What to Know About Kineret (Anakinra)

Kineret (anakinra) is a biologic therapy used to treat certain inflammatory conditions, including rheumatoid arthritis (RA). It is given as an injection into the fatty layer beneath the skin. The Food and Drug Administration (FDA) first approved Kineret for use in 2001.

Uses

Kineret blocks the effects of the immune signaling molecule (cytokine) known as IL-1. By reducing the effects of IL-1, Kineret tamps down inflammation.

Currently, Kineret is FDA-approved for adults with RA. Specifically, it is approved for people with rheumatoid arthritis who have tried methotrexate or a similar type of drug but haven’t had a good response.

Kineret can be taken over the long term to help prevent future symptoms, such as joint pain. However, it is much less commonly used than many other therapies to treat RA, including other biologic treatments such as Enbrel (etanercept).

Kineret is also FDA-approved to treat an extremely rare genetic condition called neonatal-onset multisystem inflammatory disease (NOMID). NOMID is a very serious condition that causes inflammation in multiple body systems beginning in infancy.

Excessive IL-1 seems to play a major role in causing the disease’s symptoms. Without treatment, some patients do not survive into adulthood. However, Kineret has radically improved the lives of people with NOMID. Kineret is the only FDA-approved product for this condition.

Finally, Kineret is also approved to treat deficiency of interleukin-1 receptor antagonist (DIRA), a very rare and life-threatening systemic inflammatory condition that usually presents within the first few days of birth.

Off-Label Uses

NOMID belongs to a broader group of inherited inflammatory syndromes called cryopyrin-associated periodic syndromes (CAPS). Other types of CAPS are less severe than NOMID, but they can cause similar symptoms, such as periodic episodes of fever, rash, and joint pain.

Kineret is also sometimes used to treat these other types of CAPS, such as Muckle-Wells syndrome and familial cold autoinflammatory syndrome. However, this is technically an off-label use in the United States.

Off-label just means that the drug hasn’t gone through the full set of testing needed for FDA approval. Healthcare providers may prescribe a drug off-label if there is good reason to think the therapy is relatively safe and effective, particularly if no other approved treatments are available.

Kineret is also sometimes used off-label for a wide variety of serious inflammatory diseases. Because IL-1 is such an important part of the inflammatory process in many different health conditions, Kineret has many potential uses. This may be especially helpful for serious diseases that don’t have any approved FDA treatments.

For example, the following are a sampling of the diseases for which Kineret is sometimes used:

• Behcet disease
• Kawasaki disease
• Systemic juvenile idiopathic arthritis
• Adult-onset Still’s disease
• Henoch-Schonlein purpura
• Dry eye disease
• Epilepsy unresponsive to treatment
• Hidradenitis suppurativa

Kineret is also increasingly being used as an additional treatment (given with treatments such as chemotherapy) for various kinds of metastatic cancer, which is cancer that has spread from its original site.

Metastasis can cause inflammation, and Kineret can help decrease this. For example, Kineret may help people with colorectal cancer and pancreatic cancer live longer, while experiencing fewer symptoms.

Off-Label Use in COVID-19

Kineret has also been used off-label in a condition called macrophage activation syndrome, a severe complication that can occur in some rheumatic diseases such as juvenile idiopathic arthritis. Macrophage activation syndrome is related to a cytokine storm, a severe overactivation of the immune system that can involve IL-1.

Researchers think that cytokine storms play a role in the severe symptoms of COVID-19 some people experience. In other words, too much IL-1 might be part of the reason some people get very sick from COVID-19.

Because of this, Kineret is one of the many drugs currently being studied in people with COVID-19, particularly those with severe symptoms. Theoretically, the immune-modulating qualities of Kineret might be helpful.

Small studies have shown that Kineret may indeed be helpful for people with severe symptoms from COVID-19. However, data from ongoing clinical trials are needed before we can draw any real conclusions.

Before Taking

Your clinician will need to give you a thorough medical evaluation before starting Kineret. You’ll need to talk about any current symptoms you are having. For example, if you have signs or symptoms of an ongoing infection, you should wait to start Kineret.

