ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 0189

Tapering and Discontinuation of Background Therapies During the Transition to Rilonacept Monotherapy in RHAPSODY, a Phase 3 Clinical Trial of Rilonacept in Patients with Recurrent Pericarditis

Antonio Brucato1, Alistair Wheeler2, Sushil A. Luis3, Antonio Abbate4, Paul Cremer5, Fang Fang6, Antonella Insalaco7, Martin LeWinter8, Basil S. Lewis9, David Lin10, Stephen J. Nicholls11, Allan Klein5, Massimo Imazio12 and John F Paolini6, 1Department of Biomedical and Clinical Science, University of Milano, Fatebenefratelli Hospital, Milan, Italy, 2Kiniksa Pharmaceuticals, Ltd., Hamilton, Bermuda, 3Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester, NY, 4VCU Pauley Heart Center, Virginia Commonwealth University, Richmond, VA, 5Department of Cardiovascular Imaging, Center for the Diagnosis and Treatment of Pericardial Diseases, Heart and Vascular Institute, Cleveland Clinic, Cleveland, OH, 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, 10Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, MN, 11MonashHeart, Department of Cardiology, Monash University, Clayton, Australia, 12University 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

Title: Miscellaneous Rheumatic & Inflammatory Diseases Poster I (0183–0209)

Session Type: Poster Session A

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

Background/Purpose: Post-episode tapering of Standard of Care (SoC) medication in patients with recurrent pericarditis (RP) varies considerably. Gradual tapering of corticosteroids (CS) is recommended in ESC guidelines (e.g., decreasing by 1-2.5 mg/day every 2-6 weeks over 1-2 years) to prevent recurrence. We describe successful faster tapering of SoC treatment onto rilonacept monotherapy during RHAPSODY, a Phase 3, placebo-controlled, randomized-withdrawal (RW) trial in RP.

Methods: Patients with acute symptomatic RP despite stable doses of NSAIDs, colchicine, and/or CS in any combination enrolled in a 12-week run-in period in which weekly rilonacept was initiated. After 1-week of stabilization, tapering of CS began at a rate dependent on baseline dose, to be completed by Week 10 for randomization at Week 12 when clinical response was confirmed by reduced pain and normalized CRP levels. Colchicine tapering/discontinuation was initiated no earlier than Week 4. This analysis evaluates time to rilonacept monotherapy in subgroups receiving different combinations of background therapies.

Results: 79 of 86 patients were receiving pharmacotherapy at run-in baseline. Median (95% CI) time to monotherapy (n=79) was 7.9 (7.0-8.1) weeks. Of the patients receiving CS at baseline (41/86 [48%]), 39 (95%) tapered to rilonacept monotherapy, and median time to monotherapy was 7.9 (7.1-8.1) weeks. Of the patients receiving colchicine at baseline (65/86 [76%]), 61 (94%) patients achieved rilonacept monotherapy, and median time to monotherapy was 8.0 (7.1-8.3) weeks. Patients receiving only one SoC therapy achieved rilonacept monotherapy faster (6.1 [0.4-8.1] weeks) than those receiving 2 (8.0 [6.7-9.9] weeks) or 3 (7.7 [7.0-8.3] weeks) therapies. All patients who did not achieve monotherapy had withdrawn from the study for reasons unrelated to pericarditis.

Conclusion: All patients randomized in the RHAPSODY trial discontinued SoC and transitioned to rilonacept monotherapy (median time 7.9 weeks) without a recurrent pericarditis episode during run-in. In patients treated with rilonacept, time to successful discontinuation of SoC, including CS, was substantially shorter than that described in ESC guidelines for pericardial disease (Adler et al. Eur Heart J. 2015;36(42)2921-2964).

Disclosures: A. Brucato, Kiniksa, 12, My institution received funding from Kiniksa as an investigative site to run the study, Sobi, 5, Acarpia, 5; A. Wheeler, Kiniksa Pharmaceuticals, Ltd., 2; S. Luis, Kiniksa, 1, Sobi, 1, 2, Medtronic, 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; P. Cremer, Kiniksa, 5, 12, personal fees, Novartis, 5, Sobi, 12, personal fees; F. Fang, Kiniksa Pharmaceuticals Corp., 3, 11; A. Insalaco, None; M. LeWinter, Kiniksa, 5, 12, personal fees; B. Lewis, Kiniksa, 12, personal fees; D. Lin, Regeneron, 12, fees; 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; 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:

Brucato A, Wheeler A, Luis S, Abbate A, Cremer P, Fang F, Insalaco A, LeWinter M, Lewis B, Lin D, Nicholls S, Klein A, Imazio M, Paolini J. Tapering and Discontinuation of Background Therapies During the Transition to Rilonacept Monotherapy in RHAPSODY, a Phase 3 Clinical Trial of Rilonacept in Patients with Recurrent Pericarditis [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/tapering-and-discontinuation-of-background-therapies-during-the-transition-to-rilonacept-monotherapy-in-rhapsody-a-phase-3-clinical-trial-of-rilonacept-in-patients-with-recurrent-pericarditis/. Accessed .

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