Gastroenterology

A recent study of a rapid point-of-care (POC) test shows that it is virtually identical at detecting antidrug antibodies (ADAs) to a biosimilar infliximab, SB2 (Renflexis, Flixabi), as a standard enzyme-linked immunosorbent assay (ELISA) and is suitable for therapeutic drug monitoring of any infliximab product.
A study published this month proposes that biosimilars be assessed in a quantitative benefit-risk analysis to assess whether what the authors call “uncertainty in the clinical performance of biosimilars” can be countered by lower pricing. 
Celltrion announced that it has begun recruiting patients with inflammatory bowel disease in Ohio for a phase 3 clinical trial of its subcutaneous formulation of biosimilar infliximab, CT-P13 (Inflectra, Remsima). The study is intended to support an application for the formulation to the FDA.
The study sought to assess the efficacy, tolerability, and safety of CT-P13 versus its reference and versus adalimumab in patients with Crohn disease (CD).
The retrospective, observational, multicenter study included 141 patients, 96 with ulcerative colitis and 45 with Crohn disease, at 14 centers in Italy.
The study, conducted at a hospital in Spain from 2015 to 2017, included all 100 patients who were switched to the biosimilar from the reference infliximab when the hospital transitioned to using the lower-cost product.
As more centers begin to switch patients from reference infliximab to biosimilar options, patients who have benefitted from rapid infusions of the reference product may want to continue to receive time-saving infusions that reduce the burden of lengthy visits to infusion centers. 
In a study conducted from 2017 to 2018 among all of the infliximab-treated patients with inflammatory bowel disease (IBD) in a single center, patients who were in clinical remission were invited to complete a questionnaire to assess their biosimilar knowledge and acceptance of a switch.
The introduction of infliximab for the treatment of inflammatory bowel diseases (IBD) did not result in lower population rates of hospitalizations or intestinal surgeries among patients living with IBD in Ontario, Canada, according to a study published Thursday.
A new consensus paper from the Asia-Pacific Working Group on inflammatory bowel disease (IBD) released a set of best practices for improving IBD care with biologics and biosimilars.
 

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