Usefulness of ultrasound in clinical decision-making in rheumatology clinical practice: A single-center longitudinal study.

OBJECTIVE: The purpose of the present study is to identify the extent to which it affects clinical decisions in a single-centre observational retrospective study. METHOD: The results of 801 requests and 1174 consecutive individual ultrasound examinations performed over 10 months were analysed. RESULTS: The most frequent indication was diagnostic assistance (39%) followed by assessment of inflammatory activity (34%). By topography, the hand was the most frequently studied region (51%), followed by the foot (18.1%). Of all requests, 67% had an impact on decision-making. The impact on clinical decision-making was associated with a shorter waiting time for the evaluation of the results, being the greatest in those ultrasound scans performed on demand on the same day of the request. In 73% of bilateral ultrasound studies, findings in one of the joints exemplified the overall result reported. CONCLUSIONS: Rheumatological musculoskeletal ultrasound has proven to be a useful decision-making technique, the greater the impact of which is seen the shorter the waiting time before it is performed.

Utilidad de la ecografía reumatológica en la toma de decisiones en la práctica clínica: Estudio unicéntrico longitudinal / Usefulness of ultrasound in clinical decision-making in rheumatology clinical practice: A single-center longitudinal study

Objetivo: El propósito del presente estudio es identificar en qué medida la ecografía reumatológica afecta a las decisiones clínicas mediante un estudio unicéntrico observacional retrospectivo. Método: Se analizaron los resultados de 801 solicitudes y 1174 ecografías individuales consecutivas realizadas a lo largo de 10 meses. Resultados: La indicación más frecuente fue la asistencia diagnóstica (39%) seguida de la evaluación de actividad inflamatoria (34%). Por topografía, la mano fue la región más estudiada (51%), seguida del pie (18,1%). De todas las solicitudes, en el 67% se constató un impacto en la toma de decisiones. El impacto en la decisión clínica se asoció a un menor tiempo de espera hasta la evaluación de los resultados, siendo el mayor en aquellas ecografías realizadas a demanda el mismo día de su petición. En el 73% de los estudios ecográficos bilaterales, los hallazgos en una de las articulaciones ejemplificaban el resultado global emitido. Conclusiones: La ecografía reumatológica demuestra ser una técnica útil en la toma de decisiones, cuyo mayor impacto se constata cuanto menor es el tiempo de espera hasta la evaluación de los resultados.(AU)

Objective: The purpose of the present study is to identify the extent to which rheumatological musculoskeletal ultrasound affects clinical decisions in a single-centre observational retrospective study. Method: The results of 801 requests and 1174 consecutive individual ultrasound examinations performed over 10 months were analysed. Results: The most frequent indication was diagnostic assistance (39%) followed by assessment of inflammatory activity (34%). By topography, the hand was the most frequently studied region (51%), followed by the foot (18.1%). Of all requests, 67% had an impact on decision-making. The impact on clinical decision-making was associated with a shorter waiting time for the evaluation of the results, being the greatest in those ultrasound scans performed on demand on the same day of the request. In 73% of bilateral ultrasound studies, findings in one of the joints exemplified the overall result reported. Conclusions: Rheumatological musculoskeletal ultrasound has proven to be a useful decision-making technique, the greater the impact of which is seen the shorter the waiting time before it is performed.(AU)

Recomendaciones de expertos para el uso de apremilast en artritis psoriásica / Expert recommendations for the use of apremilast in psoriatic arthritis

