Long-term goflkicept therapy for patients with idiopathic recurrent pericarditis: results of the interim analysis of an ongoing open-label extension study
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 0567...
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| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | Russian |
| Published: |
"Consilium Medicum" Publishing house
2024-10-01
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| Series: | Терапевтический архив |
| Subjects: | |
| Online Access: | https://ter-arkhiv.ru/0040-3660/article/viewFile/634806/pdf |
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| Summary: | 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 (p0.001). 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. |
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| ISSN: | 0040-3660 2309-5342 |