Living with Lupus Understanding SLE and the Role of Benlysta

1. Living with Lupus: Understanding SLE and the Role of Benlysta Systemic lupus erythematosus (SLE), commonly called lupus, is a long-term autoimmune disease where the body’s immune system—meant to protect against infections—starts attacking its own healthy cells and tissues, causing widespread inflammation and damage.1 This inflammation can affect various parts of the body including the skin, joints, blood vessels, kidneys, brain, heart, and lungs.1 What makes lupus so complicated? The disease presents differently in each individual, with variations in symptom type, combination, and severity. Typically, lupus follows a pattern, with episodes of symptom flare-ups alternating with periods of remission when symptoms lessen or temporarily resolve.1 Common Symptoms of SLE Symptoms of lupus typically appear gradually, with one or two signs emerging initially and additional or varied symptoms developing over time. Some of the most common ones include1: • Joint pain or swelling • Muscle pain or fatigue • Headaches or low-grade fever • Shortness of breath or chest pain (especially on deep breathing) • Skin rashes and hair loss • Mouth ulcers • Swelling in the face, hands, or legs • Confusion, memory issues, or blood clots The Challenge of Treatment Over the last decade, advances in medicine have helped improve the lives of people with lupus.2 Standard treatment includes corticosteroids, antimalarials, and immunosuppressive drugs. These medicines help control inflammation and reduce immune system overactivity.3 However, despite progress, many patients continue to face serious complications such as inflammation, osteoporosis, cardiovascular disease, lupus nephritis (kidney inflammation caused by lupus) and acute renal failure.4 This shows the need for more targeted, effective therapies—especially for patients who don’t respond well to conventional drugs. That’s where newer biologic treatments like Benlystacome in.4 Benlysta: A targeted treatment for lupus Benlysta is a prescription medicine that belongs to a class of treatments called biologics. It is specifically designed for people with active SLE whose symptoms haven’t improved with standard medications.5 How does Benlysta work?

2. SLE is an autoimmune disease that involves abnormal activity of B lymphocytes. Normally, B lymphocytes produce antibodies to fight infections, but in SLE, some of these produce autoantibodies that mistakenly target the body’s own cells and tissues. In lupus nephritis, these autoantibodies specifically damage the kidneys, impairing their function.5 Benlysta contains belimumab, a monoclonal antibody that targets and inhibits BLyS, a protein that promotes B lymphocyte survival. By blocking BLyS, belimumab reduces the number of active B lymphocytes, helping to control inflammation and prevent further organ damage in SLE.5 Who can use Benlysta? Benlysta is approved as an add-on therapy for: • Adults and children (aged 5 years and older) with SLE • Adults with active lupus nephritis, when used alongside other immunosuppressants What do clinical studies say about Benlysta? Benlysta has been studied in multiple large-scale clinical trials across different age groups and patient populations: • In adults with SLE, Benlysta significantly reduced disease activity compared to placebo. In one study, 43% of patients treated with Benlysta showed improvement, versus 34% with placebo. Another study showed 58% improvement with Benlysta compared to 44% with placebo.5 • In children aged 5 to 17, Benlysta behaved similarly to how it works in adults, with consistent safety and distribution in the body.5 • For lupus nephritis, a study of 448 adults showed that after 2 years, 43% of patients taking Benlysta had better kidney function, compared to 32% in the placebo group.5 How is Benlysta given? Benlysta is available in two forms5: 1.Intravenous (IV) infusion drip—given at a hospital or clinic 2.Subcutaneous injection—which you or a caregiver can learn to give at home using a pre-filled pen Dosage IV drip:The recommended dose is 10 mg/kg, administered over one hour. The first three doses are given at two-week intervals, followed by once every four weeks thereafter.5 Subcutaneous injection5: • For adults with lupus: 200 mg once a week • For lupus nephritis: an initial 400 mg once weekly for 4 weeks, followed by 200 mg once weekly Injections are typically given in the thigh or abdomen, and your first dose will usually be supervised by a healthcare provider.5 What are the side effects of Benlysta?

