Treatment patterns and intensification within 5 year of follow-up of the first-line anti-TNFα used for the treatment of IBD: Results from the VERNE study.

BACKGROUND: Anti-TNFα represent one of the main treatment approaches for the management of inflammatory bowel diseases (IBD). Therefore,the evaluation of their treatment patterns over time provides valuable insights about the clinical value of therapies and associated costs. AIMS: To assess the treatment patterns with the first anti-TNFα in IBD. METHODS: Retrospective, observational study. RESULTS: 310 IBD patients were analyzed along a 5-year follow-up period. 56.2% of Crohn's disease (CD) patients started with adalimumab (ADA), while 43.8% started with infliximab (IFX). 12.9% of ulcerative colitis (UC) patients initiated with ADA, while 87.1% initiated with IFX. Treatment intensification was required in 28.9% of CD and 37.1% of UC patients. Median time to treatment intensification was shorter in UC than in CD (5.3 vs. 14.3 months; p = 0.028). Treatment discontinuation due to reasons other than remission were observed in 40.7% of CD and 40.5% of UC patients, although, in UC patients there was a trend to lower discontinuation rates with IFX (36.6%) than with ADA (66.7%). Loss of response accounted for approximately one-third of discontinuations, in both CD and UC. CONCLUSIONS: Around one-third of IBD biologic-naive patients treated with an anti-TNFα required treatment intensification (earlier in UC) and around 40% discontinued the anti-TNFα due to inappropriate disease control.

[Involvement of intestinal dysbiosis in the etiopathogenesis and treatment of autism spectrum disorder: a bibliographic review]. / Implicación de la disbiosis intestinal en la etiopatogenia y el tratamiento del trastorno del espectro autista: una revisión bibliográfica.

INTRODUCTION: Autism spectrum disorder is a neurodevelopmental disorder with phenotypic heterogeneity and variable symptomatic course of partly unknown etiology. The prevalence of gastrointestinal disorders in autism leads to investigate the role that intestinal microbiota may have as a causal factor and to propose specific therapeutic interventions. The role of microbiota in brain development and function, demonstrated in animal models, justifies its investigation in this neuropsychiatric disorder. OBJECTIVE: The aim was to investigate the relationship between altered microbiota composition and autism spectrum disorder, and to assess the therapeutic role of prebiotics, probiotics and fecal transplantation in this neurodevelopmental disorder. DEVELOPMENT: A literature review was conducted in PubMed, Cochrane Library and Google Scholar to select relevant articles related to the topic that were published between January 2012 and April 2020. Thirty-five relevant articles were selected. In 23 of them, significant differences were found in the composition and diversity of the microbiota in children with ASD, as well as in the biomolecules involved in certain metabolic pathways. The other 12 investigations reported gastrointestinal and behavioral improvements after therapeutic intervention. CONCLUSIONS: It is reasonable to state that there is enough evidence to support the existence of a relationship between intestinal microbiota and autism spectrum disorders. This fact should be explored in depth to assess the etiopathogenic burden of dysbiosis and the possible therapeutic tools.

TITLE: Implicación de la disbiosis intestinal en la etiopatogenia y el tratamiento del trastorno del espectro autista: una revisión bibliográfica.Introducción. El trastorno del espectro autista es un trastorno del neurodesarrollo con heterogeneidad fenotípica y curso sintomático variable de etiología parcialmente desconocida. La prevalencia de trastornos gastrointestinales en este perfil de pacientes invita a investigar el papel que la microbiota intestinal puede tener como factor causal y a plantear intervenciones terapéuticas específicas. El papel de la microbiota en el desarrollo y la función cerebral, demostrado en modelos animales, justifica su investigación en este trastorno neuropsiquiátrico. Objetivo. Investigar la relación entre la alteración en la composición de la microbiota y el trastorno del espectro autista, y evaluar el papel terapéutico de prebióticos, probióticos y trasplante fecal en este trastorno del neurodesarrollo. Desarrollo. Se realizó una revisión bibliográfica en PubMed, Cochrane Library y Google Scholar con el fin de seleccionar los artículos relevantes relacionados con el tema que se publicaron entre enero de 2012 y abril de 2020. Se seleccionaron 35 artículos relevantes. En 23 de ellos se encontraron diferencias significativas en la composición y la diversidad de la microbiota en niños con TEA, así como en biomoléculas involucradas en determinadas rutas metabólicas. Las otras 12 investigaciones describieron mejorías gastrointestinales y comportamentales tras la intervención terapéutica. Conclusiones. Resulta razonable afirmar que existe evidencia suficiente para apoyar la existencia de una relación entre la microbiota intestinal y los trastornos del espectro autista. Esta vinculación ha de ser explorada en profundidad para perfilar el peso etiopatogénico de la disbiosis y las posibles herramientas terapéuticas.

