Long-term goflkicept therapy for patients with idiopathic recurrent pericarditis: results of the interim analysis of an ongoing open-label extension study DOI Creative Commons
V. Yu. Myachikova, А. L. Maslyanskiy, О. М. Моисеева

et al.

Terapevticheskii arkhiv, Journal Year: 2024, Volume and Issue: 96(09), P. 892 - 900

Published: Oct. 10, 2024

Aim. To evaluate the long-term safety and efficacy of goflkicept treatment in patients with idiopathic recurrent pericarditis (IRP). Materials methods. This report presents interim analysis an ongoing open-label extension (OLE) clinical trial IRP (NCT 05673902), as a continuation core study (NCT04692766). The assessed frequency recurrence, time to recurrence after 12 60 weeks therapy, changes C-reactive protein level, chest pain intensity, pericardial effusion size, adverse events (AEs). Results. All remained clinical-laboratory remission during treatment. was 31.3% (5/16) 90% (9/10) (p0.001). A total 64 AEs were reported 16 (94.1%), mostly mild moderate severity. most common infections, occurring 11 (64.7%). Nine serious 5 patients, none which considered drug-related. There no deaths. Conclusion. Long-term therapy resulted significant reduction risk prolonged without increase events.

Language: Английский

Long-term goflkicept therapy for patients with idiopathic recurrent pericarditis: results of the interim analysis of an ongoing open-label extension study DOI Creative Commons
V. Yu. Myachikova, А. L. Maslyanskiy, О. М. Моисеева

et al.

Terapevticheskii arkhiv, Journal Year: 2024, Volume and Issue: 96(09), P. 892 - 900

Published: Oct. 10, 2024

Aim. To evaluate the long-term safety and efficacy of goflkicept treatment in patients with idiopathic recurrent pericarditis (IRP). Materials methods. This report presents interim analysis an ongoing open-label extension (OLE) clinical trial IRP (NCT 05673902), as a continuation core study (NCT04692766). The assessed frequency recurrence, time to recurrence after 12 60 weeks therapy, changes C-reactive protein level, chest pain intensity, pericardial effusion size, adverse events (AEs). Results. All remained clinical-laboratory remission during treatment. was 31.3% (5/16) 90% (9/10) (p0.001). A total 64 AEs were reported 16 (94.1%), mostly mild moderate severity. most common infections, occurring 11 (64.7%). Nine serious 5 patients, none which considered drug-related. There no deaths. Conclusion. Long-term therapy resulted significant reduction risk prolonged without increase events.

Language: Английский

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