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ARCALYST (rilonacept) for injection

Break the Cycle of Recurrent Pericarditis

to relieve pain, resolve inflammation, and prevent recurrences1,2

ARCALYST breaks the self-perpetuating cycle of IL-1-mediated autoinflammation by blocking IL-1 signaling, thereby relieving pain, resolving inflammation, and preventing recurrences.

The cycle showing how ARCALYST therapy works by blocking IL-1-signaling and breaking the recurrence cycle.

NSAIDs, colchicine, and corticosteroids do not specifically target this IL-1-mediated pathway, and patients may continue to experience recurrences.3,4
Rhapsody Study Design

In the Rhapsody RW period and LTE, ARCALYST was proven to prevent recurrences

In the RW period (primary efficacy end point)*: 
ARCALYST significantly reduced the risk of pericarditis recurrence.1,5

A Kaplan-Meiser curve showing the difference between ARCALYST and the placebo in the reduction of risk of recurrent pericarditis recurrences.

The median time to recurrence on ARCALYST could not be estimated due to the low numbers of recurrence:

  • 7% (2 of 30) of  patients treated with ARCALYST experienced a recurrence 
  • The 2 pericarditis recurrences occurred during temporary treatment interruptions of 1 to 3 weekly ARCALYST doses 

The median time to recurrence on placebo was 8.6 weeks (95% CI: 4.0, 11.7): 

  • 74% (23 of 31) of  patients treated with placebo experienced a recurrence by the time the event-driven RW portion of the trial was closed 
  • Primary efficacy end point was time to first adjudicated pericarditis recurrence in the RW period.

    • In the LTE period

    Long-term Prevention While on Treatment

    99% (74 of 75) of eligible patients chose to remain in the study to be treated with open-label ARCALYST for up to an additional 24 months.6†
    • Participants in the LTE were treated with ARCALYST for a median of ~24 months from RI baseline
    • The median duration of ARCALYST treatment in the base study was 9 months

    ARCALYST continued to significantly reduce recurrences up to the 18-month decision milestone:

    3 of the 74 patients experienced an investigator-assessed recurrence while on treatment with ARCALYST in the LTE period up to the 18-month decision milestone.
    • These recurrences did not meet the formal RHAPSODY event adjudication criteria (eg, only symptoms without CRP elevation)  
    • Disease history during the 2.5 years (mean) prior to the entry of trial was 4.4 events per patient-year‡ 
  • N=74; 59 patients after completing the RW period and 15 directly from the RI period after enrollment in the RW period closed.  
  • While being treated with NSAIDs, colchicine, or corticosteroids, alone or in combination.

    • ARCALYST continued to significantly reduce recurrences past the 18-month decision milestone6§

    A Kaplan-Meiser curve showing the long-term prevention results while on ARCALYST treatment during the long term extension period.

    These results are consistent with the primary efficacy end point.1

    Patients received a median of ~2 years of ARCALYST treatment from RI baseline. 

    • Recurrence rate was 3% (1/33) in patients who continued ARCALYST treatment vs 75% (6/8) in patients who suspended treatment for observation  
    • The only recurrence in the group treated with ARCALYST beyond the 18-month decision milestone was associated with a treatment interruption of 4 weeks 
    • The median time to recurrence in patients who suspended ARCALYST treatment for observation was 11.8 weeks, and the median time to recurrence in patients who continued treatment was not estimable 
  • At the 18-month decision milestone, 33 continued open-label ARCALYST, 8 suspended treatment and were observed, and 11 exited the study.

    • ARCALYST Rapidly Relieved Pain and Resolved Inflammation

    In the RI period (secondary efficacy end point):

    of patients (77 of 79) achieved treatment response,‖ most as early as after the first dose.1,5

    Median time to treatment response§: 5 days (95% CI: 4.0, 7.0)
    Median time to pain response: 5 days (95% CI: 4.0, 6.0)
    Median time to CRP normalization: 7 days (95% CI: 5.0, 8.0)

  • Time to treatment response was defined as the time from the first dose to the first day when pericardial pain was NRS ≤2 (0-10) and CRP ≤0.5 mg/dL (measured within 7 days before or after the pain response).
    • In the RW period (secondary efficacy end points assessed at week 16):

    Patients reported

    of trial days with minimal or no pericarditis pain (NRS ≤2 [0-10]) compared with 40% for patients on placebo (P<0.0001).1

    ARCALYST Was Steroid Sparing

    of 41 patients receiving corticosteroids at RI baseline successfully transitioned off corticosteroids soon after initiating therapy.1,5 

    • 48% (41 of 86) of recurrent pericarditis patients entered RHAPSODY with a pericarditis flare despite taking corticosteroids¶#
    • Median time to ARCALYST monotherapy was 7.9 weeks from traditional therapies  
    • No patient in the RW period had a reintroduction of corticosteroid therapy
  • Pericarditis flare 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. 
  • Medication use at baseline: NSAIDs (58), colchicine (69), or corticosteroids (41), alone or in combination.

    • References: 1. ARCALYST. Package insert. Kiniksa Pharmaceuticals. 2. 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/nrd 3800 3. Chiabrando JG, Bonaventura A, Vecchié A, et al. Management of acute and recurrent pericarditis. J Am Coll Cardiol. 2020; 75(1): 76-92. 4. 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 5. 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. 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.

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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.