People with lupus often need to use medicine to manage their symptoms. Although there are many oral medicines that treat lupus, some people with moderate to severe lupus may not get enough benefit from them. Saphnelo is a different type of medicine, called a biologic, that may reduce symptoms of lupus.
How Does Saphnelo Work for Lupus?
Systemic lupus erythematosus (SLE), more commonly known as lupus, is an autoimmune disorder, which means your immune system attacks healthy cells in your body. In people with lupus, the immune system may attack many different parts of the body, including the skin, the joints, and certain organs. This causes swelling (inflammation) that can lead to different symptoms depending on which part of the body is affected.
Many people with lupus feel very tired and may have headaches and low fevers. Most people also have symptoms related to their skin and hair, such as sensitivity to sunlight, a butterfly-shaped rash on the face, sores in the mouth or nose, or hair loss. Some people may experience pain in their joints, pain in the chest while taking a deep breath, or swelling in the hands, feet, and around the eyes. Over time, lupus can damage the heart or kidneys, which can increase the risk for heart and kidney disease.
Some people with lupus may have relatively mild symptoms whereas others may have very severe symptoms. For many people, symptoms will change over time. Many people will have flare-ups, when symptoms become much worse for weeks or months. Some people may have periods of remission when their symptoms go away for some length of time. If a person is experiencing lupus symptoms, their disease is considered “active” at that time.
The first step to treating lupus is to manage symptoms through lifestyle changes, exercise, diet, and certain medicines. But the key to treating lupus over time is to use medicines that slow down the attacks from the immune system. Oral corticosteroids (such as prednisone) are commonly used for this purpose. Many people also take a medicine that was originally used to treat malaria, such as hydroxychloroquine (Plaquenil). There are also many medicines available that limit the activity of the entire immune system (immunosuppressants), such as methotrexate, azathioprine, and mycophenolate (Cellcept).
Saphnelo is a different type of medicine, called a biologic. The active ingredient in Saphnelo, called anifrolumab, blocks the activity of a certain substance in the body, called type I interferon (IFN). Many people with lupus have too much of this substance, which plays an important role in sending immune system signals throughout the body. By blocking the activity of type I IFN, Saphnelo can help to reduce the swelling and symptoms that occur in people with lupus.
Can Anyone With Lupus Use Saphnelo?
Saphnelo is approved for use in people with moderate to severe lupus who still have symptoms even though they are already taking other medicines to treat their overactive immune system. If you are already using other medicines and are still having difficult symptoms, your specialist may discuss a medicine like Saphnelo with you.
This medicine may not be a safe option for everyone. For example, it is not recommended for people who have severe symptoms of lupus in the central nervous system (CNS) or the kidneys (lupus nephritis). Make sure that your health care provider knows about any past or current medical conditions, especially specific conditions such as cancer.
How Was It Studied?
Three studies were done to see if Saphnelo was safe and effective for the treatment of lupus. Everyone in these studies was at least 18 years old, with an average age of about 41. Most (93%) were female. About 60% were White, 13% were Black, 9% were Asian, and less than 1% were Native American. The races of the other people were not reported. About 29% of the people in these studies identified as Hispanic or Latino.
All of the people in these studies had active lupus when the studies started. Everyone also had either: a) severe symptoms in at least one organ or body part, or b) moderate symptoms in at least two organs or body parts. To manage these symptoms, most people (83%) were taking oral corticosteroids, about three-quarters (78%) were taking an anti-malaria medicine, and about half (49%) were taking an oral immunosuppressant.
These studies measured effectiveness by counting the number of people who “responded” to treatment. A treatment response means that a person’s condition improved by a certain amount during the study. The measure for response was different for each study:
- Trials 1 and 2 used a tool called the SLE Response Index (SRI). A treatment response with this tool means that a person had their symptoms improve by a certain amount, had no new severe flare-ups, and had no more than one moderate flare-up during the study. Trial 1 also measured each person’s daily corticosteroid dose to see who was able to reduce their dose during the study.
- Trial 3 used a tool called the BICLA response. With this tool, a treatment response means that a person had all of their moderate or severe symptoms improve during the study and also did not have any other symptoms appear or get worse during that time.
In all of these studies, Saphnelo was compared with placebo. No one knew whether they were receiving the medicine or the placebo. If anyone was taking oral medicines to treat lupus before the study started, they continued taking those medicines during the study. In two of the studies, some people had to lower their dosage of oral corticosteroids. This was done to help learn about Saphnelo's effect.
