Actual Anti-TNF Trough Levels Relate to Serum IL-10 in Drug-Responding Patients With Crohn's Disease.

BACKGROUND: Patients with Crohn's disease (CD) responding to anti-tumor necrosis factor (anti-TNF) show great variability in serum drug levels, even within the therapeutic range. We aimed at exploring the role of inflammatory, genetic, and bacterial variables in relation to anti-TNF through levels in CD patients. METHODS: Consecutive CD patients receiving stable doses of infliximab or adalimumab were included. Clinical and analytical parameters were recorded. Cytokine response, bacterial DNA translocation, and several immune-related genes' genotypes were evaluated, along with serum through anti-TNF drug levels. A linear regression analysis controlled by weight and drug regimen was performed. RESULTS: One hundred nineteen patients were initially considered. Five patients on infliximab and 2 on adalimumab showed antidrug antibodies in serum and were excluded. One hundred twelve patients were finally included (62 on infliximab, 50 on adalimumab). Fourteen patients on infliximab and 15 on adalimumab (22.6% vs 30%, P = 0.37) were receiving an intensified drug regimen. C-reactive protein (CRP), fecal calprotectin, Crohn's Disease Activity Index, leukocyte count, and albumin levels in plasma were not significantly associated with infliximab or adalimumab levels in the multivariate analysis. Serum interleukin-10 (IL-10) levels were directly related to infliximab (Beta = 0.097, P < 0.0001) and adalimumab levels (Beta = 0.069, P = 0.0241). The best multivariate regression model explaining the variability of serum infliximab and adalimumab levels included IL-10. Predicted drug levels by this model robustly fitted with actual drug levels (R2 = 0.841 for infliximab, R2 = 0.733 for adalimumab). CONCLUSION: Serum IL-10 is significantly related to serum anti-TNF levels in CD patients, showing how the disposition of anti-TNF drugs is significantly influenced by the degree of immunological activation.

Gut Bacterial DNA Translocation is an Independent Risk Factor of Flare at Short Term in Patients With Crohn's Disease.

OBJECTIVES: We aimed at evaluating bacterial DNA (bactDNA) presence in blood of Crohn's disease (CD) patients in remission as an independent risk factor of flare at 6 months. METHODS: This is a prospective, multicenter study on CD patients with Crohn's disease activity index (CDAI)<150. The primary end point was time-to-relapse as evaluated by CDAI>150 in the following 6 months. BactDNA in blood, the nucleotide-binding oligomerization domain containing 2 (NOD2) genotype, and serum cytokine levels were determined at baseline. RESULTS: A total of 288 patients were included. BactDNA was detected in 98 patients (34.0%). A variant-NOD2 genotype was identified in 114 patients (39.6%). Forty patients (14%) relapsed during follow-up. Multivariate survival analysis identified bactDNA as an independent risk factor of flare (hazard ratio (HR) 8.75 (4.02-19.06) 95% confidence interval (CI)). Hospitalization, surgery, switch of treatment, initiation and escalation of anti-tumor necrosis factor (TNF) therapy, steroids initiation, and increased fecal calprotectin levels at 6 months were associated with bactDNA at baseline. A logistic regression analysis showed bactDNA as an independent and significant predictive factor of hospitalization (odds ratio (OR) 11.9 (3.4-42.3); P<0.001), steroids startup (OR 8.5 (2.7-27.1); P<0.001), and switch of treatment (OR 3.5 (1.6-7.7); P=0.002) at 6 months. No relationship was observed between bactDNA and mucosal lesions in patients with colonoscopy at admission. Serum pro-inflammatory cytokines were significantly increased in patients with bactDNA or a variant-NOD2 genotype. The combination of both factors induced decreased anti-TNF-α levels and a higher percentage of patients on intensified anti-TNF therapy. CONCLUSIONS: BactDNA is an independent risk factor of relapse at 6 months in CD patients. BactDNA is also independently associated with an increased risk of hospitalization, switch of treatment, and steroids initiation.

Short-term effectiveness of golimumab for ulcerative colitis: Observational multicenter study.

AIM: To evaluate the real-world effectiveness of golimumab in ulcerative colitis (UC) and to identify predictors of response. METHODS: We conducted an observational, prospective and multi-center study in UC patients treated with golimumab, from September 2014 to September 2015. Clinical activity was assessed at week 0 and 14 with the physician's global clinical assessment (PGA) and the partial Mayo score. Colonoscopies and blood tests were performed, following daily-practice clinical criteria, and the results were recorded in an SPSS database. RESULTS: Thirty-three consecutive patients with moderately to severely active UC were included. Among them, 54.5% were female and 42 years was the average age. Thirty percent had left-sided UC (E2) and 70% had extensive UC (E3). All patients had an endoscopic Mayo score of 2 or 3 at baseline. Twenty-seven point three percent were anti-tumor necrosis factor (TNF) treatment naïve, whereas 72.7% had previously received infliximab and/or adalimumab. Sixty-nine point seven percent showed clinical response and were steroid-free at week 14 (a decrease from baseline in the partial Mayo score of at least 3 points). Based on PGA, the clinical remission and clinical response rates were 24% and 55% respectively. Withdrawal of corticosteroids was observed in 70.8% of steroid-dependent patients at the end of the study. Three out of 10 clinical non-responders needed a colectomy. Mean fecal calprotectin value at baseline was 300 µg/g, and 170.5 µg/g at week 14. Being anti-TNF treatment naïve was a protection factor, which was related to better chances of reaching clinical remission. Twenty-seven point three percent of the patients required treatment intensification at 14 wk of follow-up. Only three adverse effects (AEs) were observed during the study; all were mild and golimumab was not interrupted. CONCLUSION: This real-life practice study endorses golimumab's promising results, demonstrating its short-term effectiveness and confirming it as a safe drug during the induction phase.

