Efficacy and Immunological Evaluation of Telitacicept and Low Dose IL2 in the Treatment of Systemic Lupus Erythematosus

Study Overview
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Brief Summary
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The purpose of this study was to explore the clinical and immunological efficacy of Telitacicept and low dose IL-2 on systemic lupus erythematosus.

Detailed Description
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Given that Telitacicept and low dose IL2 have been widespreadly applied in the treatment of systemic lupus erythematosus, this study designed a randomised, single center, prospective study to investigate the effects and safety of combined utilization of Telitacicept and low dose IL-2. 160mg Telitacicept and 1 million IU IL2 were regularly administered according to different circumstances. Then, the investigators evaluated the improvement of clinical and laboratory indexes and monitored the changes of immune cell subsets and cytokines.

Official Title
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Efficacy and Immunological Evaluation of Telitacicept and Low Dose IL2 in the Treatment of Systemic Lupus Erythematosus: a Randomise Prospective Study

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Drug: Telitacicept
* Drug: Interleukin-2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female >18 years of age at screening visits Patients meet the American-European Consensus Group 2002 classification criteria of SLE. The patient must be informed in writing of the consent to participate in the trial and the patient is expected to be able to comply with the requirements of the study follow-up plan and other protocols. Dosing of antimalarials, prednisone or equivalent, cholinergic stimulants, and topical cyclosporine required to be stable for at least 4 weeks before screening and during study; maximum doses allowed: Hydroxychloroquine, 400 mg/day; Prednisone, 10 mg/day Exclusion Criteria: Any subject meeting any of the following criteria should be excluded: Laboratory abnormality: • Hb≤9 g/dl • Neutrophil 10 mg/d) within 1 month. Serious complications: including heart failure (≥ New York Heart Association (NYHA) class III), renal insufficiency (creatinine clearance ≤ 30 ml/min), liver dysfunction (serum Alanine transaminase (ALT) or aspartate aminotransferase (AST) greater than three times the upper limit of normal, or total bilirubin greater than Normal upper limit. Known allergies, hyperreactivity or intolerance of tofacitinib or its excipients. Have a serious infection needing hospitalization (including but not limited to hepatitis, pneumonia, bacteremia, pyelonephritis, EB virus, tuberculosis infection), or use intravenous antibiotics to treat infection in 2 months before the enrollment. Infection with HIV (HIV antibody positive serology) or hepatitis C (Hep C antibody positive serology). If seropositive, it is recommended to consult a doctor who has expertise in treating HIV or hepatitis C virus infection. Any known history of malignancy in the past 5 years (except for nonmelanoma skin cancer, non-melanoma skin cancer or cervical tumor without recurrence within 3 months after surgical cure prior to the first study preparation). Uncontrolled mental or emotional disorders, including a history of drug and alcohol abuse over the past 3 years, may hinder the successful completion of the study. Pregnant, lactating women (WCBP) are reluctant to use medically approved contraceptives during treatment and 12 months after treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telitacicept and low dose IL2<br>160mg Telitacicept was subcutaneously injected to patients with systemic lupus erythematosus at the outer side of upper arm every week for 24 weeks. Interleukine-2 was first added to the original treatment for systemic lupus erythematosus with 1 million IU qod for 12 weeks, injected subcutaneously at the outer side of upper arm, abdomen and thigh, then the same dose of IL2 was injected once a week for 12 weeks subcutaneously. | Drug: Telitacicept<br>* 160mg Telitacicept was subcutaneously injected to patients with systemic lupus erythematosus at the outer side of upper arm every week for 24 weeks.<br>* Other names: RC-18;Drug: Interleukin-2<br>* Low lose interleukine-2 at a dose of 1 million IU was injected once every other day for 12 weeks, then the same dose of IL2 was injected once a week at the second stage for 12 weeks.<br>* Other names: Recombinant Human interleukine-2;|
| Active Comparator: Telitacicept<br>160mg Telitacicept was subcutaneously injected to patients with systemic lupus erythematosus at the outer side of upper arm every week for 24 weeks. | Drug: Telitacicept<br>* 160mg Telitacicept was subcutaneously injected to patients with systemic lupus erythematosus at the outer side of upper arm every week for 24 weeks.<br>* Other names: RC-18;|
| Active Comparator: low dose IL2<br>Interleukine-2 was first added to the original treatment for systemic lupus erythematosus with 1 million IU qod for 12 weeks, injected subcutaneously at the outer side of upper arm, abdomen and thigh, then the same dose of IL2 was injected once a week for 12 weeks subcutaneously. | Drug: Interleukin-2<br>* Low lose interleukine-2 at a dose of 1 million IU was injected once every other day for 12 weeks, then the same dose of IL2 was injected once a week at the second stage for 12 weeks.<br>* Other names: Recombinant Human interleukine-2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of SLE Responder Index (SRI)4 response | The number of participants who achieved SRI4 response at week 24. | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Adverse Events | The number of participants with Adverse Events throughout the study were accessed. | Week 24 | 
| Autoantibody change from baseline | Blood samples were collected at indicated time-points for analysis of autoantibodies like anti-double stranded deoxyribonucleic Acid(dsDNA). Baseline is defined as the Day 0 visit from parent studies. | Week 12 and 24 | 
| Change of complement C3 and C4 Levels from baseline | Blood samples were collected at indicated time-points for analysis of complement levels like complement 3 (C3) and complement 4 (C4). Baseline is defined as the Day 0 visit from parent studies. | Week 12 and 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SLE, Telitacicept, IL-2