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The biosimilar candidate to Humira®, BI 695501, autoinjector (AI) enables successful self-administration in patients with rheumatoid arthritis (RA): Results from a Phase II AI patient-handling clinical study (VOLTAIRE®-RL)
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Veröffentlicht: | 4. September 2017 |
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Background: PK bioequivalence of BI 695501 and its reference product Humira® has been demonstrated (VOLTAIRE®-PK: [1]). It is important that patients (pts) who self-inject their medication are able to do so without failures or complications. This is particularly relevant for pts with RA, a disease that can adversely affect hand function. The objective was to assess real-life handling of the BI 695501 AI in RA pts with no prior experience in self-injection using an AI.
Methods: This Phase II, 7-week, open-label, interventional clinical study (NCT02606903) enrolled 77 pts (aged 18–80 y) with moderately to severely active RA, not adequately controlled by non-biologic disease-modifying anti-rheumatic drugs. Pts were trained at self-injection using the AI at their first visit and were assessed at the following 3 visits (every 2 weeks) under supervision of site staff. In this study, AI handling success and experience were recorded independently by study personnel and patients using a questionnaire. The primary end point was successful self-injections (full content of the AI was injected into the body) as reported in the questionnaire. Descriptive statistics were performed.
Results: Successful initial self-injections of BI 695501 via AI, as reported by both study personnel and pts, were achieved in 216/218 (99.1%) of injections (on Days 15, 29, and 43; Table).
In the two unsuccessful attempts, subsequent successful self-injections were performed immediately with another AI. Thorough inspection by device engineers revealed no technical issues with these two AIs. One or more treatment-emergent adverse events (TEAEs) were reported in 31 pts (40.3%) for the AI assessment period. In 9 pts (11.7%), TEAEs were considered to be related to study drug. Four serious AEs were reported by 2 pts; none was considered to be treatment-related. Injection-site reactions were reported by 5 pts (6.5%), headache was reported in 5 pts (6.5%) and sinusitis was reported in 4 pts (5.2%).
Conclusion: After training by site personnel, almost all pts with moderately to severely active RA without prior experience of self-injections with AI were able to successfully self-administer BI 695501 subcutaneously using an AI. BI 695501 via AI was well tolerated.
References
- 1.
- Wynne C, Altendorfer M, Sonderegger I, Gheyle L, Ellis-Pegler R, Buschke S, Lang B, Assudani D, Athalye S, Czeloth N. Bioequivalence, safety and immunogenicity of BI 695501, an adalimumab biosimilar candidate, compared with the reference biologic in a randomized, double-blind, active comparator phase I clinical study (VOLTAIRE®-PK) in healthy subjects. Expert Opin Investig Drugs. 2016 Dec;25(12):1361-1370. DOI: 10.1080/13543784.2016.1255724