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My life with lupus

Each patient has a unique story to tell. Just as the signs and symptoms of SLE vary widely among patients, so does the severity of disease and the impact it may have on their lives.1

What would you do for a patient like Rania?*

Rania

“My joint pain and rash are keeping me from having a normal life. I wish I could do more and feel more normal, but I’m always in pain and I’m embarrassed about my rash.”

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

About Rania

Age

29

SLE Diagnosis

18 months ago

History

Recurrent flares with 1 severe flare in the last year

Symptoms

  • Uncontrolled photosensitive rash and newly developed mouth ulcers
  • Fatigue and joint pain
  • Shortness of breath

Clinical Presentation

“I know my current medications are helping me in the short-term, but I’m worried about the side effects in the future. Even with these treatments, I don’t feel as if my symptoms have improved enough. I wish there was a better way to control my symptoms so that I could feel more normal and be more engaged in life without worrying about the future.”

Current medications

  • Hydroxychloroquine 400 mg/day for last 6 months
  • Methotrexate 15 mg/week for last 6 months
  • Prednisone:
    • 20 mg/day – 1 month
    • 10 mg/day – 7 months prior

Current test results

ANA: Positive (1:320)

Baseline disease activity score

  • SELENA-SLEDAI: 10
  • Arthritis: 4
  • Rash: 2
  • Mucosal ulcers: 2
  • Pleurisy: 2

ANA = antinuclear antibodies; SELENA-SLEDAI = Safety of Estrogens in Lupus Erythematosus: National Assessment version of the Systemic Lupus Erythematosus Disease Activity Index

What would you do for a patient like Leen?*

Leen

“I’ve been dealing with this for a long time, but it never gets easier. Lupus has taken so much from me, and I’m tired of fighting it. I’m constantly struggling with nausea and having enough energy to go to work and I’ve had to miss several days of work because of my fatigue. I don’t remember what it feels like to have 100% energy anymore. My boss is really understanding, but it upsets me that she can’t rely on me all the time.”

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

About Leen

Age

38

SLE Diagnosis

7 years ago

Symptoms

  • Malar rash after sun exposure
  • Arthritis
  • Alopecia
  • Lack of energy
  • Difficulty breathing

Clinical Presentation

“I’ve been on steroids on and off since my symptoms started. Previous doctors only focused on my symptoms, but now I’ve found a specialist that understands my disease. He takes time to ask me how I’m really feeling, and understands how difficult the unpredictability of this disease is. It’s given me hope for the future.”

Current medications

  • Hydroxychloroquine (400 mg/day – 5 years)
  • Prednisone (various dosages)
  • Azathioprine for 2 years with no response
  • Methotrexate
    • 25 mg/week – 6 months
    • 15 mg/week – 2 years prior

Current test results

  • C3: Low (40 mg/dL)
  • C4: Low (10 mg/dL)
  • ANA: Positive (1:320)
  • Anti-dsDNA: Elevated (160 IU/mL)
  • Haemoglobin: 10.5 g/dL (normocytic and normochromic)

Baseline disease activity score

  • SELENA-SLEDAI: 9
  • Arthritis: 4
  • Rash: 2
  • Pleurisy: 2
  • Leucopenia: 1

ANA = antinuclear antibodies; C3 = complement 3; C4 = complement 4; dsDNA = double-stranded DNA; SELENA-SLEDAI = Safety of Estrogens in Lupus Erythematosus: National Assessment version of the Systemic Lupus Erythematosus Disease Activity Index

What would you do for a patient like Talia?*

Talia

“When my flares come on, I don’t want to face the day—but you wouldn’t know it. I assure my friends and my doctor that I’m okay. Things could be worse. The truth is, I don’t want anyone to know how much I’m struggling.”

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

About Talia

Age

27

SLE Diagnosis

3 years ago

Symptoms

  • Leg and facial oedema
  • Proteinuria
  • Polyarthritis
  • Renal involvement

Clinical Presentation

I’ve tried a couple treatments already… hydroxychloroquine, prednisone. Things improved for a while, but then I started flaring again. My doctor told me it’s important to control my disease activity as much as possible in order to help delay the progression of organ damage. My doctor was worried that my kidneys might be affected, so I just had a kidney biopsy and I’m worried about what comes next, but my doctor is taking time to explain my management plan with me, and it’s making me feel more comfortable.”