Introducción y objetivos: A pesar de la evidencia, existen dudas sobre el posicionamiento de apremilast en el algoritmo de tratamiento de la artritis psoriásica (APs). El objetivo del presente proyecto fue recoger la evidencia científica y la experiencia de un grupo de reumatólogos expertos en el manejo de la APs sobre el uso de apremilast en la práctica clínica en España. Material y métodos: Un comité científico formado por 6 expertos propuso 5 escenarios clínicos donde la evidencia sobre el uso de apremilast en APs era controvertida: 1) eficacia en APs periférica; 2) eficacia en entesitis y dactilitis; 3) eficacia en APs con afectación cutánea; 4) comorbilidades, y 5) seguridad de apremilast. Tras esto, un panel de 17 reumatólogos expertos en el tratamiento de la APs discutió estos escenarios y generó un cuestionario con 50 preguntas y 156 ítems según metodología Delphi, el cual fue respondido de forma anónima por los panelistas. Resultados: Tras 2 rondas de votación, el panel de expertos alcanzó el consenso en 93 de los 156 ítems planteados (59,6%) (67 apropiados y 26 inapropiados). El grado de consenso fue del 53,3% en el área de «Eficacia en APs periférica»; del 60,0% en «Eficacia en entesitis y dactilitis»; del 50,0% en «Eficacia en APs con afectación cutánea»; del 57,1% en «Manejo de las comorbilidades en pacientes con APs», y del 67,3% en «Implicaciones de la seguridad en el uso de apremilast». Conclusiones: La opinión estructurada de los expertos complementa la evidencia disponible y contribuye al establecimiento de pautas consensuadas para el uso de apremilast en APs.(AU)

Introduction and objectives: Despite the evidence, there are doubts about the positioning of apremilast in the psoriatic arthritis (PsA) treatment algorithm. The objective of this project was to collect the scientific evidence and the experience of a group of rheumatologists who are experts in the management of PsA with apremilast in clinical practice in Spain. Material and methods: A scientific committee made up of 6 experts proposed 5 clinical scenarios where the evidence on the use of apremilast in PsA was controversial: 1) efficacy in peripheral PsA; 2) efficacy in enthesitis and dactylitis; 3) efficacy in PsA with skin involvement; 4) comorbidities, and 5) apremilast safety. After this, a panel of 17 rheumatologists with expertise in PsA management discussed these scenarios and generated a questionnaire with 50 questions and 156 items following the Delphi methodology. This questionnaire was anonymously answered by the panel. Results: After 2 voting rounds, the panel of experts reached consensus in 93 of the 156 items raised (59.6%) (67 appropiate and 26 inappropiate). The degree of consensus was 53.3% in the area of “Efficacy in peripheral PsA”; 60.0% in “Efficacy in enthesitis and dactylitis”; 50.0% in “Efficacy in PsA with skin involvement”; 57.1% in “Management of comorbidities in patients with PsA”, and 67.3% in “Implications of safety in the use of apremilast”. Conclusions: The structured opinion of the experts complements the available evidence and contributes to the establishment of consensual guidelines for the use of apremilast in PsA.(AU)

Expert recommendations for the use of apremilast in psoriatic arthritis.

INTRODUCTION AND OBJECTIVES: Despite the evidence, there are doubts about the positioning of apremilast in the psoriatic arthritis (PsA) treatment algorithm. The objective of this project was to collect the scientific evidence and the experience of a group of rheumatologists who are experts in the management of PsA with apremilast in clinical practice in Spain. MATERIAL AND METHODS: A scientific committee made up of 6 experts proposed 5 clinical scenarios where the evidence on the use of apremilast in PsA was controversial: (i) Efficacy in peripheral PsA; (ii) Efficacy in enthesitis and dactylitis; (iii) Efficacy in PsA with skin involvement; (iv) Comorbidities; and (v) Apremilast safety. After this, a panel of 17 rheumatologists with expertise in PsA management discussed these scenarios and generated a questionnaire with 50 questions and 156 items following the Delphi methodology. This questionnaire was anonymously answered by the panel. RESULTS: After 2 voting rounds, the panel of experts reached consensus in 93 of the 156 items raised (59.6%) (67 in agreement and 26 in disagreement). The degree of consensus was 53.3% in the area of "Efficacy in peripheral PsA"; 60.0% in "Efficacy in enthesitis and dactylitis"; 50.0% in "Efficacy in PsA with skin involvement"; 57.1% in "Management of comorbidities in patients with PsA"; and 67.3% in "Implications of safety in the use of apremilast". CONCLUSIONS: The structured opinion of the experts complements the available evidence and contributes to the establishment of consensual guidelines for the use of apremilast in PsA.

