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

Abstract Background Impact of recurrent pericarditis (RP) on patient health-related quality life (HRQoL) was evaluated through qualitative interviews and as an exploratory endpoint in a Phase 2 trial evaluating the efficacy safety rilonacept (IL-1?/IL-1? cytokine trap) to treat RP. Methods Qualitative were conducted with ten adults RP understand symptoms HRQoL impacts, 10-item Patient-Reported Outcomes Measurement Information System Global Health (PROMIS GH) v1.2 determine questionnaire coverage experience. The enrolled participants active symptomatic (A-RP, n = 16) corticosteroid-dependent no recurrence at baseline (CSD-RP, 9). All received weekly during 6-week base treatment period (TP) plus optional 18-week extension (EP). Tapering concomitant medications, including corticosteroids (CS), permitted EP. assessed using PROMIS GH, patient-reported pain blood levels c-reactive protein (CRP) collected Baseline follow-up periods. A secondary, descriptive analysis results completed measures characterize both impact effect rilonacept. Results from demonstrated that GH concepts are relevant From trial, participant groups showed impacted (mean Physical [GPH] Mental [GMH], lower than population norm average). In A-RP, GPH/MPH improved by end TP sustained EP (similar trends observed for CRP). Similarly, CSD-RP, further EP, CS tapering or discontinuation, without disease (low scores CRP continued EP). Conclusion This is first study demonstrating impaired Rilonacept associated improvements scores. Maintained/improved tapering/withdrawal suggests may provide alternative CS. Trial registration : ClinicalTrials.Gov; NCT03980522; 5 June 2019, retrospectively registered; https://clinicaltrials.gov/ct2/show/NCT03980522 .