The biotechnology-derived medicines known as biosimilars are defined as non-originator treatments that have demonstrated quality, efficacy, and safety comparable to the reference biologic drug. Clinical trials have shown that the infliximab biosimilar, CT-P13, and the candidates for the adalimumab biosimilars, ABP 501 and ZRC 3197, are not significantly different, with respect to efficacy and safety, from the originator drugs in patients with other autoimmune diseases. However, controversy has arisen over the use of biosimilars in inflammatory bowel disease, due to the incipient evidence not only in patients with no previous biotechnology treatment, but also in patients in remission, that could be switched to a biosimilar for non-medical reasons. The present review is the first critical analysis by different specialists in the area of gastroenterology on the use of biosimilars in inflammatory bowel disease, the evidence on interchangeability, the extrapolation of indications, efficacy, safety, immunogenicity, and the clinical impact of the Mexican health regulations. The aim of our review was to make the positioning and recommendations of these new therapeutic options known, given that they have a potential cost-benefit for both patients and healthcare institutions.
Aim: Non-ampullary duodenal epithelial tumor is rare. For treatment planning, it is important to distinguish between duodenal adenoma and duodenal cancer. However, histological diagnosis using endoscopic biopsy is sometimes difficult because of inadequate sampling of cancerous tissue within the adenomatous lesion. Furthermore, fibrosis after endoscopic biopsy is reported to make endoscopic resection difficult. The endocytoscopy system (ECS) is a novel ultra-high-magnification endoscope that allows observation at the cellular level. Our previous ECS investigation of duodenal lesions in patients with familial adenomatous polyposis revealed that disappearance of goblet cells and spindle-shaped nuclei with loss of polarity of the nuclear arrangement were characteristic features of duodenal adenoma. In addition, round duct openings and fingerlike projections were observed in tubular adenoma and villous adenoma, respectively. Here, we evaluated the ECS features of non-ampullary mucosal duodenal cancer (NAMDC). Materials and methods: We retrospectively investigated six cases of histologically proven NAMDC observed by ECS using 2% methylene blue for vital staining of cells in vivo. We evaluated the presence or absence of goblet cells, tubular structures or villous structure, loss of nuclear arrangement polarity, nuclear enlargement, and nuclear shape. All of the cases were surgically resected mucosal duodenal cancers and histological investigation included immunohistochemical staining for CD10, MUC2, MUC5AC, and MUC6. Results: Macroscopically, all of the cases were the elevated type with a median diameter of 48.5 mm (range 25-70 mm). Immunohistochemical analysis suggested that one case involving the duodenal bulb was the gastric (mixed) type, whereas the other five cases were the intestinal type and located in the 2 nd or 3 rd portion of the duodenum. Vital staining of the case considered to be the gastric type was insufficient for ECS observation because of surface mucus. All five cases of intestinal-type duodenal cancer showed a villous structure, disappearance of goblet cells and enlarged nuclei with loss of polarity. Tubular structures were admixed in four of these cases (Figure 1). Four cases were found to have oval-shaped nuclei (Figure 2), and one case had spindle-shaped nuclei. Cases with spindle-shaped nuclei in most of the lesion were diagnosed histologically as cancer in adenoma where the adenomatous component was dominant in the cancerous area. Conclusion: Oval-shaped nuclei and nuclear enlargement are the characteristic features of NAMDC revealed by ECS, and included in the histological criteria for diagnosis. ECS may enable omission of biopsy histology for histological diagnosis of NAMDC.
The prevalence for premalignant lesions is similar for patients under 55 years of age. This highlights the importance of early diagnosis and avoiding progression. It would be convenient to extend the follow-up to second-level hospitals in patients with risk factors to contribute to improvement of public health system outcomes.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.