3. Like all medicines, Benlysta can cause side effects. Common side effects include viral respiratory infections, bronchitis, diarrhoea, urinary tract infections and shingles.5 When to be careful Talk to your doctor before taking Benlysta if you6: • Have ongoing infections or a history of serious infections • Have HIV, hepatitis B or C • Recently received or are planning to receive any vaccines • Have a history of cancer or organ transplant • Have low immunoglobulin levels or nervous system involvement from lupus Benlysta should not be taken with live vaccines. Your doctor will help you plan your vaccination schedule.6 Considerations for Special Population Benlysta has been used in a small number of elderly patients (age 65 and above). So far, age does not seem to affect how the drug works.6 Patients with kidney impairment or liver impairment do not usually require dose adjustments, as Benlysta is broken down by enzymes found throughout the body—not just in the liver.6 Storage and safety tips for home use If you are using the subcutaneous pen at home6: • Keep it in the refrigerator (2°C to 8°C) in its original box to protect it from light. • Do not freeze. • If taken out, it can stay at room temperature (up to 25°C) for up to 12 hours—after that, it must be used or discarded. • Always check the expiry date before use. • Keep the medicine out of reach of children. • Do not dispose of used pens in household waste—ask your pharmacist about safe disposal. Accessing Benlysta in India: What You need to know Benlysta is not yet widely available through local pharmacies in India. However, patients can access it through the Named Patient Program (NPP)—a legal and ethical route that allows doctors to import life-saving medicines that are not yet registered in the country.7 To access Benlysta through the NPP: 1.A registered doctor must prescribe the medication. 2.A licensed importer like Rx4U helps with the import process. 3.Patients or caregivers are guided through documentation, permissions, and delivery. Frequently Asked Questions

4. 1. Can Benlysta cure lupus? No. Benlysta is not a cure, but it can help reduce disease activity and prevent flare-ups.1,5 2. How long do I need to take Benlysta? That depends on your response. Some people may need it for years, while others may be able to stop under a doctor’s supervision.5 3. Can children use Benlysta? Yes, it is approved for children 5 years and older with active lupus.5 4. Is Benlysta safe during pregnancy? Inform your doctor if you are pregnant or planning to become pregnant. Benlysta is not typically recommended during pregnancy unless the benefits clearly outweigh the risks.6 Note: The information provided is for education purpose only and is subjected to prescribing information of the drug and the guidance of your treating physician. Always consult your health care provider before making any medical decision for starting your treatment. Disclaimer: Rx4U procures prescribed medicines directly from manufacturers or authorized distributors. It does not claim ownership of any trademarks and complies with the provisions of the Trademark Act, 1999, particularly Sections 30 and 30(1) concerning ‘Fair Use’. It solely facilitates access to new launches through named patient import. References: 1.Lupus. Cleveland Clinic. Updated June 9, 2023. Accessed July 10, 2025. https://my.clevelandclinic.org/health/diseases/4875-lupus 2.Saegusa K, Tsuchida Y, Komai T, Tsuchiya H, Fujio K. Advances in targeted therapy for systemic lupus erythematosus: current treatments and novel approaches. Int J Mol Sci 2025;26(3):929. 3.Katarzyna PB, Wiktor S, Ewa D, Piotr L. Current treatment of systemic lupus erythematosus: a clinician's perspective. Rheumatol Int. 2023;43(8):1395-407. 4.Huang H. Immunotherapeutic approaches for systemic lupus erythematosus: early overview and future potential. Med Rev. 2023;3(6):452-64. 5.Benlysta. European Medicines Agency. Updated January 13, 2025. Accessed July 10, 2025. https://www.ema.europa.eu/en/medicines/human/EPAR/benlysta 6.Benlysta. Product Information. GlaxoSmithKline (Ireland) Limited. 7.Patil S. Early access programs: Benefits, challenges, and key considerations for successful implementation.Perspect Clin Res. 2016;7(1):4-8. doi:10.4103/2229-3485.173779