Details

What is Benlysta (belimumab) for?

Benlysta (belimumab) is a B-lymphocyte stimulator (BLyS)-specific inhibitor indicated to treat:

It is taken in combination with standard of care therapies and works by suppressing the immune system.

It is available as 120 mg in a 5-mL single-use vial and 400 mg in a 20-mL single-use vial for infusion (drip) into a vein. It is also available as a pre-filled pen and pre-filled syringe (200 mg) for injection under the skin.

How does Benlysta (belimumab) work?

Approximately 50% of people with the autoimmune disease systemic lupus erythematosus (SLE) will develop lupus nephritis (LN). LN is an inflammation of the kidneys, which causes irreversible kidney damage and significantly increases the risk of kidney failure, cardiac events, and death.

B cells of the immune system play an important role in the inflammation seen in SLE. Normally, B cells make antibodies which help to fight infections. In people with lupus, so-called autoreactive B cells (cells that react against the body) are active longer in the body than normally and produce antibodies that will attack the body’s own cells and organs.

Belimumab works by inhibiting B-lymphocyte stimulator (BLyS), which is a protein that helps B cells live longer. By attaching to the BLyS protein, belimumab makes sure it cannot help B cells, including autoreactive B cells, survive.

Where has Benlysta (belimumab) been approved?

Benlysta (belimumab) was approved as add-on therapy by:

Benlysta (belimumab) was approved by the FDA under Priority Review for the treatment of lupus. The medicine was granted Breakthrough Therapy Designation and Priority Review for the treatment of adult patients with active LN.[4,7]

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Benlysta (belimumab) taken?

There are two ways to take Benlysta (belimumab):

Benlysta (belimumab) is used in combination with standard of care treatment.

Ask your doctor which treatment option is right for you. It is possible for adults to switch from IV treatment to at-home administration.

Complete information about Benlysta (belimumab) dosage and administration can be found in the official prescribing information listed in our references section.

Note: Please consult with your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Benlysta (belimumab)?

Common adverse reactions

The most common side effects ( ≥5% of patients) listed in the prescribing information include:

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include:

Use in a specific population

It is not known whether Benlysta (belimumab) is harmful for a fetus. Women of childbearing potential must use effective contraception during treatment and for at least 4 months after the last treatment.

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.

References

Clinical trials

Systemic Lupus Erythematosus (SLE) in adults

The Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals of Benlysta (belimumab) for treatment of adults with active lupus nephritis (LN) was based on the data of two clinical trials: BLISS-52.

These studies were phase 3 double-blind, placebo-controlled, multi-centre trials to study the efficacy and safety of belimumab plus standard of care, versus placebo plus standard of care.The two studies involved a total of 1,684 patients with active SLE who were treated belimumab 1 mg/kg or 10 mg/kg, or placebo by intravenous infusion on days 0, 14, and 28, and then every 28 days until 48 weeks.

Results

The main efficacy outcome was the proportion of patients achieving a clinically meaningful improvement in disease activity at week 52, as measured by the SLE responder index (SRI).

Belimumab significantly reduced lupus disease activity, mainly due to improvements in the immune system, muscles, mouth, joints, and skin. It significantly reduced risk of severe flares, and reduced need for rescue medicines (steroids) by 25% or more.

Systemic Lupus Erythematosus (SLE) in children aged ≥5 years

The FDA and EMA approvals of Benlysta (belimumab) for treatment of children aged 5 years and above with active lupus nephritis (LN) was based on the data of the PLUTO study (NCT).

PLUTO was a multicentre, randomised, double-blind study that studied the safety and efficacy of belimumab in children aged 5-17 years with SLE. The study involved 93 participants who received either 10 mg/kg belimumab intravenously with standard therapy or placebo plus standard therapy for one-year.

Results

The main efficacy outcome was the proportion of children achieving a clinically meaningful improvement in disease activity, as measured by the SLE responder index (SRI).

Intravenous belimumab has been observed to reduce lupus disease activity and reduce the chance of severe flares over the course of a year.

The SRI response rate was significantly higher in patients receiving belimumab (52.8%) compared with placebo (43.6%) at week 52.

PLUTO is made up of three phases: Part A (the herementioned study), Part B (long-term open-label safety phase) and Part C (long-term safety follow-up phase). The long-term follow-up phases of the study (Parts B and C) are planned for a total of up to 10 years.

Lupus Nephritis (LN) in adults

The FDA approval of Benlysta (belimumab) for treatment of adults with active lupus nephritis (LN) was based on the data of the BLISS-LN (Efficacy and Safety of Belimumab in Adult Patients with Active Lupus Nephritis) study (NCT01639339).

