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ARCALYST (rilonacept) for injection

CONSIDER ARCALYST® (rilonacept) BEFORE CORTICOSTEROIDS

REAL-WORLD DATA SHOW USE OF ARCALYST STEADILY INCREASED

Treatment choice over time in patients failing aspirin/NSAIDs/colchicine8*

Proportional use of ARCALYST has increased by 60% since 2020.
Proportional use of Corticosteroids has decreased by 53% since 2020.

PROPORTIONAL USE OF csDMARDs AND ANAKINRA 2020-2021II:

  • csDMARDs: 10% (1/10)
  • anakinra: 10% (1/10)

2021*:

  • csDMARDs: 3% (1/31)
  • anakinra: 13% (4/31)

2022:

  • csDMARDs: 5% (2/42)
  • anakinra: 5% (2/42)

2022:

  • csDMARDs: 3% (1/30)
  • anakinra: 0% (0/30) 

These real-world data are retrospective and observational in nature. Data should be interpreted within that context, and predictive value is therefore limited. Results are possibly subject to bias due to site experience; generalizability to centers with different experience levels may be affected.

*Failing is defined as patients who had to intensify to higher-line therapies, such as csDMARDs, corticosteroids, anakinra, or ARCALYST. †Reference group is 2020-2021. ‡Of 52 patients starting ARCALYST after aspirin/NSAIDs/colchicine, 5 patients utilized steroids as a short-term bridge prior to starting ARCALYST (2 patients in 2021, 2 patients in 2022, 1 patient in 2023); 4 patients (2 patients in 2021, 2 patients in 2023) utilized anakinra as a short-term bridge prior to starting ARCALYST. §Reference group is 2021. IIPartial year 2021 prior to ARCALYST availability on April 1, 2021. Partial year 2021 after ARCALYST availability after April 1, 2021.**Data censored at last check-in visit. 

RESONANCE is the largest US patient registry for recurrent pericarditis. These real-world data are retrospective and observational in nature. Data should be interpreted within that context, and predictive value is therefore limited. Results are possibly subject to bias due to site experience; generalizability to centers with different experience levels may be affected.

    RESONANCE INTERVAL ANALYSIS FLOWCHART1
    365 active recurrent pericarditis patients minus RHAPSODY patients > 313 active recurrent pericarditis patients > 298 active recurrent pericarditis patients on asprin/NSAIDs/colchicine minus patients > 113 active recurrent pericarditis patients.

    Data were collected starting March 2020 until the data cutoff date (July 1, 2024).

    *All patients were 12 years of age or older.
    †In patients on aspirin/NSAIDs/colchicine, proportion of patients who added/switched to conventional disease-modifying antirheumatic drugs, corticosteroids, anakinra, or ARCALYST during the observation period; data censored at last check-in visit.
    ‡The aim of the analysis was to look at temporal trends in the management of recurrent pericarditis in real-world clinical practice. ​RHAPSODY patients were excluded from the analysis to allow for the study of real-world recurrent pericarditis medication class use outside of the clinical trial setting.  

    Reference: 1. Cremer P, Garshick M, et al. Increased adoption of IL-1 pathway inhibition and the steroid-sparing paradigm shift: temporal trends in recurrent pericarditis treatment from the RESONANCE patient registry. Poster 84412. Presented at: European Society of Cardiology; August 30–September 2, 2024; London, UK.

    RESONANCE Study Design for Active Recurrent Pericarditis Patients1*

    RESONANCE is a patient registry which collects observational data from real-world practice to better understand the presentation, management, and outcomes of patients with recurrent pericarditis. These data are intended to better inform clinical decision-making and help guide clinical practice to improve the management of patients with recurrent pericarditis.

    Final data collection for RESONANCE clinical trial was start date + 5 years.

    Data Collection:

    Hybrid approach: up to 1-year retrospective data (the year prior to enrollment) were combined with prospective data into a single seamless observation period. The date range for RESONANCE is March 2020 to March 2026. 

    *Active recurrent pericarditis patients enrolled in the registry defined as: currently under the care of a physician for treatment of recurrent pericarditis at time of enrollment; currently on treatment for
    recurrent pericarditis at time of enrollment; having experienced a recurrence in the last 3 years prior to enrollment.

    Reference: 1. Cremer P, Garshick M, et al. Increased adoption of IL-1 pathway inhibition and the steroid-sparing paradigm shift: temporal trends in recurrent pericarditis treatment from the
    RESONANCE patient registry. Poster 84412. Presented at: European Society of Cardiology; August 30–September 2, 2024; London, UK. 

    References: 1. Klein AL, Cremer PC, Kafil TS. Recurrent pericarditis: a promising future for IL-1 blockers in autoinflammatory phenotypes. J Am Coll Cardiol. 2023;82(1):41-45. doi:10.1016/j.jacc.2023.05.013 2. Klein A, Cremer P, Kontzias A, et al. Clinical burden and unmet need in recurrent pericarditis: a systematic literature review. Cardiol Rev. 2022;30(2):59-69. doi:10.1097/CRD.0000000000000356 3. Brucato A, Wheeler A, Luis SA, et al. Transition to rilonacept monotherapy from oral therapies in patients with recurrent pericarditis. Heart. 2023;109:297-304. 4. Schwier NC, Luis SA, Hu X, et al. Risk factors associated with recurrence and corticosteroid-associated adverse events in patients with recurrent pericarditis. Value in Health. 2021;24(5)(suppl 1):S67. Abstract PCV5. 5. Chiabrando JG, Bonaventura A, Vecchié A, et al. Management of acute and recurrent pericarditis. J Am Coll Cardiol. 2020;75(1):76-92. 6. Klein AL, Imazio M, Cremer P, et al. Phase 3 trial of interleukin-1 trap rilonacept in recurrent pericarditis. N Engl J Med. 2021;384(1):31-41. 7. ARCALYST. Package insert. Kiniksa Pharmaceuticals; 2021. 8. Cremer P, Garshick M, et al. Increased adoption of IL-1 pathway inhibition and the steroid-sparing paradigm shift: temporal trends in recurrent pericarditis treatment from the RESONANCE patient registry. Poster 84412. Presented at: European Society of Cardiology; August 30–September 2, 2024; London, UK. 

