Informed patients are empowered patients

Helping your patients understand their lupus.

Icon: Three checked boxes

Setting expectations

By making sure your patients know what to expect from BENLYSTA, you’re also making sure they know how to do their part.

Read more

Icon: Patient Doctor guide

Patient-doctor guide

Successful conversations start with a common language. This guide will show patients how to best communicate their needs to you.

See the guide

Icon: Information

FAQs

Some frequently asked questions your patients may have about BENLYSTA.

Find out more

Setting expectations

Getting started

The better informed your patients are, the easier it will be for them to ask important questions and stay involved in the decisions and best practices related to their care and treatment. The examples below offer some patient-friendly answers to common questions.

To get a better understanding of where your patient might be having a hard time, use open-ended questions that encourage them to discuss their experience or uncertainties.

How does lupus impact my body?

  • Lupus is a chronic disease that results from abnormal activity in the immune system. Because lupus is chronic, your symptoms will come and go1
  • Normally, your immune system acts like a bodyguard against invaders. But when you have lupus, your immune system mistakenly attacks your own body’s healthy tissues. Attacking healthy tissues can result in inflammation and pain, and can affect many different body systems including your joints, skin, kidneys, blood cells, brain, heart, and lungs1
  • Lupus can affect everyone differently, but the most common signs and symptoms include, but are not limited to, fatigue, fever, joint pain, stiffness, swelling, and more1
  • As lupus progresses, there is a chance that the disease could permanently damage your organs, such as your kidneys or your heart and lungs1

What is a biologic, and why should I consider using one?

  • A biologic is a type of treatment that is infused in a clinic or injected at home and is often used along with conventional oral medications like hydroxychloroquine and steroids, among others
  • Biologics for lupus are designed to target specific pathways within your immune system, such as B cells and T cells, and differ from immunosuppressants that suppress your entire immune system in order to reduce your immune system’s attack on your body2
  • BENLYSTA is one example of a biologic2

How does BENLYSTA work?

  • In many people with lupus, certain white blood cells of the immune system, called autoreactive B cells (cells that react against the body), stay in the body longer than they should3,4
  • One of the important proteins for the survival of these B cells is called BLyS, also known as BAFF. BENLYSTA selectively blocks the binding of soluble BLyS to its receptor on B cells3,4
  • When BLyS is blocked, it can no longer bind to and stimulate B cells, thus inhibiting the survival of B cells. The clinical relevance on B cells has not been established

BAFF = B cell activating factor; BLyS = B-lymphocyte stimulator protein.

Starting patients on BENLYSTA

Access can be an important barrier for patients to overcome to both start and stay on therapy. Familiarize yourself with the steps to help your patients access BENLYSTA.

Here’s how to start your patients today

Get the help your patients need

BENLYSTA Cares is a patient support program that your patients can utilize to make their treatment journey with BENLYSTA more manageable. BENLYSTA Cares provides support for at-home administration, text reminders for prescriptions, help with benefits and savings, access to exclusive resources, and more.

Get support for your patients

Staying on treatment

You’ve worked hard to put your patients on the treatment path of BENLYSTA, but it can be just as difficult to keep them on course. Remind your patients why it’s so important to remain on BENLYSTA and what they can expect.

How you can help them:

For those patients who take the weekly SC injection, provide them with medication reminder tips:

  • When your patients set a reminder, tell them to try noting each step they’ll take, from ensuring they have necessary materials the day before to removing the Autoinjector from the refrigerator 30 minutes prior to injection
  • Advise your patients to add a sticky note on their refrigerator to remind themselves which day of the week they do their self-injection
  • Suggest utilizing technology such as smart assistants, phone reminders, or even asking family members to help set reminders

Remind them that BENLYSTA works with their lupus medicines over time:

  • At 52 weeks, pivotal clinical trials showed up to 61% of patients were able to meet the primary endpoint of reducing their disease activity (as measured by SRI-4) with BENLYSTA added to their standard lupus medicines (ST) vs ST alone5-7
  • In a post hoc, pooled analysis involving 5 SLE studies, the proportion of patients that achieved SRI-4 response was 38% at 8 weeks.*†‡ In a long-term extension trial, 76% of patients showed SRI-4 response at 7 years8,9*†§
  • Set expectations with your patients that while BENLYSTA may show results for approximately 4 in 10 patients as early as 8 weeks, they should plan to commit to treatment for 6 to 9 months to see the effect of BENLYSTA on their lupus8¶
  • In addition, talk to your patients about the safety profile for BENLYSTA, including monitoring for the most serious and most common side effects

* Results are descriptive.

