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Clinical Trial
. 2023 Jul 4;82(1):30-40.
doi: 10.1016/j.jacc.2023.04.046.

Treatment of Idiopathic Recurrent Pericarditis With Goflikicept: Phase II/III Study Results

Valentina Yu Myachikova  1 , Alexey L Maslyanskiy  2 , Olga M Moiseeva  3 , Oksana V Vinogradova  4 , Ekaterina V Gleykina  5 , Yan Lavrovsky  6 , Antonio Abbate  7 , Sergey A Grishin  8 , Alina N Egorova  8 , Margarita L Schedrova  8 , Mikhail Yu Samsonov  8
Affiliations
Free article
Clinical Trial

Treatment of Idiopathic Recurrent Pericarditis With Goflikicept: Phase II/III Study Results

Valentina Yu Myachikova et al. J Am Coll Cardiol. .
Free article

Abstract

Background: Idiopathic recurrent pericarditis (IRP) is a rare autoinflammatory disease. Interleukin (IL)-1α and IL-1β are the pivotal cytokines in the pathophysiology of acute pericarditis and its recurrence. We created a phase II/III study with a new IL-1 inhibitor-goflikicept in IRP.

Objectives: This study sought to evaluate the efficacy and safety of goflikicept treatment in patients with IRP.

Methods: We conducted a 2-center open-label study of goflikicept in patients with IRP with and without recurrence at time of enrollment. The study consisted of 4 periods: screening, run-in (open-label treatment period), randomized withdrawal, and follow-up. Patients with clinical response to goflikicept in the run-in period were randomized (1:1) to a placebo-controlled withdrawal period, where the time to first pericarditis recurrence (primary endpoint) was evaluated.

Results: We enrolled 22 patients, and 20 of these patients were randomized. Reduction of C-reactive protein level accompanied by reduction of chest pain and pericardial effusion compared to baseline was demonstrated during the run-in period. Recurrence of pericarditis occurred in 9 of 10 patients in the placebo group, and there were no recurrence events in goflikicept group within 24 weeks after randomization (P < 0.001). A total of 122 adverse events were reported in 21 patients (95.5%), with no deaths and no new safety signals identified for goflikicept.

Conclusions: Treatment with goflikicept prevented recurrences and maintained IRP remission with a favorable risk-benefit ratio. Goflikicept reduced the risk of recurrence compared with placebo. (Study to Evaluate the Efficacy and Safety of RPH-104 Treatment in Patients With Idiopathic Recurrent Pericarditis; NCT04692766).

Keywords: autoinflammatory diseases; biologics; inflammation; interleukin-1 inhibitor.

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Conflict of interest statement

Funding Support and Author Disclosures The study was funded by R-Pharm International. The funder, R-Pharm, participated in the design and conduct of the study, in the collection, analysis, and interpretation of the data, and in the preparation, review, and approval of the manuscript. Dr Myachikova has received speaker fees from Novartis and Sobi. Dr Maslyanskiy has served as a consultant for R-Pharm. Dr Moiseeva has received speaker fees from Bayer, Janssen, and Pfizer. Dr Vinogradova has received speaker fees from AstraZeneca. Dr Gleykina has received speaker fees from Bayer, Johnson and Johnson, AstraZeneca, and Pfizer. Dr Lavrovsky is an employee of R-Pharm Overseas Inc. Drs Grishin, Egorova, Schedrova, and Samsonov are employees of R-Pharm JSC. Dr Abbate has served as a consultant to Applied Clinical Intel, AstraZeneca, Cardiol, Effetti s.r.l, Eli Lilly, Implicit Biosciences, Janssen Pharmaceuticals, Kiniksa, Novo Nordisk, Olatec, R-Pharma, Sanofi, and Serpin Pharma. Dr Samsonov has reported that he has no relationships relevant to the contents of this paper to disclose.

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