    Consider Treating Your Patients With ARCALYST For At Least 24 Months to Maintain Prevention of Recurrences‖

    Control of recurrent pericarditis requires continued blockade of IL-1 signaling for the duration of disease.7,8

    ARCALYST relieves pain and resolves inflammation while on treatment.1

    • Absence of abnormal NRS pain scores or CRP levels while on treatment has limited value for predicting future recurrence should treatment be stopped

    Duration of treatment relies on understanding the natural history of recurrent pericarditis and clinical experience with ARCALYST.

    Recurrent pericarditis is a chronic autoinflammatory disease, mediated by IL-1, that can last for several years8

    Checkmark

    Patients with recurrent pericarditis received long-term treatment with ARCALYST in RHAPSODY3

    • Participants in the LTE were treated with ARCALYST for a median of ~24 months (from RI baseline)
    Checkmark

    ARCALYST has been proven to prevent recurrences as long as there are no interruptions in therapy3

    Checkmark
  • The duration of a patient’s ARCALYST treatment should be determined by the prescribing physician.

    • If prematurely discontinued, ARCALYST may be reinitiated.

    In both RW and LTE periods, all patients who reinitiated ARCALYST after a flare experienced resolution2,3,9:

    • In the RW period, all patients who had a recurrence (25) reinitiated ARCALYST and experienced resolution of their flare
    • In the LTE period, all patients who had a recurrence and reinitiated ARCALYST (6/7) experienced resolution of their flare

    1 patient experienced a recurrence, but did  not reinitiate ARCALYST.

    Tell your patients to watch for signs and symptoms of  recurrence.10

    • In a secondary analysis of RHAPSODY, patients who experienced recurrence in the RW period reported incremental increases in average daily NRS scores in the 2 weeks before the event
    • Patients who experienced a recurrence and received ARCALYST bailout reported resolution of pain within 1 to 2 weeks

    Patient and Caregiver Experiences With Recurrent pericarditis and ARCALYST

    Warren: Experience With ARCALYST
    Warren, a patient with recurrence pericarditis, talks about his experience with ARCALYST
    Cathy: Experience With ARCALYST
    Cathy, a patient with recurrence pericarditis, talks about their experience with ARCALYST
    Warren: The Burden of Recurrent Pericarditis
    Warren, a patient with recurrence pericarditis, talks about the burden of recurrent pericarditis and how it affected his daily life
    Cathy: The Burden of Recurrent Pericarditis
    Cathy, a patient with recurrence pericarditis, talks about her burden with recurrent pericarditis and how it affected her daily life
    Fran (Caregiver): The Burden of Recurrent Pericarditis
    Fran, a caregiver of someone with recurrence pericarditis, shares how the disease affected her.
    Warren: Experience With Steroids
    Warren, a patient with recurrence pericarditis, talks about his experience when prescribed corticosteroids.
    Warren: Case Study
    A case study of Warren and their experience with recurrent pericarditis from diagnosis to treatment

    References: 1. ARCALYST. Package insert. Kiniksa Pharmaceuticals. 2. Klein AL, Imazio M, Cremer P, et al. Phase 3 trial of interleukin-1 trap rilonacept in recurrent pericarditis. N Engl J Med. 2021;384(1):31-41. 3. L Imazio M, Klein AL, Brucato A, et al. Sustained Pericarditis Recurrence Risk Reduction With Long-Term Rilonacept. J Am Heart Assoc. 2024;13(6):e032516. doi:10.1161/JAHA.123.032516. 4. Brucato A, Wheeler A, Luis SA, et al. Transition to rilonacept monotherapy from oral therapies in patients with recurrent pericarditis. Heart. 2023;109:297-304. 5. Schwier NC, Luis SA, Hu X, et al. Risk factors associated with recurrence and corticosteroid-associated adverse events in patients with recurrent pericarditis. Value in Health. 2021;24(5)(suppl 1):S67. Abstract PCV5. 6. Imazio M, Klein AL, Brucato A, et al. Sustained Pericarditis Recurrence Risk Reduction With Long-Term Rilonacept. J Am Heart Assoc. 2024;13(6):e032516. doi:10.1161/JAHA.123.032516. 7. Imazio M, Mardigyan V, Andreis A, Franchin L, De Biasio M, Collini V. New developments in the management of recurrent pericarditis. Can J Cardiol. 2023;39(8):1103-1110. doi:10.1016/j.cjca.2023.04.008  8. 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 9. Data on file. Kiniksa Pharmaceuticals (UK), Ltd. 10. Brucato A, Lim-Watson MZ, Klein A, et al; RHAPSODY Investigators.Interleukin-1 trap rilonacept improved health-related quality of life and sleep in patients with recurrent pericarditis: results from the phase 3 clinical trial RHAPSODY. J Am Heart Assoc. 2022;11(20):e023252. doi:10.1161/JAHA.121.0232526

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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 be performed, and the individual dose of the medicinal product may need to be adjusted.

    For more information about ARCALYST, see full Prescribing Information.

    ARCALYST (rilonacept) for injection
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