Consensus statement on the use of alemtuzumab in daily clinical practice in Spain.

INTRODUCTION: Alemtuzumab is a highly effective drug approved by the European Medicines Agency as a disease-modifying drug for the treatment of relapsing-remitting multiple sclerosis. OBJECTIVE: A consensus document was drafted on the management of alemtuzumab in routine clinical practice in Spain. DEVELOPMENT: A group of multiple sclerosis specialists reviewed articles addressing treatment with alemtuzumab in patients with multiple sclerosis and published before December 2017. The included studies assessed the drug's efficacy, effectiveness, and safety; screening for infections and vaccination; and administration and monitoring aspects. The initial proposed recommendations were developed by a coordinating group and based on the available evidence and their clinical experience. The consensus process was carried out in 2 stages, with the initial threshold percentage for group agreement established at 80%. The final document with all the recommendations agreed by the working group was submitted for external review and the comments received were considered by the coordinating group. CONCLUSION: The present document is intended to be used as a tool for optimising the management of alemtuzumab in routine clinical practice.

Consenso de expertos sobre el uso de alemtuzumab en la práctica clínica diaria en España / Consensus statement on the use of alemtuzumab in daily clinical practice in Spain

Introducción: Alemtuzumab es un fármaco de alta eficacia aprobado por la Agencia Europea de Medicamentos como tratamiento modificador de la enfermedad en pacientes con esclerosis múltiple remitente recurrente.ObjetivoElaborar un documento de consenso sobre el manejo de alemtuzumab en la práctica clínica habitual, que sea de aplicación en el ámbito español.DesarrolloUn grupo de expertos en esclerosis múltiple revisó las publicaciones disponibles hasta diciembre de 2017, de tratamiento con alemtuzumab y esclerosis múltiple. Se incluyeron trabajos sobre eficacia, efectividad y seguridad, despistaje de infecciones y vacunación, administración y monitorización. La propuesta inicial de recomendaciones fue desarrollada por un grupo coordinador con base en la evidencia disponible y en su experiencia clínica. El proceso de consenso se llevó a cabo en 2 etapas; se estableció como porcentaje inicial de acuerdo grupal el 80%. El documento final con todas las recomendaciones acordadas por el grupo de trabajo se sometió a revisión externa y los comentarios recibidos fueron considerados por el grupo coordinador.ConclusionesEl documento aportado pretende ser una herramienta útil para facilitar el manejo del fármaco en condiciones de práctica clínica habitual. (AU)

Introduction: Alemtuzumab is a highly effective drug approved by the European Medicines Agency as a disease-modifying drug for the treatment of relapsing-remitting multiple sclerosis.ObjectiveA consensus document was drafted on the management of alemtuzumab in routine clinical practice in Spain.DevelopmentA group of multiple sclerosis specialists reviewed articles addressing treatment with alemtuzumab in patients with multiple sclerosis and published before December 2017. The included studies assessed the drug's efficacy, effectiveness, and safety; screening for infections and vaccination; and administration and monitoring aspects. The initial proposed recommendations were developed by a coordinating group and based on the available evidence and their clinical experience. The consensus process was carried out in 2 stages, with the initial threshold percentage for group agreement established at 80%. The final document with all the recommendations agreed by the working group was submitted for external review and the comments received were considered by the coordinating group.ConclusionThe present document is intended to be used as a tool for optimising the management of alemtuzumab in routine clinical practice. (AU)

Consensus statement on the use of alemtuzumab in daily clinical practice in Spain. / Consenso de expertos sobre el uso de alemtuzumab en la práctica clínica diaria en España.

