Efficacy and safety of rilonacept for recurrent pericarditis: results from a phase II clinical trial. (Record no. 6252)

MARC details
000 -LEADER
fixed length control field 03236nam a22003857a 4500
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 210401s202020120 xxu||||| |||| 00| 0 eng d
022 ## - INTERNATIONAL STANDARD SERIAL NUMBER
International Standard Serial Number 1355-6037
024 ## - OTHER STANDARD IDENTIFIER
Standard number or code 10.1136/heartjnl-2020-317928 [doi]
024 ## - OTHER STANDARD IDENTIFIER
Standard number or code heartjnl-2020-317928 [pii]
024 ## - OTHER STANDARD IDENTIFIER
Standard number or code PMC7925818 [pmc]
040 ## - CATALOGING SOURCE
Original cataloging agency Ovid MEDLINE(R)
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC)
PMID 33229362
245 ## - TITLE STATEMENT
Title Efficacy and safety of rilonacept for recurrent pericarditis: results from a phase II clinical trial.
251 ## - Source
Source Heart. 2020 Nov 23
252 ## - Abbreviated Source
Abbreviated source Heart. 2020 Nov 23
253 ## - Journal Name
Journal name Heart (British Cardiac Society)
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Year 2020
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Manufacturer FY2021
265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE]
Publication status aheadofprint
266 ## - Date added to catalog
Date added to catalog 2021-04-01
520 ## - SUMMARY, ETC.
Abstract CONCLUSIONS: Rilonacept led to rapid and sustained improvement in pain, inflammation (CRP and pericarditis manifestations) and HRQOL. CSs were successfully tapered or discontinued; safety was consistent with known rilonacept safety profile.
520 ## - SUMMARY, ETC.
Abstract METHODS: This multicentre, open-label study enrolled adult patients with idiopathic or postpericardiotomy RP, symptomatic (>=2 pericarditis recurrences) or corticosteroid (CS) dependent (>=2 recurrences prior). Patients received rilonacept 320 mg SC load/160 mg SC weekly maintenance in a 6-week base treatment period (TP) followed by an optional 18-week on-treatment extension period (EP) (option to wean background therapy).
520 ## - SUMMARY, ETC.
Abstract OBJECTIVE: Recurrent pericarditis (RP) incurs significant morbidity. Rilonacept inhibits both interleukin-1 alpha (IL-1alpha) and IL-1beta; these cytokines are thought to play a major role in RP. This phase II study evaluated rilonacept efficacy and safety in RP.
520 ## - SUMMARY, ETC.
Abstract RESULTS: Outcomes: pericarditis pain (numeric rating scale (NRS)) and inflammation (C reactive protein (CRP)) for symptomatic patients; disease activity after CS taper for CS-dependent patients.
520 ## - SUMMARY, ETC.
Abstract SECONDARY OUTCOMES: health-related quality of life (HRQOL), pericarditis manifestations and additional medications. 25 unique patients enrolled, while 23 completed the EP (seven colchicine failures and five CS failures). In symptomatic patients, NRS and CRP decreased; response was observed after first rilonacept dose. NRS decreased from 4.5 at baseline to 0.7, and CRP decreased from 4.62 mg/dL at baseline to 0.38 mg/dL at end of TP. Median time to CRP normalisation: 9 days. Pericarditis manifestations resolved. 13 patients on CS at baseline completed the EP; 11 (84.6%) discontinued CS, and 2 tapered; CRP and NRS remained low without recurrence. Mean HRQOL scores improved in symptomatic patients. One serious adverse event (SAE) resulted in discontinuation of rilonacept.
520 ## - SUMMARY, ETC.
Abstract TRIAL REGISTRATION NUMBER: NCT03980522. Copyright ♭ Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.
546 ## - LANGUAGE NOTE
Language note English
651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME
Institution MedStar Washington Hospital Center
656 ## - INDEX TERM--OCCUPATION
Department Internal Medicine
657 ## - INDEX TERM--FUNCTION
Medline publication type Journal Article
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Ertel, Andrew
790 ## - Authors
All authors Abbate A, Beutler A, Cremer PC, Ertel A, Fang F, Klein AL, LeWinter M, Lin D, Luis SA, Nasir S, Paolini JF
856 ## - ELECTRONIC LOCATION AND ACCESS
DOI <a href="https://dx.doi.org/10.1136/heartjnl-2020-317928">https://dx.doi.org/10.1136/heartjnl-2020-317928</a>
Public note https://dx.doi.org/10.1136/heartjnl-2020-317928
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type Journal Article
Item type description Article
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          MedStar Authors Catalog MedStar Authors Catalog 04/01/2021   33229362 33229362 04/01/2021 04/01/2021 Journal Article

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