus (SLE) patients.

Study Overview

• Status: Recruiting
• Conditions: Systemic Lupus Erythematosus

• Study Type: Observational
• Enrollment (Estimated): 139

Contacts and Locations

• Study Contact: Name: Cai Shaozhe, MD; Phone Number: 15623423810; Email: 540361903@qq.com
• Study Contact Backup: Name: Dong Lingli, MD; Phone Number: 17742804229; Email: tjhdongll@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 43003
      • Recruiting
      • Tongji Hospital
      • Contact: Dong Lingli, MD; Phone Number: +862783665519; Email: tjhdongll@163.com
      • Contact: Cai Shaozhe, MD; Phone Number: 15623423810; Email: 540361903@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Systemic lupus erythematosus (SLE) is a highly specific autoimmune disease involving multiple systems caused by abnormal immune activation. It is a classic diffuse connective tissue disease characterized by autoimmune inflammation. Our study population is the people who confirmed diagnosis of systemic lupus erythematosus (SLE) by 2019 American College of Rheumatology/European League Against Rheumatism (2019ACR/EULAR) International classification diagnostic criteria and patients receiving Tacrolimus injections.

Description

Inclusion Criteria:

1. Age ≥ 18 years old, not exceeding 70 years old (including 70 years old);
2. Patients diagnosed with systemic lupus erythematosus (SLE) according to 2019 American College of Rheumatology/European League Against Rheumatism (2019ACR/EULAR) international classification diagnostic criteria;
3. Accepting the treatment of telitacicept.

Exclusion Criteria:

Subjects who meet any of the following criteria should be excluded from this study:

1. Patients with other rheumatic immune system diseases;
2. Patients in the active stage of acute and chronic infections;
3. Patients using other biologics;
4. Patients with wasting diseases such as malignant tumors

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of Estrogens in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index （SELENA-SLEDAI）	Safety of Estrogens in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index （SELENA-SLEDAI） is a cumulative and weighted index used to assess disease activity across 24 different disease descriptors in patients with SLE. It is scored by a table named "SELENA-SLEDAI (Systemic Lupus Erythematosus Disease Activity Index) INSTRUMENT SCORE" . The minimum and maximum values are 0 points and 105 points separately, but very few patients score higher than 45 points. Higher scores indicate higher disease activity.	Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Physician's Global Assessment	Physician's global assessment for patients with Systemic Lupus Erythematosus (SLE) is a subjective assessment tool used by a same physicians to evaluate the overall disease activity based on clinical observations and patient reports(the patient's symptoms, physical examination findings, laboratory results, and any other relevant clinical information). The physician's global assessment (PGA) scale typically ranges from 0 to 3, with 0 representing no disease activity and 3 representing severe disease activity. Some variations of the scale may include intermediate markers, such as 1 and 2, to indicate varying degrees of disease activity.	Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)	Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a questionnaire-based tool (FACIT-F, Vision 4) used to measure fatigue in patients. It consists of multiple items, each focusing on a different aspect of fatigue. The items are typically rated on a scale from 0 to 4, with 0 representing "not at all" and 4 representing "very much". Example items include: "I feel tired" or "I'm too tired to working". Higher scores indicate less fatigue.	Baseline and Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Serum anti-double stranded DNA (anti-dsDNA)	to describe the qualitative feature of systemic lupus erythematosus (SLE) patients' serum anti-double stranded DNA (anti-dsDNA).	Baseline, Month 6, Month 12 after injecting Telitacecipt
Serum complement C3 levels	Serum complement C3 levels (g/L)	Baseline, Month 6, Month 12 after injecting Telitacecipt
Serum complement C4 levels	Serum complement C4 levels (g/L)	Baseline, Month 6, Month 12 after injecting Telitacecipt
Serum immunoglobulin quantification	Serum immunoglobulin quantification (g/L)	Baseline, Month 6, Month 12 after injecting Telitacecipt
Levels of C-reactive protein (CRP) levels	Levels of C-reactive protein (CRP) levels (mg/L)	Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Levels of interleukin-10 (IL-10) levels	Levels of interleukin-10 (IL-10) levels (pg/mL)	Baseline and Month 6，Month 12 after injecting Telitacecipt
Levels of ferritin levels	Levels of ferritin levels (ug/L)	Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
the safety of telitacicept for SLE patients	The probability of adverse reactions （Local adverse reactions after injection） and the probability of major drug-related adverse events	Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
the reasons for medication discontinuation	The investigators will survey the reasons for medication discontinuation by telephone or outpatient follow-up ,the different reasons include economic reasons、 disease improved or be a stable condition、 poor effect、 arise adverse reaction, etc.	Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Levels of leukocyte levels	Levels of leukocyte levels （*10^9/L）	Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Levels of hemoglobin (Hb) levels	Levels of hemoglobin (Hb) levels (g/L)	Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Levels of blood platelet (PLT) levels	Levels of blood platelet (PLT) levels (*10^9/L)	Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
routine urine test	To evaluate the grade of urine occult blood and urine protein	Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Levels of erythrocyte sedimentation rate (ESR) levels	Levels of erythrocyte sedimentation rate (ESR) levels (mm/h）	Baseline and Month1, Month 2, Month 3, Month 6, Month 9, Month 12 after injecting Telitacecipt
Levels of interleukin-6 (IL-6) levels	Levels of interleukin-6 (IL-6) levels (pg/mL)	Baseline and Month 6，Month 12 after injecting Telitacecipt
Levels of interleukin-4 (IL-4) levels	Levels of interleukin-4 (IL-4) levels (pg/mL)	Baseline and Month 6，Month 12 after injecting Telitacecipt
Levels of interleukin-2 (IL-2) levels	Levels of interleukin-2 (IL-2) levels (pg/mL)	Baseline and Month 6，Month 12 after injecting Telitacecipt
Levels of tumor necrosis factor-α (TNF-α) levels	Levels of tumor necrosis factor-α (TNF-α) levels (pg/mL)	Baseline and Month 6，Month 12 after injecting Telitacecipt
Levels of interferon-γ（IFN-γ） levels	Levels of interferon-γ（IFN-γ） levels (pg/mL)	Baseline and Month 6，Month 12 after injecting Telitacecipt

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Collaborators: The First People's Hospital of Jingzhou; Wuhan Central Hospital; Wuhan No.1 Hospital; China Three Gorges University, Yichang, China; Xiangyang Central Hospital; Zhongnan Hospital Affiliated to Wuhan University; Jingzhou Central Hospital
• Investigators: Principal Investigator: Dong Lingli, MD, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 31, 2024
• First Submitted That Met QC Criteria: June 13, 2024
• First Posted (Actual): June 14, 2024

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: safety; adherence; effectiveness; Systemic Lupus Erythematosus; Telitacicept
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: TJ-IRB20231298

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No