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Study objective: Needle fear is common among patients with rheumatoid arthritis(RA) who require subcutaneous (SC) injections. The convenience, usability and safety ofthe etanercept biosimilar YLB113 in an injection pen were evaluated among patients whoswitched from syringe injection. Methods: Patients with RA who had completed the phaseIII 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 8weeks. After 8 weeks, patients completed a qualitative survey evaluating the form anddesign of the pen, its operability, and patient preference for pen or syringe. Adverseevents 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 tooperate. The click signalling the start and end of the injection could be heard ‘verywell’ or ‘well’. Similarly, the injection solution check window could be seen by mostpatients. About three-quarters of respondents preferred the pen over a syringe. The penwas considered easier to use for the following reasons: the body is easy to grasp; theprocedure 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 thestudy judged the YLB113 50 mg delivered by injection pen to be easy to use, convenientand well tolerated

gabi journal

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