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Assessment of real-life patient handling experience of AVT02 administered subcutaneously via autoinjector in patients with moderate to severe active rheumatoid arthritis: an open-label, single-arm clinical trial, then an extension phase of AVT02 administered with a prefilled syringe.
- Source :
-
Expert opinion on biological therapy [Expert Opin Biol Ther] 2023 Jul-Dec; Vol. 23 (8), pp. 781-789. Date of Electronic Publication: 2022 Oct 26. - Publication Year :
- 2023
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Abstract
- Background: This study investigated the ability of patients, naïve to adalimumab treatment and self-injection with an autoinjector (AI), to successfully self-administer AVT02, an adalimumab biosimilar, using a custom, ergonomic AI (Alvotech hf., Reykjavik, Iceland).<br />Research Design and Methods: This was a single-arm, open-label study, consisting of an 8-week active period and 48-week extension phase. Patients with moderate to severe rheumatoid arthritis (RA) self-administered 40 mg AVT02 subcutaneously via AI in the active period, followed by prefilled syringe in the extension phase. The primary endpoint was the percentage of successful self-injections up to Week 8. Usability and robustness of the AI were evaluated in the active period; safety, efficacy, pharmacokinetic and immunogenicity data were assessed throughout the study.<br />Results: The AI success rate was 100%. No handling events were noted up to Week 8. Both C <subscript>trough</subscript> measurements and immunogenicity profile were in line with expectations from previous studies, with no unexpected safety signals.<br />Conclusions: This study demonstrated that AVT02-AI can be successfully and reliably used for repeated self-injections of AVT02 by moderate to severe RA patients, despite no previous experience of adalimumab self-administration. The extension phase provides long-term efficacy and safety data for AVT02 in RA.<br />Study Identifier: NCT04224194.
Details
- Language :
- English
- ISSN :
- 1744-7682
- Volume :
- 23
- Issue :
- 8
- Database :
- MEDLINE
- Journal :
- Expert opinion on biological therapy
- Publication Type :
- Academic Journal
- Accession number :
- 36205514
- Full Text :
- https://doi.org/10.1080/14712598.2022.2131392