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.
Background Recent, albeit limited, studies indicate that combination oral antibiotic therapy may be an efficacious, immunosuppressive-free, alternative strategy to achieve remission in a subset of medically refractory IBD patients. We sought to identify incidence data and provide cohort analysis of any refractory IBD patients who subsequently responded to combination oral antibiotic therapy from a large paediatric inflammatory bowel disease [PIBD] centre. Methods We identified a regional cohort of prospectively acquired incident cases of paediatric inflammatory bowel disease (CD, UC and IBD-U) diagnosed <16 years of age in South-East Scotland over a, 10-year period (2009–2018) and conducted a retrospective review identifying all cases with treatment refractory disease who subsequently achieved remission with a quadruple oral antibiotic regimen (vancomycin/doxycycline/metronidazole/amoxicillin) as salvage therapy. We characterised demographic data, IBD disease type, classification, severity, duration, as well as prior treatment efficacy and duration. There was a minimum of, 2 years of follow data available. Results In total, 4 cases of successful treatment with a quadruple oral antibiotic regimen in refractory patients were identified from our, 10-year PIBD registry that included, 222 new cases of PIBD (cumulative incidence, 1.8%). Treatment was attempted in, 9 refractory patients over the period. All responders were male, median age at diagnosis, 13.1yrs (0.5, 11.3, 14.8, 15.7yrs), median disease duration was, 1.3yrs. All responders had chronically active moderate-severe disease., 3 had ulcerative colitis (Paris classification E4), the remainder had Crohn’s disease (Montreal classification B1, L3/4). All responders had disease refractory to a least, 2 biological therapies that were co-administered with either thiopurines or methotrexate., 3 of the, 4 had failed at least one steroid induction course., 3 of the, 4 maintained clinical remission at the minimum, 2 year follow up on regular oral vancomycin therapy. Conclusion A subset of patients with PIBD that is highly refractory to conventional therapeutics, including to steroids and multiple biologics, may achieve remission with a quadruple combination oral antibiotic regimen. Those with active colitic phenotypes at intervention were more likely to respond and longer-term disease remission may be maintained with regular oral vancomycin.
Results Eight-four (63%) of the 133 were categorised, using the RFH-GA, as being moderately or severely malnourished. In contrast the MUST tool identified only 45 (34%) patients as being at nutritional risk. Thus the sensitivity and specificity of MUST for determining nutritional risk were 34% (95% CI 20 to 51) and 94% (95% CI 86 to 97); respectively; the k value was 0.19 demonstrating a poor level of agreement. The sensitivity and specificity of MUST improved when the patients with fluid retention were excluded from the analysis, 100% (95% CI 46 to 100) and 91% (74e98); respectively. The performance of the MUST also improved as the accurate dry body weight was better calculated but still did not reach 100% sensitivity indicating body weight alone is not a good marker of nutritional status in this patient population.The performance of the MUST utilising alternative weight adjustments in patients with fluid retention Conclusion The performance characteristics of the MUST tool in this setting are poor. This tool, can not be recommended for screening patients with chronic liver disease for nutritional risk.
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