† The same patient may not have responded at each visit.

‡ Five randomized, controlled efficacy and safety studies included: BLISS-52, BLISS-76, NE Asia, BLISS-SC, and EMBRACE. The primary endpoint (SRI-4 at Week 52) was not met in EMBRACE.

§ Other efficacy endpoint. Exploratory results should be interpreted with additional care. See study design for design limitations.

¶ Individual studies were not designed to establish onset of effect, and not all studies showed improvement at Week 8.

View the efficacy data and study design:

When patients start to feel better on treatments, they often ask when they may stop treatment. Emphasize that it is important to continue taking BENLYSTA as prescribed. Lupus is not a curable disease and requires consistent monitoring and treatment.10

  • Reinforce to your patients that many chronic illnesses, such as lupus, require long-term treatment10
  • Ensure your patients understand the importance of adhering to treatment by informing them about the impact that lupus and lupus nephritis can have on their organs, such as their skin, joints, and kidneys11-14
  • For your patients on BENLYSTA IV, remind them to stick to their infusion schedule and inform your office immediately if their infusion schedule changes

BLISS = Belimumab International SLE Study; EMBRACE = Efficacy and Safety of Belimumab in Adult Subjects of Black Race; IV = intravenous; NE = Northeast; SC = subcutaneous; SRI = SLE Responder Index; SLE = systemic lupus erythematosus; ST = standard therapy.

Make sure they know:

Irreversible organ damage can be a consequence of lupus.11,12

See data

Each renal flare increases the risk of ESKD and the need for dialysis.13,14

See data

ESKD = end-stage kidney disease.

Patient stories videos

Starting a new medication can be scary for patients, but it doesn’t have to be that way. With the help of these real patient stories, you’ll be better equipped to alleviate concerns that your patients may have about BENLYSTA. Share these stories with your patients today.

Featured patients have been compensated by GSK to share their stories.

BENLYSTA patient: Nadine

Nadine

Enjoys time with her family and dogs
Patient with lupus nephritis

“ If your doctor thinks BENLYSTA
could help, I would recommend it. ”

“ If your doctor thinks BENLYSTA could help, I would recommend it. ”

View Nadine's story

BENLYSTA patient: Stephanie

Stephanie

Enjoys being an active mom
Patient with lupus

“ Sorry, lupus. You don’t get to run
this show today. ”

“ Sorry, lupus. You don’t get to run this show today. ”

View Stephanie’s story

BENLYSTA patient: Elijah

Elijah

Enjoys photography and his motorcycle
Patient with lupus nephritis

“ If I could speak directly to lupus, I would
honestly laugh and say, ‘I’m winning.’ ”

“ If I could speak directly to lupus, I would honestly laugh and say, ‘I’m winning.’ ”

View Elijah’s story

BENLYSTA patient: Morgan

Morgan

Enjoys fishing and her pets
Patient with lupus

“ If I could tell lupus off, I’d say, ‘Leave me
alone, I’m going to push forward. Sorry
lupus, not today.’ ”

“ If I could tell lupus off, I’d say, ‘Leave me alone, I’m going to push forward. Sorry lupus, not today.’ ”

View Morgan’s story

Patient-doctor discussion guide

BENLYSTA doctor discussion guide

Discussion guide

Time is valuable and limited in a busy practice, and yours is likely no different. Make each patient interaction count. Ask your patients to use this tool to help focus discussion at their next appointment.

The tool includes:

  • Symptom tracking
  • Treatment planning
  • Common questions about BENLYSTA

Download discussion guide

Frequently asked questions from patients about BENLYSTA

Show allCollapse all

  • What kind of medicine is BENLYSTA?

    BENLYSTA (belimumab) is a biologic therapy, not a steroid. It is taken in addition to your other lupus medications and is available in 3 options for adults with lupus and lupus nephritis:

    • An autoinjector you self-inject
    • A prefilled syringe you self-inject
    • An intravenous (IV) infusion that is administered by a healthcare provider

    For children aged 5 and above with lupus or lupus nephritis, BENLYSTA is available as an IV infusion.

