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
Authors: Brucato Antonio , Lim‐Watson Michelle Z. , Klein Allan , Imazio Massimo , Cella David , Cremer Paul , LeWinter Martin M. , Luis Sushil Allen , Lin David , Lotan Dor , Pancrazi Massimo , Trotta Lucia , Klooster Brittany , Litcher‐Kelly Leighann , Zou Liangxing , Magestro Matt , Wheeler Alistair , Paolini John F. , Abbate Antonio , Abo‐Auda Wael , Akhtar Asif , Arad Michael , Atar Shaul , Baibhav Bipul , Bhalla Karan , Brucato Antonio , Collins Sean , Colquhoun David , Cremer Paul , Cross David , Dwivedi Girish , Eisen Alon , Freedberg Nahum , Fuchs Shmuel , Gaddam Eliyazar , Gattorno Marco , Gelfand Eli , Grena Paul , Halabi Majdi , Harris David , Imazio Massimo , Insalaco Antonella , Karim Amin , Klein Allan , Knowlton Kirk , Kontzias Apostolos , Kornberg Robert , Latif Faisal , Leibowitz David , LeWinter Martin , Lin David , Lotan Dor 
Published: October 2022

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.