Abstract
BackgroundImpact 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.MethodsQualitative 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.ResultsInformation 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).ConclusionThis 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.
Highlights
Pericarditis, or inflammation of the pericardium, has a variety of etiologies but is most commonly referred to as “idiopathic” [1, 2]
While participants were asked to complete the health-related quality of life (HRQoL) questionnaire at multiple timepoints in the clinical trial, the analyses focus on the baseline, (Day 0), end of base treatment period (TP) (Week 6), and Final Visit at end of extension period (EP) timepoints
Qualitative patient interviews Qualitative interviews were conducted via telephone with ten adults diagnosed with recurrent pericarditis (RP) to understand the patient experience of the condition, including the signs, symptoms, and HRQoL impacts
Summary
Pericarditis, or inflammation of the pericardium, has a variety of etiologies but is most commonly referred to as “idiopathic” [1, 2]. Pericarditis is considered recurrent if symptoms and inflammation recur at least 4 weeks after an initial acute episode [1]. Recurrent pericarditis (RP) affects approximately 15–30% of patients who have an acute episode of pericarditis, and up to 50% of patients who experience one recurrence will experience two or more [1]. Empiric “off-label” therapy with nonsteroidal anti-inflammatory drugs [NSAIDs] and colchicine is often used successfully to treat the first pericarditis episode or initial recurrence [3]. 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
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
