Sustained Pericarditis Recurrence Risk Reduction With Long-Term Rilonacept
BACKGROUND: Rilonacept, a once-weekly interleukin-1 alpha and beta cytokine trap, reduced pericarditis recurrence in the phase 3 study, RHAPSODY (Rilonacept Inhibition of Interleukin-1 Alpha and Beta for Recurrent Pericarditis: A Pivotal Symptomatology and Outcomes Study). The RHAPSODY long-term extension further explored recurrent pericarditis natural history and treatment duration decision-making during 24 additional months of open-label rilonacept treatment.
METHODS AND RESULTS: Seventy-four patients commenced the long-term extension, with a median (maximum) total rilonacept duration of 22 (35) months. Individually, 18 months after the most proximal pericarditis recurrence, investigators decided to continue rilonacept on study, suspend rilonacept for off-treatment observation (rescue allowed), or discontinue the study. The annualized incidence of pericarditis recurrence on rilonacept up to the 18-month decision milestone was 0.04 events/patient-year versus 4.4 events/patient-year prestudy while on oral therapies. At the 18-month decision milestone, 64% (33/52) continued rilonacept, 15% (8/52) suspended rilonacept for observation, and 21% (11/52) discontinued the study. Among the 33 patients (1/33; 3.0%) continuing rilonacept (median time to recurrence could not be estimated due to too few events), a single recurrence occurred 4 weeks after a treatment interruption. Among patients suspending rilonacept, 75% (6/8) experienced recurrence (median time to recurrence, 11.8 weeks [95% CI, 3.7 weeks to not estimable]). There was a 98% reduction in risk of pericarditis recurrence among patients continuing rilonacept treatment after the 18-month decision milestone versus those suspending treatment for observation (hazard ratio, 0.02; P<0.0001).
CONCLUSIONS: In the RHAPSODY long-term extension, continued rilonacept treatment resulted in continued response; treatment suspension at the 18-month decision milestone was associated with pericarditis recurrence.
REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03737110.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:13 |
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| Enthalten in: |
Journal of the American Heart Association - 13(2024), 6 vom: 19. März, Seite e032516 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Imazio, Massimo [VerfasserIn] |
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| Links: |
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| Themen: |
8K80YB5GMG |
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| Anmerkungen: |
Date Completed 20.03.2024 Date Revised 25.04.2024 published: Print-Electronic ClinicalTrials.gov: NCT03737110 Citation Status MEDLINE |
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| doi: |
10.1161/JAHA.123.032516 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM369615387 |
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| 100 | 1 | |a Imazio, Massimo |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Sustained Pericarditis Recurrence Risk Reduction With Long-Term Rilonacept |
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| 500 | |a Date Revised 25.04.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT03737110 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a BACKGROUND: Rilonacept, a once-weekly interleukin-1 alpha and beta cytokine trap, reduced pericarditis recurrence in the phase 3 study, RHAPSODY (Rilonacept Inhibition of Interleukin-1 Alpha and Beta for Recurrent Pericarditis: A Pivotal Symptomatology and Outcomes Study). The RHAPSODY long-term extension further explored recurrent pericarditis natural history and treatment duration decision-making during 24 additional months of open-label rilonacept treatment | ||
| 520 | |a METHODS AND RESULTS: Seventy-four patients commenced the long-term extension, with a median (maximum) total rilonacept duration of 22 (35) months. Individually, 18 months after the most proximal pericarditis recurrence, investigators decided to continue rilonacept on study, suspend rilonacept for off-treatment observation (rescue allowed), or discontinue the study. The annualized incidence of pericarditis recurrence on rilonacept up to the 18-month decision milestone was 0.04 events/patient-year versus 4.4 events/patient-year prestudy while on oral therapies. At the 18-month decision milestone, 64% (33/52) continued rilonacept, 15% (8/52) suspended rilonacept for observation, and 21% (11/52) discontinued the study. Among the 33 patients (1/33; 3.0%) continuing rilonacept (median time to recurrence could not be estimated due to too few events), a single recurrence occurred 4 weeks after a treatment interruption. Among patients suspending rilonacept, 75% (6/8) experienced recurrence (median time to recurrence, 11.8 weeks [95% CI, 3.7 weeks to not estimable]). There was a 98% reduction in risk of pericarditis recurrence among patients continuing rilonacept treatment after the 18-month decision milestone versus those suspending treatment for observation (hazard ratio, 0.02; P<0.0001) | ||
| 520 | |a CONCLUSIONS: In the RHAPSODY long-term extension, continued rilonacept treatment resulted in continued response; treatment suspension at the 18-month decision milestone was associated with pericarditis recurrence | ||
| 520 | |a REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03737110 | ||
| 650 | 4 | |a Clinical Trial | |
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| 650 | 4 | |a rilonacept | |
| 650 | 7 | |a Interleukin-1alpha |2 NLM | |
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| 700 | 1 | |a Klein, Allan L |e verfasserin |4 aut | |
| 700 | 1 | |a Brucato, Antonio |e verfasserin |4 aut | |
| 700 | 1 | |a Abbate, Antonio |e verfasserin |4 aut | |
| 700 | 1 | |a Arad, Michael |e verfasserin |4 aut | |
| 700 | 1 | |a Cremer, Paul C |e verfasserin |4 aut | |
| 700 | 1 | |a Insalaco, Antonella |e verfasserin |4 aut | |
| 700 | 1 | |a LeWinter, Martin M |e verfasserin |4 aut | |
| 700 | 1 | |a Lewis, Basil S |e verfasserin |4 aut | |
| 700 | 1 | |a Lin, David |e verfasserin |4 aut | |
| 700 | 1 | |a Luis, Sushil A |e verfasserin |4 aut | |
| 700 | 1 | |a Nicholls, Stephen J |e verfasserin |4 aut | |
| 700 | 1 | |a Sutej, Paul |e verfasserin |4 aut | |
| 700 | 1 | |a Wasserstrum, Yishay |e verfasserin |4 aut | |
| 700 | 1 | |a Clair, JoAnn |e verfasserin |4 aut | |
| 700 | 1 | |a Agarwal, Indra |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Sheldon |e verfasserin |4 aut | |
| 700 | 1 | |a Paolini, John F |e verfasserin |4 aut | |
| 700 | 0 | |a RHAPSODY Investigators |e verfasserin |4 aut | |
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