Open Access Article

Title: Human factors validation for a rheumatoid arthritis auto-injector for the adalimumab biosimilar FKB327

Authors: Talia Serrecchia; Kimberly A. Waller; Tomoyoshi Ishikawa; Rafael Muniz; Thomas R. Varricchione

Addresses: Human Research & Regulatory Affairs Lead, Ximedica, 55 Dupont Drive, Providence, RI 02907, USA ' Human Research & Regulatory Affairs Lead, Ximedica, 55 Dupont Drive, Providence, RI 02907, USA ' Analytical and Formulation Development Department, Fujifilm Kyowa Kirin Biologics Co., Ltd., Ohtemachi Building, 1-6-1, Ohtemachi, Chiyoda-ku, Tokyo 100-0004, Japan ' Global Medical Affairs, Mylan, 1000 Mylan Blvd., Canonsburg, PA 15317, USA ' Clinical Research & Regulatory Affairs, Ximedica, 55 Dupont Drive, Providence, RI 02907, USA

Abstract: Rheumatoid arthritis (RA) is a chronic autoimmune disorder, often treated with adalimumab. This study was designed to validate usability of the adalimumab biosimilar FKB327 auto-injector (AI) and document risk associated with the device. A total of 136 participants were enrolled, including patients with RA, caregivers of patients with RA, and healthcare providers of patients with RA. Use errors and close calls were evaluated during 2 simulated injections. A full dose was administered by 90.4% and 97.8% of users for the first and second injections, respectively. The most common use errors were failure to squeeze injection site, check expiration date, check medication in viewing window, and rotate injection site during the second injection. The device, packaging, and instructions received favourable user ratings. FKB327-AI is an easy-to-use device for patients with RA, their caregivers, and healthcare providers. Errors that could lead to incorrect dose were infrequent and not associated with serious harm.

Keywords: adalimumab biosimilar; autoinjector; human factors validation; device usability validation; rheumatoid arthritis; rheumatoid arthritis caregivers; rheumatoid arthritis patients; safety analysis; simulated injections; user error analysis.

DOI: 10.1504/IJHFE.2020.109561

International Journal of Human Factors and Ergonomics, 2020 Vol.7 No.2, pp.144 - 160

Received: 04 Nov 2019
Accepted: 09 Mar 2020

Published online: 14 Sep 2020 *