What Benefits Were Seen in These Studies?
Treatment response. The studies measured treatment response in different ways. The results from each study were also different and are discussed separately below.
- Trial 1: To be counted as a treatment response, a person had to have a response on the SRI tool and also be taking a lower daily dose of oral corticosteroids than when the study started. After 6 months in the study, people who used Saphnelo were more likely to respond to treatment and also reduce their daily dose of oral corticosteroids than people who used a placebo. This happened for 34% of people using Saphnelo and 18% of people using a placebo. After 1 year, this happened in about 52% of people using Saphnelo and about 25% of people using a placebo.
- Trial 2: This study measured “treatment response” using the SRI tool. After 1 year in the study, there was no clear difference in treatment response between the people who used Saphnelo and the people who used a placebo.
- Trial 3: This study measured treatment response using the BICLA tool. After 1 year in the study, people who used Saphnelo were more likely to respond to treatment than people who used a placebo. About 48% of people who used Saphnelo responded to treatment, compared with about 32% of people who used placebo.
Many different aspects of a study can affect its ability to determine whether a treatment is safe and effective. This is why most medicines are evaluated in multiple studies. Although one of these studies did not confirm whether Saphnelo works better than placebo, two studies did show a benefit over placebo. When all three of these studies are considered together, they indicate that Saphnelo may be more helpful than placebo for reducing symptoms and flare-ups in some people with moderate to severe lupus.
How Quickly Will Saphnelo Work for Lupus?
If Saphnelo is working, your symptoms may start to improve within the first month of treatment. Most people see the greatest improvements during the first 3-4 months of treatment. Over time, this should mean that your symptoms are less severe and that you do not experience as many flare-ups. If you take an oral corticosteroid, your health care provider may be able to lower your dose of this medicine.
Do not stop using Saphnelo or any other medicines for lupus without talking to your health care provider first, even if your symptoms have gotten better. Your symptoms may get worse again if you stop or change any of your medicines.
Tell your health care provider if your symptoms do not seem to be improving after about 3 months of using Saphnelo. Your health care provider may discuss other options for treating this condition.
How Do I Use It?
Saphnelo is a liquid that is given as an infusion into the vein (IV) in a health care facility. Each infusion lasts about 30 minutes, and you will receive an infusion every 4 weeks.
How Can I Prevent or Manage Side Effects?
In rare cases, some people may have a serious allergic reaction (anaphylaxis) to Saphnelo. Each dose of the medicine will be given in a health care facility where a health care professional can monitor you for an allergic reaction. If you develop a reaction to the medicine, they will be able to treat it right away.
Some people may have other, milder side effects during their infusions. The most common side effects that occur during or right after the infusion are headaches, nausea, vomiting, tiredness, and dizziness. Until you know how the medicine affects you, it may be best to have someone else drive you to and from your infusion appointments. You should also let your health care provider know if you develop any of these symptoms during your infusions. They may be able to prescribe medicines that can help to limit these side effects during future doses.
People who use Saphnelo are more likely to have infections, including shingles or an infection of the airways. The best way to prevent airway infections is to reduce your exposure to germs by washing your hands and avoiding people who are sick. You should also stay current on vaccinations, such as getting an annual flu shot. Before you start Saphnelo, speak with your health care provider about whether you are due for any vaccines, including the shingles vaccine.
These are not all of the possible side effects. Talk with your health care provider if you are having symptoms that bother you. If you experience anything that you think may be caused by Saphnelo, you can also report side effects to the FDA at 800-FDA-1088.
Are There Any Interactions With Other Medicines?
It is important for your health care provider to be aware of all the prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken.
It is especially important to let your health care provider know if you are using any other biologic medicines. Using multiple biologic medicines together may increase the risk of side effects.
Are There Any Interactions With Vaccines?
It is important to discuss any recent or upcoming vaccines with your health care provider. There are certain vaccines (“live” vaccines) that you should not receive either right before starting Saphnelo or once you have already started using it. Your health care provider will confirm whether any recent or upcoming vaccines are safe.
Is There a Coupon Card Available?
There is a savings coupon available from the manufacturer that may allow you to pay as little as $0 for the medicine. Whether you are eligible depends on whether you have prescription insurance and what type of insurance you have. You can find out more at www.saphnelo.com/patient/support/savings-support.html.
