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ARCALYST (rilonacept) for injection

Recurrent pericarditis (RP) is a 2 to 3 year journey for many patients,1

THE TREATMENT YOU CHOOSE TODAY COULD MAKE A DIFFERENCE FOR THOSE YEARS

An episodic treatment approach can be a painful experience for patients with recurrent pericarditis.

PREVALENCE AND IMPACT

If you treat pericarditis, it is likely that a patient in your practice has recurrent pericarditis or will develop it.

‎

~30%

of patients with a first episode of pericarditis will develop recurrent pericarditis.2

‎‎Approximately

40,000

people in the United States seek care for recurrent pericarditis annually.2

There are an estimated

~20,000

new cases of recurrent pericarditis in the United States each year.2

Klein A, et al. JAHA 2021. Data from the PharMetrics Plus database, collected between January 1, 2013, and March 31, 2018, were used for this retrospective analysis (N=7502 patients with pericarditis, 2096 of whom experienced ≥1 recurrence).

Recurrent pericarditis has a detrimental impact on patients

Patients living with recurrent pericarditis may face many challenges, including3,4:

  • Chest pain
  • Fatigue
  • Anxiety
  • Depression
  • Inability to perform physical activities
  • Missed work
  • LeWinter M, et al. Am J Cardiol –based on a survey of 83 adult patients with recurrent pericarditis, 75% of whom were not experiencing a recurrence at that time.
    • In a survey, patients not actively experiencing a flare reported living in fear of their next one.4
    95% reported living in fear of their next recurrence

    In a Harris poll of 125 patients diagnosed with RP5:

    80%

    of patients agreed that they have not fully regained their prior quality of life since experiencing recurrent pericarditis.

    89%

    of patients were afraid of the potential long-term risks associated with repeated recurrent pericarditis flares.

    90%

    of patients were willing to take a medication for several years in order to not experience another recurrence/flare.

    Diagnosis of Recurrent Pericarditis May Not Be Straightforward

    In a Harris poll of 125 patients diagnosed with recurrent pericarditis5:

    96%

    of patients were diagnosed with other conditions before receiving a recurrent pericarditis diagnosis.

    88%

    of patients want their HCP to ask more questions about symptoms and/or flares.

    85%

    of patients said they often feel like they “fall through the cracks.”*

    Patients experienced an average of
    ~ 3 episodes before receiving a recurrent pericarditis diagnosis.
    Patients saw an average of
    3 healthcare providers before receiving an recurrent pericarditis diagnosis.
  • This survey was conducted online within the United States by The Harris Poll on behalf of Kiniksa Pharmaceuticals from May 4–June 1, 2023, among 125 US adults ages 18+ who have been diagnosed with recurrent pericarditis and are not currently pregnant or breastfeeding and have never used/are not currently using an IL-1 antagonist. The sampling precision of Harris online polls is measured by using a Bayesian credible interval. For this study, the sample data are accurate to within +/– 8.7 percentage points using a 95% confidence level.

    • Diagnosing subsequent recurrences of pericarditis in patients with an established history of recurrent pericarditis is challenging as these patients often6:

    • Have chest pain regardless of their recurrence status
    • Lack enough clinical evidence to meet the diagnostic criteria of pericarditis because they are on multiple anti-inflammatory medications

    A First Episode of Pericarditis and Recurrent Pericarditis Are Distinct Entities with Different Treatment Needs

    While the etiology of single- or first-episode pericarditis may be caused by several factors, including viral illness and post cardiac injury, the pathogenesis of recurrent pericarditis is a self-perpetuating cycle of IL-1-mediated autoinflammation.8-11

    The cycle showing how recurrent pericarditis is driven by a self-perpetuating cycle of IL-1-meidated autoinflammation.
    1. INJURED PERICARDIAL CELL

    Pericardial cell damage causes release of IL-1α.

    2. MACROPHAGE

    IL-1α binds to IL-1 receptors on the surface of macrophages, causing the activation and release of IL-1β in a cascade amplification system.

    3. CAPILLARY

    ENDOTHELIAL CELLS 
    Active IL-1α and IL-1β bind to IL-1 receptors on the surface of vascular endothelial cells, causing inflammation and additional cell damage.

    4. PERICARDIAL INFLAMMATION

    Additional IL-1-mediated inflammation results in cell damage, causing the cycle of autoinflammation to continue.

    Treatment of recurrent pericarditis requires a paradigm shift1,12

    From:

    Temporarily addressing pain and inflammation associated with a flare.

    To:

    Preventing future flares by breaking the self-perpetuating cycle of IL-1-mediated autoinflammation that drives the disease.

