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Belimumab - Overview, Uses and Warnings

Published on May 16, 2022 and last reviewed on May 24, 2022   -  21 min read


Belimumab is an immunomodulatory drug indicated for use in systemic lupus erythematosus. Read the following article for more particulars on Belimumab.



Belimumab is a recombinant, fully human monoclonal antibody developed by Human Genome Sciences Incorporated and GlaxoSmithKline. It is indicated for treating adult patients with lupus nephritis that occurs in patients with systemic lupus erythematosus (SLE).

Belimumab is directed against the B-cell activating factor (BAFF) or the cytokine BLyS. It is effective in treating adult patients with systemic lupus erythematosus who are already undergoing therapy with a standard treatment regimen.

Belimumab was approved to treat active, autoantibody-positive SLE by the US Food and Drug Administration on March 9, 2011, and by the European Medicines Association (EMA) in July 2011. It is available in the markets under the trade name Benlysta and can be used as either an intravenous infusion or subcutaneous injection.

How Does Belimumab Work?

The action of Belimumab is directed against the B-cell activating factor (BAFF) or the cytokine BLyS. When the body is affected by overexpression of BLyS, that can result in B-cell survival, including the autoreactive B-cells. In contrast, inhibition can result in autoreactive B-cell apoptosis (programmed cell death). The elevation of circulating BLyS and subsequent B-cell increase is typical of autoimmune diseases like SLE. Therefore, therapy that reduces or inhibits BLyS activity is considered a useful treatment option. Belimumab is a BLYs-specific inhibitor capable of binding to soluble BLyS and blocking its action - this results in the inhibition of B-cell survival

Belimumab Work

Belimumab Work

B-Cells: B cells are lymphocytes (a type of white blood cell) responsible for humoral immunity in the body. They produce antibodies as part of their immune response function.

B-Cell Activating Factor (BAFF): Also known as tumor necrosis factor (TNF) ligand superfamily member 13B (TNFSF13B) or B-lymphocyte stimulator (BLyS), BAFF is a necessary factor for the survival and maturation of B cells. BAFF, when overproduced, can result in the occurrence of systemic autoimmune diseases like SLE.

Uses of Belimumab:

Uses of Belimumab

Dosage Restrictions:

Routes of Administration:

Dosage Forms:

Available Strengths:

Dosage Administration:



First 3 doses - 10 mg/kg at two-week intervals (after reconstitution and dilution) - followed by 4-week intervals.

Duration of Administration:

Over an hour.


Sites of Injection:


Special Considerations:

Warnings and Contraindications:

Contraindications: Belimumab is contraindicated in patients who have previously experienced anaphylaxis with the administration of Belimumab.

Warnings and Precautions:

For Patients:

What Is Systemic Lupus Erythematosus?

SLE is an autoimmune condition where your immune system attacks tissues and causes destruction and inflammation in your organs (skin, brain, lungs, kidneys, etc.). You can read more on this condition here.

What Is Lupus Nephritis?

Lupus nephritis is a type of kidney disease resulting from SLE, where waste filtration by your kidneys is compromised due to lupus antibodies. This can lead to inflammation of your kidneys along with impaired functioning of the kidneys, high blood pressure, and the presence of blood and protein in the urine. For more information on lupus nephritis, visit this page.

Why Is Belimumab Prescribed for SLE?

Belimumab is an inhibitor of the B-lymphocyte stimulatory cytokine (BLyS), which has been linked to the development and progression of systemic lupus erythematosus. When administered with standard therapy, the efficacy of Belimumab has been demonstrated as superior to that of placebo with standard treatment.

Belimumab is particularly important from a therapeutic perspective due to the multisystem disease activity approach rather than targeting specific organs. This multisystem approach may prevent the all-around escalation and worsening of the disease.

How Should You Take Belimumab?

There are two possible ways to take Belimumab:

How Should You Self-Administer Belimumab?

What Should You Discuss With Your Doctor Before Beginning Belimumab Therapy?

Is Belimumab Safe?

Data on Belimumab safety has shown that it is well-tolerated with a good safety profile and negligible risk of side effects even on long-term administration.

Is Belimumab Effective?

In combination with standard therapy, Belimumab may increase response rates and prevent the worsening of symptoms of kidney disease in lupus nephritis patients compared to standard treatment alone.

What Side Effects Can You Expect With Belimumab?

Can You Stop Treatment With Belimumab Without Your Doctor's Approval?