Oferta y composición nutricional de ensaladas en patios de comida de centros comerciales de Lima Metropolitana, 2014 / Supply and nutritional composition of salads in the food courts of shopping centers of Metropolitan Lima, 2014

Evaluar la oferta y composición nutricional de las ensaladas ofrecidas como plato principal en los patios de comida de los centros comerciales de Lima, Perú. Materiales y métodos. Se revisó las cartas de comida de todas las franquicias presentes en los patios de comida de los once centro comerciales de Lima, luego se evaluó la composición nutricional de las ensaladas ofertadas como plato principal calculando su contenido calórico, proteico, carbohidratos, grasas, colesterol, fibra y sodio, y la adecuación de ingesta para una cena (30% de una dieta de 2000 kcal). Resultados. Las ensaladas como plato principal representaron el 4,7% de la oferta, solo 7/17 franquicias ofrecían al menos una ensalada. El costo promedio de las ensaladas fue superior a los otros platos ($5,3 vs 4,7; p<0,001). El contenido calórico promedio fue de 329 kcal y de 2,7 g de fibra; con relación a una cena, se encontró un alto porcentaje de adecuación proteica (172,9%), de colesterol (121,0%), y bajo para calorías (54,8%), carbohidratos (23,1%) y fibra (36,4%). Conclusiones. Las ensaladas que se ofertan en patios de centros comerciales de Lima son escasas y más costosas, presentan poco aporte de fibra y altos contenidos de colesterol. Se deben revisar estrategias para mejorar la accesibilidad de ensaladas de calidad en escenarios donde solo ofertan comidas rápidas...

To assess supply and nutritional composition of the salads offered as an entrée main course in the food courts of the shopping centers in Lima, Peru. Materials and methods. The menus of all food franchises present in the food courts of the eleven shopping centers of Lima were reviewed. The nutritional composition of salads offered as an entrée were calculated for calories, protein content, carbohydrates, fats, cholesterol, fiber and sodium, and the adequacy of intake for a dinner (30% of a diet of 2000 kcal). Results. Salads as entrées accounted for 4.7% of the supply, and only 7 out of 17 franchises offered at least one salad. The average cost of the salads was higher than the other dishes ($5.3 vs $4.7; p<0.001). The average calorie content was 329 kcal and 2.7 g fiber; in relation to a dinner, we found a high percentage of adequacy for protein (172.9%), cholesterol (121.0%), and low adequacy for calories (54.8%), carbohydrates (23.1%) and fiber (36.4%). Conclusions. The salads that are offered in food courts in the shopping centers of Lima are scarce and more expensive, have little fiber content and are high in cholesterol. Strategies should be reviewed to improve the accessibility of quality salads offered in areas where only fast food is offered...

[Supply and nutritional composition of salads in the food courts of shopping centers of Metropolitan Lima, 2014]. / Oferta y composición nutricional de ensaladas en patios de comida de centros comerciales de Lima Metropolitana, 2014.

OBJECTIVES: To assess supply and nutritional composition of the salads offered as an entrée main course in the food courts of the shopping centers in Lima, Peru. MATERIALS AND METHODS: The menus of all food franchises present in the food courts of the eleven shopping centers of Lima were reviewed. The nutritional composition of salads offered as an entrée were calculated for calories, protein content, carbohydrates, fats, cholesterol, fiber and sodium, and the adequacy of intake for a dinner (30% of a diet of 2000 kcal). RESULTS: Salads as entrées accounted for 4.7% of the supply, and only 7 out of 17 franchises offered at least one salad. The average cost of the salads was higher than the other dishes ($5.3 vs $4.7; p<0.001). The average calorie content was 329 kcal and 2.7 g fiber; in relation to a dinner, we found a high percentage of adequacy for protein (172.9%), cholesterol (121.0%), and low adequacy for calories (54.8%), carbohydrates (23.1%) and fiber (36.4%). CONCLUSIONS: The salads that are offered in food courts in the shopping centers of Lima are scarce and more expensive, have little fiber content and are high in cholesterol. Strategies should be reviewed to improve the accessibility of quality salads offered in areas where only fast food is offered.