ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 0162

Cardiac Magnetic Resonance Imaging for Guiding Decision-making on Treatment Duration: Data from RHAPSODY, a Phase 3 Clinical Trial of Rilonacept in Recurrent Pericarditis

Paul Cremer1, David Lin2, Alistair Wheeler3, Antonio Abbate4, Antonio Brucato5, Fang Fang6, Antonella Insalaco7, Martin LeWinter8, Basil S. Lewis9, Sushil A. Luis10, Stephen J. Nicholls11, John Petersen12, Allan Klein1, Massimo Imazio13 and John F Paolini6, 1Department of Cardiovascular Imaging, Center for the Diagnosis and Treatment of Pericardial Diseases, Heart and Vascular Institute, Cleveland Clinic, Cleveland, OH, 2Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, MN, 3Kiniksa Pharmaceuticals, Ltd., Hamilton, Bermuda, 4VCU Pauley Heart Center, Virginia Commonwealth University, Richmond, VA, 5Department of Biomedical and Clinical Science, University of Milano, Fatebenefratelli Hospital, Milan, Italy, 6Kiniksa Pharmaceuticals Corp., Lexington, MA, 7Department of Pediatric Medicine, Division of Rheumatology, Bambino Gesù Children's Hospital, Rome, Italy, 8Cardiology Unit, The University of Vermont Medical Center, The University of Vermont, Burlington, VT, 9Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center, Haifa, Israel, 10Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester, NY, 11MonashHeart, Department of Cardiology, Monash University, Clayton, Australia, 12Swedish Medical Center, Seattle, WA, 13University Cardiology, Cardiovascular and Thoracic Department, AOU Città della Salute e della Scienza di Torino, Torino, Italy

Meeting: ACR Convergence 2021

Keywords: , , , ,

Session Information

Date: Saturday, November 6, 2021

Session Title: Imaging of Rheumatic Diseases Poster (0149–0182)

Session Type: Poster Session A

Session Time: 8:30AM-10:30AM

Background/Purpose: The magnitude of pericardial delayed hyperenhancement (DHE) by cardiac magnetic resonance imaging (CMR) illustrates the severity of inflammation in pericarditis. We hypothesized that patients with more severe DHE at baseline may experience earlier recurrence of pericardial disease after interruption of pharmacotherapy that had led to clinical response.

Methods: RHAPSODY is a phase 3 randomized withdrawal (RW) trial of rilonacept, an Interleukin-1α and 1β trap, in patients with recurrent pericarditis (RP) presenting with acute symptoms despite standard of care. Following a run-in period of 12 weeks of rilonacept treatment, clinical responders on rilonacept monotherapy were randomized 1:1 to placebo or continued rilonacept in a double-blind RW period. CMR was collected at baseline prior to rilonacept initiation in 25/86 patients, of whom 14 were later randomized to placebo in the RW period. CMRs were graded (none, trace, mild, moderate, severe, or not measurable) by a central imaging laboratory. We analyzed the baseline CMR data in the context of time to recurrence after randomization.

Results: 25 patients had CMR at baseline: 8% trace, 28% mild, 20% moderate, and 44% severe DHE. In patients randomized to placebo with moderate or severe DHE at baseline, 71.4% experienced a recurrence, with a median time to recurrence of 4.2 weeks. In patients randomized to placebo with trace or mild DHE at baseline, 71.4% experienced a recurrence, but with a longer median time to recurrence of 10.7 weeks after randomization. In patients with CMR at baseline randomized to receive continued rilonacept, none experienced a recurrence during the RW period; 82% had moderate or severe DHE at baseline.

Conclusion: These data support the hypothesis that more severe pericardial DHE at baseline may be associated with shorter time to pericarditis recurrence after interruption of rilonacept therapy. There is growing evidence that the assessment of DHE in the broader context of the evaluation of patients with recurrent pericarditis could be a helpful adjunct for determining treatment duration in affected patients.

Disclosures: P. Cremer, Kiniksa, 5, 12, personal fees, Novartis, 5, Sobi, 12, personal fees; D. Lin, Regeneron, 12, fees; A. Wheeler, Kiniksa Pharmaceuticals, Ltd., 2; A. Abbate, Kiniksa, 5, Olatec, 5, 12, personal fees, Serpin, 5, 12, personal fees, Novartis, 5, 12, personal fees, Novo-Nordisk, 12, personal fees, Cromos Pharma, 12, personal fees, Janssen, 5, 12, personal fees; A. Brucato, Kiniksa, 12, My institution received funding from Kiniksa as an investigative site to run the study, Sobi, 5, Acarpia, 5; F. Fang, Kiniksa Pharmaceuticals Corp., 3, 11; A. Insalaco, None; M. LeWinter, Kiniksa, 5, 12, personal fees; B. Lewis, Kiniksa, 12, personal fees; S. Luis, Kiniksa, 1, Sobi, 1, 2, Medtronic, 2; S. Nicholls, Kiniksa, 5, 12, personal fees, AstraZeneca, 2, 5, Amgen, 5, Anthera, 2, 5, Eli Lilly, 2, 5, Esperion, 2, 5, Novartis, 5, Cerenis, 5, The Medicines Company, 5, Resverlogix, 2, 5, InfraReDx, 5, Roche, 5, Sanofi-Regeneron, 2, 5, Liposcience, 5, Akcea, 2, Omthera, 2, Merck, 2, Takeda, 2, CSL Behring, 2, Boehringer Ingelheim, 2; J. Petersen, None; A. Klein, Kiniksa, 1, 5, Sobi, 1, Pfizer, 1; M. Imazio, Kiniksa, 1, Sobi, 1; J. Paolini, Kiniksa Pharmaceuticals Corp., 2, 10, 11.

To cite this abstract in AMA style:

Cremer P, Lin D, Wheeler A, Abbate A, Brucato A, Fang F, Insalaco A, LeWinter M, Lewis B, Luis S, Nicholls S, Petersen J, Klein A, Imazio M, Paolini J. Cardiac Magnetic Resonance Imaging for Guiding Decision-making on Treatment Duration: Data from RHAPSODY, a Phase 3 Clinical Trial of Rilonacept in Recurrent Pericarditis [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 10). https://acrabstracts.org/abstract/cardiac-magnetic-resonance-imaging-for-guiding-decision-making-on-treatment-duration-data-from-rhapsody-a-phase-3-clinical-trial-of-rilonacept-in-recurrent-pericarditis/. Accessed July 4, 2022.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/cardiac-magnetic-resonance-imaging-for-guiding-decision-making-on-treatment-duration-data-from-rhapsody-a-phase-3-clinical-trial-of-rilonacept-in-recurrent-pericarditis/