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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| Format: | Article |
| Language: | Russian |
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"Consilium Medicum" Publishing house
2024-10-01
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| Series: | Терапевтический архив |
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| Online Access: | https://ter-arkhiv.ru/0040-3660/article/viewFile/634806/pdf |
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| author | Valentina Yu. Myachikova Alexey L. Maslyanskiy Olga M. Moiseeva Margarita L. Schedrova Alina N. Egorova Еkaterina G. Ponomar Mikhail Yu. Samsonov |
| author_facet | Valentina Yu. Myachikova Alexey L. Maslyanskiy Olga M. Moiseeva Margarita L. Schedrova Alina N. Egorova Еkaterina G. Ponomar Mikhail Yu. Samsonov |
| author_sort | Valentina Yu. Myachikova |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-b05eb9ec1ac34696b30bb4daa7622294 |
| institution | OA Journals |
| issn | 0040-3660 2309-5342 |
| language | Russian |
| publishDate | 2024-10-01 |
| publisher | "Consilium Medicum" Publishing house |
| record_format | Article |
| series | Терапевтический архив |
| spelling | doaj-art-b05eb9ec1ac34696b30bb4daa76222942025-08-20T02:11:58Zrus"Consilium Medicum" Publishing houseТерапевтический архив0040-36602309-53422024-10-01960989290010.26442/00403660.2024.09.20298478610Long-term goflkicept therapy for patients with idiopathic recurrent pericarditis: results of the interim analysis of an ongoing open-label extension studyValentina Yu. Myachikova0https://orcid.org/0000-0002-7590-742XAlexey L. Maslyanskiy1https://orcid.org/0000-0003-2427-4148Olga M. Moiseeva2https://orcid.org/0000-0002-7817-3847Margarita L. Schedrova3https://orcid.org/0009-0002-4660-913XAlina N. Egorova4https://orcid.org/0000-0002-0405-9590Еkaterina G. Ponomar5https://orcid.org/0009-0009-9779-0507Mikhail Yu. Samsonov6https://orcid.org/0000-0003-2685-1623Almazov National Medical Research CentreAlmazov National Medical Research CentreAlmazov National Medical Research CentreR-Pharm JSCR-Pharm JSCR-Pharm JSCR-Pharm JSCAim. 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.https://ter-arkhiv.ru/0040-3660/article/viewFile/634806/pdfidiopathic recurrent pericarditisinterleukin-1 inhibitorsrph-104goflikicept |
| spellingShingle | Valentina Yu. Myachikova Alexey L. Maslyanskiy Olga M. Moiseeva Margarita L. Schedrova Alina N. Egorova Еkaterina G. Ponomar Mikhail Yu. Samsonov Long-term goflkicept therapy for patients with idiopathic recurrent pericarditis: results of the interim analysis of an ongoing open-label extension study Терапевтический архив idiopathic recurrent pericarditis interleukin-1 inhibitors rph-104 goflikicept |
| title | Long-term goflkicept therapy for patients with idiopathic recurrent pericarditis: results of the interim analysis of an ongoing open-label extension study |
| title_full | Long-term goflkicept therapy for patients with idiopathic recurrent pericarditis: results of the interim analysis of an ongoing open-label extension study |
| title_fullStr | Long-term goflkicept therapy for patients with idiopathic recurrent pericarditis: results of the interim analysis of an ongoing open-label extension study |
| title_full_unstemmed | Long-term goflkicept therapy for patients with idiopathic recurrent pericarditis: results of the interim analysis of an ongoing open-label extension study |
| title_short | Long-term goflkicept therapy for patients with idiopathic recurrent pericarditis: results of the interim analysis of an ongoing open-label extension study |
| title_sort | long term goflkicept therapy for patients with idiopathic recurrent pericarditis results of the interim analysis of an ongoing open label extension study |
| topic | idiopathic recurrent pericarditis interleukin-1 inhibitors rph-104 goflikicept |
| url | https://ter-arkhiv.ru/0040-3660/article/viewFile/634806/pdf |
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