2. Universidad Cardenal Herrera-CEU

Objetivo: Comparar la persistencia, tasa de retención y pauta de prescripción de infliximab original e infliximab CT-P13 en pacientes naive a biológicos con colitis ulcerosa. Método: Estudio ambispectivo de pacientes naive a biológicos en colitis ulcerosa que recibieron tratamiento en primera línea con Remicade® (infliximab) y Remsima® (infliximab CT-P13) de forma no simultánea durante un periodo de estudio de 10 años (2012-2021). Se tomaron datos de su edad, peso, persistencia, tasa de retención y si precisó de intensificación o desintensificación a lo largo del periodo de estudio. Se determinó el coste paciente/año real de Remicade® y Remsima® de forma individualizada en función de las administraciones durante el periodo del estudio. Resultados: Un total de 27 pacientes naive a biológicos fueron tratados con Remicade® y 53 con Remsima®. Ambos grupos de pacientes no presentaron diferencias en cuanto al peso y edad. La persistencia (mediana ± rango intercuartílico) con Remicade® fue de 42,49 ± 57,48 meses frente a 27,50 ± 58,50 meses para Remsima®, sin demostrar diferencias significativas (p = 0,455). La tasa de retención a los 6, 12 y 24 meses fue del 81%, 63% y 33%, respectivamente, para el grupo de Remicade®, y del 71%, 47% y 37%, respectivamente, para el grupo de Remsima®. En el grupo de pacientes tratados con Remicade®, 9 pacientes fueron intensificados frente a 11 pacientes en el grupo de Remsima®. En cuanto a las desintensificaciones, 5 pacientes que recibieron tratamiento con Remicade® fueron desintensificados frente a 7 pacientes en tratamiento con Remsima®. El ahorro obtenido con el uso de Remsima® fue de 203.649 €, que equivaldría a tratar a 118 pacientes adicionales con infliximab biosimilar durante un año. Conclusiones: No existen diferencias significativas en la persistencia, tasa de retención y número de intensificaciones y desintensificaciones entre los pacientes naive que fueron tratados con Remicade® y aquellos tratados con Remsima®, siendo una alternativa eficaz, segura y económica en el tratamiento biológico de la colitis ulcerosa.

Intestinal dysbiosis is key in the onset and development of Crohn’s disease (CD). We evaluated the microbiota changes in CD patients before and after a six-month anti-TNF treatment, comparing these changes with the microbiota of healthy subjects. This prospective multicenter observational study involved 27 CD patients initiating anti-TNF treatment and 16 healthy individuals. Inflammatory activity was determined at baseline, 3 and 6 months, classifying patients into responders and nonresponders. Fecal microbiota was analyzed by massive genomic sequencing thought 16S rRNA amplicon sequencing before and after six months of anti-TNF treatment. The CD cohort showed a decrease in genera of the class Clostridia, short-chain fatty acid producers, and an increase in the phylum Proteobacteria (p < 0.01) versus the healthy cohort. After anti-TNF treatment, the phylum Proteobacteria also increased in non-responders versus responders (13/27) (p < 0.005), with the class Clostridia increasing. In addition, alpha diversity increased in responders versus non-responders (p < 0.01), tending towards eubiosis. An association was found (p < 0.001) in the F.prausnitzii/E.coli ratio between responders and non-responders. The F/E ratio was the most accurate biomarker of anti-TNF response (area under the curve 0.87). Thus, anti-TNF treatment allows partial restoration of intestinal microbiota in responders and the F.prausnitzii/E.coli ratio can provide a reliable indicator of response to anti-TNF in CD.

Background. Patients with inflammatory bowel disease (IBD) have a high prevalence of emotional disturbances which worsen the symptoms of the disease. As a therapeutic alternative that is part of a comprehensive care alongside medication, the Bonny Method of Guided Imagery and Music (BMGIM) music-assisted therapy has achieved promising emotional improvements in patients with chronic diseases. The objective of the study was to determine the impact of a treatment based on a BMGIM group adaptation on patients with inflammatory bowel disease (IBD) and their emotional state, therefore analyzing state of mind, quality of life, anxiety, depression, immunocompetence as a marker of well-being, and levels of acute and chronic stress. Methods. Longitudinal, prospective, quantitative, and experimental study including 43 patients with IBD divided into an intervention group (22 patients), who received eight sessions over eight weeks, and a control group (21 patients). A saliva sample was taken from each patient before and after each session in order to determine cortisol and IgA levels. Similarly, a hair sample was taken before the first and after the last session to determine the cumulative cortisol level. All molecules were quantified using the ELISA immunoassay technique. In addition, patients completed several emotional state questionnaires: HADS, MOOD, and CCVEII. Results. An improvement was observed in the following states of mind: sadness, fear, anger, and depression. No significant effect was observed in state of mind in terms of happiness or anxiety, in the levels of cortisol in hair, and in patients’ perceived quality of life. A reduction in cortisol was observed in saliva, although this did not significantly affect the IgA titer. Conclusions. BMGIM seems to improve the emotional state of patients with IBD.

Mindfulness-based interventions have shown some efficacy in decreasing stress levels and improving quality of life. However, so far, only a few studies have studied this type of intervention among patients with inflammatory bowel disease and none of them have studied their effects on inflammatory biomarkers. This current study was a two-armed, single-centre, randomised (2:1 ratio) controlled trial used to evaluate the effects of a mindfulness-based intervention (n = 37) compared to standard medical therapy (n = 20) in patients with Crohn’s disease or ulcerative colitis. The mindfulness intervention blended four internet-based therapy modules with four face-to-face support sessions. The outcomes we assessed were faecal calprotectin (primary outcome), C-reactive protein, and cortisol levels measured in hair samples at several timepoints. The between-group analysis highlighted significant decreases in faecal calprotectin and in C-reactive protein levels in the mindfulness-based intervention group compared to the standard medical therapy group at the six-month follow-up (faecal calprotectin: −367, [95% CI: −705, −29], P = 0.03; C-reactive protein: −2.82, [95% CI: −5.70, 0.08], P = 0.05), with moderate to large effect sizes (faecal calprotectin: ηp2 = 0.085; C-reactive protein: ηp2 = 0.066). We concluded that mindfulness-based therapy administered as part of standard clinical practice effectively improves inflammatory biomarkers in patients diagnosed with inflammatory bowel disease.

The purpose of this study is to investigate whether implementing a myofascial release (MFR) protocol designed to restore the myofascial properties of the diaphragm has any efect on the symptoms, quality of life, and consumption of proton pump inhibitors (PPI) drugs by patients with non-erosive gastroesophageal refux disease (GERD). We randomized 30 patients with GERD into a MFR group or a sham group. Changes in symptomatology and quality of life were measured with the Refux Disease Questionnaire and the Gastrointestinal Quality of Life Index. Need of PPIs was measured as the milligrams of drug intake over the 7 days prior to each assessment. All variables were assessed at baseline, one week and 4 weeks after the end of the treatment. At week 4, patients receiving MFR showed signifcant improvements in symptomatology (mean diference-1.1; 95% CI: −1.7 to −0.5), gastrointestinal quality of life (mean diference 18.1; 95% CI: 4.8 to 31.5), and PPIs use (mean diference-97mg; 95% CI: −162 to −32), compared to the sham group. These preliminary fndings indicate that the application of the MFR protocol we used in this study decreased the symptoms and PPIs usage and increased the quality of life of patients with non-erosive GERD up to four weeks after the end of the treatment.