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.

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.