12 Jun rhapsody trial pericarditis

Currently, there are no FDA approved therapies for pericarditis. The trial was conducted in Australia, Israel, Italy, and the United States. An accurate diagnosis of recurrent pericarditis, possibly supported by advanced imaging tools, is critical to provide timely and appropriate treatment of symptoms and prevention of further episodes. Targeting interleukin-1 (IL-1) may represent a paradigm shift in the treatment of patients with recurrent pericarditis, suggest results from the phase 3 RHAPSODY trial presented at the virtual 2020 Scientific Sessions of the American Heart Association (AHA) and published simultaneously in the New England Journal of Medicine. For the RHAPSODY trial, researchers randomly assigned patients with acute symptoms of recurrent pericarditis and elevated C-reactive protein levels to … This treatment is an IV injection which works to block IL-1a and IL-1B signaling. In patients with symptomatic recurrent pericarditis failing standard of care, addition of the interleukin (IL) 1α/1β inhibitor rilonacept resolved pericarditis episodes in the RHAPSODY trial. Further Proof. The commercial launch is expected in April 2021.The FDA approval of Arcalyst in recurrent pericarditis follows positive data from RHAPSODY, a pivotal Phase III trial of Arcalyst in recurrent pericarditis. Background/Purpose: Recurrent pericarditis (RP) is characterized by the recurrence of pericarditis signs and symptoms after a symptom-free period of ≥4 to 6 weeks and affects 20-30 % of acute pericarditis patients. About RHAPSODY RHAPSODY is the ongoing, pivotal Phase 3 clinical trial in recurrent pericarditis utilizing rilonacept. Secondarily, monotherapy rilonacept reduced the risk of pericarditis recurrence by 96%. The company expects that at least 50 patients will be randomized into the RW period. RHAPSODY, a double-blind, placebo-controlled, randomized-withdrawal (RW) pivotal Phase 3 trial (NCT03737110), enrolls patients 12 years or older presenting with at least a third pericarditis episode, pericarditis pain score ≥4 (11-point numeric rating scale [NRS]), and C … Results of this pivotal phase 3 trial suggest the interleukin-1 trap rilonacept may soon change that. Trial Design. The Rhapsody global Phase 3 clinical trial studied 61 patients with recurrent pericarditis, who were randomized to rilonacept or placebo. The RHAPSODY trial showed that an interleukin 1-α and 1-β inhibitor was superior to placebo in reducing recurrent pericarditis. The regulatory submission was based on positive data from RHAPSODY, a pivotal Phase 3 trial of rilonacept in recurrent pericarditis. This trial sought to understand the safety, efficacy, and tolerability of Rilonacept for patients with recurrent pericarditis. Objective Recurrent pericarditis (RP) incurs significant morbidity. Recent data suggest a potential role for anti-interleukin-1 (IL-1) agents for this condition. Kiniksa Pharmaceuticals reported positive data from RHAPSODY, a pivotal Phase 3 trial of rilonacept, a weekly, subcutaneously-injected, recombinant fusion protein, in recurrent pericarditis.RHAPSODY met its prespecified primary and all major secondary efficacy endpoints. Klein AL, Imazio M, Brucato A, et al. RHAPSODY is the ongoing, pivotal Phase 3 clinical trial in recurrent pericarditis utilizing rilonacept. ‘Recurring pericarditis is painful and can be debilitating. RHAPSODY was a phase 3, multicenter, double-blind, "randomized-withdrawal" trial of rilonacept vs placebo in patients with acute symptoms of recurrent pericarditis and systemic inflammation. Anti-inflammatories and steroids- often with harsh side effects- are used to treat the condition. Up to 30% have a recurrent episode. PHASE 3 RHAPSODY TRIAL. Pericarditis. Trial details were: It was a pivotal Phase 3 trial of ARCALYST in recurrent pericarditis. Methods: RHAPSODY is a double-blind, placebo-controlled, randomized-withdrawal trial; ∼50 patients will be enrolled (Figure). Rilonacept monotherapy reduced the risk of pericarditis recurrence by 96%. The subcutaneous drug therapy prevents IL-1α and IL-1β signaling. We