Informed patients are empowered patients

Helping your patients understand their lupus.

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.

JUMP TO SETTING EXPECTATIONS

Patient-doctor discussion guide

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

JUMP TO PATIENT-DOCTOR DISCUSSION GUIDE

FAQs

Answers to some frequently asked questions your patients may have about BENLYSTA.

JUMP TO FAQS

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

We're here to help provide personalized support, whether your patient is new to BENLYSTA or has already added it to their treatment plan.

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 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

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 that 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
  • *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.
  • 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; ST = standard therapy.

Make sure they know:

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

LEARN ABOUT ORGAN DAMAGE

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

SEE LN DATA

ESKD = end-stage kidney disease; LN = lupus nephritis.

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.

WATCH REAL PATIENT STORIES

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 the 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

    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.

    SEE COVERAGE

    Resources center

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

    VIEW RESOURCES

    Indication & Safety Info

    Indication

    Important Safety Information

    Indication

    BENLYSTA is indicated for patients aged ≥5 with active systemic lupus erythematosus (SLE) or active lupus nephritis who are receiving standard therapy. BENLYSTA is not recommended in patients with severe active central nervous system lupus.

    Important Safety Information

    CONTRAINDICATION

    Previous anaphylaxis with BENLYSTA.

    WARNINGS AND PRECAUTIONS

    Serious Infections: Serious and sometimes fatal infections have been reported and occurred more frequently with BENLYSTA. Use caution in patients with severe or chronic infections, and consider interrupting therapy in patients with a new infection.

     

    Progressive Multifocal Leukoencephalopathy (PML): Cases of JC virus-associated PML resulting in neurological deficits, including fatal cases, have been reported. If PML is suspected, immunosuppressant therapy, including BENLYSTA, must be suspended until PML is excluded. If confirmed, stop immunosuppressant therapy, including BENLYSTA.

     

    Hypersensitivity Reactions (Including Anaphylaxis): Acute hypersensitivity reactions, including anaphylaxis and death, and infusion-related reactions have been reported. Generally, reactions occurred within hours of the infusion but may occur later, including in patients who have previously tolerated BENLYSTA. Non-acute hypersensitivity reactions (eg, rash, nausea, fatigue, myalgia, headache, and facial edema) typically occurred up to a week after infusion. Monitor patients during and after treatment and be prepared to manage anaphylaxis and infusion-related reactions. Be aware of the risk of hypersensitivity reactions, which may present as infusion-related reactions. Discontinue immediately in the event of a serious reaction. With intravenous administration, if an infusion reaction develops, slow or interrupt the infusion.

     

    Depression and Suicidality: Depression and suicidality were reported in patients receiving BENLYSTA. Before adding BENLYSTA, assess patients’ risk of depression and suicide and monitor them during treatment. Instruct patients/caregivers to contact their HCP if they experience new/worsening depression, suicidal thoughts/behavior, or other mood changes.

     

    Malignancy: There is an increased risk of malignancies with the use of immunosuppressants. The impact of BENLYSTA on the development of malignancies is unknown.

     

    Immunization: Live vaccines should not be given for 30 days before or concurrently with BENLYSTA as clinical safety has not been established.

     

    Use With Biologic Therapies: Available data do not support the safety and efficacy of concomitant use of BENLYSTA with rituximab in patients with SLE. An increased incidence of serious infections and post-injection systemic reactions in patients receiving BENLYSTA concomitantly with rituximab compared to patients receiving BENLYSTA alone has been observed. The safety and efficacy of BENLYSTA concomitantly with other biologic therapies, including B-cell-targeted therapies, have not been established. Caution should be exercised if BENLYSTA is administered in combination with other biologic therapies.

     

    ADVERSE REACTIONS

    The most common serious adverse reactions in adult SLE clinical trials were serious infections; some were fatal. The most common adverse reactions (≥5%) were nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, pharyngitis, and injection site reactions (subcutaneous injection).

     

    Adverse reactions reported in clinical trials with SLE pediatric patients (≥5 years) and adult patients with lupus nephritis were consistent with those observed in adult SLE trials.

     

    USE IN SPECIFIC POPULATIONS

    Pregnancy: There are insufficient data in pregnant women to establish whether there is drug-associated risk for major birth defects or miscarriage. After a risk/benefit assessment, if prevention is warranted, women of childbearing potential should use contraception during treatment and for ≥4 months after the final treatment.

     

    Pregnancy Registry: HCPs are encouraged to refer patients and pregnant women are encouraged to enroll themselves by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/benlysta-belimumab/.

     

    Please see full Prescribing Information and Medication Guide for BENLYSTA.

    To report SUSPECTED ADVERSE REACTIONS, contact GSK at gsk.public.reportum.com or 1-888-825-5249, or
    FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    References

    1. Guidelines for referral and management of systemic lupus erythematosus in adults. American College of Rheumatology Ad Hoc Committee on Systemic Lupus Erythematosus Guidelines. Arthritis Rheumatol. 1999;42(9):1785-1796.

    2. Raychaudhuri SP, Raychaudhuri SK. Biologics: target-specific treatment of systemic and cutaneous autoimmune diseases. Indian J Dermatol. 2009;54(2):100-109.

    3. Stohl W, Hilbert DM. The discovery and development of belimumab: the anti-BLyS-lupus connection. Nat Biotechnol. 2012;30(1):69-77.

    4. Neusser MA, Lindenmeyer MT, Edenhofer I, et al. Intrarenal production of B-cell survival factors in human lupus nephritis. Modern Pathology. 2011;24(1):98-107.

    5. Navarra SV, Guzmán RM, Gallacher AE, et al. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial. Lancet. 2011;377(9767):721-731.

    6. Furie R, Petri M, Zamani O, et al. A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus. Arthritis Rheum. 2011;63(12):3918-3930.

    7. Stohl W, Schwarting A, Okada M, et al. Efficacy and safety of subcutaneous belimumab in systemic lupus erythematosus: a fifty-two-week randomized, double-blind, placebo-controlled study. Arthritis Rheumatol. 2017;69(5):1016-1027.

    8. Data on file, GSK.

    9. Furie RA, Wallace DJ, Aranow C, et al. Long-term safety and efficacy of belimumab in patients with systemic lupus erythematosus: a continuation of a seventy-six-week Phase III parent study in the United States. Arthritis Rheumatol. 2018;70(6):868-877.

    10. Fanouriakis A, Kostopoulou M, Andersen J, et al. EULAR recommendations for the management of systemic lupus erythematosus: 2023 update. Ann Rheum Dis. 2024;83(1):15-29.

    11. Chambers SA, Allen E, Rahman A, et al. Damage and mortality in a group of British patients with systemic lupus erythematosus followed up for over 10 years. Rheumatology (Oxford). 2009;48:673-675.

    12. Urowitz MB, Gladman DD, Ibañez D, et al. Evolution of disease burden over five years in a multicenter inception systemic lupus erythematosus cohort. Arth Care Res. 2012;64(1):132-137.

    13. Anders HJ, Saxena R, Zhao M-H, et al. Lupus nephritis. Nat Rev Dis Primers. 2020;6(1):7.

    14. Sprangers B, Monahan M, Appel GB. Diagnosis and treatment of lupus nephritis flares—an update. Nat Rev Nephrol. 2012;8(12):709-717.