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ARCALYST (rilonacept) for injection

CONSIDER ARCALYST® (rilonacept) BEFORE CORTICOSTEROIDS

Pericarditis treatment pathway1-3

Type
Treatment

First or
Single Event

Traditional therapies:

  • NSAIDs and/or colchicine

Recurrent
Pericarditis

ARCALYST monotherapy uninterrupted for the duration of the disease:

  • In the clinical trial, RHAPSODY, patients were transitioned off all traditional therapies*
    • Median time to monotherapy was 7.9 weeks 
  • ARCALYST significantly reduced the risk of pericarditis recurrence by 96% (HR: 0.04; P<0.0001)
  • ARCALYST significantly reduced the risk of recurrence by 98% in the LTE period (HR: 0.02; P<0.0001), consistent with the primary efficacy point 

Corticosteroids have broad anti-inflammatory actions. However, they may be associated with AEs4-6:

  • While the guidelines suggest several months of tapering to reduce the potential of recurrence, the longer patients are on corticosteroid therapy the greater the risk of AEs
    • It is estimated that with each additional week of treatment there is 1.11-fold increased risk of related AEs†
  • Reduction in dose or premature cessation of therapy to minimize AEs may unmask the underlying autoinflammatory process and result in a recurrence

48% (41 of 86) of patients  were taking corticosteroids at baseline and all these patients were experiencing a qualifying pericarditis flare.1,2‡

  • 97% of patients (77 of 79) achieved treatment response with ARCALYST, regardless of corticosteroid treatment at baseline§
  • No patient in the RW period had a reintroduction of corticosteroid therapy
  • Medication use at baseline: NSAIDs (58), colchicine (69), or corticosteroids (41), alone or in combination. 
  • Data from the Inovalon Ability claims database (2013-2020) of 3899 patients with recurrent pericarditis. 
  • Qualifying event included at least a second recurrence and NRS ≥4 and CRP ≥1 mg/dL within 7 days prior to administration of the first dose of ARCALYST. 
  • Treatment response was defined as pericardial pain NRS ≤2 (0-10) and CRP ≤0.5 mg/dL (measured within 7 days before or after the pain response).

    • 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

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

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  • 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 /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.