Qualitative survey-based evaluation of operability and convenience for the etanercept biosimilar YLB113 in a unique injection pen in patients with rheumatoid arthritis

Study objective: Needle fear is common among patients with rheumatoid arthritis (RA) who require subcutaneous (SC) injections. The convenience, usability and safety of the etanercept biosimilar YLB113 in an injection pen were evaluated among patients who switched from syringe injection. Methods: Patients with RA who had completed the phase III clinical study of YLB113 in a pre-filled syringe (YLB113-002) were enrolled (n = 35) and received once-weekly SC injections with the injection pen (YLB113 50 mg) for 8 weeks. After 8 weeks, patients completed a qualitative survey evaluating the form and design of the pen, its operability, and patient preference for pen or syringe. Adverse events were evaluated throughout the study. Results: Most patients reported the pen was ‘very easy to grasp’ or ‘easy to grasp.’ The pen was also reported to be easy to operate. The click signalling the start and end of the injection could be heard ‘very well’ or ‘well’. Similarly, the injection solution check window could be seen by most patients. About three-quarters of respondents preferred the pen over a syringe. The pen was considered easier to use for the following reasons: the body is easy to grasp; the procedure is easy to understand; and the procedure can be performed without anxiety, fear, or tenseness. Conclusions: The majority of these Japanese subjects with RA in the study judged the YLB113 50 mg delivered by injection pen to be easy to use, convenient and well tolerated