What side effects are associated with this type of intervention?

Belimumab, a BLyS inhibitor, is generally well-tolerated but can cause side effects such as nausea, diarrhea, fever, and infusion reactions. Other common treatments for lupus, such as corticosteroids, immunosuppressants (e.g., azathioprine, mycophenolate mofetil), and antimalarials (e.g., hydroxychloroquine), have their own side effect profiles. Corticosteroids can lead to weight gain, osteoporosis, and increased infection risk. Immunosuppressants may cause liver toxicity, bone marrow suppression, and increased susceptibility to infections. Antimalarials are generally well-tolerated but can cause retinal toxicity with long-term use.

What prior FDA approvals exist?

Belimumab (Benlysta) is the first FDA-approved drug specifically for systemic lupus erythematosus (SLE) that targets B-lymphocyte stimulator (BLyS). It works by inhibiting the activity of BLyS, a protein that promotes the survival of B cells, which are responsible for producing antibodies. Other treatments for lupus include immunosuppressive drugs like cyclophosphamide and biologics such as rituximab, which targets CD20 on B cells. These treatments help reduce the activity of the immune system to prevent it from attacking the body's own tissues.

What other types of research exist?

Promising novel alternatives to Belimumab for Lupus patients include Anifrolumab, a monoclonal antibody targeting the type I interferon receptor, and Voclosporin, a calcineurin inhibitor. Both have shown efficacy in recent clinical trials and offer different mechanisms of action compared to Belimumab.

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Monoclonal Antibodies

Belimumab for Lupus

Phase 2

Waitlist Available

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have or have had in series 4 or more of the 11 ACR criteria for the classification of SLE.

Have documented positive autoantibody test results within the study screening period, defined as an anti-nuclear antibody (ANA) titre >= 1:80 and/or a positive anti-dsDNA (>=30 international units per milliliter [IU/mL]) serum antibody test based on either the study's central laboratory results or the local laboratory results. Only unequivocally positive values as defined in the laboratory's reference range are acceptable; borderline values will not be accepted

Must not have

Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria).

Hepatitis B: Serologic evidence of Hepatitis B (HB) infection defined as Hepatitis B surface antigen positive (HBsAg+) or Hepatitis B core antibody positive (HBcAb+).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre dose on week 1, week 2, week 4, week 8, week 12, week 16, week 24, week 36, week 52, and week 60

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a medication called belimumab, given as an injection under the skin, in children with lupus. The goal is to see if it is safe and effective by calming down their overactive immune systems. Belimumab is approved for the treatment of lupus in adults with moderate disease activity.

Who is the study for?

This trial is for children aged 5 to 17 with Systemic Lupus Erythematosus (SLE) who weigh at least 15 kg. They should have active SLE, positive autoantibody test results, and be on a stable treatment regimen for at least 30 days prior to the start of the study. Participants must not be pregnant or breastfeeding and agree to use effective contraception.

What is being tested?

The trial tests subcutaneous injections of Belimumab in pediatric patients with SLE. It aims to understand how the drug behaves in their bodies (pharmacokinetics), its safety profile, and how it affects disease activity (pharmacodynamics). The study includes an initial 12-week treatment phase followed by an optional 40-week continuation.

What are the potential side effects?

While specific side effects for this pediatric trial are not listed, Belimumab may generally cause infections, infusion reactions like pain or swelling at injection site, allergic reactions including rash or difficulty breathing, nausea, diarrhea and fever.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I meet at least 4 of the criteria for lupus.

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My blood tests show positive for specific autoantibodies.

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My blood tests show positive for specific autoantibodies.

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My lupus is active with a SELENA SLEDAI score of 6 or more.

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I am taking a low dose of steroids, not exceeding 0.5 mg/kg/day.

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I am not currently taking NSAIDs.

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I am not taking anti-malarial medications like hydroxychloroquine.

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I am between 5 and 17 years old.

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I am not currently taking any immune system altering drugs.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on medication for a long-term infection like TB or herpes.

