Health-related quality of life in patients with recurrent pericarditis: results from a phase 2 study of rilonacept

Autor: Andrew Ertel, Leighann Litcher-Kelly, Sushil Allen Luis, Antonio Abbate, David Cella, Matt Magestro, David Lin, Brittany Klooster, Fang Fang, A. Beutler, Allan L. Klein, Martin M. LeWinter, Paul Cremer, John F. Paolini
Rok vydání: 2021
Předmět:
Male
Time Factors
Health-related quality of life
Anti-Inflammatory Agents
Phases of clinical research
Pilot Projects
030204 cardiovascular system & hematology
0302 clinical medicine
Quality of life
Adrenal Cortex Hormones
Recurrence
Pericarditis
030212 general & internal medicine
Qualitative Research
education.field_of_study
Middle Aged
Rilonacept
C-Reactive Protein
Mental Health
Treatment Outcome
Female
Recurrent pericarditis
Cardiology and Cardiovascular Medicine
Research Article
medicine.drug
Adult
medicine.medical_specialty
Adolescent
Recombinant Fusion Proteins
Population
Interviews as Topic
Young Adult
03 medical and health sciences
Internal medicine
Patient experience
medicine
Humans
Diseases of the circulatory (Cardiovascular) system
Patient Reported Outcome Measures
education
Aged
Angiology
Drug Tapering
business.industry
Discontinuation
Functional Status
RC666-701
Concomitant
Quality of Life
Interleukin-1 cytokine trap
business
Biomarkers
Zdroj: BMC Cardiovascular Disorders, Vol 21, Iss 1, Pp 1-14 (2021)
BMC Cardiovascular Disorders
ISSN: 1471-2261
Popis: 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-1α/IL-1β cytokine trap) to treat RP. 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). 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. Trial registration: ClinicalTrials.Gov; NCT03980522; 5 June 2019, retrospectively registered; https://clinicaltrials.gov/ct2/show/NCT03980522.
Databáze: OpenAIRE
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