Evidence map›Paper›PMID 36250662›Full record

Trial reportJournal of the American Heart Association2022

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.

Antonio Brucato, Michelle Z Lim-Watson, Allan Klein, Massimo Imazio, David Cella, Paul Cremer, Martin M LeWinter, Sushil Allen Luis, David Lin, Dor Lotan and 9 more

Open access · goldAbstract readClinical Trial, Phase III
In one paragraph

Trial report in Journal of the American Heart Association, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
3.1field-weighted citation impact, top 7% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 22 citations in OpenAlex.

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  13. Novel Treatments in Refractory Recurrent Pericarditis.Pharmaceuticals (Basel, Switzerland) · 2024
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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 3 countries.

Antonio BrucatoUniversità di Milano Fatebenefratelli Hospital Milan Italy.ORCID 0000-0002-7566-5600
Michelle Z Lim-WatsonKiniksa Pharmaceuticals Lexington MA.ORCID 0000-0001-7123-2931
Allan KleinCleveland Clinic Cleveland OH.ORCID 0000-0001-9240-8369
Massimo ImazioCardiology, Cardiothoracic Department University Hospital "Santa Maria della Misericordia," ASUFC Udine Italy.ORCID 0000-0002-5722-0245
David CellaNorthwestern University Evanston IL.
Paul CremerCleveland Clinic Cleveland OH.ORCID 0000-0002-0794-3306
Martin M LeWinterUniversity of Vermont Medical Center Burlington VT.ORCID 0000-0003-3938-3531
Sushil Allen LuisMayo Clinic Rochester MN.ORCID 0000-0001-9821-1225
David LinMinneapolis Heart Institute Minneapolis MN.
Dor LotanSheba Medical Center and Sackler School of Medicine Tel Aviv University Israel.ORCID 0000-0003-3501-6259
Massimo PancraziAdelphi Values Patient-Centered Outcomes Boston MA.
Lucia TrottaUniversità di Milano Fatebenefratelli Hospital Milan Italy.
Brittany KloosterAdelphi Values Patient-Centered Outcomes Boston MA.ORCID 0000-0002-2018-8982
Leighann Litcher-KellyAdelphi Values Patient-Centered Outcomes Boston MA.ORCID 0000-0001-9005-6582
Liangxing ZouKiniksa Pharmaceuticals Corp Lexington MA.
Matt MagestroKiniksa Pharmaceuticals Corp Lexington MA.
Alistair WheelerKiniksa Pharmaceuticals Corp Lexington MA.
John F PaoliniKiniksa Pharmaceuticals Corp Lexington MA.ORCID 0000-0001-7622-8851
RHAPSODY Investigators
Cleveland Clinic · USFatebenefratelli Hospital · ITMinneapolis Heart Institute Foundation · USOspedale Santa Maria della Misericordia di Udine · ITSynta Pharmaceuticals (United States) · USAdelphi Laboratory Center · USSheba Medical Center · ILTel Aviv University · ILUniversity of Vermont Medical Center · USKaneka (United States) · USMayo Clinic · USMayo Clinic in Arizona · USNorthwestern University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background Recurrent pericarditis is characterized by painful flares and inflammation, which negatively impact health-related quality of life. RHAPSODY (rilonacept inhibition of interleukin-1 alpha and beta for recurrent pericarditis: a pivotal symptomatology and outcomes study) evaluated the efficacy and safety of rilonacept (IL-1α and -β cytokine trap) in recurrent pericarditis. A secondary analysis of these data evaluated the patient-reported outcome questionnaire score change during the trial. Methods and Results Participants completed 5 patient-reported outcome (PRO) questionnaires assessing pericarditis pain, health-related quality of life, general health status, sleep impact, and overall symptom severity. PRO score changes during the treatment run-in period (12 weeks) and the blinded randomized withdrawal period (up to 24 weeks) were evaluated using descriptive statistics and mixed model repeated measures analyses. Participants with PRO data from the run-in period (n=84) and the randomized withdrawal period (n=61; 30 rilonacept, 31 placebo) were included in analyses. Run-in baseline PRO scores indicated that pericarditis symptoms during pericarditis recurrence impacted health-related quality of life. All PRO scores significantly improved (

Indexed as

Interleukin-1alphaPericarditisHumansPainQuality of LifeRecombinant Fusion ProteinsSleepTreatment OutcomeInterleukin-1alphaRecombinant Fusion Proteinsrilonaceptinflammationinterleukin‐1patient‐reported outcome measurespericarditisquality of liferilonaceptsurveys and questionnaires

Identifiers

PMID36250662
PMCPMC9673658
OpenAlexW4306406524

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.