Abstract 241: Health-related Quality of Life in Patients With Recurrent Pericarditis: Results From a Phase 2 Study of Rilonacept

Abstract

Background: Recurrent pericarditis (RP) episodes and conventional treatments result in morbidity, but the impact on patient health-related quality of life (HRQoL) has not been quantified. The Phase 2 trial NCT03980522 of rilonacept (IL-1α/IL-1β inhibitor) evaluated HRQoL. Methods: Patients with active RP who were symptomatic at Baseline (A-RP, n=16) and RP patients who were not currently experiencing a recurrence but were corticosteroid-dependent at Baseline (CSD-RP, n=9) were enrolled. All received rilonacept weekly for 6 weeks to end of base treatment period (TP) plus an optional 18-week extension treatment period (EP). Corticosteroid tapering occurred in the EP. Physical and mental HRQoL (PROMIS Global Health v1.2 Physical and Mental Component Scores [PCS/MCS]) were assessed at baseline and follow-up. Results: Figure 1 presents the PROMIS PCS/MCS and pain scale scores (both patient-reported) as well as C-reactive protein levels over time. Mean PCS/MCS scores at baseline were 39.9/44.5 and 43.3/46.5 for A-RP and CSD-RP groups respectively (versus the norm mean of 50). In A-RP, PCS/MCS scores improved by 11.4/5.6 points by end of base TP, and this improvement was sustained throughout the EP (increase of 11.4/6.0 points from baseline at end of EP). In CSD-RP, PCS/MCS scores increased by 1.8/1.4 points by end of TP and improved by 3.5/4.2 points at end of study, after tapering or discontinuation of corticosteroid without disease recurrence. Conclusion: Impaired baseline HRQoL suggests negative impact of RP. For A-RP, rilonacept rapidly improved pericarditis signs and symptoms which was associated with HRQoL improvements. For CSD-RP, rilonacept supported tapering/withdrawal of corticosteroids without recurrence, with maintained/improved HRQoL. These results suggest rilonacept can improve RP patient HRQoL while providing an alternative to corticosteroids.

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

“…These findings align with prior research that has documented the substantial burden of the condition. 4 , 5 …”

“…The burden of RP on patients' HRQoL has been reported previously, including in a real‐world patient survey 4 and in the Phase 2 clinical trial of rilonacept using the PROMIS Global Health questionnaire. 4 , 5 This is further demonstrated in RHAPSODY using the SF‐36v2, and expanded to include evaluations for changes in sleep impact with the ISI, as well as general health using the EQ VAS and EQ‐5D‐5L Utility Index and pericarditis symptom severity using the PGIPS and Pericarditis Pain NRS. Furthermore, the negative impact of recurrences in patients with RP is substantial, and the magnitude of the change in HRQoL while on rilonacept is notably larger than demonstrated in prior research for other cardiovascular conditions.…”

“…The PRO questionnaires included in RHAPSODY were informed by qualitative research, including interviews with adults with RP, to develop a patient‐centric conceptual model of RP. 5 , 12 Results from this qualitative research provided insight into the patient experience, notably the symptoms associated with RP and also the impacts, including impacts on sleep, physical functioning, emotional functioning, and other domains of quality of life. 12 All PRO questionnaires, with the exception of the daily pericarditis pain assessment, were completed by participants at clinic visits before clinician interaction.…”

“…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).…”

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

“…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].…”