TY - JOUR
T1 - Interleukin-1 Trap Rilonacept Improved Health-Related Quality of Life and Sleep in Patients With Recurrent Pericarditis
T2 - Results From the Phase 3 Clinical Trial RHAPSODY
AU - RHAPSODY Investigators
AU - Brucato, Antonio
AU - Lim-Watson, Michelle Z.
AU - Klein, Allan
AU - Imazio, Massimo
AU - Cella, David
AU - Cremer, Paul
AU - Lewinter, Martin M.
AU - Luis, Sushil Allen
AU - Lin, David
AU - Lotan, Dor
AU - Pancrazi, Massimo
AU - Trotta, Lucia
AU - Klooster, Brittany
AU - Litcher-Kelly, Leighann
AU - Zou, Liangxing
AU - Magestro, Matt
AU - Wheeler, Alistair
AU - Paolini, John F.
N1 - Funding Information:
The study was funded in full by Kiniksa Pharmaceuticals.
Publisher Copyright:
© American Heart Association Inc.. All rights reserved.
PY - 2022/10/18
Y1 - 2022/10/18
N2 - BACKGROUND: Recurrent pericarditis is characterized by painful flares and inflammation, which negatively impact health-related quality of life. RHAPSODY (rilonacept inhibition of interleukin-1 alpha and beta for recurrent pericarditis: a pivotal symptomatol-ogy and outcomes study) evaluated the efficacy and safety of rilonacept (IL-1α and-β cytokine trap) in recurrent pericarditis. A secondary analysis of these data evaluated the patient-reported outcome questionnaire score change during the trial. METHODS AND RESULTS: Participants completed 5 patient-reported outcome (PRO) questionnaires assessing pericarditis pain, health-related quality of life, general health status, sleep impact, and overall symptom severity. PRO score changes during the treatment run-in period (12 weeks) and the blinded randomized withdrawal period (up to 24 weeks) were evaluated using descriptive statistics and mixed model repeated measures analyses. Participants with PRO data from the run-in period (n=84) and the randomized withdrawal period (n=61; 30 rilonacept, 31 placebo) were included in analyses. Run-in baseline PRO scores indicated that pericarditis symptoms during pericarditis recurrence impacted health-related quality of life. All PRO scores significantly improved (P<0.001) on rilonacept treatment during the run-in period. For the randomized withdrawal period, PRO scores were maintained for participants receiving rilonacept. For those receiving placebo and who experienced a recurrence, PRO scores deteriorated at the time of recurrence and then improved following rilonacept bailout. At randomized withdrawal Week 24/End of Study, scores of participants who received bailout rilonacept were similar to those of participants who had continued rilonacept. CONCLUSIONS: These results demonstrate the burden of pericarditis recurrences and the improved physical and emotional health of patients with recurrent pericarditis while on rilonacept treatment. These findings extend prior rilonacept efficacy results, demonstrating improvements in patient-reported health-related quality of life, sleep, pain, and global symptom severity while on treatment. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03737110.
AB - BACKGROUND: Recurrent pericarditis is characterized by painful flares and inflammation, which negatively impact health-related quality of life. RHAPSODY (rilonacept inhibition of interleukin-1 alpha and beta for recurrent pericarditis: a pivotal symptomatol-ogy and outcomes study) evaluated the efficacy and safety of rilonacept (IL-1α and-β cytokine trap) in recurrent pericarditis. A secondary analysis of these data evaluated the patient-reported outcome questionnaire score change during the trial. METHODS AND RESULTS: Participants completed 5 patient-reported outcome (PRO) questionnaires assessing pericarditis pain, health-related quality of life, general health status, sleep impact, and overall symptom severity. PRO score changes during the treatment run-in period (12 weeks) and the blinded randomized withdrawal period (up to 24 weeks) were evaluated using descriptive statistics and mixed model repeated measures analyses. Participants with PRO data from the run-in period (n=84) and the randomized withdrawal period (n=61; 30 rilonacept, 31 placebo) were included in analyses. Run-in baseline PRO scores indicated that pericarditis symptoms during pericarditis recurrence impacted health-related quality of life. All PRO scores significantly improved (P<0.001) on rilonacept treatment during the run-in period. For the randomized withdrawal period, PRO scores were maintained for participants receiving rilonacept. For those receiving placebo and who experienced a recurrence, PRO scores deteriorated at the time of recurrence and then improved following rilonacept bailout. At randomized withdrawal Week 24/End of Study, scores of participants who received bailout rilonacept were similar to those of participants who had continued rilonacept. CONCLUSIONS: These results demonstrate the burden of pericarditis recurrences and the improved physical and emotional health of patients with recurrent pericarditis while on rilonacept treatment. These findings extend prior rilonacept efficacy results, demonstrating improvements in patient-reported health-related quality of life, sleep, pain, and global symptom severity while on treatment. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03737110.
KW - Inflammation
KW - interleukin-1
KW - patient-reported outcome measures
KW - pericarditis
KW - quality of life
KW - rilonacept
KW - surveys and questionnaires
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UR - http://www.scopus.com/inward/citedby.url?scp=85140271451&partnerID=8YFLogxK
U2 - 10.1161/JAHA.121.023252
DO - 10.1161/JAHA.121.023252
M3 - Article
C2 - 36250662
AN - SCOPUS:85140271451
SN - 2047-9980
VL - 11
JO - Journal of the American Heart Association
JF - Journal of the American Heart Association
IS - 20
M1 - e023252
ER -