  • How does BENLYSTA work?

    • In many people with lupus, certain white blood cells of the immune system, called autoreactive B cells (cells that react against the body), stay in the body longer than they should3,4
    • One of the important proteins for the survival of these B cells is called BLyS, also known as BAFF. BENLYSTA selectively blocks the binding of soluble BLyS to its receptor on B cells3,4
    • When BLyS is blocked, it can no longer bind to and stimulate B cells, thus inhibiting the survival of B cells. The clinical relevance on B cells has not been established

  • What is the most important safety information I should know about BENLYSTA?

    Immunosuppressive agents, including BENLYSTA, can cause serious side effects. Some of these side effects may cause death. Please refer your patients to the Prescribing Information and Medication Guide for BENLYSTA.

  • Can BENLYSTA have serious side effects?

    Immunosuppressive agents, including BENLYSTA, can cause serious side effects. Some of these may cause death.

     

    Infections

    Infections could be serious, leading to hospitalization or death.

     

    Allergic (hypersensitivity) reactions

    Serious allergic reactions can happen the day of, or in days after, receiving BENLYSTA and may cause death. Your healthcare provider will watch you closely while you are receiving BENLYSTA given in a vein (intravenous infusion) and after your infusion for signs of a reaction. Allergic reactions can sometimes be delayed. Tell your doctor right away if you have any symptoms of an allergic reaction.

     

    Mental health problems and suicide

    Symptoms of mental health problems can occur. Tell your healthcare provider right away if you have any of the following symptoms: thoughts of suicide or dying; new or worse depression; attempt to commit suicide; acting on dangerous impulses; trouble sleeping (insomnia); other unusual changes in your behavior or mood; new or worse anxiety; thoughts of hurting yourself or others.

     

    Progressive multifocal leukoencephalopathy (PML)

    PML is a serious and life-threatening brain infection. Your chance of getting PML may be higher if you are treated with medicines that weaken your immune system, including BENLYSTA. PML can result in death or severe disability. If you notice any new or worsening medical problems such as the following, tell your doctor right away: memory loss; trouble thinking; dizziness or loss of balance; difficulty talking or walking; or loss of vision.

     

    Cancer

    BENLYSTA may reduce the activity of your immune system. Medicines that affect the immune system may increase your risk of certain cancers.

     

    Please refer to the Prescribing Information and Medication Guide for BENLYSTA for additional information.

  • What are the most common side effects of BENLYSTA?

    The most common side effects of BENLYSTA include nausea, diarrhea, fever, stuffy or runny nose and sore throat (nasopharyngitis), persistent cough (bronchitis), trouble sleeping (insomnia), leg or arm pain, depression, headache (migraine), and pain, redness, itching, or swelling at the site of injection (when given subcutaneously).

     

    These are not all the possible side effects of BENLYSTA. Contact your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

    You may also find this link useful to learn more about the safety and side effects of BENLYSTA.

Study design

Show allCollapse all

  • Study design for adult lupus trials

    Study design

    Phase III trials in adults were randomized, double-blind, and placebo-controlled, and assessed intravenous and subcutaneous methods of administration

