Efectividad,seguridad y análisis económico de Benepali en práctica clínica

ObjectiveTo assess the effectiveness, safety and cost of Etanercept biosimilar in patients with rheumatoid arthritis (RA), spondyloarthritis (SpA) and psoriatic arthritis (PsA) compared to the standard drug in real clinical practice.Patients and methodsRetrospective observational study. Case series of 138 patients with RA, SpA or PsA treated with at least one dose of Benepali® (n = 79) or Enbrel® (n = 59). Drug retention time was the primary efficacy endpoint compared to the biosimilar and the original. The proportion of patients achieving low disease activity or remission after 52 weeks was used as the secondary outcome. Safety was assessed by means of the adverse effects incidence rate. A cost minimization analysis was performed.ResultsNo differences were observed regarding treatment retention time between drugs (median [95% confidence interval, 95% CI] at 12.0 months [10.2-12.0] for the biosimilar and 12.0 months [12.0-12.0] for the original). Similar improvements, in terms of inflammatory activity and physical function, were obtained after 52 weeks except for patients with SpA and PsA who, in general, experienced improvements of BASDAI and ASDAS with the original compared with the biosimilar. No significant differences were observed in the total number of adverse effects (.43 events/patient-years versus the biosimilar and .53 versus the original). Using the biosimilar in place of the original drug resulted in a net savings of 118,383.55 € (1,747.20 €/patient-years) for the hospital.ConclusionThe biosimilar Benepali is as effective and safe as the original and much more cost-effective.     

Dispepsia funcional y test de saciedad: utilidad en la práctica clínica

IntroductionAccording to the Rome III Criteria, functional dyspepsia (FD) is classified as postprandial distress syndrome (PDS) and epigastric pain syndrome (EPS). On the other hand, the satiety test (ST) has been used to evaluate gastric accommodation and emptying, distinguishing healthy individuals from those with dyspepsia.AimsTo determine whether the ST can distinguish dyspeptic individuals from healthy ones and to evaluate its usefulness in differentiating the two FD subtypes.MethodsAdults with FD were consecutively enrolled in a cross-sectional study within the time frame of August 2011 and October 2012. Healthy subjects participated as controls. The ST consisted of the intake of a nutritional supplement (Fortisip^®, Nutricia Bagó^®) at a constant speed; satiety was graded at 5-minute intervals (1 to 5 points). Intake was suspended when the maximum score was reported. The total ingested volume and caloric intake was recorded and the Mann-Whitney U test was used in the statistical analysis.ResultsThe study included 39 dyspeptic patients and 20 control individuals. The patients were predominantly women (84.6 vs. 25%; p < 0.0001) and they were similar in age (39.59 ± 13.53 vs. 34.70 ± 9.85 years) and BMI (24.32 ± 3.52 vs. 25.82 ± 3.34 kg/m2) with respect to the controls. The FD subtype percentages were PDS: 61%, EPS: 31%, and Mixed syndrome: 8%. There was a lower ingested volume and caloric intake on the part of the dyspeptic patients (185 vs. 300 ml and 277 vs. 520 Kcal, respectively. Both: P<.001). No differences in the ST were observed between the two pure dyspepsia subtypes.ConclusionsThere was a difference in the ST between healthy individuals and those with dyspepsia, but the ingested volume and caloric intake in the two FD subtypes were similar.     

