• V.Yu. Myachikova
  • A.L. Maslyanskiy
  • O.M. Moiseeva
  • M.L. Schedrova
  • A.N. Egorova
  • E.G. Ponomar
  • M.Yu. Samsonov
Aim. To evaluate the long-term safety and efficacy of goflkicept treatment in patients with idiopathic recurrent pericarditis (IRP). Materials and methods. This report presents the interim analysis of an ongoing open-label extension (OLE) clinical trial of goflkicept in patients with IRP (NCT 05673902), as a continuation of the core study (NCT04692766). The study assessed the frequency of pericarditis recurrence, time to recurrence after 12 and 60 weeks of goflkicept therapy, changes in C-reactive protein level, chest pain intensity, pericardial effusion size, and adverse events (AEs). Results. All patients remained in clinical-laboratory remission during the 60 weeks of goflkicept treatment. The recurrence frequency was 31.3% (5/16) after 60 weeks and 90% (9/10) after 12 weeks of goflkicept treatment (p<0.001). A total of 64 AEs were reported in 16 patients (94.1%), mostly of mild to moderate severity. The most common AEs were infections, occurring in 11 patients (64.7%). Nine serious adverse events were reported in 5 patients, none of which were considered drug-related. There were no deaths. Conclusion. Long-term goflkicept therapy resulted in a significant reduction in the risk of recurrence and prolonged remission without an increase in adverse events. © 2024 Consilium MediCum. All rights reserved.
Язык оригиналарусский
Страницы (с-по)892-900
Число страниц9
ЖурналTerapevticheskii Arkhiv
Том96
Номер выпуска9
DOI
СостояниеОпубликовано - 10 окт 2024

    Области исследований

  • goflikicept, idiopathic recurrent pericarditis, interleukin-1 inhibitors, RPH-104

ID: 126463161