Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is a group of rare disorders that cause swelling and damage to your blood vessels. Treatment is commonly immunosuppression, with azathioprine, cyclophosphamide, methotrexate, mycophenolate, or rituximab, and corticosteroids for flare-ups. But these medicines, especially corticosteroids, have long-term side effects.
Tavneos is the first medicine approved to help people decrease the use of corticosteroids, while controlling vasculitis symptoms.
How Does Tavneos Work?
Vasculitis is a long-term (chronic) autoimmune disease, where your overactive immune system causes inflammation in your blood vessels, organs, or other tissues. This causes your blood vessels to swell and get smaller inside, preventing blood from getting to your organs. There are many types of vasculitis, based on the type of blood vessels involved. AAV includes the following disorders:
ANCA Vasculitis Disorder | Type | Body Parts Affected | Common Symptoms |
| Granulomatosis with polyangiitis (GPA), formerly known as Wegener’s granulomatosis | Small and medium blood vessels |
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| Microscopic polyangiitis (MPA) | Small blood vessels |
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AAV is diagnosed based on symptoms listed above and the following laboratory tests. Based on which organs that may not be functioning well, imaging or biopsy may be performed.
- ANCA test, which is a blood test that is considered a key way to identify AAV
- Erythrocyte sedimentation rate (ESR) test, which is a blood test to look for inflammation
- Blood and urine tests to check how well your kidneys and liver are working
The goals of treatment are remission and decreasing the risk of flare-ups (relapses). A person is considered in remission when the disease is not active, blood tests show less inflammation, and there are no symptoms. Even with usual treatment, some people can have flare-ups, where symptoms worsen. Symptoms are commonly controlled with corticosteroids and immunosuppressants. Using corticosteroids for a long time can cause a lot of unwanted side effects. Health care providers try to decrease how often you take corticosteroids and how long you need them for your symptoms.
Tavneos is a new medicine for AAV that targets a specific part of your immune system. Unlike corticosteroids, which affect the whole immune system, Tavneos works on just one part. It blocks the C5a receptor in the complement pathway. This pathway is thought to be the main cause of AAV. By focusing on this pathway, Tavneos can control symptoms with fewer side effects and help people go into remission. As the symptoms are controlled, some people can decrease how much corticosteroids they take.
How Should I Use This Medicine?
Tavneos is a capsule that is taken with food and water. The common dose is three capsules, twice daily. Do not crush, chew, or open the capsules. Your health care provider may change your dose based on other medicines that you take.
ADVOCATE Study
The ADVOCATE study was done to see if Tavneos was safe and effective for treating AAV, compared with prednisone, a corticosteroid. People in the study received either Tavneos or a prednisone taper (decreasing dose). They were all on immunosuppression treatments including cyclophosphamide plus azathioprine or mycophenolate, or rituximab.
Everyone in the study was newly diagnosed or had a relapse of GPA or MPA vasculitis and had positive ANCA blood tests for disease activity. They had to have AAV symptoms or kidney issues based on the Birmingham Vasculitis Activity Score (BVAS), a tool used to measure severity of disease. The BVAS score ranges from 0 to 63, where a higher score means more severe disease.
- A little more than half of the people were male (59%), with an average age of 61 years.
- Most of the people identified as White (83%), 17% as Asian, and fewer than 2% as Black.
- The average BVAS score was 16, which means active disease but not severe symptoms.
- Most of the people (80%) had kidney problems.
- All patients were allowed to use prednisone, even when taking Tavneos, if they had a relapse or signs of severe disease.
Efficacy was based on a person going into remission by week 26 and staying in remission until week 52 (sustained remission). In the study, a person was in remission if they had a BVAS score of 0 and did not take a corticosteroid within 4 weeks at weeks 26 and 52. Other survey tools were used to look at side effects from corticosteroid use and overall quality of life (like mental and physical abilities).
What Benefits Were Seen in the Studies?
At week 26, a similar number of people taking Tavneos were in remission (72%), compared with people who completed the prednisone taper (70%). By the end of the study (week 52), people taking Tavneos were more likely to have sustained remission (65%), compared to those on the prednisone taper (55%).
