Studies from M. Radin and Co-Researchers in the Area of Inflammatory Bowel Disease Reported (Infliximab Biosimilars in the Treatment of Inflammatory Bowel Diseases: A Systematic Review)
By a News Reporter-Staff News Editor at Clinical Trials Week A new study on Digestive System Diseases and Conditions - Inflammatory Bowel Disease is now available. According to news reporting originating in Turin, Italy, by NewsRx journalists, research stated, "Biological therapies represent a fundamental innovation for the management of inflammatory bowel diseases (IBD). However, many biological originators have reached, or are about to reach, patent expiry and long-term therapy costs have become progressively unsustainable."
The news reporters obtained a quote from the research, "CT-P13, a biosimilar of the anti-tumor necrosis factor (anti-TNF) monoclonal antibody infliximab, might represent a significant alternative to its originator, with the potential to decrease medical care costs and, therefore, become available to a large number of patients. In this systematic review, we analyzed the data from available clinical trials that recently investigated the validity of indication extrapolation of CT-P13 for the treatment of IBD in naive patients and in patients who switched from its originator infliximab, focusing on clinical efficacy, safety and immunogenicity. A detailed literature search was developed a priori to identify articles that investigated the validity of indication extrapolation of CT-P13 for the treatment of IBD in TNF inhibitor treatment-naive patients and in patients who switched from the originator infliximab. This was applied to Ovid MEDLINE, In-Process and Other Non-Indexed Citations, EMBASE, Cochrane Central Register of Controlled Trials, and Scopus for content from 2012 to September 2016. We based our review on the available data from 11 studies that included a total of 1007 IBD patients: 570 patients suffering from Crohn's disease (294 switched and 276 nave), 435 patients suffering from ulcerative colitis (127 switched and 308 naive), and two IBD unclassified patients (switched). Overall, no significant difference in efficacy and safety between the originator infliximab and its biosimilar CT-P13 was observed. When assessing the safety of CT-P13, we found that 9.2% of patients experienced adverse effects (4.1% infusion-related reactions and 4.3% infections). The analyzed studies did not report a significant difference in terms of efficacy, safety and immunogenicity when comparing the clinical experience with CT-P13 with the available literature data on the originator treatment in IBD."
According to the news reporters, the research concluded: "However, some debate is ongoing regarding interchangeability and immunogenicity."
For more information on this research see: Infliximab Biosimilars in the Treatment of Inflammatory Bowel Diseases: A Systematic Review. Biodrugs, 2017;31(1):37-49. Biodrugs can be contacted at: Adis Int Ltd, 5 The Warehouse Way, Northcote 0627, Auckland, New Zealand (see also Digestive System Diseases and Conditions - Inflammatory Bowel Disease).
Our news correspondents report that additional information may be obtained by contacting S. Sciascia, S Giovanni Bosco Hosp, SCDU Nephrol & Dialysis, I-10154 Turin, Italy. Additional authors for this research include S. Sciascia, D. Roccatello and M.J. Cuadrado.
Keywords for this news article include: Turin, Italy, Europe, Digestive System Diseases and Conditions, Gastrointestinal Diseases and Conditions, Tumor Necrosis Factor (TNF) Inhibitors, Monoclonal Antibodies, Article Review, Bowel Diseases and Conditions, Inflammatory Bowel Disease, Drugs and Therapies, Immunologic Agents, Pharmaceuticals, Gastroenteritis, Antirheumatics, Biotechnology, Infliximab.
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