INTRODUCTION: Alemtuzumab is a highly effective drug approved by the European Medicines Agency as a disease-modifying drug for the treatment of relapsing-remitting multiple sclerosis. OBJECTIVE: A consensus document was drafted on the management of alemtuzumab in routine clinical practice in Spain. DEVELOPMENT: A group of multiple sclerosis specialists reviewed articles addressing treatment with alemtuzumab in patients with multiple sclerosis and published before December 2017. The included studies assessed the drug's efficacy, effectiveness, and safety; screening for infections and vaccination; and administration and monitoring aspects. The initial proposed recommendations were developed by a coordinating group and based on the available evidence and their clinical experience. The consensus process was carried out in 2 stages, with the initial threshold percentage for group agreement established at 80%. The final document with all the recommendations agreed by the working group was submitted for external review and the comments received were considered by the coordinating group. CONCLUSION: The present document is intended to be used as a tool for optimising the management of alemtuzumab in routine clinical practice.

Long-term effects of continuous subcutaneous insulin infusion in adults with type 1 diabetes mellitus patients: Results of a public healthcare system.

AIM: To evaluate the long-term clinical effect of continuous subcutaneous insulin infusion (CSII) in adult type 1 diabetes mellitus (T1DM) patients in a regional public healthcare system real-world scenario. METHODS: All adult T1DM patients on CSII for ≥10 years subjected to follow-up in the regional Castilla-La Mancha Public Health Service were included. The primary efficacy outcome was the variation in HbA1c during follow-up. Direct patient data were compiled through the web-based Spanish national registry on CSII therapy. RESULTS: A total of 69 T1DM adult patients were treated with insulin pumps for ≥10 years in our region. The mean age was 45.0±10.5 years, with a T1DM duration of 13.9±8.5 years. The mean duration of CSII therapy was 11.4±2.1 years. The main indications for treatment were high glucose variability (39%), problematic hypoglycemia (26%), and HbA1c >53mmol/mol (7%) on multiple daily injections (20%). Sensor-augmented pump therapy was used by 31% of the patients. Glycosylated hemoglobin did not change during follow-up (58±11mmol/mol vs. 58±11mmol/mol; 7.5±1.0 vs. 7.5±1.0; p=0.66). However, the percentage of patients with at least one episode of severe hypoglycemia during the last year and unnoticed hypoglycemia decreased from 36% to 7% (p=0.006) and from 38% to 32% (p<0.001), respectively. The proportion of subjects with ≥1 episode of diabetic ketoacidosis in the last year decreased from 30% to 6% (p=0.045). CONCLUSIONS: The reduction of severe hypoglycemia without deterioration of glycemic control can be sustained over long-term CSII therapy.

Intravenous tocilizumab in the management of rheumatoid arthritis: Clinical practice findings from a 6-month international, multicentre, observational study in Central America and the Caribbean / El tocilizumab intravenoso en el tratamiento de la artritis reumatoide: resultados de la práctica clínica de un estudio internacional, multicéntrico y observacional de 6 meses de duración en América Central y el Caribe

ABSTRACT Tocilizumab (TCZ), an 1interieukin-6 receptor-α Inhibitor, is Indicated in patients with moderate to severe rheumatoid arthritis with inadequate response to disease modifying drugs. ACT UP is a multinational project co11ecting information from severa1 post-marketing TCZ studies. Aim: To determine the proportion of patients in the routine clinical care setting receiving intravenous TCZ after 6 months treatment. Identification of TCZ treatment patterns, efficacy, and safety were also recorded. Method: This prospective non-interventional 6-month study, collected real-world information from 169 Central American and Caribbean patients. No interventional procedures or additional visits outside routine clinical care practice were performed. Statistical analysis was essentially descriptive. Results: Adherence rate was 74.0%, with 97% of patients receiving TCZ as first biological therapy line and there were no deviations from the local label. Almost 85% of patients started with combination therapy, and the majority remained under this scheme throughout the study. A significant decrease in disease activity assessments and acute phase reactants values were detected during TCZ treatment. The percentage of patients that achieved improvement according to the different levels of the American College of Rheumatology (ACR) increased during the study, and relevant enhancements in quality of life were also accomplished. Adverse events (AEs) occurred in 35 patients, with metabolic and nutritional disorders being the most common. Serious AEs were reported in 3% of patients, and special interest AEs occurred in 6 patients. Conclusion: Treatment adherence was mainly determined by follow-up and compliance with the administration schedule. Efficacy analysis showed better results than those reported in international literature. The incidence of AEs was also lower than in previously published data.

