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Objective: The adalimumab biosimilars FKB327 and GP2017 were approved for the therapy of patients with inflammatory bowel disease (IBD). Relatively few prospective studies with biosimilar adalimumab in patients with IBD have been published. The aim of this prospective observational study was to evaluate the effectiveness and safety of the biosimilar adalimumab., Material and Methods: Adalimumab biosimilars FKB327 (Hulio®) and GP2017 (Hyrimoz®) were indicated to 50 naive patients in terms of biological therapy with Crohn's disease (CD) or ulcerative colitis (UC). Effectiveness of therapy was evaluated via the Crohn's Disease Activity Index [CDAI] or the Mayo Scoring System [MSS] in patients with CD or UC, respectively, before and after 12 weeks. Additional goals were to evaluate weight changes, laboratory tests and complications or adverse events of this therapy., Results: In CD patients, remission (CDAI <150) was achieved in 73.5% of cases, partial response (≥70-point decrease in CDAI score from baseline) in 11.8%, no response in 11.8% and 2.9% patients discontinued therapy. In UC patients, remission (total score on partial Mayo index ≤2 points) was achieved only in 18.8% of cases, partial response (≥2-point decrease in partial Mayo score from baseline) in 43.8%, no response in 25.0% and 12.5% patients discontinued therapy. There were statistically significant improvements in CDAI, MSS, haemoglobin, fecal calprotectin, albumin and CRP serum levels after 12 weeks of therapy. Seven adverse events were identified, three of which resulted in therapy being discontinued., Conclusions: This prospective observational study proved the effectiveness of the adalimumab biosimilars FKB327 and GP2017 in IBD., Competing Interests: The authors have declared that no competing interests exist.

Objectives: Body weight is one of the factors affecting blood levels of 25-hydroxyvitamin D (25OHD). The aim of this study was to establish whether a vitamin D (vitD) weight-based dosing is more appropriate to a fixed daily dose in patients with inflammatory bowel disease (IBD). Materials/methods: This was an open label randomised trial. Patients with IBD were assigned to receive oral cholecalciferol at a dose of 28 IU/kg (IU/kg) or 2000 IU per day (IU/day) for 12 weeks during winter months. 25OHD plasma levels and other biochemical parameters were measured at baseline and after supplementation period. The primary outcome measure was 25OHD level after a follow-up period. Results: A total of 173 patients were analysed. The mean BMI was 25.5 ± 5.1 and initial mean 25OHD level was 62.7 ± 25.5 nmol/l. A similar increase (9.7 ± 26.9 vs 9.8 ± 26.7 nmol/l) in 25OHD levels occurred both in IU/kg and IU/day group. The proportion of subjects with normal and sub-normal levels following the substitution was comparable irrespective of body weight. The change in 25OHD level correlated positively only with the dose of vitD ( p  < .001) and negatively with the baseline 25OHD level ( p  < .001). A sustained 25OHD level of 75 nmol/l corresponds with a calculated daily vitD dose of 2034 IU. Conclusions: Weight-based dosing of vitamin D is not superior to a fixed dose in order to maintain stable 25OHD levels in IBD patients. Cholecalciferol dose of 2,000 IU/day is safe and sufficient during winter period.

Background & Aims: The optimal duration of bowel preparation has only been assessed for polyethylene glycol (PEG). The aim of the study was to determine the intervals for achieving a satisfactory quality/tolerability of the preparation using PEG/ascorbic acid (PEGA) and sodium picosulphate/magnesium citrate (SPMC), and to compare them with 4L of PEG., Methods: A randomized, endoscopist-blinded, multicentre study. The 612 outpatients referred to a colonoscopy, were prepared using PEG, SPMC, PEGA. The quality, tolerability, duration of the preparation, and the interval from the end of the preparation to the colonoscopy was assessed., Results: Optimum duration of the preparation was similar for both PEG and SPMC (≥7.3 vs. ≥8.8 h, overall ≥8.4 h). Optimum interval to the colonoscopy was ≤11.8 h and did not differ between preparations (PEG, PEGA ≤ 11.8, SPMC ≤ 13.3 h). These times were the only predictors for a satisfactory preparation. The tolerability depends on the product type (SPMC) only. Timing of the preparation or the other factors had no impact on tolerability., Conclusion: The optimum intervals for bowel preparation are identical for all preparations. Satisfactory preparation is achived at the preparation length ≥8.4 h and the time to colonoscopy ≤11.8 h., (Copyright © 2017 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Purpose: The purpose of this study is to compare the efficacy and tolerability of polyethylene glycol (PEG) to sodium picosulfate/magnesium citrate (SPMC) and low-volume polyethylene glycol/ascorbic acid (PEGA) in a single- or split-dose regimen for colonoscopy bowel preparation., Methods: This was a prospective, randomized, endoscopist-blinded, multicentre study. Outpatients received either PEG or SPMC or PEGA in a single or a split dose before the colonoscopy. Quality and tolerability of the preparation and complaints during preparation were recorded., Results: Nine hundred seventy-three patients were analysed. Satisfactory bowel cleansing (Aronchick score 1 + 2) was more frequent when a split dose was used irrespective of the solution type (PEG 90.1 vs 68.8%, PEGA 86.0 vs 71.6%, SPMC 84.3 vs 60.2%, p < 0.001). SPMC was the best tolerated followed by PEGA (p < 0.006) and PEG as the worst (p < 0.001). Tolerability did not correlate with the regimen and amount of the solution used. Female gender is associated with a higher incidence of nausea, vomiting and pain (p < 0.029)., Conclusions: Both PEG, PEGA and SPMC are fully comparable in terms of colonic cleansing when used in similar regimens. The split-dose preparation is more effective in all agents. SPMC and PEGA are better tolerated than PEG. The preparation regimen and/or the volume do not affect tolerability.

Neuroendocrine tumors and intraductal papillary-mucinous neoplasms constitute histologically distinctive but relatively rare entities among pancreatic tumors. Collision of these tumors is extremely rare and causes several diagnostic problems regarding the histopathologic differential diagnosis of other pancreatic epithelial tumors. The question of whether the neoplastic populations originate from common progenitor cell or whether they represent only a fortuitous association has not been sufficiently explained. Here, we describe a new case of poorly differentiated endocrine carcinoma combined with an intraductal papillary-mucinous neoplasm. To disclose the relationship between the two histologic components, neuroendocrine differentiation was studied by confocal laser scanning microscopy using double immunofluorescence labeling with chromogranin-A and CD57 antibodies. Our results revealed a co-localization of both antigens in neuroendocrine cells of the intraductal papillary-mucinous neoplasm. The finding has previously been described in non-neoplastic neuroendocrine cells. Cells forming poorly differentiated endocrine carcinoma showed a wide heterogeneity in immunoreactions. Our results do not indicate a potential histogenetic similarity between these two neoplasms, which are dissimilar histologically, and underline the previous thesis that cells in intraductal papillary-mucinous neoplasm revealing neuroendocrine differentiation represent only a non-neoplastic cell admixture.