Evidence map›Paper›PMID 38471825›Full record

Trial reportJournal of the American Heart Association2024

Sustained Pericarditis Recurrence Risk Reduction With Long-Term Rilonacept.

Massimo Imazio, Allan L Klein, Antonio Brucato, Antonio Abbate, Michael Arad, Paul C Cremer, Antonella Insalaco, Martin M LeWinter, Basil S Lewis, David Lin and 9 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in Journal of the American Heart Association, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 23 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 2 pooled it
14.5field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03737110 phase3completednot on this map

Phase 3, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study With Open-label Extension, to Assess the Efficacy and Safety of Rilonacept Treatment in Subjects With Recurrent Pericarditis

TypeinterventionalSponsorKiniksa Pharmaceuticals (UK), Ltd.Ran2019 to 2022Enrolled86ConditionsRecurrent PericarditisArmsRilonacept, Placebo
NCT06708299 phase3recruitingnot on this mapstarted 2025, after this paper: background citation

CardiolRxTM in Recurrent Pericarditis (MAVERIC Phase 3) A Randomized, Double-blind, Placebo-controlled Trial

TypeinterventionalSponsorCardiol Therapeutics Inc.Ran2025 to 2026Enrolled110ConditionsRecurrent PericarditisArmsCardiolRx
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 36 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Biologics for cardiovascular diseases: from bench to bedside.Signal transduction and targeted therapy · 2026
    Review
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  8. Article
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  12. Review
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  15. Review
  16. Article
  17. Neutrophil diversity and function in health and disease.Signal transduction and targeted therapy · 2024
    Review
  18. Review
  19. Novel Treatments in Refractory Recurrent Pericarditis.Pharmaceuticals (Basel, Switzerland) · 2024
    Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 13 institutions in 4 countries.

Massimo ImazioDepartment of Medicine (DMED), University of Udine and Cardiothoracic Department University Hospital Santa Maria della Misericordia, ASUFC Udine Italy.ORCID 0000-0002-5722-0245
Allan L KleinCleveland Clinic Cleveland OH USA.ORCID 0000-0001-9240-8369
Antonio BrucatoUniversity of Milano, Fatebenefratelli Hospital Milan Italy.ORCID 0000-0002-7566-5600
Antonio AbbateBerne Cardiovascular Research Center, School of Medicine University of Virginia Charlottesville VA USA.ORCID 0000-0002-1930-785X
Michael AradLeviev Heart Center, Ramat Gan Tel Aviv University School of Medicine Ramat Gan Israel.ORCID 0000-0003-3723-7493
Paul C CremerCleveland Clinic Cleveland OH USA.ORCID 0000-0002-0794-3306
Antonella InsalacoDivision of Rheumatology, Ospedale Pediatrico Bambino Gesù IRCCS [European Reference Network (ERN) for Rare Immunodeficiency, Autoinflammatory and Autoimmune Diseases (RITA) Center] Rome Italy.
Martin M LeWinterUniversity of Vermont Medical Center Burlington VT USA.ORCID 0000-0003-3938-3531
Basil S LewisLady Davis Carmel Medical Center and Technion-Israel Institute of Technology Haifa Israel.ORCID 0000-0001-5604-6399
David LinAbbott Northwestern Hospital Minneapolis MN USA.
Sushil A LuisMayo Clinic Rochester MN USA.ORCID 0000-0001-9821-1225
Stephen J NichollsVictorian Heart Institute Monash University Clayton Australia.
Paul SutejNorthside Hospital Atlanta GA USA.
Yishay WasserstrumLeviev Heart Center, Ramat Gan Tel Aviv University School of Medicine Ramat Gan Israel.ORCID 0000-0001-8063-2806
JoAnn ClairKiniksa Pharmaceuticals Lexington MA USA.ORCID 0000-0003-0281-1651
Indra AgarwalKiniksa Pharmaceuticals Lexington MA USA.
Sheldon WangKiniksa Pharmaceuticals Lexington MA USA.
John F PaoliniKiniksa Pharmaceuticals Lexington MA USA.ORCID 0000-0001-7622-8851
RHAPSODY Investigators
Synta Pharmaceuticals (United States) · USCleveland Clinic · USTel Aviv University · ILAbbott Northwestern Hospital · USAustralian Regenerative Medicine Institute · AUBambino Gesù Children's Hospital · ITMayo Clinic · USNorthside Hospital · USTechnion – Israel Institute of Technology · ILUniversity of Milan · ITUniversity of Udine · ITUniversity of Vermont Medical Center · USUniversity of Virginia · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRilonacept, a once-weekly interleukin-1 alpha and beta cytokine trap, reduced pericarditis recurrence in the phase 3 study, RHAPSODY (Rilonacept Inhibition of Interleukin-1 Alpha and Beta for Recurrent Pericarditis: A Pivotal Symptomatology and Outcomes Study). The RHAPSODY long-term extension further explored recurrent pericarditis natural history and treatment duration decision-making during 24 additional months of open-label rilonacept treatment. METHODS AND

resultsSeventy-four patients commenced the long-term extension, with a median (maximum) total rilonacept duration of 22 (35) months. Individually, 18 months after the most proximal pericarditis recurrence, investigators decided to continue rilonacept on study, suspend rilonacept for off-treatment observation (rescue allowed), or discontinue the study. The annualized incidence of pericarditis recurrence on rilonacept up to the 18-month decision milestone was 0.04 events/patient-year versus 4.4 events/patient-year prestudy while on oral therapies. At the 18-month decision milestone, 64% (33/52) continued rilonacept, 15% (8/52) suspended rilonacept for observation, and 21% (11/52) discontinued the study. Among the 33 patients (1/33; 3.0%) continuing rilonacept (median time to recurrence could not be estimated due to too few events), a single recurrence occurred 4 weeks after a treatment interruption. Among patients suspending rilonacept, 75% (6/8) experienced recurrence (median time to recurrence, 11.8 weeks [95% CI, 3.7 weeks to not estimable]). There was a 98% reduction in risk of pericarditis recurrence among patients continuing rilonacept treatment after the 18-month decision milestone versus those suspending treatment for observation (hazard ratio, 0.02;

conclusionsIn the RHAPSODY long-term extension, continued rilonacept treatment resulted in continued response; treatment suspension at the 18-month decision milestone was associated with pericarditis recurrence. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03737110.

Indexed as

Interleukin-1alphaPericarditisHumansRecombinant Fusion ProteinsRecurrenceRisk Reduction BehaviorTreatment OutcomeInterleukin-1alphaRecombinant Fusion Proteinsrilonaceptautoinflammatory diseaseinterleukin‐1recurrent pericarditisrilonacept

Identifiers

PMID38471825
PMCPMC11010039
OpenAlexW4392755945

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.