Effects of diaphragmatic myofascial release on gastroesophageal reflux disease: a preliminary randomized controlled trial.

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 effect on the symptoms, quality of life, and consumption of proton pump inhibitors (PPI) drugs by patients with non-erosive gastroesophageal reflux 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 Reflux 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 significant improvements in symptomatology (mean difference-1.1; 95% CI: -1.7 to -0.5), gastrointestinal quality of life (mean difference 18.1; 95% CI: 4.8 to 31.5), and PPIs use (mean difference-97 mg; 95% CI: -162 to -32), compared to the sham group. These preliminary findings 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.

Prevalence and Factors Associated With Fatigue in Patients With Inflammatory Bowel Disease: A Multicentre Study.

BACKGROUND AND AIMS: The aims of this study were to determine the prevalence of fatigue in patients with inflammatory bowel disease [IBD], to identify the factors associated with fatigue and its severity, to assess the impact of fatigue on quality of life [QoL], and to evaluate the relationship between fatigue and sleep disorders. METHODS: This was a prospective multicentre study conducted at 22 Spanish centres. Consecutive patients followed at IBD Units were included. Fatigue was evaluated with the Fatigue Severity Scale [FSS] and the Fatigue Impact Scale [FIS]. Quality of life and sleep quality were assessed using the IBD Questionnaire-Short Form [IBDQ-9] and the Pittsburgh Sleep Quality Index [PSQI], respectively. RESULTS: A total of 544 consecutive adult IBD patients were included [50% women, mean age 44 years, 61% Crohn's disease]. The prevalence of fatigue was 41% (95% confidence interval [CI] = 37-45%). The variables associated with an increased risk of fatigue were: anxiety [OR = 2.5, 95% CI = 1.6-3.7], depression [OR = 2.4, 95% CI = 1.4-3.8], presence of extraintestinal manifestations [EIMs] [OR = 1.7, 95% CI = 1.1-2.6], and treatment with systemic steroids [OR = 2.8, 95% CI = 1.4-5.7]. The presence of EIMs [regression coefficient, RC = 8.2, 95% CI = 2.3-14.2], anxiety [RC = 25.8, 95% CI = 20.0-31.5], depression [RC = 30.6, 95% CI = 24.3-37.0], and sleep disturbances [RC = 15.0, 95% CI = 9.3-20.8] were associated with severity of fatigue. Patients with fatigue had a significantly decreased IBDQ-9 score [p < 0.001]. CONCLUSIONS: The prevalence of fatigue in IBD patients is remarkably high and has a negative impact on QoL. Therapy with systemic steroids is associated with an increased risk of fatigue. The severity of fatigue is associated with anxiety, depression, sleep disorders, and the presence of EIMs. Fatigue was not associated with anaemia, disease activity or anti-TNF therapy.

Ustekinumab therapy for Crohn's disease during pregnancy: a case report and review of the literature.

WHAT IS KNOWN AND OBJECTIVES: The safety of continued ustekinumab (UST) therapy during pregnancy remains unclear in patients with Crohn's disease (CD). There are no meta-analysis reports of exposure to UST during pregnancy. The objective was to describe a case of a pregnant patient with CD who was successfully treated with UST maintenance therapy throughout the pregnancy and delivered a baby boy without any congenital malformations, neurological abnormalities or birth defects. CASE SUMMARY: A 37-year-old patient with CD treated with UST became pregnant. She had been receiving UST for 8 months at the time. After discussion with the patient and the obstetric team, the UST therapy was continued. The result of treatment was an uneventful pregnancy with delivery, at term, of a healthy boy and the maintenance of clinical, biological and endoscopic remission of CD during and after pregnancy. WHAT IS NEW AND CONCLUSION: To our knowledge, this is the first reported use of continued UST therapy for CD throughout a pregnancy. The result of treatment was an uncomplicated pregnancy with the mother giving birth to a healthy boy at term and the maintenance of clinical biological and endoscopic remission of CD during and after pregnancy.

Evolution After Anti-TNF Discontinuation in Patients With Inflammatory Bowel Disease: A Multicenter Long-Term Follow-Up Study.