RESUMEN El tocilizumab (TCZ) está indicado en la artritis reumatoide moderada a severa, principalmente en respuestas inadecuadas a fármacos convencionales. ACT UP es un proyecto multinacional que recopila información relacionada con varios estudios de poscomercialización. Objetivo: Determinar la proporción de pacientes en la atención clínica de rutina que continúan en tratamiento con TCZ intravenoso después de 6 meses. Se llevó a cabo la identificación de patrones de administración, eficacia y seguridad. Método: Este estudio observacional prospectivo recopiló información de la vida real de 169 pacientes de América Central y el Caribe. No se hicieron intervenciones ni visitas adicionales fuera de la práctica clínica habitual. El análisis estadístico fue esencialmente descriptivo. Resultados: La tasa de adherencia al tratamiento fue del 74,0%, el 97% de los pacientes reci bieron TCZ como primera línea biológica y no existieron desviaciones en las indicaciones de administración según el inserto local. Aproximadamente el 85% de los pacientes inició TCZ como terapia combinada, y la mayoría permaneció bajo este esquema. Se evidenció una dis minución en la actividad de la enfermedad y un aumento en el porcentaje de pacientes que lograron respuesta según los diferentes grados del Colegio Americano de Reumatología. En 35 pacientes se presentaron eventos adversos (EA), siendo los relacionados con metabolismo y nutrición los más comunes. Se informaron EA graves en el 3% de los pacientes y de interés especial en 6 casos. Conclusión: El seguimiento de los pacientes y el cumplimiento del programa fueron los prin cipales determinantes en la adherencia. El análisis de eficacia mostró mejores resultados que los reportados previamente y la incidencia de EA fue menor que en otros estudios.

Prescription patterns of antihyperglycemic drugs in elderly patients in Spain: A national cross-sectional study. / Patrones de prescripción de fármacos antihiperglucemiantes en pacientes ancianos en España: un estudio transversal nacional.

BACKGROUND AND OBJECTIVE: Elderly patients with type 2 diabetes represent a growing and heterogeneous group of subjects where treatment targets and antihyperglycemic drugs prescriptions should be tailored according to coexisting illnesses, functional and social domains. METHODS: We carried-out a national cross-sectional study (from February 2014 to December 2014) to assess prescription patterns and treatment inadequacy in patients with type 2 diabetes older than 65 years with at least 6 months of treatment with antihyperglycemic drugs. RESULTS: We included a total of 4,917 patients cared by 2,100 family physicians and 450 specialists. Diabetes prescriptions were monotherapy (21.2%), dual therapy (58.1%) and triple therapy (20.6%). The most common prescription patterns were metformin in monotherapy (66.5%), metformin plus DPP4 inhibitors in dual therapy (77.3%) and, in triple therapy, oral drugs (45.5%) and oral drugs plus insulin (45.8%). A total of 1,272 (25.9%) patients were at risk of serious hypoglycemia, 643 of them due to treatment with secretagogues (25%) or treatment with human insulin types (25.6%). CONCLUSIONS: Elderly patients with type 2 diabetes often receive antihyperglycemic therapy with higher risk of hypoglycemia. Substitution of secretagogues and human insulin therapy for safer medication could significantly reduce the adverse effects of diabetes treatment in this population.

Hyperkalemia in heart failure patients in Spain and its impact on guidelines and recommendations: ESC-EORP-HFA Heart Failure Long-Term Registry.

