Efficacy and Safety of Belimumab in SLE Patients

Phase 4

Completed

• Conditions: Systemic Lupus Erythematosus
• Interventions: Biological: Placebo; Biological: Belimumab

• Registration Number: NCT04515719
• Lead Sponsor: RenJi Hospital

Brief Summary

Systemic lupus erythematosus (SLE) is a chronic inflammatory systemic autoimmune disease. Recurrent relapses of disease and development of long-term organ damage are two key unsolved clinical problems. Belimumab is the only FDA-approved biological agent for SLE. Data showed that treatment with belimumab on the background of standard therapy was effective in active SLE patients. However, the efficacy of low-dose belimumab for prevention of disease flares in SLE patients with low disease activity is to be explored.

Detailed Description

Systemic lupus erythematosus (SLE) is a chronic systemic autoimmune disease with the incidence of about 70/100,000 in China. Recurrent relapses of disease and development of long-term organ damage are two key unsolved clinical problems. Its pathogenesis is still unclear, but B cells have been confirmed to play a vital role in it. Belimumab, a B-lymphocyte stimulating factor (Blys) inhibitor, was the only FDA-approved biological agent for SLE. BLISS-52 showed that more active lupus patients had their SELENA-SLEDAI score reduced by at least 4 points during 52 weeks with belimumab 10 mg/kg (58% vs 46%, p=0·0024) than with placebo. But there was limited data about belimumab in SLE patients with low disease activity. Our previous study indicated that even these patients still have an annual flare rate of 30-40%. Therefore, we try to explore whether low-dose of belimumab could prevent the disease flares in SLE patients with low disease activity.

Study Timeline

• Study First Submitted: 2020-08-13
• Study First Submitted QC: 2020-08-13
• Study First Posted: 2020-08-17
• Study Start: 2021-03-10
• Primary Completion: 2022-04-10
• Study Completion: 2022-04-10
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-11
• Last Update Posted: 2025-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 231

Inclusion Criteria

1. Age 18-70 years;
2. Patients with low disease activity (score≤ 6 at screening on SLEDAI); no British Isles Lupus Assessment Group (BILAG) A and no more than one B;
3. A stable treatment regimen with fixed doses of prednisone (≤ 20mg/day), antimalarial, or immunosuppressive drugs (azathioprine/mycophenolate mofetil/ methotrexate/ciclosporin/leflunomide/tacrolimus) for at least 30 days.
4. Sign the informed consent;

Exclusion Criteria

1. Alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) > 2 times upper normal limits;
2. Creatinine clearance rate < 60ml/min;
3. Exposure to cyclophosphamide within past 6 months before screening;
4. Exposure to any B cell targeted therapy (Rituximab/belimumab) within past 1 year before screening;
5. History of Malignancy;
6. History of herpes zoster with past 3 months before screening.
7. Chronic HBV/HCV hepatitis；
8. Current infections (HIV/tuberculosis)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Eligible patients were randomized in a 1:1 ratio to belimumab/placebo on the background of standard therapy. Placebo (normal saline) is administered intravenously at week 0, week 2, week 4 and then every 4 weeks until 48 weeks.
Belimumab 2mg/kg	Belimumab	Eligible patients were randomized in a 1:1 ratio to belimumab/placebo on the background of standard therapy. Belimumab 2mg/kg is administered intravenously at week 0, week 2, week 4 and then every 4 weeks until 48 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of patients with disease flares	52 weeks	Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).

Secondary Outcome Measures

Name	Time	Method
SELENA-SLEDAI score at each visit	52 weeks	compare the disease activity measured by SELENA-SLEDAI score at each visit
BiLAG score at each visit	52 weeks	compare the disease activity measured by BILAG score at each visit
Percentage of patients with mild/moderate flares	52 weeks	Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).
prednisone dose at each visit	52 weeks	compare the prednisone dose at each visit
Percentage of patients with major flares	52 weeks	Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).
Time to first disease flare	52 weeks	Time to first disease flare
The percentage of patients achieving prednisone-free successfully	52 weeks	the percentage of patients achieving prednisone-free successfully
Number of participants with adverse events as assessed by CTCAE v4.0	52 weeks	the safety of belimumab

Trial Locations

Locations (1)

Shuang Ye, MD; 🇨🇳 Shanghai, Shanghai, China