OBJECTIVES: The aims of this study were to assess the risk of relapse after discontinuation of anti-tumor necrosis factor (anti-TNF) drugs in patients with inflammatory bowel disease (IBD), to identify the factors associated with relapse, and to evaluate the overcome after retreatment with the same anti-TNF in those who relapsed. METHODS: This was a retrospective, observational, multicenter study. IBD patients who had been treated with anti-TNFs and in whom these drugs were discontinued after clinical remission was achieved were included. RESULTS: A total of 1,055 patients were included. The incidence rate of relapse was 19% and 17% per patient-year in Crohn's disease and ulcerative colitis patients, respectively. In both Crohn's disease and ulcerative colitis patients in deep remission, the incidence rate of relapse was 19% per patient-year. The treatment with adalimumab vs. infliximab (hazard ratio (HR)=1.29; 95% confidence interval (CI)=1.01-1.66), elective discontinuation of anti-TNFs (HR=1.90; 95% CI=1.07-3.37) or discontinuation because of adverse events (HR=2.33; 95% CI=1.27-2.02) vs. a top-down strategy, colonic localization (HR=1.51; 95% CI=1.13-2.02) vs. ileal, and stricturing behavior (HR=1.5; 95% CI=1.09-2.05) vs. inflammatory were associated with a higher risk of relapse in Crohn's disease patients, whereas treatment with immunomodulators after discontinuation (HR=0.67; 95% CI=0.51-0.87) and age (HR=0.98; 95% CI=0.97-0.99) were protective factors. None of the factors were predictive in ulcerative colitis patients. Retreatment of relapse with the same anti-TNF was effective (80% responded) and safe. CONCLUSIONS: The incidence rate of inflammatory bowel disease relapse after anti-TNF discontinuation is relevant. Some predictive factors of relapse after anti-TNF withdrawal have been identified. Retreatment with the same anti-TNF drug was effective and safe.

Study of quality of life in patients with benign prostatic hyperplasia under treatment with silodosin.

OBJECTIVES: To assess the impact of urinary symptoms associated with benign prostatic hyperplasia and its treatment with silodosin, on quality of life (QoL) and sexual function, depending on age, severity of symptoms, time on treatment and prostate size. MATERIAL AND METHODS: A cross-sectional, observational study was conducted in 305 urology practices all around Spain. Socio-demographic and clinical data were collected and patients filled the following questionnaires: EQ-5D, Sexual Function Index (SFI) and International Prostate Symptom Score (IPSS). Multiple regression models were used to determine factors independently associated with patients' QoL. RESULTS: A total of 1,019 patients were enrolled, mean (SD) for: age 62.7 (5.7), EQ-5D 89.9 (13.9), sexual drive-SFI 3.71 (1.67), erection-SFI 6.11 (3.08), ejaculation-SFI 4.50 (2.06) problems-SFI 6.85 (3.37) and overall satisfaction-SFI 2.00 (0.99). The EQ-5D and SFI score were statistically lower with: older age, severe LUTS and greater prostate size (P<.01), but no differences were found related to time on treatment with silodosin. The EQ-5D score was positively associated with sexual satisfaction and desire size of SFI and the EQ-5D VAS score, and negatively with disability, semi-urban residence and comorbidities in the multiple regression analyses. CONCLUSIONS: Severe LUTS and older age are associated to a greater deterioration in sexual function and quality of life. However time on treatment with silodosin does not produce deterioration in the quality of life.

Treatment persistence and compliance with a combination of calcium and vitamin D.

INTRODUCTION: The persistence and compliance of patients in Spain with calcium and vitamin D supplementation are unknown, and thus the purpose of the present study was to determine the current figures. METHODS: This was a multicenter, cross-sectional study. Throughout Spain, 1342 primary-care physicians and specialists were asked to recruit 7888 patients aged 45 years or over, who had been prescribed with a calcium and vitamin D combination (CaVitD) at least 1 year prior to the study. Data on biodemographics, the reason for prescription and fracture risk factors were collected. Persistence with treatment, reasons for discontinuation, and compliance among persistent patients were assessed and patients' profiles analyzed. RESULTS: From the recruited sample, a total of 7624 patients were finally analyzed. Most subjects were postmenopausal (mean age 65.7 ± 9.4 years). The main reason for CaVitD prescription was osteoporosis (56.3%), started 2-5 years earlier. A family history of osteoporosis (41.4%) and previous fractures (40.7%) occurred frequently in the patients' clinical histories. At the study visit, 27.7% had discontinued CaVitD treatment, the main reason being fatigue due to the long-term treatment. Just 31.2% of persistent patients were adherent. Non-persistent patients were more likely to be smokers, alcohol consumers, have a long immobilization history, malabsorption syndrome and previous bone fractures. CONCLUSIONS: Only two in ten patients effectively comply with CaVitD treatment after 1 year or more of its prescription.

