RESUMO
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.
Assuntos
Medicamentos Biossimilares/uso terapêutico , Doenças Inflamatórias Intestinais/tratamento farmacológico , Adalimumab , Humanos , Infliximab , Legislação de Medicamentos , MéxicoRESUMO
BACKGROUND: The prevalence of colorectal polyps in the general population is 10%. Hormonal alterations in acromegaly stimulates adenomatose polyps development making that increase it prevalence. Colonoscopy has elevated sensibility and specificity in detection of colorectal adenomas. OBJECTIVE: Identify colonic polyps in patients with acromegaly and establish the importance of colonoscopy as a detection method. MATERIAL AND METHODS: Retrospective, observational and descriptive study made in Colon and Rectum Surgery Department from March 2000 to March 2007 in patients with acromegaly and colonoscopy. Analyzed variables were: gender,age, endoscopy findings and histopathological results. Descriptive statistics were used to analysis of results. RESULTS: Thirty-two patients were included: 14 (44%) men, 18 (56%) women. The mean age was 48 (range 22 to 75 years old). In 9 (28%) patients were detected colorectal polyps, predominately in the sigmoid. Fifteen polyps lesion were found: 7 (46.6%) adenomas: 5 (33.3%) tubular and 2 (13.3) villous, 6 (40%) hyperplasic, 1 (6.6%) inflammatory and 1 (6.6%) carcinoma. Colonoscopy was complete in 30 (93.7%) patients. CONCLUSIONS: The prevalence of colonic polyps inpatients with acromegaly undergoing colonoscopy,was 28%, higher than expected in the general population. Colonoscopy constitutes an important diagnosis technique in early neoplasia detection.