    BLISS-SC (52-week duration)7
    Treatment arms
    • BENLYSTA SC 200 mg + ST (n=556)
    • Placebo + ST (n=280)
    Regions
    177 centers throughout North America, South America, Europe, and Asia
    BLISS-52 (52-week duration)5
    Treatment arms
    • BENLYSTA IV 1 mg/kg* + ST (n=288)
    • BENLYSTA IV 10 mg/kg + ST (n=290)
    • Placebo + ST (n=287)
    Regions
    92 centers throughout South America, Asia, Eastern Europe, and Australia
    BLISS-76 (76-week duration, primary endpoint measured at Week 52)6
    Treatment arms
    • BENLYSTA IV 1 mg/kg* + ST (n=271)
    • BENLYSTA IV 10 mg/kg + ST (n=273)
    • Placebo + ST (n=275)
    Regions
    136 centers throughout North America and Europe
    EMBRACE (52-week duration)15
    Treatment arms
    • BENLYSTA IV 10 mg/kg + ST (n=299)
    • Placebo + ST (n=149)
    Regions
    96 centers throughout North America, South America, South Africa, and Europe
    NE Asia (52-week duration)16
    Treatment arms
    • BENLYSTA IV 10 mg/kg + ST (n=451)
    • Placebo + ST (n=226)
    Regions
    49 centers throughout China, Japan, and South Korea
    BLISS-SC (52-week duration)7
    Treatment arms Regions
    • BENLYSTA SC 200 mg + ST (n=556)
    • Placebo + ST (n=280)
    		 177 centers throughout North America, South America, Europe, and Asia
    BLISS-52 (52-week duration)5
    Treatment arms Regions
    • BENLYSTA IV 1 mg/kg* + ST (n=288)
    • BENLYSTA IV 10 mg/kg + ST (n=290)
    • Placebo + ST (n=287)
    		 92 centers throughout South America, Asia, Eastern Europe, and Australia
    BLISS-76 (76-week duration, primary endpoint measured at Week 52)6
    Treatment arms Regions
    • BENLYSTA IV 1 mg/kg* + ST (n=271)
    • BENLYSTA IV 10 mg/kg + ST (n=273)
    • Placebo + ST (n=275)
    		 136 centers throughout North America and Europe
    EMBRACE (52-week duration)15
    Treatment arms Regions
    • BENLYSTA IV 10 mg/kg + ST (n=299)
    • Placebo + ST (n=149)
    		 96 centers throughout North America, South America, South Africa, and Europe
    NE Asia (52-week duration)16
    Treatment arms Regions
    • BENLYSTA IV 10 mg/kg + ST (n=451)
    • Placebo + ST (n=226)
    		 49 centers throughout China, Japan, and South Korea

    Key inclusion criteria5-8,15

    • Patients were ≥18 years of age
    • Patients were self-identified as Black race (EMBRACE)
    • Patients were diagnosed with SLE according to the ACR criteria
    • Patients met ≥1 of the following:
      • ANA titer ≥1:80
      • Anti-dsDNA autoantibodies ≥30 IU/mL
    • Patients were receiving stable doses of any of the following, alone or in combination, for ≥30 days:
      • Antimalarial
      • Immunosuppressant
      • Corticosteroid
      • NSAID
    • Patients had active disease†
      • SELENA-SLEDAI score ≥8 (BLISS-SC, EMBRACE, NE Asia)
      • SELENA-SLEDAI score ≥6 (BLISS-52 and BLISS-76)

    Key exclusion criteria5-8

    • Severe active lupus nephritis
      • Proteinuria >6 g over 24 hours or equivalent with spot urine protein:creatinine ratio
      • Serum creatinine >2.5 mg/dL
      • Required hemodialysis within 90 days of study entry
      • Required high-dose prednisone(>100 mg/day) within 90 days of study entry
    • Severe active CNS lupus
      • Patient required therapeutic intervention for any of the following within 60 days of study entry:
        • Seizures, psychosis, organic brain syndrome, CVA, cerebritis, or CNS vasculitis
    • Use of other biologics or IV cyclophosphamide was not permitted

     

    * The 1-mg/kg dose is not recommended.
    † Can include clinical (eg, arthritis, rash, and hair loss) and serological (eg, decreased complement and anti-dsDNA) SLE manifestations.

     

    ACR = American College of Rheumatology; ANA = antinuclear antibody; anti-dsDNA = anti-double–stranded DNA; BLISS = Belimumab International SLE Study; CNS = central nervous system; CVA = cardiovascular accident; EMBRACE = Efficacy and Safety of Belimumab in Adult Subjects of Black Race; IV = intravenous; NE = Northeast; NSAID = nonsteroidal antiinflammatory drug; SC = subcutaneous, SELENA-SLEDAI = Safety of Estrogens in Lupus Erythematosus: National Assessment version of the Systemic Lupus Erythematosus Disease Activity Index; SLE = systemic lupus erythematosus; ST = standard therapy.

