Lupus Patient Profiles | BENLYSTA (belimumab) for HCPs

Do these patients* look familiar to you?

Discover the experience of these patients* with lupus and BENLYSTA.

Meet Kayla*

A patient with active lupus on HCQ and steroids

Meet Maria*

A patient with active lupus on HCQ, steroids, and an immunosuppressant

Meet Emma*

A pediatric patient with lupus

* Hypothetical patient profiles. May not be representative of all BENLYSTA patients.

HCQ = hydroxychloroquine.

Kayla*

A 27-year-old patient with a 6-year history of lupus symptoms. Correctly diagnosed 2 years ago.

Getting diagnosed was a long journey filled with many obstacles, but I learned that I am much more than just my diagnosis.

Initial lupus manifestations and lab values

Fatigue, arthritis (6^†) with morning stiffness
Non-scarring alopecia (2^†)
Anti-dsDNA antibodies (6^†)
Low complement 3 and 4 (4^†)

Initial treatment

HCQ 400 mg/day
Initiated on prednisone 10 mg/day
Adjusted to prednisone 20 mg/day due to persistent flares

Kayla’s concerns while on initial treatment

The disease is largely invisible, so it’s hard when others don’t understand a flare-up

Transitioning to BENLYSTA

After starting treatment for lupus, my doctor told me that the delay in my diagnosis could have put me at risk for complications.

He recommended adding BENLYSTA, and after understanding what it may do for me, I started on the IV infusions. After a while, I was feeling better since my symptoms had improved. My doctor was even able to reduce my steroid dose. When my doctor mentioned that I had the opportunity to change to at-home injections, I took it. It’s a more flexible option for me.

Current treatment

BENLYSTA SC + HCQ 200 mg/day + prednisone 5 mg/day

* Hypothetical patient profile. May not be representative of all BENLYSTA patients.

† EULAR/ACR 2019 criteria score for SLE classification.

ACR = American College of Rheumatology; anti-dsDNA = anti-double–stranded DNA; EULAR = European Alliance of Associations for Rheumatology; IV = intravenous; SC = subcutaneous; SLE = systemic lupus erythematosus.

Could your patients reduce their steroid dose like Kayla?

See what BENLYSTA can do

Maria*

A 32-year-old patient with a 9-year history of lupus symptoms. Correctly diagnosed 6 years ago.

Don't give up. Find what works best for you and your body.

Initial lupus manifestations and lab values

Arthritis of hands and wrists (6^†), malar and anterior neck rash (4^†), and oral ulcers (2^†)
Low complement 3 (3^†)
Anti-dsDNA antibodies (6^†)

Initial treatment

HCQ 400 mg/day
Initiated on prednisone 20 mg/day
MTX 15 mg/week added 6 months ago
Medications for comorbidities: ramipril 5 mg/day

speech-bubbles

Maria’s concerns while on initial treatment

I was not sure what was happening with my lupus. After starting therapy, I started feeling better, but that lasted only for a short time. After a few months, I was still not feeling a 100%. I was so tired and I was gaining weight. Every time we tried reducing my steroid dose, the symptoms would come right back.

Transitioning to BENLYSTA

Last year, my doctor expressed concerns about the long-term effect of steroid use and how it could put me at greater risk of infections and impact my organs. He felt it was time for me to consider a biologic. He recommended BENLYSTA due to its well-known safety profile and its impact on certain drivers of organ damage. Initially, I thought it would just be another medication to add to the list, but within less than a year, I was able to reduce my steroid dose.

It wasn't too complicated to start BENLYSTA and the support program helped me get started and feel confident in using the at-home Autoinjector.

Current treatment

BENLYSTA SC + MTX 15 mg/week + HCQ 400 mg/day + prednisone 5 mg/day

* Hypothetical patient profile. May not be representative of all BENLYSTA patients.

† EULAR/ACR 2019 criteria score for SLE classification.

MTX = methotrexate.

Discover how BENLYSTA may help impact some of the drivers of organ damage in lupus for a patient like Maria.

Emma*

A 12-year-old patient with a 3-year history of lupus symptoms. Correctly diagnosed 2 years ago.

I’m seeing my friends way more these days and even having sleepovers on the weekends. I know my mom worries less now, so that makes me happy!

Initial lupus manifestations and lab values

Positive ANA titer of ≥1:80
Arthritis (6^†)
Cutaneous lupus (4^†)
Lymphadenopathy
Low complement 3 (3^†)

Initial treatment

HCQ 200 mg/day
Prednisone 15 mg/day

speech-bubbles

Parent concerns while on initial treatment

Starting the medications was tough at first, but Emma got used to them and felt better most of the time. However, the leg pain and severe rashes made her feel extremely tired and she still missed school too often.

- Emma’s mother

Transitioning to BENLYSTA

When Emma’s doctor suggested adding BENLYSTA 2 years after her diagnosis, her parents were a bit hesitant to introduce a biologic. After many discussions with her doctor, they felt hopeful that it could make a difference and help her get back to being a kid again. They wanted nothing more than to see her feel better.

Emma started with the in-office BENLYSTA IV infusions and her doctor recently transitioned her to the Autoinjector. Being able to do the at-home injections works well for her family.

Current treatment

BENLYSTA SC + HCQ 200 mg/day + prednisone 7.5 mg/day

* Hypothetical patient profile. May not be representative of all BENLYSTA patients.

† EULAR/ACR 2019 criteria score for SLE classification.

ANA = antinuclear antibodies.

Have you explored our efficacy data for lupus in pediatric patients like Emma?

See the pediatric efficacy data

Learn more

Efficacy for lupus

BENLYSTA improved key clinical outcomes for appropriate patients.

BENLYSTA Autoinjector

This option with at-home convenience is available for adult patients with lupus or lupus nephritis.

Do you have patients with lupus nephritis in your practice? We can help you identify if BENLYSTA is right for them.

Meet these patients now

BENLYSTA is the first-and-only FDA- approved biologic for both lupus and lupus nephritis

BENLYSTA is the first-and-only FDA-approved biologic for both lupus and lupus nephritis

INDICATION & IMPORTANT SAFETY INFO

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.

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.

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.

CONTRAINDICATION

Previous anaphylaxis with BENLYSTA.

WARNINGS AND PRECAUTIONS

Serious Infections: Serious and sometimes fatal infections have been reported and occurred more frequently with BENLYSTA.

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.

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