BENLYSTA Patients
BENLYSTA Patients

INFORMED PATIENTS ARE
EMPOWERED PATIENTS

Resources to empower your patients on
their lupus journey.

Setting Expectations There’s more to treatment than just starting. Ensure your patients know what to expect so they are better prepared to stay on therapy.

Patient-Doctor Guides A useful tool you can recommend to your patients to help guide your discussions together.

FAQs Select frequently asked questions about BENLYSTA that you can refer to in discussions with your patients.

SETTING EXPECTATIONS

Getting started

Talk using patient-friendly language

Encourage your patients to participate in decision-making relating to their care by keeping them informed and making them feel comfortable with asking you questions. You can find examples of patient-friendly answers to common questions below. When it’s your turn to ask questions, using open-ended ones may encourage your patients to share more information and help you more easily identify gaps in their understanding.

Icon: Inflammation in multiple organ systems

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 go.1
  • 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 lungs.1
  • 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 more.1
Icon: Target BLySIcon: Target BLyS

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

  • A biologic is a type of treatment that is infused or injected 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 body.2
  • BENLYSTA is one example of a biologic.2
Icon: magnifying glass

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 should.3,4
  • One of the important proteins for the survival of these B cells is called BLyS, also known as BAFF. BENLYSTA works by binding to BLyS.3,4
  • When BENLYSTA is attached to BLyS, BLyS can no longer bind to and stimulate the autoreactive B cells. Therefore, it reduces the survival of B cells, including autoreactive B cells.3,4

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

STARTING PATIENTS ON BENLYSTA

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Access can be an important barrier for patients to overcome to both start and stay on therapy. Familiarize yourself with steps to help your patients access BENLYSTA so that you’re prepared.

Here’s how to start your patients today.

GET THE HELP YOUR PATIENTS NEED

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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 subcutaneous injection, provide them with medication reminder tips:

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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.5

Advise your patients to add a sticky note on their refrigerator to remind themselves which day of the week they do their self-injection.5

Suggest utilizing technology such as smart assistants, phone reminders, or even leaning on family members to help set reminders.

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

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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 alone.6-8

In a post hoc, pooled analysis involving 5 SLE studies, the proportion of patients that achieved SRI-4 response was 38% at 8 weeks.9*† †† In a long-term extension trial, 76% of patients showed SRI-4 response at 7 years.16*†¶

Set expectations with your patients that while BENLYSTA may show results for approximately 4 in 10 patients as early as 8 weeks,9 they should plan to commit to treatment for 6 to 9 months to see the effect to BENLYSTA on their lupus.§

* 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, 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:

Primary Endpoint

SRI-4 Response at Week 8

SRI-4 Response over 7 years

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 in order to experience the full benefit of treatment. Lupus is not a curable disease and requires consistent monitoring and treatment.5

Icon: Calendar

Reinforce to your patients that many chronic illnesses, such as lupus, require long-term treatment.5

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 kidneys.10-13

For your patients on BENLYSTA intravenous, remind them to stick to their infusion schedule and inform your office immediately if their infusion schedule changes.

Make sure they know:

Icon: Silhouette highlighting organ domains

Irreversible
organ damage

is a consequence of lupus.10,11

SEE DATA

Icon: Renal flare

Each
renal flare

increases the risk of ESKD and the need for dialysis.12,13

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
Lupus nephritis
Started BENLYSTA in 2018

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

VIEW NADINE’S STORY

BENLYSTA patient: Stephanie

Stephanie

Enjoys being an active mom
Lupus
Started BENLYSTA in 2017

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

VIEW STEPHANIE’S STORY

BENLYSTA patient: Elijah

Elijah

Enjoys photography and his motorcycle
Lupus nephritis
BENLYSTA clinical trial patient

“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
Lupus
Started BENLYSTA in 2011

“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

DISCUSSION GUIDE

BENLYSTA doctor 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

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  • 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 a healthcare provider administers

    For children ages 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 should.3,4
    • One of the important proteins for the survival of these B cells is called BLyS, also known as BAFF. BENLYSTA works by binding to BLyS.3,4
    • When BENLYSTA is attached to BLyS, BLyS can no longer bind to and stimulate the autoreactive B cells. Therefore, it reduces the survival of B cells, including autoreactive B cells.3,4

  • What is the most important 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.

  • 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), 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.

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

STUDY DESIGN

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  • 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

    Study design for adult lupus trials
    Study design for adult lupus trials
    KEY INCLUSION CRITERIA1-4,8
    • 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 CRITERIA1-4
    • 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 = cerebrovascular accident; EMBRACE = Efficacy and Safety of Belimumab in Adult Subjects of Black Race; IV = intravenous; NE = Northeast; NSAID = nonsteroidal anti-inflammatory drug; SELENA-SLEDAI = Safety of Estrogens in Lupus Erythematosus: National Assessment version of the Systemic Lupus Erythematosus Disease Activity Index; SC = subcutaneous; 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 three 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; SRI = SLE Responder Index.

  • STUDY PARAMETERS FOR Be-SLE9

    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

    Study Parameters for Be-SLE
    Study Parameters for Be-SLE
    KEY LIMITATIONS:
    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; IV = intravenous; EMBRACE = Efficacy and Safety of Belimumab in Adult Subjects of Black Race; NE = Northeast; SRI = SLE Responder Index; SC = subcutaneous.

  • STUDY DESIGN FOR BLISS-76 LTE16

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

    TRIAL PARAMETERS

    Study Design for BLISS-76 LTE
    Study Design for BLISS-76 LTE
    KEY LIMITATIONS:
    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 standard therapy. 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; SRI = SLE Responder Index; ST = standard therapy.

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