BLISS-LN was a phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 104-week trial that involved 448 adult patients with active LN. Patients were given intravenous (IV) infusion of belimumab together with standard of care medicines compared to other lupus medicines alone.

Results

The main efficacy outcome was the Primary Efficacy Renal Response (PERR) at two years (or 104 weeks).

Belimumab significantly reduced kidney disease activity, with maintained kidney function, reduced protein in the urine, and reduced need for rescue medicines. It also significantly reduced risk of kidney worsening.

The study met its primary endpoint: a significantly greater number of LN patients achieved PERR at 104 weeks when treated with belimumab (43%) compared to placebo (32% [95% CI 1.04, 2.32]).

Additionally, belimumab improved outcome across all four major secondary endpoints, including Complete Renal Response and Time to Renal-Related Event or Death.

Please refer to the summary of product characteristics below and in the resource section for comprehensive information about the safety and effectiveness of Benlysta (belimumab) for the approved indication.

References

Price & Costs

Kevzara (sarilumab) price in other currencies*

Package	Euro	Australian dollars	Canadian dollar	New Zealand dollar	Nigerian naira	Singapore dollar	Pound sterling	United States dollar
Single-dose vial x 120 mg	449 EUR	742 AUD	670 CAD	816 NZD	746729 NGN	634 SGD	370 GBP	473 USD
Autoinjector pen x 200 mg	578 EUR	954 AUD	862 CAD	1050 NZD	960681 NGN	816 SGD	476 GBP	609 USD
Single-dose vial x 400 mg	900 EUR	1486 AUD	1343 CAD	1635 NZD	1495601 NGN	1271 SGD	742 GBP	948 USD
4 Autoinjector pen x 200 mg	1572 EUR	2595 AUD	2346 CAD	2855 NZD	2611858 NGN	2220 SGD	1296 GBP	1655 USD
12 Autoinjector pen x 200 mg	4162 EUR	6872 AUD	6211 CAD	7560 NZD	6915262 NGN	5880 SGD	3431 GBP	4384 USD

*The prices listed above are based on the cheapest package size and strength everyone.org has access to. Please make an enquiry for more specific pricing. The prices listed above are a guide only, we operate in Euros.

Benlysta (belimumab) treatment costs

The cost for a monthly or yearly treatment of Benlysta (belimumab) depends on your prescription requirements which includes the dosage in mg and medicine type (Single-dose vial or pre-filled syringe).

The price of the medicines you see on sale is the cost set by the manufacturer. In addition, shipping costs and a Named Patient support fee will apply.

Make an enquiry and we will help you calculate the total price to buy Benlysta (belimumab) online and have it delivered where you live. From your side, we’ll simply need a prescription from your treating doctor. In some countries we might also need an import license. Our Patient Support team will guide you throughout the process.

Benlysta (belimumab) price and additional costs

Benlysta (belimumab) reimbursement

It might be possible for you to claim the cost of Benlysta (belimumab) via your country's healthcare system. Some countries have a government fund providing financial assistance for citizens to access lifesaving medical treatment abroad. The best thing would be to check with your country's own health ministry. We also highly recommend checking out local patient blogs, communities and patient organisations to find out more about your options.

Medical insurance

Generally, we do not support medical insurance, but we do provide you with an invoice after you make the payment that you may send to your medical insurance company so they can reimburse you. In some limited circumstances, we do accept insurance. Contact us for more details. You can pay by bank transfer or credit card.

Crowdfunding

Crowdfunding might also be an option for you. It is a means of raising funds by using an online platform to group together many small donations from friends, family and others, in order to help you afford medical treatment. Here are some crowdfunding platforms where you can seek support: GoFundMe, GiveForward, FundRazr and Watsi.

Shipping

Cold chain shipping

Some medicinal ingredients are susceptible to damage from heat, light and handling. Using "cold chain" delivery, specialised medical couriers have temperature regulated boxes and vehicles to ensure that the medicine is uncompromised. For that reason, cold chain shipping can be more expensive than regular shipping. For more details, please see our article on cold chain delivery.

Your order will be shipped to you by our partner couriers, such as DHL, UPS and specialised cold chain couriers. If you would like your order to be shipped by a specific courier, please inform us when you place the order.

Our standard delivery time varies from 5 to 10 working days.

The shipping cost depends on the medicine and the destination country. After making an enquiry, you will receive a detailed quote that includes the shipping costs.

You can also pick up your medicine from our partner pharmacy in Amsterdam or our partner pharmacy in Luxembourg after the order has been paid for.

Our Process

Four steps to access the medicines you need

How and where to access and buy Benlysta: You can access Benlysta from everyone.org if the drug has not been approved or is not available in your country.