Impacto clínico de la capilaroscopia periungueal en la práctica clínica diaria

IntroductionNailfold capillaroscopy (NC) is useful in the evaluation of Raynaud's phenomenon, associated with some connective tissue diseases and in the follow-up of patients with systemic sclerosis. Our study evaluates the impact of NC in the diagnosis, according to the reason for the request and profile of autoantibodies in daily clinical practice.Material and methodsAll patients that undergone at least one NC between June 2012 and December 2017 were included. Clinical records were reviewed and analysed in a dichotomous way (yes/no), to see whether the NC contributed to a change of diagnosis in subsequent consultations. In addition, demographic, clinical and laboratory data were collected, and the relationship with NC patterns evaluated.ResultsOf the 530 patients who had undergone at least one NC, 266 had Raynaud's phenomenon as primary indication for the technique. Of those, 20 patients (3.8%) had a diagnostic change in the post-NC consultation; 15 were diagnosed with systemic sclerosis, 4 with undifferentiated connective tissue disease and one with mixed connective tissue disease. All patients had, except for one patient diagnosed with undifferentiated connective tissue disease, positive antinuclear antibodies titres, 11 of them had disease specific antibodies (9 anti-centromere, one anti-Scl70 and other anti-RNPC). The positivity of antinuclear antibodies titres was associated with a higher probability of presenting a scleroderma pattern in the NC, and all patients with a specific rheumatological diagnosis had an abnormal NC.ConclusionNC is a useful technique, but with limited impact in the diagnosis of connective tissue diseases. Autoantibody positivity is associated with a greater likelihood of presenting pathological NC patterns.     

Utilidad y aplicación en la práctica clínica de los criterios CASPAR

Several classification criteria for psoriatic arthritis have been proposed in the literature but it is still unclear which one of them best represents the diseases’ ample spectrum. None of these classification criteria have been universally accepted. New classification criteria (CASPAR) have been recently published. Their application is simple, fast and easy to perform. In addition, they show two important qualities. One is that they allow for the diagnosis of psoriatic arthritis even when there is no skin disease present at the moment of diagnosis. The other is is that it enables us to classify a patient as having psoriatic arthritis in spite of a positive rheumatoid factor. The CASPAR criteria have a sensitivity of 91.4% and a specificity of 98.7%. It seems, in contrast, that it is not as high for recent-onset psoriatic arthritis. Therefore establishing the definition of inflammatory arthritis becomes paramount.     

Eficacia y seguridad de ustekinumab en la práctica clínica real. Estudio multicéntrico retrospectivo. Cohorte ARAINF

IntroductionUstekinumab, a monoclonal antibody that blocks interleukins 12/23, has proven in clinical trials its efficacy in inducing and maintaining clinical remission of Crohn's disease (CD). Its effectiveness and safety in actual clinical practice is less known and may differ from trials.ObjectiveTo evaluate its effectiveness and safety in clinical practice (intravenous induction pattern essentially), such as induction and over the long term, in patients with CD refractory to biological treatment.Material and methodsMulticentre retrospective analysis (6 hospitals in Aragón), which includes all patients (N = 69) with CD undergoing treatment with ustekinumab (either with intravenous or subcutaneous induction), who had at least 16 weeks of follow-up. The clinical response or remission has been evaluated at weeks 16, 24, 32 and 48 using the Harvey-Bradshaw index.ResultsA total of 69 patients have been included, mean age 42 years, 54% men. A percentage of 89.86 (95% CI [0.805, 0.949]) of the patients presented clinical improvement at week 16 (15.95% remission, 73.92% response). In the subsequent follow-up, this response has been maintained. Age (OR 0.95, P = .028) and smoking habits (OR 0.19, P = .027) have been identified by an ordinal regression model as predictors of poor treatment response while the need for biological change due to adverse effect (OR 96, P = .00017) and due to loss of secondary response (OR 7.07, P = .034) have been predictors of good response. No serious adverse effects have been reported that forced them to stop taking ustekinumab.ConclusionUstekinumab is effective and safe in real clinical practice to achieve induction and maintenance of the response in patients with refractory CD. Tobacco and age have been shown to be predictors of poor response, while the indication for adverse effect to previous biological and for loss of secondary response has been shown to be predictors of good response.     

