TY  - BOOK
AU  - Ertel, Andrew
TI  - Health-related quality of life in patients with recurrent pericarditis: results from a phase 2 study of rilonacept
SN  - 1471-2261
PY  - 2021///
KW  - *Anti-Inflammatory Agents/tu [Therapeutic Use]
KW  - *Pericarditis/dt [Drug Therapy]
KW  - *Quality of Life
KW  - *Recombinant Fusion Proteins/tu [Therapeutic Use]
KW  - Adolescent
KW  - Adrenal Cortex Hormones/ad [Administration & Dosage]
KW  - Adult
KW  - Aged
KW  - Anti-Inflammatory Agents/ae [Adverse Effects]
KW  - Biomarkers/bl [Blood]
KW  - C-Reactive Protein/me [Metabolism]
KW  - Drug Tapering
KW  - Female
KW  - Functional Status
KW  - Humans
KW  - Interviews as Topic
KW  - Male
KW  - Mental Health
KW  - Middle Aged
KW  - Patient Reported Outcome Measures
KW  - Pericarditis/di [Diagnosis]
KW  - Pericarditis/pp [Physiopathology]
KW  - Pericarditis/px [Psychology]
KW  - Pilot Projects
KW  - Qualitative Research
KW  - Recombinant Fusion Proteins/ae [Adverse Effects]
KW  - Recurrence
KW  - Time Factors
KW  - Treatment Outcome
KW  - Young Adult
KW  - MedStar Heart & Vascular Institute
KW  - Journal Article
N2  - 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; 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; 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; 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); TRIAL REGISTRATION: ClinicalTrials.Gov; NCT03980522; 5 June 2019, retrospectively registered; https://clinicaltrials.gov/ct2/show/NCT03980522
UR  - https://dx.doi.org/10.1186/s12872-021-02008-3
UR  - https://dx.doi.org/10.1186/s12872-021-02008-3xl  - https://dx.doi.org/10.1186/s12872-021-02008-3
ER  -