INTRODUCTION AND OBJECTIVES: Hyperkalemia is a growing concern in the treatment of patients with heart failure and reduced ejection fraction because it limits the use of effective drugs. We report estimates of the magnitude of this problem in routine clinical practice in Spain, as well as changes in potassium levels during follow-up and associated factors. METHODS: This study included patients with acute (n=881) or chronic (n=3587) heart failure recruited in 28 Spanish hospitals of the European heart failure registry of the European Society of Cardiology and followed up for 1 year. Various outcomes were analyzed, including changes in serum potassium levels and their impact on treatment. RESULTS: Hyperkalemia (K+> 5.4 mEq/L) was identified in 4.3% (95%CI, 3.7%-5.0%) and 8.2% (6.5%-10.2%) of patients with chronic and acute heart failure, respectively, and was responsible for 28.9% of all cases of contraindication to mineralocorticoid receptor antagonist use and for 10.8% of all cases of failure to reach the target dose. Serum potassium levels were not recorded in 291 (10.8%) of the 2693 chronic heart failure patients with reduced ejection fraction. During follow-up, potassium levels increased in 179 of 1431 patients (12.5%, 95%CI, 10.8%-14.3%). This increase was directly related to age, diabetes, and history of stroke and was inversely related to history of hyperkalemia. CONCLUSIONS: This study highlights the magnitude of the problem of hyperkalemia in patients with heart failure in everyday clinical practice and the need to improve monitoring of this factor in these patients due to its interference with the possibility of receiving optimal treatment.

Efficacy and Safety of Ixekizumab in a Real-Life Practice: A Retrospective Bicentric Study. / Eficacia y seguridad de ixekizumab en la práctica clínica habitual: estudio retrospectivo bicéntrico.

BACKGROUND: Ixekizumab has proven efficacy and safety for the treatment of psoriasis in clinical trials. The aim of this study was to evaluate its effectiveness and safety in routine clinical practice. METHODS: Retrospective study of all patients treated with ixekizumab in 2 dermatology departments in the city of Valencia, Spain. RESULTS: Seventy-five patients (53.3% men and 46.7% women) with a mean age of 48.61 years were studied; 77.3% (n = 58) had plaque psoriasis and 22.7% (n = 17) had psoriasis predominantly affecting a specific area. The most common comorbidity was obesity (present in 48% of patients) and 40% of the overall group had not been previously treated with a biologic drug. Mean psoriasis area and severity index (PASI) fell from 9.99 at baseline to 1.5 at week 16. PASI-75 and PASI-90 (improvements of at least 75% and 90% in PASI) were independent of sex, age, baseline PASI, and the comorbidities analyzed. Responses at week 16 and 52 were significantly better in biologic-naïve patients for the overall group and the subgroup of patients with localized psoriasis. Adverse effects were reported for 25.7% of patients and the most common effect was injection-site reaction. There were no serious adverse effects. CONCLUSIONS: Our findings show that ixekizumab is both effective and safe in the treatment of psoriasis in routine clinical practice.

Health-related Quality of Life of Patients With Chronic Systolic Heart Failure in Spain: Results of the VIDA-IC Study.

INTRODUCTION AND OBJECTIVES: Although heart failure negatively affects the health-related quality of life of Spanish patients there is little information on the clinical factors associated with this issue. METHODS: Cross-sectional multicenter study of health-related quality of life. A specific questionnaire (Kansas City Cardiomyopathy Questionnaire) and a generic questionnaire (EuroQoL-5D) were administered to 1037 consecutive outpatients with systolic heart failure. RESULTS: Most patients with poor quality of life had a worse prognosis and increased severity of heart failure. Mobility was more limited and rates of pain/discomfort and anxiety/depression were higher in the study patients than in the general population and patients with other chronic conditions. The scores on both questionnaires were very highly correlated (Pearson r =0.815; P < .001). Multivariable linear regression showed that being older (standardized ß=-0.2; P=.03), female (standardized ß=-10.3; P < .001), having worse functional class (standardized ß=-20.4; P < .001), a higher Charlson comorbidity index (standardized ß=-1.2; P=.005), and recent hospitalization for heart failure (standardized ß=6.28; P=.006) were independent predictors of worse health-related quality of life. CONCLUSIONS: Patients with heart failure have worse quality of life than the general Spanish population and patients with other chronic diseases. Female sex, being older, comorbidity, advanced symptoms, and recent hospitalization are determinant factors in health-related quality of life in these patients.