    References: 1. Lin D, Laliberté F, Majeski C, et al. Disease and economic burden associated with recurrent pericarditis in a privately insured United States population. Adv Ther. 2021;38(10):5127-5143. doi:10.1007/s12325-021-01868-7 2. Klein A, Cremer P, Kontzias A, et al. US database study of clinical burden and unmet need in recurrent pericarditis. J Am Heart Assoc. 2021;10:e018950. doi:10.1161/JAHA.120.018950 3. Pericarditis. Cleveland Clinic. Reviewed July 1, 2022. Accessed September 28, 2023. https://my.clevelandclinic.org/health/diseases/17353-pericarditis 4. LeWinter M, Kontzias A, Lin D, et al. Burden of recurrent pericarditis on health-related quality of life. Am J Cardiol. 2021;141:113-119. doi:10.1016/j.amjcard.2020.11.018  5. Data on file. Kiniksa Pharmaceuticals. 6. Kumar A, Sato K, Verma BR, et al. Quantitative assessment of pericardial delayed hyperenhancement helps identify patients with ongoing recurrences of pericarditis. Open Heart. 2018;5:e000944. doi:10.1136/openhrt-2018-000944 7. Adler Y, Charron P, lmazio M, et al. 2015 ESC guidelines for the diagnosis and management of pericardial diseases: The Task Force for the Diagnosis and Management of Pericardial Diseases of the European Society of Cardiology (ESC). Eur Heart J. 2015;36(42):2921-2964. doi:10.1097/CRD.0000000000000356 8. Dinarello CA, Simon A, van der Meer JWM. Treating inflammation by blocking interleukin-1 in a broad spectrum of diseases. Nat Rev Drug Discov. 2012;11(8):633-652. doi:10.1038/nrd3800 9. Chiabrando JG, Bonaventura A, Vecchié A, et al. Management of acute and recurrent pericarditis. J Am Coll Cardiol. 2020;75(1):76-92. 10. Brucato A, Emmi G, Cantarini L, et al. Management of idiopathic recurrent pericarditis in adults and in children: a role for IL-1 receptor antagonism. Intern Emerg Med. 2018:13:475-489. https://doi.org/10.1007 /s11739-018-1842-x  11. Ridker PM. From C-reactive protein to interleukin-6 to interleukin-1: moving upstream to identify novel targets for atheroprotection. Circ Res. 2016;118(1):145-156. doi:10.1161/CIRCRESAHA.115.306656  12. Vecchié A, Del Buono MG, Mauro AG, et al. Advances in pharmacotherapy for acute and recurrent pericarditis. Expert Opin Pharmacother. 2022;23(6):681-691.

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    Indication

    ARCALYST® (rilonacept) is an interleukin-1 blocker indicated for:

    • Treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and pediatric patients 12 years and older.
    • Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS), and Muckle-Wells Syndrome (MWS) in adults and children 12 years and older. 
    • Maintenance of remission of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) in adults and pediatric patients weighing 10 kg or more.

    Important Safety Information

    Warnings and Precautions

    • Interleukin-1 (IL-1) blockade may interfere with the immune response to infections. Treatment with another medication that works through inhibition of IL-1 or inhibition of tumor necrosis factor (TNF) is not recommended as this may increase the risk of serious infection. Serious, life-threatening infections have been reported in patients taking ARCALYST. Do not initiate treatment with ARCALYST in patients with an active or chronic infection.
    • Discontinue ARCALYST if a patient develops a serious infection.
    • It is possible that taking drugs such as ARCALYST that block IL-1 may increase the risk of tuberculosis (TB) or other atypical or opportunistic infections.
    • Although the impact of ARCALYST on infections and the development of malignancies is not known, treatment with immunosuppressants, including ARCALYST, may result in an increase in the risk of malignancies.
    • Hypersensitivity reactions associated with ARCALYST occurred in clinical trials. Discontinue ARCALYST and initiate appropriate therapy if a hypersensitivity reaction occurs. 
    • Increases in non-fasting lipid profile parameters occurred in patients treated with ARCALYST in clinical trials. Patients should be monitored for changes in their lipid profiles.
    • Since no data are available, avoid administration of live vaccines while patients are receiving ARCALYST. ARCALYST may interfere with the normal immune response to new antigens, so vaccines may not be effective in patients receiving ARCALYST. It is recommended that, prior to initiation of therapy with ARCALYST, patients receive all recommended vaccinations, as appropriate.

    Adverse Reactions

    • In patients with CAPS or RP, the most common adverse reactions (≥10%) include injection-site reactions and upper respiratory tract infections.
    • In patients with DIRA, the most common adverse reactions (>10%) include upper respiratory tract infections, rash, otitis media, pharyngitis, and rhinorrhea.

    Drug Interactions

    • In patients being treated with CYP450 substrates with narrow therapeutic indices, therapeutic monitoring of the effect or drug concentration should /pi.pdfbe performed, and the individual dose of the medicinal product may need to be adjusted.

    For more information about ARCALYST, see full Prescribing Information.