BACKGROUND/AIMS: An interim analysis of post-marketing surveillance of CT-P13, an infliximab biosimilar, was performed to evaluate its safety and efficacy in Japanese patients with inflammatory bowel disease.METHODS: Patients were prospectively enrolled between November 2014 and March 2017, after the launch of CT-P13 in Japan, and case report forms of patients followed for at least 4 months were analyzed as of July 2018.RESULTS: Of 523 patients in the analysis set, 372 remained on CT-P13 therapy, while 54 (20.2%) of 267 patients with Crohn’s disease, and 97 (37.9%) of 256 patients with ulcerative colitis were withdrawn during follow-up. A total of 144 adverse drug reactions (ADRs) were reported in 106 patients (20.3%). Infusion reaction was the most frequent ADR observed in 49 patients (9.4%). Efficacy parameters decreased immediately after the start of treatment in naïve patients to anti-tumor necrosis factor-α antibody. In the patients switched from originator infliximab for nonmedical reasons, the decreased parameters due to proceeded treatment with the originator were maintained in low ranges, and the treatment continuation rate was high with low ADR incidence. In contrast, in patients switched for medical reasons such as adverse event or loss of response, the incidence of ADRs was high. However, the efficacy parameters were improved, and the treatment continuation rate was not significantly different from that of the naïve patient group.CONCLUSIONS: In this interim analysis, CT-P13 was comparable to the originator infliximab with respect to ADRs and efficacy, and is therefore considered to be a cost-efficient interchangeable biosimilar for Japanese patients with inflammatory bowel disease.
Asian Continental Ancestry Group ; Colitis, Ulcerative ; Drug-Related Side Effects and Adverse Reactions ; Follow-Up Studies ; Humans ; Incidence ; Inflammatory Bowel Diseases ; Infliximab ; Japan ; Necrosis ; Prospective Studies

Background: Imprinting tablet bodies is an essential element for the safe use of pharmaceuticals. It has been observed that reports on tablet imprint design that incorporate pharmacists’ perspectives are scarce. Objectives: The aim of this study was to provide a better understanding of the concept of universal design in tablet body identification and differentiation, specifically in two scenarios: normal handling of tablets and encountering tablets with similar appearances. Methods: A survey was conducted among pharmacists registered with the Yamaguchi Prefecture Pharmaceutical Association to collect data on optimal tablet imprint designs from a dispensing perspective. Results: Analysis of the survey results indicated that: 1. In normal use of tablets, a simple design with “horizontal Kana notation without emphasis on one character” was most preferred. 2. In cases where tablets were similar in appearance, designs such as “horizontal Kana notation with an underline on one character” and “horizontal Kana notation with emphasis on one character” were preferred. Conclusions: The study may indicate that certain tablet imprint designs may enhance the ability to differentiate and recognize pharmaceuticals, particularly in cases where tablets have similar appearances. To aid in distinguishing tablets with similar appearances, it is suggested that the design should incorporate ‘horizontal Kana notation’ and give emphasis to one character. This design has been shown to result in a clear improvement in identification. It is recommended that tablet imprint designs prioritize high readability for pharmacists and provide appropriate pharmaceutical information. When considering similarity with other tablets, it may be advisable to use ‘emphasis on one character’ as a universal design for differentiating and identifying tablet bodies.

Background: This study surveyed pharmacists registered with the Yamaguchi Prefectural Pharmacists Association to determine the key elements of tablet printing design that enhance visibility and distinguishability during dispensing.Objectives: The purpose of this study is to identify suitable design components for tablets that enhance visibility and distinguishability by utilizing text data.Methods: Given the high risk of medication errors due to similar-looking tablets, the study employed KH Coder for text mining analysis of free-text responses.Results: Results indicated that design elements such as "horizontal writing," "straight lines, " and "emphasis on characters" significantly improve visibility and distinguishability, particularly for similar-looking tablets. The findings from this study provide specific guidelines for optimal tablet design, aiming to improve pharmacists' efficiency and enhance medication safety.Conclusions: KH Coder proved to be a valuable tool for analyzing qualitative data in the medical field. While the study focused on pharmacists in Yamaguchi Prefecture, expanding the survey to a national scale is recommended to validate and generalize the findings. This research supports the development of standardized tablet designs that can minimize dispensing errors and ensure patient safety, highlighting the importance of effective tablet printing design in pharmaceutical practice.