Belimumab is typically not recommended by doctors if you do not have an active lupus infection or you have not exhausted most other therapeutic options. If your doctor prescribes Belimumab in combination with your standard treatment regimen, you must remember that it is intended as a long-term therapy, and effects may only be shown in 6 months. It may be administered by the doctor as an intravenous infusion, or self-administered via a subcutaneous injection. In either case, never stop treatment unless you are experiencing severe adverse reactions. Whether the therapy does not appear to be effective initially, or notice positive changes, you must continue treatment until your doctor advises otherwise.

What Are the Long-Term Effects of Taking Belimumab?

The long-term effects of Belimumab are pretty positive. However, SLE patients may experience irreversible organ damage that can also contribute to an increased risk of death. Patients who received Belimumab in combination with standard therapy showed less organ damage over five years than patients receiving standard treatment alone or standard treatment with a placebo.

Are There Any Dietary Restrictions to Consider When Taking Belimumab?

No dietary restrictions exist as such with the use of Belimumab. However, you may want to consider an appropriately nutritious diet to aid in controlling symptoms of the disease itself.

How Should You Store and Dispose of Belimumab?

What Can You Do if You Suffer From These Disorders?

Some of the lifestyle modifications you can make when you are suffering from SLE to prevent worsening of symptoms include:

What Can You Do in Case of Overdose?

If your healthcare provider administers the dose, you are not likely to experience a Belimumab overdose. However, if you self-administer subcutaneous injections of Belimumab and accidentally overdose, you must seek immediate medical attention. You can call your healthcare provider or local Poison Control Services for more information on managing an overdose. Alternatively, you may seek out emergency medical services.

What Should You Do if You Miss a Dose?

Take your dose as soon as you realize you have missed it. If this is closer to your next dose, then you may proceed with that dose. Do not double-dose yourself under any circumstances.

What Else Should You Keep In Mind?

Keep your doctor informed on your medical history, and ensure you carry information on your condition, medications, or any other conditions you may be suffering from. Contact your doctor if you begin to experience any adverse effects while taking this medication. Hypersensitivity reactions, including itching, rashes, trouble breathing and swallowing, and swelling, must be brought to your doctor's attention.

For Doctors:





Intravenous Infusion:

Subcutaneous Injection:

Prefilled Autoinjector:

Prefilled Syringe:

Mechanism of Action:

Belimumab is an inhibitor of BLyS - it blocks the binding of soluble BLyS to its receptors present on B-cells. This results in:


Treatment with Belimumab in adult patients causes the following changes:

In Lupus Nephritis Patients:


Intravenous Infusion:

Pharmacokinetic Parameters in Adult SLE Patients After IV Infusion of Belimumab 10 mg/kg:

Pharmacokinetic Parameters

Lupus Nephritis:

Pharmacokinetic Parameters in Adult SLE Patients After Subcutaneous Injection of Belimumab 200 mg Once Weekly:

Pharmacokinetic Parameters

Lupus Nephritis:

Steady-state average concentrations of Belimumab 200 mg (SC) once weekly in adults with lupus nephritis are predicted to be similar to concentrations in adults receiving IV Belimumab 10 mg/kg every four weeks for lupus nephritis.

Special Considerations:

Drug Interaction Studies:

Formal studies on drug interactions have not been conducted for Belimumab. However, the concomitant use of certain drugs has not given rise to adverse reactions. These drugs include:

Coadministration of steroids and angiotensin-converting enzyme (ACE) inhibitors caused a clinically insignificant increase in systemic clearance of Belimumab.

Clinical Trials:

The Belimumab in Subjects With Systemic Lupus Erythematosus -76 (BLISS-76) Trial (Phase III) evaluated the safety and efficacy of Belimumab in patients with SLE when added to standard therapy.

All patients were also given standard therapy. IV infusion of Belimumab was given on Days 0, 14, 28 -followed by every 28 days during the entire study period (76 weeks).

Rates of adverse events were similar to that of the placebo group. These included:

Lupus Nephritis: The Belimumab International Study in Lupus Nephritis (BLISS-LN Trial, Phase III) evaluated the safety and efficacy of Belimumab in patients with lupus nephritis when added to standard therapy.

All patients were also given standard therapy. IV infusion of Belimumab or placebo was given on Days 1, 15, 29 -followed by every 28 days during the entire study period (104 weeks).