Current medications

  • Hydroxychloroquine (400 mg/day – 3 years)
  • Prednisone:
    • 10 mg/day – 4 months
    • 7.5 mg/day – 8 months prior
    • 5 mg/day – 2 years prior

Current test results

  • Urine sediments with RBC casts
  • Serum creatinine stable
  • C3: Low (78 mg/dL)
  • C4: Low (8 mg/mL)
  • ANA: Positive (1:160)
  • Anti-dsDNA: Elevated (>200 IU/mL)
  • Anti-phospholipid antibodies: Negative
  • Proteinuria: 2.5 g/24 hours
  • Serum creatinine: 139 µmol/L (1.5 mg/dL)

Baseline disease activity score

  • SELENA-SLEDAI: 12
  • Proteinuria: 4
  • Arthritis: 4
  • Low C3/C4: 2
  • Elevated anti-dsDNA: 2

More than 50% of patients treated with Benlysta in the BLISS-SC and BLISS-IV trials were not receiving immunosuppressants at baseline.2-4

ANA = antinuclear antibodies; C3 = complement 3; C4 = complement 4; dsDNA = double-stranded DNA; SELENA-SLEDAI = Safety of Estrogens in Lupus Erythematosus: National Assessment version of the Systemic Lupus Erythematosus Disease Activity Index

Benlysta can be used in patients with renal involvement, excluding those with severe active lupus nephritis.5

Resources for you and your patients
Consider adding Benlysta for your appropriate patients with SLE

 

 

Benlysta IV:

Indications:

BENLYSTA IV is indicated for reducing disease activity in patients aged 5 years and older with active autoantibody positive systemic lupus erythematosus (SLE) who are receiving standard therapy.

Dosage:

Adults:
The recommended dosage regimen is 10 mg/kg on Days 0, 14 and 28, and at 4-week intervals thereafter.

Children
The recommended dosage regimen for children aged 5 years and older is 10 mg/kg on Days 0, 14 and 28, and at 4-week intervals thereafter.

Safety:

BENLYSTA is contraindicated in patients who have demonstrated anaphylaxis to BENLYSTA. BENLYSTA has not been studied in combination with other B cell targeted therapy or intravenous cyclophosphamide. Caution should be exercised if BENLYSTA is co-administered with other B cell targeted therapy or cyclophosphamide. Administration of BENLYSTA may result in infusion-related systemic reactions and hypersensitivity reactions, which can be severe or fatal. In the event of a severe reaction, BENLYSTA administration must be interrupted and appropriate medical therapy administered. Patients with a history of multiple drug allergies or significant hypersensitivity may be at increased risk.

Adverse Events

Very common:
Infections.
Common:
Hypersensitivity reaction, Depression, Pyrexia, Infusion related systemic reactions.

Benlysta SC:

Indications:

Benlysta is indicated as add-on therapy in adult patients with active, autoantibodypositive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti-dsDNA and low complement) despite standard therapy.

Dosage:

Adults:

The recommended dose is 200 mg once weekly, administered subcutaneously. Dosing is not based on weight.

Safety:

Benlysta is contraindicated in patients with Hypersensitivity to the active substance or to any of the excipients listed in prescribing information.

In order to improve traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded. Benlysta has not been studied in the following patient groups and is not recommended in:

  • severe active central nervous system lupus
  • severe active lupus nephritis
  • HIV
  • a history of, or current, hepatitis B or C
  • hypogammaglobulinaemia (IgG <400 mg/dl) or IgA deficiency (IgA <10 mg/dl)
  • a history of major organ transplant or hematopoietic stem cell/marrow transplant or renal transplant

References

  1. Firestein GS, Budd RC, Gabriel SE, et al., ed. Kelley and Firestein’s Textbook of Rheumatology. 10th ed. Philadelphia, PA: Elsevier; 2017:1346-67.
  2. Navarra SV, Guzman RM, Gallacher AE, et al. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomized, placebo-controlled, phase 3 trial. Lancet. 2011;377(9767):721-31.
  3. 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):3918-30.
  4. 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):1016-27.
  5. Benlysta Local prescribing information based on GDS16 & EMA_CPI0062.

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PM-SA-BEL-WCNT-200009 Date of preparation: October 2020