Evidence map›Paper›PMID 39022168›Full record

ArticleCJC open2024

Absence of Pericarditis Recurrence in Rilonacept-Treated Patients With COVID-19 and SARS-CoV-2 Vaccination: Results From the RHAPSODY Long-term Extension.

Antonio Brucato, Lucia Trotta, Michael Arad, Paul C Cremer, Antonella Insalaco, Marc Klutstein, Martin LeWinter, David Lin, Sushil A Luis, Yishay Wasserstrum and 6 more

Registry-linked trialAbstract read
In one paragraph

Article in CJC open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03737110 (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), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
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
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
  4. Article
  5. Review
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

16 authors.

Antonio BrucatoDepartment of Biomedical and Clinical Science, University of Milan, Fatebenefratelli Hospital, Milan, Italy.
Lucia TrottaInternal Medicine, Fatebenefratelli Hospital, Milan, Italy.
Michael AradThe Heart Failure Institute, Leviev Heart Centre, Sheba Hospital and the School of Medicine, Tel Aviv University, Tel Aviv, Israel.
Paul C CremerCenter for the Diagnosis and Treatment of Pericardial Diseases, Section of Cardiovascular Imaging, Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio, USA.
Antonella InsalacoDivision of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome, Italy.
Marc KlutsteinShaare Zedek Medical Center, Jerusalem, Israel.
Martin LeWinterThe Cardiology Unit, University of Vermont Medical Center, Burlington, Vermont, USA.
David LinThe Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, Minnesota, USA.
Sushil A LuisDivision of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA.
Yishay WasserstrumChaim Sheba Medical Center, Clinical Research Unit, Leviev Heart Center, Ramat Gan, Israel.
JoAnn ClairKiniksa Pharmaceuticals, Lexington, Massachusetts, USA.
Sheldon WangKiniksa Pharmaceuticals, Lexington, Massachusetts, USA.
Allan L KleinCenter for the Diagnosis and Treatment of Pericardial Diseases, Section of Cardiovascular Imaging, Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio, USA.
Massimo ImazioDepartment of Medicine (DMED), Cardiothoracic Department, University Hospital "Santa Maria della Misericordia", ASUFC, Udine, Italy.
John F PaoliniKiniksa Pharmaceuticals, Lexington, Massachusetts, USA.
RHAPSODY Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Rilonacept inhibits the interleukin-1 pathway, and extended treatment in patients with recurrent pericarditis (RP) reduced recurrence risk by 98% in the phase 3 trial, RHAPSODY long-term extension (LTE). Severe acute respiratory syndrome (SARS)-CoV-2 vaccination and/or infection may trigger pericarditis recurrence, and in clinical practice, it is unknown whether to continue rilonacept during SARS-CoV-2 infection. This post-hoc analysis of the RHAPSODY LTE aimed to inform rilonacept management in RP patients vaccinated against SARS-CoV-2 or who contract COVID-19. Methods: Analysis was conducted from May 2020 to June 2022. The LTE portion of RHAPSODY LTE enabled up to 24 months of additional open-label rilonacept treatment beyond the pivotal study. Rilonacept efficacy data in preventing pericarditis recurrence were assessed, and concomitant SARS-CoV-2 vaccination and COVID-19 adverse event data were evaluated. Results: No pericarditis recurrences were temporally associated with vaccination. Sixteen COVID-19 cases were reported; 10 in 30 unvaccinated or partially vaccinated patients (33%) vs 6 of 44 fully vaccinated patients (14%; Conclusions: Full vaccination effectively reduced COVID-19 events in patients treated with rilonacept. Vaccination or COVID-19 during rilonacept treatment did not increase pericarditis recurrence. Continued rilonacept treatment in patients contracting COVID-19 did not worsen disease severity, whereas rilonacept interruption increased pericarditis recurrence, supporting a recommendation for continued rilonacept treatment for RP during vaccination or COVID-19. ClinicalTrialsgov identifier: NCT03737110.

Identifiers

PMID39022168
PMCPMC11250856

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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.