Burden of Recurrent Pericarditis on Health-Related Quality of Life

LeWinter, Martin M.; Kontzias, Apostolos; Lin, David; Cella, David; DerSarkissian, Maral; Zhou, Mo; Duh, Mei Sheng; Lim-Watson, M.; Magestro, Matt

doi:10.1016/j.amjcard.2020.11.018

Cited by 14 publications

(22 citation statements)

References 22 publications

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“…Recurrent pericarditis (RP) is characterized by painful, debilitating, and unpredictable flares, 1 , 2 , 3 which have a negative impact on health‐related quality of life (HRQoL). 4 , 5 Up to 30% of patients who have a first pericarditis episode will experience a recurrence within 18 months of the initial episode. 6 Interleukin 1 (IL‐1) is a mediator of RP disease pathophysiology, with evidence of systemic inflammation during recurrences (eg, elevated CRP [C‐reactive protein] levels).…”

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confidence: 99%

Interleukin‐1 Trap Rilonacept Improved Health‐Related Quality of Life and Sleep in Patients With Recurrent Pericarditis: Results From the Phase 3 Clinical Trial RHAPSODY

Brucato

Lim-Watson

Klein

et al. 2022

JAHA

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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 symptomatology 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.

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confidence: 99%

Interleukin‐1 Trap Rilonacept Improved Health‐Related Quality of Life and Sleep in Patients With Recurrent Pericarditis: Results From the Phase 3 Clinical Trial RHAPSODY

Brucato

Lim-Watson

Klein

et al. 2022

JAHA

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“…Although generally benign and self-limiting, the risk of various complications and recurrences reached over 30% in affected population under the standard therapies ( 75 ). However, the pathophysiology of pericarditis has remained poorly demonstrated, and therefore only limited drugs was approved for the treatment of acute pericarditis ( 76 ).…”

Section: The Role Of the Nlrp3 Inflammasome In Cardiovascular Diseasesmentioning

confidence: 99%

NLRP3 inflammasome: The rising star in cardiovascular diseases

Zheng

Dong

et al. 2022

Front. Cardiovasc. Med.

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Cardiovascular diseases (CVDs) are the prevalent cause of mortality around the world. Activation of inflammasome contributes to the pathological progression of cardiovascular diseases, including atherosclerosis, abdominal aortic aneurysm, myocardial infarction, dilated cardiomyopathy, diabetic cardiomyopathy, heart failure, and calcific aortic valve disease. The nucleotide oligomerization domain-, leucine-rich repeat-, and pyrin domain-containing protein 3 (NLRP3) inflammasome plays a critical role in the innate immune response, requiring priming and activation signals to provoke the inflammation. Evidence shows that NLRP3 inflammasome not only boosts the cleavage and release of IL-1 family cytokines, but also leads to a distinct cell programmed death: pyroptosis. The significance of NLRP3 inflammasome in the CVDs-related inflammation has been extensively explored. In this review, we summarized current understandings of the function of NLRP3 inflammasome in CVDs and discussed possible therapeutic options targeting the NLRP3 inflammasome.

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“…While the impact of RP on patients' health-related quality of life (HRQoL) has been reported in the literature [7][8][9][10][11][12] and is thought to be due to the primary symptom of the condition (e.g., chest pain) and the resulting uncertainty and anxiety about new recurrences, impact on HRQoL has not been explicitly evaluated in previous clinical research. In addition, corticosteroids (CS), despite well-known warnings and precautions in patients with cardio-metabolic comorbidities, are widely used to treat RP [13], putting patients at risk for additional adverse events, including recurrence and steroid dependence [14]; comorbidities associated with chronic CS use may also lead to adverse impacts on HRQoL [15,16].…”

Section: Introductionmentioning

confidence: 99%

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

Lin

Klein

Cella

et al. 2021

BMC Cardiovasc Disord

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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.

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Burden of Recurrent Pericarditis on Health-Related Quality of Life

Cited by 14 publications

References 22 publications

Interleukin‐1 Trap Rilonacept Improved Health‐Related Quality of Life and Sleep in Patients With Recurrent Pericarditis: Results From the Phase 3 Clinical Trial RHAPSODY

Interleukin‐1 Trap Rilonacept Improved Health‐Related Quality of Life and Sleep in Patients With Recurrent Pericarditis: Results From the Phase 3 Clinical Trial RHAPSODY

NLRP3 inflammasome: The rising star in cardiovascular diseases

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

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