You’ll also need to talk about your medical history. For example, your clinician should ask about whether you have health conditions such as tuberculosis or HIV. It’s important that you don’t have any other conditions that are contraindicated with Kineret, like anything that makes you more prone to getting certain infections.

Depending on the context, you may need certain blood tests before starting this therapy. For example, a a complete blood count test is often ordered to check on levels of certain immune cells before you start therapy.

Precautions and Contraindications

People starting Kineret may need to get a test for tuberculosis (TB) before starting treatment. This might involve getting a chest X-ray or a TB skin test. Some people have dormant infections that aren’t giving them any symptoms. Because of the way it affects the immune system, starting Kineret may make a TB infection more active.

People with active infections should wait until these clear up before starting Kineret. You also may not be able to start taking it right away if you’ve recently taken a certain kind of vaccine called a “live vaccine,” and shouldn’t get this type of vaccine while you are taking Kineret.

Talk to your healthcare provider if you are pregnant, thinking of becoming pregnant, or are breastfeeding. It is not known if Kineret increases the chance of birth defects or death of the fetus. However, the risks should be weighed with your healthcare provider, and this medication shouldn’t be used unless clearly necessary.

You shouldn’t take Kineret if you know you are allergic to it. People with kidney disease may also be at higher risk for certain drug side effects, so it may not be the best option for them. Kineret may also not be the best treatment option for elderly individuals, who may have an increased risk of infection.

It’s also recommended that Kineret not be taken along with TNF-inhibitors, another type of biologic therapy.

Other Therapies

For RA, other biologic treatments are available that are usually used instead of Kineret. For example, this includes TNF-blockers like Humira (adalimumab). Other non-biologic, pharmacologic treatments are also available, like methotrexate. For NOMID, Kineret is the only FDA-approved therapy.

Dosage

Kineret is given as an injection into the fatty layer beneath the skin, typically once a day. Amount per injection can vary based on clinical context and sometimes the person’s weight. Additional modifications may be needed for certain medical conditions. For example, a person with kidney disease might only take Kineret every other day.

How to Take and Store

Kineret is supplied in single-use, pre-filled syringes. It should be stored in the fridge until ready for use, but you should let it come to room temperature before injecting. Its outer container keeps it protected from light.

You’ll want to move around the places you choose to inject Kineret, avoiding any injured areas or areas close to a visible vein. Typically you will use areas on your belly, thighs, or upper arms.

Before injection, you’ll clean your hands and the injection site. After injecting, you can use a cotton ball to apply pressure to the area. Your healthcare provider can provide you with detailed instructions about how to take Kineret.

Side Effects

Common

The most commonly reported side effect is a mild injection reaction, which might cause a little redness, pain, or swelling at the injection site.

Some of the other relatively common side effects of Kineret are:

• Headache
• Mild fever
• Muscle or joint aches
• Stuffy nose (or other symptoms of upper respiratory tract infection)
• Vomiting
• Belly pain

However, most people do pretty well with Kineret, and they are able to keep taking it over a long period of time.

Severe

Kineret can increase your risk of infection, including some infections that might be serious such as pneumonia, cellulitis, and meningitis.

Because of the way Kineret affects your body’s immune system, it’s possible that your body will have a harder time fighting off certain kinds of infections that wouldn’t affect most people. An example might be a serious fungal infection that requires hospitalization for treatment.

Your healthcare provider may want to run periodic complete blood count tests while you continue to take Kineret, at least for a while. These tests can make sure your blood cells—specifically, a type of immune cells known as neutrophils—aren’t getting too low. Low neutrophils would put you at greater risk of an infection.

Weighing Risks and Benefits

It’s important to keep these possibilities in perspective. Though Kineret does carry certain risks, it can be a very helpful therapy for some people. For some health conditions with few or no FDA-approved alternatives, Kineret represents the best hope of getting your disease under control. Weigh the risks and benefits in your situation with your healthcare provider.