Answers from a Doctor

Tania González-Rivera is a rheumatologist who specializes in lupus and clinical trials. Tania is also a Medical Director at GSK, the maker of BENLYSTA.

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Dr. Tania González-Rivera: Clinical trials are medical research studies that test the safety and effectiveness of a medicine. BENLYSTA was tested in the largest clinical trial program involving people with systemic lupus erythematosus ever conducted. This clinical trial program involved three different trials with over 2,500 patients, of whom over 1,100 received BENLYSTA plus other medicines commonly used to treat lupus.

In clinical trials, BENLYSTA was added to other lupus medicines. These treatments, which varied among the people who participated in the trials, are accepted by experts and widely used to treat lupus symptoms including steroids, nonsteroidal anti-inflammatory drugs, also called NSAIDS, antimalarials, and immunosuppressants.

The most common side effects of BENLYSTA are nausea, diarrhea, fever, stuffy or runny nose and sore throat, cough, trouble sleeping, leg or arm pain, depression, headache, and pain, redness, itching, or swelling at the site of injection (when given subcutaneously). These are not all the possible side effects of BENLYSTA. Call your doctor for medical advice about side effects.

Dr. Tania González-Rivera: The results of clinical trials showed that BENLYSTA plus other lupus medicines was superior at reducing lupus disease activity compared to other lupus treatments alone. The reduction in disease activity seen with BENLYSTA plus other lupus medicines was mainly due to improvements in parts of the body most commonly affected by lupus. These body areas included the skin, the mouth, the vascular system, the joints and muscles, and the immune system.

However, individual results may vary and it is important to discuss the benefits of any treatment as well as the risks with your doctor.

Dr. Tania González-Rivera: In a person with lupus, some B cells, called autoreactive B cells, react against your own body. These cells contribute to symptoms of lupus.

Dr. Tania González-Rivera: Researchers discovered a protein known by the abbreviation B-L-Y-S, or BLyS, which stimulates the growth of these autoreactive B cells. BENLYSTA works by binding to the BLyS protein. In other words, BENLYSTA prevents BLyS from stimulating the type of B cells that have been associated with lupus. So adding BENLYSTA to your lupus medicines may help reduce the abnormal immune system activity seen in lupus that is making it active.

Dr. Tania González-Rivera: No, BENLYSTA is not a steroid. BENLYSTA contains belimumab, which belongs to a group of medicines called monoclonal antibodies. These are large, complex proteins produced in laboratories.

Dr. Tania González-Rivera: Medicines such as BENLYSTA, which are made of complex proteins, cannot be taken by mouth. That's because these protein-based medications would be broken down in the stomach before they ever reach the bloodstream. Once BENLYSTA is broken down, it cannot work properly. For this reason, this type of medication is either given directly into the bloodstream through an intravenous infusion or administered through a subcutaneous injection (under the skin) in the stomach (abdomen) or thigh.

Dr. Tania González-Rivera: Your healthcare team may show you how to give yourself an injection the first time. The injection itself takes very little time to do. Once you’ve learned how to self-inject BENLYSTA, you will be able to do it by yourself at home.

Dr. Tania González-Rivera: You should take BENLYSTA as prescribed by your doctor. Staying on treatment can be very important, so that you experience the full benefit of BENLYSTA. For most patients who responded to BENLYSTA, they did so within the first 7 months of treatment and continued to respond over the course of the clinical trials (one year).

In clinical trials, BENLYSTA plus other medicines commonly used to treat lupus were superior to those medicines used alone in reducing lupus disease activity. Be sure to continue taking BENLYSTA as directed by your doctor even if you are feeling better. And if you aren't feeling better right away, talk to your doctor about how BENLYSTA may take time to work in your body.