HAMILTON, Bermuda, Aug. 31, 2020 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (“Kiniksa”), a biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutic medicines for patients with significant unmet medical need, presented findings from a real-world patient survey assessing the substantial impact of recurrent pericarditis on health-related quality of life at ESC Congress 2020, the annual meeting of the European Society of Cardiology.
“The results of the patient survey highlight the severe and complex impact of recurrent pericarditis on both physical and mental quality of life. Furthermore, this study highlights the unmet need for a therapy that can rapidly resolve pericarditis episodes with the potential to prevent future recurrences,” said Qasim Rizvi, Chief Commercial Officer and SVP of Operations at Kiniksa. “The pivotal Phase 3 trial of rilonacept in recurrent pericarditis demonstrated a high degree of statistical significance on the primary and all major secondary endpoints, therefore we plan to submit an sBLA to the FDA in recurrent pericarditis this year. In preparation for commercialization we are continuing to generate additional evidence on the burden of recurrent pericarditis and also increasing disease awareness among payers, physicians and advocacy groups. We look forward to bringing this potential treatment to patients as soon as possible.”
Martin LeWinter, MD, Larner College of Medicine, University of Vermont, was the lead author of the virtual poster Clinical Characteristics and Health-Related Quality of Life of Patients with Recurrent Pericarditis in the United States: Findings from a Patient Survey. The materials are available through the Science section of Kiniksa’s website (www.Kiniksa.com).
“This study represents the first real-world analysis of patient-reported health-related quality of life in recurrent pericarditis,” said Martin LeWinter, MD, Larner College of Medicine, University of Vermont. “Quantifying the impact of recurrent pericarditis on important health-related quality of life measures, including physical and emotional well-being, has enabled a more complete appreciation of the overall burden of recurrent pericarditis. For example, we found that pericarditis pain significantly impacts the ability to work, to be with family members, and to sleep for many patients at a level greater than that reported for many other debilitating diseases. These insights can help clinicians and patients evaluate treatment options and ultimately may contribute to improving outcomes.”
Kiniksa reported positive data from RHAPSODY, a global, randomized withdrawal design, pivotal Phase 3 clinical trial of rilonacept in recurrent pericarditis. RHAPSODY showed that rilonacept improved clinically meaningful outcomes associated with the unmet medical need in recurrent pericarditis for patients in the study. The primary efficacy endpoint of time-to-first adjudicated pericarditis recurrence in the randomized withdrawal period was highly statistically significant: rilonacept treatment resulted in a 96% reduction in risk of recurrent pericarditis events (Hazard Ratio = 0.04, p