Rilonacept inHibition of interleukin-1 Alpha and beta for recurrent Pericarditis: a pivotal Symptomatology and Outcomes stuDY - RHAPSODY

Nov 16, 2020
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Kiniksa Pharmaceuticals
Date Presented:
11/16/2020
Date Published:
11/16/2020
Date Updated:
11/16/2020
Original Posted Date:
11/16/2020
References

Contribution To Literature:

The RHAPSODY trial showed that an interleukin 1-α and 1-β inhibitor was superior to placebo in reducing recurrent pericarditis.

Description:

The goal of the trial was to evaluate rilonacept, an interleukin 1-α and 1-β inhibitor, compared with placebo among patients with recurrent pericarditis.

Study Design

  • Randomized
  • Parallel
  • Double-blind
  • Placebo

Patients with recurrent pericarditis received rilonacept 320 mg subcutaneous, followed by a run-in period with rilonacept 160 mg subcutaneous weekly for 12 weeks, then were randomized to rilonacept 160 mg subcutaneous weekly (n = 30) versus placebo (n = 31).

  • Total number of enrollees: 61
  • Duration of follow-up: 16 weeks
  • Mean patient age: 45 years
  • Percentage female: 57%

Inclusion criteria:

  • At least second pericarditis recurrence (multiple etiologies)
  • Pain numeric rating scale ≥4
  • C-reactive protein ≥1 mg/dl
  • Nonsteroidal anti-inflammatory drugs (NSAIDs)/colchicine/corticosteroids

Other salient features/characteristics:

  • Etiology: idiopathic, 85%; post-pericardiotomy syndrome, 14%; Dressler’s syndrome, 1%
  • Medication at baseline: colchicine, 80%; NSAID, 67%; steroids, 49%

Principal Findings:

The primary outcome of pericarditis recurrence occurred in 6.7% of the rilonacept group compared with 74.2% of the placebo group (p < 0.0001).

Secondary outcomes:

  • Proportion of patients who maintained clinical response at 16 weeks: 81% of the rilonacept group compared with 20% of the placebo group (p = 0.0002)
  • Proportion of patients with absent/minimal symptoms at 16 weeks: 81% of the rilonacept group compared with 25% of the placebo group (p = 0.0006)
  • No drug-related serious adverse events occurred in either group
  • Treatment emergent adverse event of upper respiratory tract infection: 23.3% of the rilonacept group compared with 0 of the placebo group
  • Treatment emergent adverse event of injection site reaction: 16.7% of the rilonacept group compared with 0 of the placebo group

Interpretation:

Among patients with recurrent pericarditis, rilonacept, a subcutaneously administered interleukin 1-α and 1-β inhibitor, was associated with a significant reduction in recurrent pericarditis over the study period. Rilonacept was associated with an increased frequency of upper respiratory tract infections. Currently there are no Food and Drug Administration approved therapies for this condition.

References:

Klein AL, Imazio M, Cremer P, et al., on behalf of the RHAPSODY Investigators. Phase 3 Trial of Interleukin-1 Trap Rilonacept in Recurrent Pericarditis. N Engl J Med 2020;Nov 16:[Epub ahead of print].

Presented by Dr. Allan L. Klein at the American Heart Association Virtual Scientific Sessions, November 16, 2020.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Pericardial Disease, Prevention, Cardiac Surgery and Arrhythmias

Keywords: AHA20, AHA Annual Scientific Sessions, Adrenal Cortex Hormones, Anti-Inflammatory Agents, Non-Steroidal, Colchicine, C-Reactive Protein, Pericardiectomy, Pericarditis, Postpericardiotomy Syndrome, Primary Prevention, Receptors, Interleukin-1, Recombinant Fusion Proteins, Respiratory Tract Infections


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