Kiniksa Pharmaceuticals, Ltd. (NASDAQ:KNSA) (“Kiniksa”), a biopharmaceutical company with a pipeline of assets designed to modulate immunological pathways across a spectrum of diseases, today announced that data from RHAPSODY, the pivotal Phase 3 trial of rilonacept in recurrent pericarditis, were published in The New England Journal of Medicine. Additionally, the RHAPSODY data were presented at the late-breaking science session during the American Heart Association (AHA) Scientific Sessions 2020. Kiniksa previously reported positive top-line RHAPSODY results in June 2020. Rilonacept is a weekly, subcutaneously-injected, recombinant fusion protein that blocks interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) signaling.
The manuscript entitled Phase 3 Trial of Interleukin-1 Trap Rilonacept in Recurrent Pericarditis, is available on The New England Journal of Medicine website with open access for seven days.
The AHA presentation entitled RHAPSODY: Rilonacept an IL-1α and IL-1β Trap Resolves Pericarditis Episodes and Reduces Risk of Recurrence in a Phase 3 Trial of Patients with Recurrent Pericarditis was presented virtually by Allan Klein, MD, of Cleveland Clinic, co-principal investigator of the study and compensated member of a 2019 Kiniksa scientific advisory committee. Massimo Imazio, MD, of the University of Torino, Italy, is co-principal investigator.
“Recurrent pericarditis is a debilitating autoinflammatory disease with a clear unmet need,” said Dr. Klein. “Data were reported which showed that patients treated with rilonacept experienced a 96% reduction in risk of recurrent pericarditis events. Furthermore, in acutely symptomatic patients who were failing standard management, rilonacept treatment in the study provided rapid and sustained reductions in pain and C-reactive protein as soon as after the first dose. These data suggest that targeted immunomodulation with rilonacept may signal a paradigm shift in the management of patients with recurrent pericarditis.”
In RHAPSODY, the primary efficacy endpoint of time-to-first adjudicated pericarditis recurrence in the randomized withdrawal period was highly statistically significant (Hazard Ratio = 0.04, p<0.0001). Additionally, annualized incidence of pericarditis recurrence decreased from 4.42 episodes per year prior to the study to 0.15 episodes per year while on rilonacept treatment. All major secondary endpoints were also highly statistically significant.
Rilonacept was well-tolerated in the study, with adverse events consistent with the U.S. Food and Drug Administration (FDA)-approved label for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS). The most common adverse events were injection site reactions and upper respiratory tract infections. There were no drug-related serious adverse events.