Efficacy and safety of a new vedolizumab subcutaneous formulation in Japanese patients with moderately to severely active ulcerative colitis

Background/Aims@#A subgroup analysis was conducted in Japanese patients with moderate to severe ulcerative colitis (UC) enrolled in the phase 3 VISIBLE 1 study, which evaluated the safety and efficacy of a new vedolizumab subcutaneous (SC) formulation. @*Methods@#Eligible patients received open-label infusions of vedolizumab 300 mg intravenous (IV) at weeks 0 and 2 in the induction phase. Patients with clinical response by complete Mayo score at week 6 entered the double-blind maintenance phase and were randomized to vedolizumab 108 mg SC every 2 weeks, placebo, or vedolizumab 300 mg IV every 8 weeks. The primary endpoint was clinical remission (complete Mayo score ≤ 2 points; no individual subscore > 1 point) at week 52. @*Results@#Of 49 patients who entered the induction phase, 22 out of 49 patients (45%) had clinical response at week 6 and were randomized to vedolizumab 108 mg SC (n = 10), placebo (n = 10), or vedolizumab 300 mg IV (n = 2). At week 52, 4 out of 10 patients (40%) who received vedolizumab SC had clinical remission versus 2 out of 10 patients (20%) who received placebo (difference: 20% [95% confidence interval, –27.9 to 61.8]). Two patients (2/10, 20%) who received vedolizumab SC experienced an injection-site reaction versus none who received placebo. @*Conclusions@#Our results indicate that the efficacy of vedolizumab SC in a subgroup of Japanese patients with UC are similar with those in the overall VISIBLE 1 study population, and with those established with vedolizumab IV. The safety and tolerability of vedolizumab SC were generally similar to that established for vedolizumab IV. (ClinicalTrials.gov ID NCT02611830; EudraCT 2015-000480-14)

Strategy for the effective management of adverse drug reactions / 医薬品情報学

<b>Abstruct</b><br>  Effective method for the management of information on adverse reactions is not uniformly in place, due to differences among medical facilities.  We have been developing a strategy for the effective management of adverse drug reactions on the transition of clinical records from paper to electronic media.<br>  We have taken a forward-thinking approach after 4 years identifying each year’s main target, predicted problems and how to address them in every year.  The targets for the four 1-year periods were: enabling the collection and analysis of information on adverse reactions from paper-based clinical records, standardized handling of adverse reactions in situations where paper records are still in use, transition of adverse reaction information to electronic records, and sharing of information on adverse reactions where electronic records are in use.  The Committee on Adverse Events conducted analysis of information on adverse reactions which were collected regardless of seriousness, disseminated useful information to all medical staff, and determined the degree to which each period target was achieved.<br>  The transition to electronic form of information on adverse reactions achieved 0% success within the target period.  Establishing effective management of adverse reactions will require 5 years, with as yet unresolved issues remaining.  During 5 years, 767 incidents of adverse reactions were reported, 73.1% by physicians, the proportion by nurses increasing from 6.7% to 22.3%.<br>  Strategic approach will help to establish a effective management of adverse reactions, which contribute to the adequate use of drugs and safety management of patients.