People taking Tavneos also had a lower risk of relapse, were more likely to have better kidney function based on symptoms and blood tests, used less corticosteroids, and had better quality-of-life scores at week 52.
Your results may differ from what was seen in clinical studies. You and your health care provider should determine if the benefits outweigh any potential risks.
When Will the Medicine Start Working?
If Tavneos is working, your symptoms should improve after 1-2 months. For some people, it may take longer to see these improvements. Over time, you may be able to decrease or even stop (taper off) the corticosteroids. It is important to track your symptoms and review with your health care provider.
Contact your health care provider if you don’t see improvements after 4 months or continue to have symptoms or relapses that bother you. Do not stop using Tavneos without talking with your health care provider.
Are There Reasons I Should Not Use This Medicine?
Tavneos should not be used if you have liver problems, including cirrhosis, a serious infection, had hepatitis B or C, or had a serious allergic reaction to Tavneos or its ingredients. Your health care provider will check how your liver functions before starting Tavneos (see Monitoring section).
Some medicines affect the level of Tavneos in your blood and should not be taken at the same time due to risk of side effects (see Interactions section). Tell your health care provider about all the medicines you are taking before you start Tavneos.
How Can I Prevent and Manage Side Effects?
The most common side effects are nausea and vomiting, headache, and rash. Take Tavneos with food to help reduce the nausea. Most of the side effects get better over time. Talk with your health care provider if the symptoms are bothersome or continue.
These are not all of the possible side effects. Talk with your health care provider if you are having symptoms that bother you. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What Monitoring or Blood Tests May I Need Before Starting and During Treatment?
Your health care provider may perform lab tests to monitor your health and assess how your body responds to the medicine. The following are key pieces of that monitoring:
- Liver function tests (LFTs) to check your liver before you start Tavneos and for the first 6 months of treatment
- Blood tests to check your body for the hepatitis B virus
- ACNA test to look for inflammation
What Types of Interactions Can Happen?
Several medicines can affect the blood levels of Tavneos. This may increase the risk of side effects or decrease how well Tavneos works. Talk with your health care provider if you are using any of the following medicines or foods.
- Strong or moderate CYP3A4 inducers, which include apalutamide (Erleada), carbamazepine, enzalutamide (Xtandi), ivosidenib (Tibsovo), lumacaftor/ivacaftor (Orkambi), phenytoin, rifampin, and St. John’s wort.
- Strong CYP3A4 inhibitors, which include ceritinib (Zykadia), clarithromycin (Biaxin), idelalisib (Zydelig), itraconazole (Sporanox, Tolsura), ketoconazole (Nizoral), medicines used for HIV (like elvitegravir/ritonavir, indinavir/ritonavir), and grapefruit juice.
Tavneos may affect the blood levels of some medicines. This may increase the risk of side effects of those medicines. Talk with your health care provider if you are using any of the following medicines.
- CYP3A4 substrates, like atorvastatin, simvastatin, and other medicines
This is not a complete list of medicines that may interact with Tavneos. Tell your pharmacist or other health care provider about all the prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken. This will help them determine if there are any interactions, or if you need a dosage adjustment.
Getting Your Medicine: What to Expect
Tavneos is considered a specialty medicine, which is a high-cost medicine that is taken for rare, complex, or chronic diseases. It requires a different process than picking up a prescription at your local pharmacy. This process helps you stay on track with your treatment. The drugmaker has a program to help support the process.
Here are some differences that you may expect.
Insurance approval. Your insurance may require approval for using this medicine, also called a prior authorization. The insurance company reviews the prescription from your health care provider to make sure it is covered.
Pharmacy access. You will use a specific pharmacy to get your medicine. Your health care provider will work with you and the drugmaker on which pharmacy to use and the information that will be provided. The pharmacy will work with your insurance company to determine the costs. They will also talk with you each month to review your treatment and schedule your delivery.
Copay assistance. There is a copay assistance program from the drugmaker that may allow you to pay $0 for your prescription. Whether you are eligible depends on whether you have prescription insurance and what type of insurance you have. You can find out more at https://www.tavneos.com/support/paying-for-tavneos or by calling 833-828-6367.