Hernia diafragmática con riñón intratorácico / Diaphragmatic hernia with intrathoracic kidney

Las hernias diafragmáticas congénitas son un defecto poco común, diagnosticadas generalmente en las primeras horas de vida. Su diagnóstico en la etapa adulta es poco frecuente. La ectopia renal intratorácica es una patología aún más rara, y la asociación de ésta con un defecto diafragmático no llega al 0,3 por ciento de los casos. Se comunica un caso de una paciente de 40 años en la que se diagnostica mediante radiografía de tórax y TAC de tórax y abdómen la presencia de una hernia de Bochdaleck derecha asociada a riñón intratorácico ipsilateral.

[Factors associated with the development of atopy in young adults]. / Factores asociados al desarrollo de atopia en adultos jóvenes.

BACKGROUND: To determine the risk factors for the development of atopy in Spanish young adults. SUBJECTS AND METHODS: Case-control study over prevalent cases. Carried out in general population between the ages of 20 to 44 years old. Spanish participants of the ECRHS, a random representative sample of Spanish young adults (n = 16,884), and a 20% randomised subsample made by those who answered to a short respiratory questionnaire and had atopy assessed, was studied. Atopy was defined as having serum specific IgE positivity to the following aeroallergnes: cat dander, Cladosporium herbarum, Dermatophagoides pteronyssinus, Parietaria judaica and Phleum pratense. RESULTS: Several factors had a statistically significant effect. In addition to male gender and lower age, maternal allergy (OR = 1.63; 95% CI = 1.11-2.40), having allergic siblings (OR = 1.40; 95% CI = 1.06-1.90) and a higher educational level (OR = 1.69; 95% CI = 1.22-2.34) were associated with the presence of high levels of specific IgE in our sample. Moreover, having had older siblings, especially older brothers appears to be a protective factor to the development of atopy but not in a statistically significant way, while having had pet birds during childhood appears to enhance the risk. CONCLUSIONS: In addition to the familial variables that indicates both environmental and genetic factors, educational level seems to have low degree of association with atopy; this feature shows that variables related with life style are involved in atopy development.

[European study of asthma. Prevalence of atopy in young adults of 5 areas in Spain. Spanish Group of European Asthma Study]. / Estudio Europeo del Asma. Prevalencia de atopia en adultos jóvenes de 5 áreas españolas. Grupo Español del Estudio Europeo del Asma.

BACKGROUND: The aim of the current study is to show the prevalence of atopy in five Spanish areas, and its variability according to area, age and gender. PATIENTS AND METHODS: From a populational based sample of 16,884 individuals aged 20 to 44 years-old, we obtained a randomized 20% subsample (n = 3,310). Participants performed specific IgE measurements, skin prick tests, forced spirometries and metacholine challenges to measure bronchial hyperresponsiveness. The response rate was 40%, and 1,313 individuals were finally included in the study. Specific atopy to the following aeroallargens was determined: cat dander, Cladosporium, Dermatophagoides, Phleum, Parietaria, birch, Alternaria, ambrosia, olive, rye grass and dog dander. RESULTS: The global prevalence of atopy (detectable specific antibodies IgE in serum and/or skin reactivity) widely varied by area, skin reactivity ranking in males from a minimum in Albacete (24.6%; 95% CI: 18-33) to a maximum in Huelva (39.6%; 95% CI: 30-53), and in females ranking from a minimun in Galdakao (10.3%; 95% CI: 6-17) to a maximum in Barcelona (28.8%; 95% CI: 19-43). Considering separately seropositivity and skin reactivity we observed a similar trend. Males showed a higher prevalence of global atopy (40.1%) than females (29.4%). Our data indicate that there is a decrease in the prevalence of atopy according to age in the general population, but only significant in men. Dermatophagoides pteronyssinus is the most common allergen in all ares but Albacete, where the most common allergen is the olive pollen. CONCLUSIONS: By means of a standard methodology, we report population data of the prevalence of atopy in five Spanish areas. The distribution of the prevalence of atopy varies widely in the five areas surveyed, according to the composition of the most common environmental allergens.