Primary Efficacy Renal Response: This was measured as:

Complete Renal Response: This was measured as:

Week 104: Significant differences in primary efficacy renal response and complete renal response in the Belimumab group compared to the placebo group.

Renal-Related Event or Death Risk: Lower in Belimumab patients compared to the placebo group (hazard ratio, 0.51; 95 % CI, 0.34 to 0.77; P=0.001).

  1. Subcutaneous Injection (SC Injection):

SLE: The BLISS-SC Trial (Phase III) evaluated the efficacy and safety of SC Belimumab in SLE patients receiving standard therapy over 52 weeks.

Prefilled syringes were used for drug administration. All patients were also given standard SLE therapy.

Comparable between both groups.

Clinical Trials for Other Therapeutic Uses of Belimumab:

Ongoing clinical trials on Belimumab have considered an array of possible uses of Belimumab in other autoimmune disorders, including:

Belimumab as Prophylaxis:

A Phase 1 study has also demonstrated the possibility of using Belimumab as a prophylactic therapy to prevent chronic graft-versus-host disease in adult patients undergoing allogeneic transplantation.

Patients received Belimumab (10 mg/kg) every two weeks for three doses. This was followed by four doses (one per month).

Initiation of Treatment: 50 days to 80 days after allogeneic hematopoietic cell transplantation.

Belimumab appeared to be well-tolerated and was not linked to severe infections or myelosuppression (suppressed bone marrow activity, leading to fewer red blood cells, white blood cells, and platelets). Eight out of nine patients received all seven doses of Belimumab in accordance with pre-planned parameters. Five patients are alive after over 20 months of follow-up with no signs of chronic graft-versus-host disease (cGVHD).

Patient Counseling Information:

Additional Information:

Frequently Asked Questions


Is Belimumab an Immunosuppressant Type of Drug?

Belimumab is an immunosuppressant monoclonal antibody that inhibits the differentiation of B cells into plasma cells.


Is Belimumab a Chemotherapeutic Drug?

Belimumab is not a chemotherapeutic drug. It is a biologic therapeutic drug that is administered either as an injection (self-injection) or intravenous (IV) infusion. It works by decreasing the cells that cause lupus.


Does Belimumab Cause an Increase in Weight?

Belimumab is not known to cause an increase in weight. Clinical trials conducted for Belimumab use have not reported weight changes (gain or loss of weight) in study participants.


What Long-term Effects Are Associated With the Use of Belimumab?

Long-term efficacy studies have demonstrated that the use of Belimumab along with standard of care (SoC) results in less organ damage than in patients receiving only standard of care. Patients receiving this combination therapy show about a 61 % decrease in organ damage progression.


Can Belimumab Infusion Cause Tiredness?

Belimumab infusion can leave patients feeling tired and fatigued for a few days after treatment.

Patients receiving Belimumab infusion should ideally plan for this and get adequate rest.


What Are the Side Effects Associated With Belimumab Injection?

Common side effects one may notice with the use of Belimumab include:

- Nausea.

- Diarrhea.

- Swelling at the injection site.

- Difficulty sleeping.

- Fever.

- Runny nose.

- Cough.

- Headache.

- Arm or leg pain.


How Long Does It Take for Belimumab to Be Effective?

- Although Belimumab actually starts working from the first dose administered, the effects may be noticeable in about 8 weeks.

- Patients will usually notice an improvement in their symptoms within six to eight weeks of starting Belimumab therapy.


Can Belimumab Cause Mood Swings or Anxiety?

- Belimumab has been known to cause mood swings, anxiety, depression, and suicidal ideation.

- Belimumab infusions have caused these side effects more often than injections.

- The severity of these reactions has also been noted more in association with infusions of Belimumab than injections.


How Does Belimumab Work?

- Belimumab is a drug used in the treatment of lupus.

- The immune system produces antibodies that attack the body’s own tissues in patients with lupus.

- Belimumab is directed against the B-cells (a type of white blood cell) that are responsible for the production of these harmful antibodies.


Can Belimumab Help Treat Joint Pain?

- Alleviation of severe joint pain that may occur due to lupus has been reported by some patients on Belimumab therapy.

- Joint inflammation and resulting pain may be lessened with the use of Belimumab.


Can Belimumab Help With Fatigue?

Long-term treatment with Belimumab in patients with lupus not only helps control the disease, but also reduces fatigue and improves the quality of life.

Article Resources

Last reviewed at:
24 May 2022  -  21 min read




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