reported data from RHAPSODY, a global, randomized withdrawal (RW) design, pivotal Phase 3 clinical trial of rilonacept in recurrent pericarditis in June 2020. Kiniksa to Present Data on the Burden of Disease in Patients with Recurrent Pericarditis at the International Society for. Am Heart J … Kiniksa reported positive data from RHAPSODY, a global, randomized withdrawal design, pivotal Phase 3 clinical trial of rilonacept in recurrent pericarditis. RHAPSODY met its prespecified primary endpoint of time-to-first adjudicated pericarditis recurrence in the randomized withdrawal period and all major secondary efficacy endpoints with statistical significance. Eligible patients presented at screening with at least a third pericarditis episode, defined as at least 1 day with pericarditis pain of ≥ 4 on the 11-point NRS and a CRP value ≥ 1 mg/dL within the 7-day period prior to first study drug administration. Researchers enrolled 86 patients with symptomatic pericarditis recurrence. Rilonacept received both Breakthrough Therapy and Orphan Drug designations for pericarditis treatment. Recurrent pericarditis is a true challenge for clinicians, especially when the patient becomes unresponsive or not tolerant to conventional treatments. Developed by Regeneron Pharmaceuticals, rilonacept (ARCALYST) is currently approved for the treatment of cryopyrin-associated periodic syndromes, or cryoprin-associated auto inflammatory syndromes ( CAPS ). The trial seeks to test the efficacy of the drug candidate in treating recurrent pericarditis. RHAPSODY met its prespecified primary endpoint of time-to-first adjudicated pericarditis recurrence in the randomized withdrawal period and all major secondary efficacy endpoints with statistical significance. RHAPSODY is a global, randomized withdrawal design, pivotal Phase 3 clinical trial of rilonacept in recurrent pericarditis. RHAPSODY: rationale for and design of a pivotal phase 3 trial to assess efficacy and safety of rilonacept, an interleukin-1α and interleukin-1β trap, in patients with recurrent pericarditis. The pericardium is a thin membrane around your heart. 1 It aimed to investigate rilonacept in patients with recurrent pericarditis. Methods: RHAPSODY is a double-blind, placebo-controlled, randomized-withdrawal trial; ∼50 patients will be enrolled (Figure). The FDA approval of ARCALYST in recurrent pericarditis follows positive data from RHAPSODY, a pivotal Phase 3 trial of ARCALYST in recurrent pericarditis. All patients initially received Arcalyst for 12 weeks. RHAPSODY was a double-blind, event-driven, randomized-withdrawal trial that included patients with acute symptoms of recurrent pericarditis and … The trial is investigating the use of rilonacept, an IL-1α And IL-1β trap, in resolving and reducing the risk of recurrence in patients with recurrent pericarditis. RHAPSODY: Rationale for and design of a pivotal Phase 3 trial to assess efficacy and safety of rilonacept, an interleukin-1α and interleukin-1β trap, in patients with recurrent pericarditis. RHAPSODY: Rationale for and design of a pivotal Phase 3 trial to assess efficacy and safety of rilonacept, an interleukin-1α and interleukin-1β trap, in patients with recurrent pericarditis. RHAPSODY is the global, randomized withdrawal design, pivotal Phase 3 clinical trial of rilonacept in recurrent pericarditis. RHAPSODY met … RHAPSODY met its prespecified primary and all major secondary efficacy endpoints. Reprinted with permission from Klein AL, Imazio M, Brucato A, et al. The trial was unique because it utilized a randomized withdrawal design. Cleveland Clinic led trial shows drug effective in 96% of patients with recurrent pericarditis Pericarditis can be caused by a viral infection … RHAPSODY is a global, randomized withdrawal design, pivotal Phase 3 clinical trial. Kiniksa will host a conference call and webcast at 5:30 p.m. Eastern Time on Thursday, March 18, 2021 to discuss the FDA approval of ARCALYST for recurrent pericarditis… Trial shows drug effective in 96% of patients with recurrent pericarditis.

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