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 ...

• 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.v2; 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/21310759/2

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 ...