The safety, clinical efficacy, and cost-effectiveness of biosimilar infliximab in adult inflammatory bowel disease (IBD) have now been extensively shown. Limited data have been collected in the paediatric setting. We report nationwide, prospective, clinical safety and effectiveness data for patients from all 3 Scottish paediatric inflammatory bowel disease networks switching from originator to biosimilar infliximab. Prospective clinical data were collected for 33 patients. Information was collected from electronic patient records, laboratory reports, and patient case notes. There were no clinically significant changes to disease activity, biomarkers, antidrug antibodies, or trough drug levels (P > 0.1) within a 12-month follow-up period; in addition, there were no significant adverse events reported. No infusion reactions were seen in the 264 infusions delivered. Switching from originator infliximab to the biosimilar (CT-P13) appears to be associated with neither an increase in infusion reactions nor significant loss of effectiveness in the short term.
Background Exclusive enteral nutrition (EEN) is the recommended induction treatment of mild to moderate active pediatric Crohn’s disease (CD). This study compared outcomes of 2 proprietary polymeric formulas. Treatment effectiveness was examined along with practical aspects of formula delivery and differences in estimated treatment costs. Methods Data were retrospectively collected from patients with CD who received a generic oral nutritional supplement (Fortisip) across 2 centers (RCH, Melbourne and RHSC, Edinburgh). This was compared with a prospective cohort (RHC, Glasgow) that used a specialized formula (Modulen IBD). The data collected included patient demographics, remission rates, biochemical markers, administration method, and anthropometrics. The estimated treatment cost was performed by comparing price per kcal between each formula. Results One hundred seventy-one patients were included (106 Fortisip, 65 Modulen IBD, 70 female; median age 13.3 yrs). No difference was demonstrated in remission rate (Fortisip n = 67 of 106 [63%] vs Modulen IBD n = 41 of 64 [64%], P = .89), nonadherence rate (Fortisip n = 7 of 106 [7%] vs Modulen IBD 3 of 64 [5%], P = .57) or method of administration (NGT Fortisip use n = 16 of 106 [12%] vs Modulen IBD 14 of 65 [22%]; P = .31). There was no difference in reduction of biochemical disease markers between the groups (C-reactive protein , P = .13; erythrocyte sedimentation rate, P = .49; fecal calprotectin, P = .94). However, there was a cost-saving of around £500/patient/course if the generic oral nutritional supplement was used. Conclusions The generic oral nutritional supplement and specialized formulas both had similar clinical effectiveness in induction of remission in pediatric CD. However, there is considerable cost-saving when using a generic oral nutritional supplement.
Cattle in wetlands impact water quality through waste excretion, which deposits excess nutrients, as well as decreasing the biomass and height of vegetation through trampling and herbivory. Amphibians are sensitive to these changes due to their porous skin and reliance on vegetated microhabitats. Previous studies examining the effect of cattle on amphibians in wetlands report conflicting results, exemplifying the need to avoid overgeneralizations and instead examine specific environments. In the Ñeembucú Wetland Complex in Paraguay, low-intensity cattle ranching is a common practice. This study seeks to understand how the presence of cattle in these operations impacts water chemistry and amphibian species richness, as well as determining which cattle effects (eutrophication, nutrient loading, and decreased vegetation height diversity) have the greatest impact on amphibian communities. We anticipated that increased cattle presence would negatively impact wetland condition, and consequentially lower amphibian species richness. Data was collected over seven weeks at Estancia Santa Ana, a low-intensity cattle ranch in Pilar, Paraguay. Cattle presence was measured through cow footprints and feces densities, while a vegetation survey and water quality testing (nitrate, phosphate, and dissolved oxygen) served as environmental metrics. Pitfall trapping was used to gather information on amphibian species richness and community composition. A Pearson parametric correlation test and Factor Analysis of Mixed Data in R were then used to understand the relationship between variables. Very few statistically relationships were found between variables, and those that existed showed a very weak correlation. This suggests that cow presence does not have as strong of an impact on water quality or amphibian species richness as expected. Terrestrial and aquatic vegetation were found to explain much of the variation among the data, which verifies the importance of amphibians’ microhabitats. While future research comparing generalist and specialist species in the area is necessary, these initial results suggest a hopeful future for collaboration on environmental efforts with low-intensity cattle ranchers.
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