ARCALYST was proven to prevent future flares





2 of 30 participants taking ARCALYST had a flare. In both cases, the flare happened during a temporary interruption in ARCALYST treatment.


23 of 31 of participants taking placebo had a flare. In every case, the flare went away when they were given ARCALYST.


The only flares that occurred in participants taking ARCALYST happened when they temporarily stopped their treatment.

ARCALYST was proven to provide rapid symptom relief



Of participants achieved symptom relief AS EARLY AS the first dose

On average, after starting ARCALYST, participants experienced pain reduction in 5 days and reduced levels of C-reactive protein (CRP) within 7 days.


  • Participants rated their pain based on the Numerical Rating Scale
  • CRP is a protein that is detected when inflammation is present

ARCALYST delivered more pain-free days

Days with minimal or no RP pain:




Compared with 40% with placebo, as reported by participants.

ARCALYST offers freedom from steroids



Of people taking steroids successfully transitioned to ARCALYST alone

All participants on steroids when the study began were able to successfully taper off and stop taking them after starting ARCALYST.*


*Average time to transition to ARCALYST alone from traditional therapies, including NSAIDs, colchicine, or corticosteroids (alone or in combination), was 7.9 weeks.

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ARCALYST was studied in people diagnosed with recurrent pericarditis who were experiencing at least a second recurrence (third flare). Symptom relief and time to transition to ARCALYST alone were evaluated in 86 participants taking ARCALYST. Risk of recurrence and days with minimal or no pain were evaluated in 30 participants taking ARCALYST compared with 31 taking placebo.

How ARCALYST works

Recurrent pericarditis is an autoinflammatory disease, which means flares are caused by the body’s immune system attacking the pericardium, not by an external factor like a virus or injury. Each attack creates damage that causes more immune system response in an ongoing cycle.

ARCALYST Blocks the Cycle of Autoinflammation that Drives Recurrent Pericarditis

autoinfmation cycle track


Cells in the pericardium become inflamed, causing a flare.


Inflamed cells release a protein called interleukin-1 (IL-1).


IL-1 signals the immune system to send immune cells to the pericardium.


Immune cells cause damage and inflammation.

The Cycle of Autoinflammation in Recurrent Pericarditis


Cells in the pericardium become inflamed, causing a flare.


Inflamed cells release a protein called interleukin-1 (IL-1).


IL-1 signals the immune system to send immune cells to the pericardium.


Immune cells cause damage and inflammation.

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by blocking IL-1 from signaling the immune system, thereby preventing future flares.

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Image - Businessman Facing Front

ARCALYST is the first and only FDA-approved therapy for recurrent pericarditis

Commonly prescribed pericarditis therapies—such as nonsteroidal anti-inflammatory drugs (NSAIDs), colchicine, and steroids—do not specifically block IL-1, and people with recurrent pericarditis who are treated with these medications may still suffer from flares.


If you experience another flare after you have a first one, ask your doctor about ARCALYST.



What is the most important information I should know about ARCALYST?

ARCALYST can affect your immune system. ARCALYST can lower the ability of your immune system to fight infections. Serious infections, including life-threatening infections and death, have happened in people taking ARCALYST. Taking ARCALYST can make you more likely to get infections, including life-threatening serious infections, or may make any infection that you have worse.


You should not begin treatment with ARCALYST if you have an infection or have infections that keep coming back (chronic infection).



After starting ARCALYST, if you get an infection, any sign of an infection, including a fever, cough, flu-like symptoms, or have any open sores on your body, call the healthcare provider right away. Treatment with ARCALYST should be stopped if you get a serious infection.



You should not take medicines that block tumor necrosis factor (TNF), such as Enbrel® (etanercept), Humira® (adalimumab), or Remicade® (infliximab), while you are taking ARCALYST. You should also not take other medicines that block interleukin-1 (IL-1), such as Kineret® (anakinra), while taking ARCALYST. Taking ARCALYST with any of these medicines may increase your’s risk of getting a serious infection.


Before starting treatment with ARCALYST, tell the healthcare provider if you:

  • Think you have an infection
  • Are being treated for an infection
  • Have signs of an infection, such as fever, cough, or flu-like symptoms
  • Have any open sores on your body
  • Have a history of infections that keep coming back
  • Have asthma. People with asthma may have an increased risk of infection
  • Have diabetes or an immune system problem. People with these problems have a higher chance for infections
  • Have tuberculosis, or if you have been in close contact with someone who has had tuberculosis
  • Have or have had HIV, hepatitis B, or hepatitis C
  • Take other medicines that affect your immune system

Before you begin treatment with ARCALYST, talk with the healthcare provider about your vaccine history. Ask the healthcare provider whether you should receive any vaccines, including the pneumonia vaccine and flu vaccine, before you begin treatment with ARCALYST.

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What are the possible side effects of ARCALYST?

ARCALYST can cause serious side effects, including:

  • Risk of Cancer. Medicines that affect the immune system may increase the risk of getting cancer.
  • Allergic Reaction. Stop taking or giving ARCALYST and call the healthcare provider or get emergency care right away if you get any of the following symptoms of an allergic reaction while taking ARCALYST:
    • Rash
    • Swollen face
    • Trouble breathing
  • Changes in your blood cholesterol and triglycerides (lipids). Your healthcare provider will do blood tests to check for these changes.
  • In people with CAPS and RP, the most common side effects of ARCALYST include:
    • Injection-site reactions including: pain, redness, swelling, itching, bruising, lumps, inflammation, skin rash, blisters, warmth, and bleeding at the injection site.
    • Upper respiratory tract infections
    • Joint and muscle aches in RP
  • In people with DIRA, the most common side effects of ARCALYST include:
    • Upper respiratory tract infections
    • Rash
    • Ear infection
    • Sore throat
    • Runny nose

These are not all the possible side effects of ARCALYST. Tell your healthcare provider if you have any side effect that bothers you or does not go away. For more information, ask your healthcare provider or pharmacist.

Please report side effects by contacting Kiniksa Pharmaceuticals

toll-free at 1-833-546-4572, Option 3


contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.