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I have tested positive for Hepatitis B.

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I have not been treated with medications targeting B-cells.

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I am receiving IVIG treatment.

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I have protein in my urine.

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I am taking anakinra for my condition.

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My blood clotting time is stable due to my warfarin treatment.

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I have undergone plasmapheresis.

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I haven't taken any IV or IM antibiotics for infections in the last 60 days.

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I am not taking any new immune system altering drugs.

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I have stable low white blood cell counts due to lupus.

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I am currently taking or have taken anti-TNF medication.

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I am not taking high doses of steroids or receiving them by injection.

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I tested positive for Hepatitis C antibody but negative for the virus itself.

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I have stable low blood protein levels due to kidney issues from lupus, not because of liver disease or poor nutrition.

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My blood takes longer to clot due to lupus, not liver disease or medication.

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I have been treated with belimumab before.

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I have had cancer in the past 5 years.

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I have not received a live vaccine in the last 30 days.

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My kidney function, measured by eGFR, is below 30 mL/min.

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I have had a major organ or stem cell transplant.

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I haven't had certain treatments in the last 364 days.

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I am receiving or have received IV cyclophosphamide.

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I have been on dialysis or needed it in the last 90 days.

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I have not taken any experimental drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre dose on week 1, week 2, week 4, week 8, week 12, week 16, week 24, week 36, week 52, and week 60

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre dose on week 1, week 2, week 4, week 8, week 12, week 16, week 24, week 36, week 52, and week 60

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre dose on week 1, week 2, week 4, week 8, week 12, week 16, week 24, week 36, week 52, and week 60 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Estimated Average Concentration (Cavg) of Belimumab at Steady State

Estimated Maximum Concentration (Cmax) of Belimumab at Steady State

Estimated Minimum Concentration (Cmin) of Belimumab at Steady State

+1 more

Secondary study objectives

Number of Participants With Adverse Events (AEs)

Number of Participants With Adverse Events of Special Interest (AESIs)

Number of Participants With Serious Adverse Events (SAEs)

+7 more

Side effects data

From 2018 Phase 3 trial • 80 Patients • NCT02119156

36%

Nasopharyngitis

18%

Hypokalaemia

Cystitis

Gastroenteritis

Periodontal disease

Joint injury

Vertigo

Ocular discomfort

Lumbar vertebral fracture

Upper respiratory tract infection

Dental caries

Musculoskeletal chest pain

Cough

Otitis externa bacterial

100%

80%

60%

40%

20%

Study treatment Arm

Treatment Phase: Treatment Holiday Group - Re-start Phase

Maintenance Phase: Treatment Holiday

Treatment Phase: Long-term Discontinuation Group

Treatment Phase: Treatment Control Group

Treatment Phase: Treatment Holiday Group - Holiday Phase

Maintenance Phase: Treatment Control

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Belimumab 200 mgExperimental Treatment1 Intervention

Participants with Systemic Lupus Erythematosus were administered with Belimumab 200 milligram per milliliter (mg/mL) subcutaneous (SC) injection. The dosing frequency was based on body weight. Participants who weigh more than or equal to 50 kilograms were administered every week, who weigh between 30 to less than 50 kg were administered every 10 days and who weigh less than 30 kg were administered every 2 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Belimumab

2013

Completed Phase 4

~1940

0 / 34Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Belimumab, a monoclonal antibody, targets and inhibits B-lymphocyte stimulator (BLyS), a protein that promotes the survival of B cells, which are responsible for producing antibodies. By inhibiting BLyS, Belimumab reduces the number of abnormal B cells, thereby decreasing the production of autoantibodies that attack the body's own tissues in Lupus patients. This mechanism is crucial as it helps in preventing disease flares, reducing the need for glucocorticoids, and improving the overall quality of life for patients. Other treatments, such as Rituximab, also target B cells by binding to the CD20 protein on their surface, leading to their depletion. These therapies are significant as they directly address the underlying immune dysregulation in Lupus, offering more targeted and effective management of the disease.

[Biologics in SLE].