Health-related quality of life in patients with recurrent pericarditis: results from a phase 2 study of rilonacept. (Record no. 6352)

MARC details
000 -LEADER
fixed length control field 05332nam a22007577a 4500
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 210607s20212021 xxu||||| |||| 00| 0 eng d
022 ## - INTERNATIONAL STANDARD SERIAL NUMBER
International Standard Serial Number 1471-2261
024 ## - OTHER STANDARD IDENTIFIER
Standard number or code 10.1186/s12872-021-02008-3 [doi]
024 ## - OTHER STANDARD IDENTIFIER
Standard number or code 10.1186/s12872-021-02008-3 [pii]
024 ## - OTHER STANDARD IDENTIFIER
Standard number or code PMC8061027 [pmc]
040 ## - CATALOGING SOURCE
Original cataloging agency Ovid MEDLINE(R)
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC)
PMID 33882846
245 ## - TITLE STATEMENT
Title Health-related quality of life in patients with recurrent pericarditis: results from a phase 2 study of rilonacept.
251 ## - Source
Source BMC Cardiovascular Disorders. 21(1):201, 2021 04 21.
252 ## - Abbreviated Source
Abbreviated source BMC Cardiovasc Disord. 21(1):201, 2021 04 21.
252 ## - Abbreviated Source
Former abbreviated source BMC Cardiovasc Disord. 21(1):201, 2021 Apr 21.
253 ## - Journal Name
Journal name BMC cardiovascular disorders
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Year 2021
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Manufacturer FY2021
265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE]
Publication status epublish
266 ## - Date added to catalog
Date added to catalog 2021-06-07
268 ## - Previous citation
-- BMC Cardiovascular Disorders. 21(1):201, 2021 Apr 21.
520 ## - SUMMARY, ETC.
Abstract BACKGROUND: Impact of recurrent pericarditis (RP) on patient health-related quality of life (HRQoL) was evaluated through qualitative patient interviews and as an exploratory endpoint in a Phase 2 trial evaluating the efficacy and safety of rilonacept (IL-1alpha/IL-1beta cytokine trap) to treat RP.
520 ## - SUMMARY, ETC.
Abstract CONCLUSION: This is the first study demonstrating impaired HRQoL in RP. Rilonacept treatment was associated with HRQoL improvements using PROMIS GH scores. Maintained/improved HRQoL during tapering/withdrawal of CS without recurrence suggests that rilonacept may provide an alternative to CS.
520 ## - SUMMARY, ETC.
Abstract METHODS: Qualitative interviews were conducted with ten adults with RP to understand symptoms and HRQoL impacts, and the 10-item Patient-Reported Outcomes Measurement Information System Global Health (PROMIS GH) v1.2 was evaluated to determine questionnaire coverage of patient experience. The Phase 2 trial enrolled participants with active symptomatic RP (A-RP, n = 16) and corticosteroid-dependent participants with no active recurrence at baseline (CSD-RP, n = 9). All participants received rilonacept weekly during a 6-week base treatment period (TP) plus an optional 18-week extension period (EP). Tapering of concomitant medications, including corticosteroids (CS), was permitted during EP. HRQoL was assessed using the PROMIS GH, and patient-reported pain and blood levels of c-reactive protein (CRP) were collected at Baseline and follow-up periods. A secondary, descriptive analysis of the Phase 2 trial efficacy results was completed using HRQoL measures to characterize both the impact of RP and the treatment effect of rilonacept.
520 ## - SUMMARY, ETC.
Abstract RESULTS: Information from qualitative interviews demonstrated that PROMIS GH concepts are relevant to adults with RP. From the Phase 2 trial, both participant groups showed impacted HRQoL at Baseline (mean PROMIS Global Physical Health [GPH] and Global Mental Health [GMH], were lower than population norm average). In A-RP, GPH/MPH improved by end of base TP and were sustained through EP (similar trends were observed for pain and CRP). Similarly, in CSD-RP, GPH/MPH improved by end of TP and further improved during EP, during CS tapering or discontinuation, without disease recurrence (low pain scores and CRP levels continued during the TP and EP).
520 ## - SUMMARY, ETC.
Abstract TRIAL REGISTRATION: ClinicalTrials.Gov; NCT03980522; 5 June 2019, retrospectively registered; https://clinicaltrials.gov/ct2/show/NCT03980522 .
546 ## - LANGUAGE NOTE
Language note English
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Anti-Inflammatory Agents/tu [Therapeutic Use]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Pericarditis/dt [Drug Therapy]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Quality of Life
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Recombinant Fusion Proteins/tu [Therapeutic Use]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Adolescent
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Adrenal Cortex Hormones/ad [Administration & Dosage]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Adult
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Aged
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Anti-Inflammatory Agents/ae [Adverse Effects]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Biomarkers/bl [Blood]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element C-Reactive Protein/me [Metabolism]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Drug Tapering
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Female
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Functional Status
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Humans
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Interviews as Topic
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Male
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Mental Health
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Middle Aged
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Patient Reported Outcome Measures
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Pericarditis/di [Diagnosis]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Pericarditis/pp [Physiopathology]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Pericarditis/px [Psychology]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Pilot Projects
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Qualitative Research
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Recombinant Fusion Proteins/ae [Adverse Effects]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Recurrence
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Time Factors
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Treatment Outcome
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Young Adult
651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME
Institution MedStar Heart & Vascular Institute
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, Cella D, Cremer P, Ertel A, Fang F, Klein A, Klooster B, LeWinter MM, Lin D, Litcher-Kelly L, Luis SA, Magestro M, Paolini JF
856 ## - ELECTRONIC LOCATION AND ACCESS
DOI <a href="https://dx.doi.org/10.1186/s12872-021-02008-3">https://dx.doi.org/10.1186/s12872-021-02008-3</a>
Public note https://dx.doi.org/10.1186/s12872-021-02008-3
-- https://dx.doi.org/10.1186/s12872-021-02008-3xl - https://dx.doi.org/10.1186/s12872-021-02008-3
856 ## - ELECTRONIC LOCATION AND ACCESS
DOI <a href="https://dx.doi.org/10.1186/s12872-021-02008-3xl - https://dx.doi.org/10.1186/s12872-021-02008-3">https://dx.doi.org/10.1186/s12872-021-02008-3xl - https://dx.doi.org/10.1186/s12872-021-02008-3</a>
Public note https://dx.doi.org/10.1186/s12872-021-02008-3
-- https://dx.doi.org/10.1186/s12872-021-02008-3xl - https://dx.doi.org/10.1186/s12872-021-02008-3
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type Journal Article
Item type description Article
Holdings
Withdrawn status Lost status Damaged status Not for loan Collection Home library Current library Date acquired Total Checkouts Full call number Barcode Date last seen Price effective from Koha item type
          MedStar Authors Catalog MedStar Authors Catalog 06/07/2021   33882846 33882846 06/07/2021 06/07/2021 Journal Article

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