  • Definition of primary endpoint

    SRI-4 at Week 52

    To be considered a responder, patients must meet all 3 components:

    • SELENA-SLEDAI: ≥4-point reduction
    • BILAG: No new BILAG A or 2 new BILAG B organ domain scores
    • PGA: No worsening of ≥0.30 points

     

    BILAG = British Isles Lupus Assessment Group; PGA = Physician’s Global Assessment; SELENA-SLEDAI = Safety of Estrogens in Lupus Erythematosus: National Assessment version of the Systemic Lupus Erythematosus Disease Activity Index.

  • Study parameters for Be-SLE8

    Post hoc pooled analysis of 5 double-blind placebo-controlled studies evaluating BENLYSTA

    Comparison for all efficacy endpoints:

    • Pooled BENLYSTA (10 mg/kg IV + 200 mg SC) vs pooled placebo (IV + SC)

    Analysis parameters

    Studies included Patients evaluated Endpoints
    • BLISS-52
    • BLISS-76
    • NE Asia
    • EMBRACE*
    • BLISS-SC
    		 BENLYSTA (n=1869)
    Placebo (n=1217)
    • SRI-4 + subgroups
    • Severe flares and subgroups
    • Organ domains
    • Steroid outcomes
    Studies included
    • BLISS-52
    • BLISS-76
    • NE Asia
    • EMBRACE*
    • BLISS-SC
    Patients evaluated
    BENLYSTA (n=1869)
    Placebo (n=1217)
    Endpoints
    • SRI-4 + subgroups
    • Severe flares and subgroups
    • Organ domains
    • Steroid outcomes

    Key limitations:

    • Post hoc analysis
    • Pooled dosage groups
    • Results not adjusted for multiple comparisons
    • Individual endpoints may not have been achieved in all clinical studies pooled for this analysis

     

    * The primary endpoint (SRI-4 at Week 52) was not met in EMBRACE.

     

    BLISS = Belimumab International SLE Study; EMBRACE = Efficacy and Safety of Belimumab in Adult Subjects of Black Race; IV = intravenous; NE = Northeast; SC = subcutaneous, SLE = systemic lupus erythematosus; SRI = SLE Responder Index.

  • Study design for BLISS-76 LTE9

    US patients who completed the BLISS-76 Phase III trial were eligible for the BLISS-76 LTE open-label trial

    Trial parameters

    Study details
    Multicenter US extension study (up to 8 years)
    • BENLYSTA IV 10 mg/kg + ST*
    Patients enrolled
    N=268
    (US sites only)
    Endpoints
    Assessed every 48 weeks
    • Primary: safety
      • AEs, AESI, vital signs, laboratory measures, SDI
    • Other:
      • Efficacy by SRI-4
      • Disease activity scores
      • Flare rates
      • Steroid use
    Studies details Patients enrolled Endpoints
    Multicenter US extension study (up to 8 years)
    • BENLYSTA IV 10 mg/kg + ST*
    		 N=268
    (US sites only)    		 Assessed every 48 weeks
    • Primary: safety
      • AEs, AESI, vital signs, laboratory measures, SDI
    • Other:
      • Efficacy by SRI-4
      • Disease activity scores
      • Flare rates
      • Steroid use

    Key limitations:

    • Open-label design with lack of comparator arm
    • Selection bias and responder bias may be present
    • Pooled dosage groups
    • Small group of patients at later time points

     

    * Patients who received placebo in BLISS-76 received 10 mg/kg BENLYSTA in the LTE study, and patients who received BENLYSTA continued to receive the same dose (1 or 10 mg/kg IV every 28 days) plus ST. Following a protocol amendment in March 2011, patients receiving 1 mg/kg BENLYSTA had their dose increased to 10 mg/kg.

     

    AE = adverse event; AESI = adverse events of special interest; BLISS = Belimumab International SLE Study; IV = intravenous; LTE = long-term extension; SDI = SLICC/ACR Damage Index; SLE = systemic lupus erythematosus; SLICC/ACR = Systemic Lupus International Collaborating Clinics/American College of Rheumatology; SRI = SLE Responder Index; ST = standard therapy.
Icon: headset


Looking for more information? A BENLYSTA rep is just a click away.

Connect now

Learn more

Accessing BENLYSTA

Find out if BENLYSTA is covered for patients in your local area.

Find out more

Resources Center

A library of resources designed to help you and your patients.

Find out more