Guía de práctica clínica de la enfermedad pulmonar obstructiva crónica (EPOC) ALAT-2014: Preguntas y respuestas

ALAT-2014 COPD Clinical Practice Guidelines used clinical questions in PICO format to compile evidence related to risk factors, COPD screening, disease prognosis, treatment and exacerbations. Evidence reveals the existence of risk factors for COPD other than tobacco, as well as gender differences in disease presentation. It shows the benefit of screening in an at-risk population, and the predictive value use of multidimensional prognostic indexes. In stable COPD, similar benefits in dyspnea, pulmonary function and quality of life are achieved with LAMA or LABA long-acting bronchodilators, whereas LAMA is more effective in preventing exacerbations. Dual bronchodilator therapy has more benefits than monotherapy. LAMA and combination LABA/IC are similarly effective, but there is an increased risk of pneumonia with LABA/IC. Data on the efficacy and safety of triple therapy are scarce. Evidence supports influenza vaccination in all patients and anti-pneumococcal vaccination in patients < 65 years of age and/or with severe airflow limitation. Antibiotic prophylaxis may decrease exacerbation frequency in patients at risk. The use of systemic corticosteroids and antibiotics are justified in exacerbations requiring hospitalization and in some patients managed in an outpatient setting.     

Experiencia en práctica clínica de optimización de tiopurinas mediante determinación de sus metabolitos en la enfermedad inflamatoria intestinal

Introduction

Thiopurine therapy can be optimised by determining the concentration of the drug's metabolites.

Uso de la cápsula endoscópica en enfermedad inflamatoria intestinal en práctica clínica en España. Resultados de una encuesta nacional

IntroductionSmall bowel capsule endoscopy (SBCE) is a non-invasive diagnostic technique whose use in inflammatory bowel disease (IBD) has spread. A panenteric capsule, PillCam Crohn's (PCC), has recently been developed. We lack information on the availability and use of the CEID and PCC in our environment.MethodsWe conducted an electronic and anonymous survey among the members of the Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU) [Spanish Working Group on Crohn's Disease and Ulcerative Colitis] and the Asociación Española de Gastroenterología (AEG) [Spanish Association of Gastroenterology], consisting of 37 multiple-choice questions.ResultsOne hundred and fifty members participated, the majority dedicated to IBD (69.3%). 72.8% worked at centres with an IBD unit. 79% had SBCE available at their hospital, 14% referred patients to another centre; 22% had a PCC available, 9% referred patients to another centre. 79.3% of respondents with available SBCE used it in a small percentage of patients with IBD and 15.6% in the majority. The most frequent scenarios were suspicion of Crohn's disease (76.3%), assessment of inflammatory activity (54.7%) and assessment of the extent of the disease (54.7%). More than half (59.7%) preferentially used the Patency capsule to assess intestinal patency. Almost all respondents (99.3%) considered that training resources should be implemented in this technique.ConclusionsSBCE is widely available in Spanish hospitals for the management of IBD, although its use is still limited. There is an opportunity to increase training in this technique, and consequently its use.     

Terapia triple en pacientes con fibrosis avanzada y cirróticos: aspectos relevantes en la práctica clínica

The first-line option in the treatment of patients with advanced fibrosis and cirrhosis due to genotype 1 hepatitis C virus is currently triple therapy with boceprevir/telaprevir and pegylated interferon-ribavirin. However, certain limitations could constitute a barrier to starting treatment or achieving sustained viral response in these patients. These limitations include the patient's or physician's perception of treatment effectiveness in routine clinical practice–which can weight against the decision to start treatment–, the advanced stage of the disease with portal hypertension and comorbidity, treatment interruption due to poor adherence, and adverse effects, mainly anemia. In addition, it is now possible to identify patients who could benefit from a shorter therapeutic regimen with a similar cure rate.This review discusses these issues and their possible effect on the use of triple therapy.     

Recomendaciones para el manejo de la comorbilidad en la práctica clínica en pacientes con espondiloartritis axial

Objectives

To identify priorities among comorbidities in axial spondyloarthritis (AxSpA) and recommend how to follow them from an eminently practical perspective.