Evidence map›Paper›PMID 36316102›Full record

Trial reportHeart (British Cardiac Society)2023

Transition to rilonacept monotherapy from oral therapies in patients with recurrent pericarditis.

Antonio Brucato, Alistair Wheeler, Sushil Allen Luis, Antonio Abbate, Paul C Cremer, Liangxing Zou, Antonella Insalaco, Martin Lewinter, Basil S Lewis, David Lin and 5 more

Erratum issued Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Heart (British Cardiac Society), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. 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 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.6field-weighted citation impact, top 9% 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
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 17 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Review
  5. Review
  6. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 12 institutions in 4 countries.

Antonio BrucatoDepartment of Biomedical and Clinical Sciences "Sacco", University of Milano, Milano, Italy.
Alistair WheelerClinical Development, Kiniksa Pharmaceuticals Corp, Lexington, Massachusetts, USA.
Sushil Allen LuisDepartment of Cardiovascular Medicine, Mayo Clinic College of Medicine, Rochester, Minnesota, USA.
Antonio AbbateDivision of Cardiology, Pauley Heart Center, Virginia Commonwealth University, Richmond, Virginia, USA.
Paul C CremerCardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio, USA.
Liangxing ZouClinical Development, Kiniksa Pharmaceuticals Corp, Lexington, Massachusetts, USA.
Antonella InsalacoDivision of Rheumatology, Ospedale Pediatrico Bambino Gesù, Roma, Lazio, Italy.
Martin LewinterCardiology Unit, University of Vermont Medical Center, Burlington, Vermont, USA.
Basil S LewisDepartment of Cardiology, Lady Davies Carmel Medical Center, Haifa, Haifa, Israel.
David LinDepartment of Cardiology, Minneapolis Heart Institute, Minneapolis, Minnesota, USA.
Stephen NichollsMonash Cardiovascular Research Centre, Victorian Heart Institute, Monash University, Clayton, Victoria, Australia.
Massimo PancraziDepartment of Internal Medicine, Fatebenefratelli Hospital, Milan, Italy.
Allan L KleinCardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio, USA.ORCID 0000-0001-9240-8369
Massimo ImazioCardiothoracic Department, Santa Maria della Misericordia University Hospital, Udine, Friuli-Venezia Giulia, Italy.
John F PaoliniClinical Development, Kiniksa Pharmaceuticals Corp, Lexington, Massachusetts, USA jpaolini@kiniksa.com.ORCID 0000-0001-7622-8851
Kaneka (United States) · USCleveland Clinic · USBambino Gesù Children's Hospital · ITCarmel Medical Center · ILFatebenefratelli Hospital · ITMayo Clinic · USMinneapolis Heart Institute Foundation · USMonash Medical Centre · AUOspedale Santa Maria della Misericordia di Udine · ITUniversity of Milan · ITUniversity of Vermont Medical Center · USVirginia Commonwealth University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivePolypharmacy management of recurrent pericarditis (RP) often involves long-term therapies, often with negative effects. Slow tapering of oral therapies is often required to avoid recurrence. A post hoc analysis of the phase III trial Rilonacept inHibition of interleukin-1 Alpha and beta for recurrent Pericarditis: a pivotal Symptomatology and Outcomes Study (RHAPSODY) evaluated investigator approaches to transitioning to IL-1 blockade monotherapy with rilonacept, which was hypothesised to allow accelerated withdrawal of common multidrug pericarditis regimens.

methodsRHAPSODY was a multicentre (Australia, Israel, Italy, USA), double-blind, placebo-controlled, randomised-withdrawal trial in adults and adolescents with RP. Investigators initiated rilonacept at the labelled dose level and discontinued oral pericarditis therapies during the 12-week run-in; randomised patients received study drug as monotherapy. Time to rilonacept monotherapy was quantified in patients receiving multidrug regimens at baseline who achieved rilonacept monotherapy during run-in.

resultsIn 86 enrolled patients, mean time to rilonacept monotherapy was 7.9 weeks, with no recurrences. Of these, 64% (n=55) entered on multidrug regimens: non-steroidal anti-inflammatory drugs (NSAIDs) plus colchicine (44% (24/55)), colchicine plus glucocorticoids (24% (13/55)), or NSAIDs, colchicine, plus glucocorticoids (33% (18/55)). Investigators transitioned patients receiving colchicine and glucocorticoids at baseline to rilonacept monotherapy without recurrence regardless of taper approach: sequential (n=14; median, 7.7 weeks) or concurrent (n=17; median, 8.0 weeks). Median time to rilonacept monotherapy was similar regardless of glucocorticoid dose and duration: ≤15 mg/day (n=21): 7.3 weeks; >15 mg/day (n=18): 8.0 weeks; long-term (≥28 days): 7.6 weeks.

conclusionsRapid discontinuation of oral RP therapies while transitioning to rilonacept monotherapy was feasible without triggering pericarditis recurrence. TRIAL REGISTRATION NUMBER: NCT03737110.

Indexed as

GlucocorticoidsPericarditisAdolescentAdultAnti-Inflammatory Agents, Non-SteroidalColchicineHumansRecombinant Fusion ProteinsTreatment OutcomeAnti-Inflammatory Agents, Non-SteroidalColchicineGlucocorticoidsRecombinant Fusion Proteinsrilonaceptpericarditis

Identifiers

PMID36316102
PMCPMC9887401
OpenAlexW4307716639

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.