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 ...

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). This was a single-arm, open-label study, cons...

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Bibliographic Details
Main Authors: Damjanov, Nemanja, Kirvalidze, Nana, Kurashvili, Nana, Berti, Fausto, Steiger, Matjaz, Sobierska, Joanna, Guenzi, Eric, Otto, Hendrik, Sattar, Abid, Haliduola, Halimu N., Edwald, Elin, Stroissnig, Heimo
Format: Other Non-Article Part of Journal/Newspaper
Language:unknown
Published: Taylor & Francis 2022
Subjects:
Biochemistry
Microbiology
FOS Biological sciences
Pharmacology
Ecology
Sociology
FOS Sociology
Immunology
FOS Clinical medicine
Biological Sciences not elsewhere classified
Iceland
Online Access:https://dx.doi.org/10.6084/m9.figshare.21310759
https://tandf.figshare.com/articles/journal_contribution/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_AVT/21310759
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Summary: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). 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. The AI success rate was 100%. No handling events were noted up to Week 8. Both C trough measurements and immunogenicity profile were in line with expectations from previous studies, with no unexpected safety signals. This ...

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