Patrones de tratamiento biológico en pacientes con enfermedades articulares inflamatorias. Estudio retrospectivo de 4 años de seguimiento / Biological treatment patterns in patients with inflammatory joint diseases. Retrospective study with 4 years follow-up

OBJETIVO: Describir el manejo terapéutico de la artritis reumatoide (AR), la artritis psoriásica (Aps) y la espondilitis anquilosante (EA) en pacientes que inician tratamiento con agentes biológicos. MATERIALES Y MÉTODOS: Estudio observacional, retrospectivo, longitudinal en 33 hospitales españoles. Se incluyeron pacientes con AR, Aps y EA que iniciaron tratamiento con agentes biológicos entre septiembre de 2009 y agosto de 2010, con un seguimiento de más de 3 años. Se analizaron las características clínico-demográficas, los fármacos, la supervivencia de la terapia biológica y las causas de cambio o interrupción. RESULTADOS: Se incluyeron 463 pacientes (183 AR, 119 Aps y 161 EA) con un seguimiento medio de 3,8 años. Al final del seguimiento una elevada proporción continuaba con el primer biológico prescrito (41,0% de AR, 59,7% de Aps y 51,6% de EA), precisando ajustes de dosis el 31,1%, 47,9% y 42,9% de pacientes con AR, Aps y EA, respectivamente. Hubo interrupción temporal en el 8,2%, 8,4% y 15,5% de los pacientes y se precisó cambio de biológico en el 37,7%, 26,1% y 24,2%. La interrupción definitiva ocurrió en el 13,1%, 5,9% y 8,7% de pacientes con AR, Aps y EA, respectivamente. El tiempo medio de cambio o interrupción fue de 30,1 meses para la AR y de 35,7 meses para la Aps y la EA. CONCLUSIONES: Nuestros resultados sugieren que, en la práctica, la mitad de los pacientes con AR y 2/3 con Aps o EA continúan con el primer biológico, pero con frecuentes ajustes de tratamiento

OBJECTIVES: To describe the therapeutic management of Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) and Ankylosing Spondylitis (AS) in patients initiating treatment with biological agents. MATERIALS AND METHODS: Observational, retrospective, longitudinal study in 33 Spanish hospitals. Patients with RA, PsA and AS starting treatment with biological agents between September 2009 and August 2010 and a follow-up longer than 3 years were included. Clinical-demographic characteristics, drugs, biological therapy survival, and reasons for discontinuation or switching were analyzed. RESULTS: Four hundred and sixty-three patients were included (183 RA, 119 PsA and 161 AS), with a mean follow-up of 3.8 years. At the end of follow-up, a high proportion continued with the first biological prescribed (41.0% of RA, 59.7% of PsA and 51.6% of AS), 31.1%, 47.9% and 42.9% of RA, PsA and AS patients requiring dosage adjustments, respectively. There was temporary discontinuation in 8.2%, 8.4% and 15.5% of patients, and a switch of biologic agent was required in 37.7%, 26.1% and 24.2%. Definitive discontinuation occurred in 13.1%, 5.9% and 8.7% of RA, PsA and AS patients, respectively. Mean time to discontinuation or switching was 30.1 months for RA and 35.7 months for PsA and AS. CONCLUSIONS: Our results suggest that, in practice, half of patients with RA and two thirds with PsA or AS maintained the first biological, but with frequent dose adjustments

Iron deficiency and safety of ferric carboxymaltose in patients with acute heart failure. AHF-ID study.

INTRODUCTION: The presence of iron deficiency (ID) in patients with acute heart failure (AHF) is high. There are few studies on the characteristics of these patients and the safety of ferric carboxymaltose administration (FCM). OBJECTIVE: Study the differences among patients with AHF based on the presence and type of ID as well as the safety of FCM administration in these patients. METHOD: The AHF-ID study is a multicentre, analytical, prospective follow-up cohort including patients admitted to six Spanish hospitals for AHF. ID was defined as serum ferritin <100 µg/L (group A) or ferritin 100-299 µg/L with a TSAT <20% (group B). In cases receiving FCM the appearance of adverse events was analysed. Adjusted Cox regression was used to determine the association with 30-days reattendance for AHF after discharge. RESULTS: A total of 221 patients were recruited; 191 (86.4%) presented ID, 121 (63.4%) group A and 70 (36.6%) group B. There were scarce differences between the groups analysed. No differences were found in 30-days reattendance for AHF. FCM was administered to 158 (71.5%) patients, with 8 (5.1%) presenting adverse events, the most frequent being digestive alterations. Treatment was not discontinued in any case. CONCLUSIONS: There are scarce differences between the presence and the type of ID in patients with AHF. The administration of FCM in patients with ID and AHF is safe.

Biological Treatment Patterns in Patients with Inflammatory Joint Diseases. Retrospective Study with 4 Years Follow-up. / Patrones de tratamiento biológico en pacientes con enfermedades articulares inflamatorias. Estudio retrospectivo de 4 años de seguimiento.

OBJECTIVES: To describe the therapeutic management of Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) and Ankylosing Spondylitis (AS) in patients initiating treatment with biological agents. MATERIALS AND METHODS: Observational, retrospective, longitudinal study in 33 Spanish hospitals. Patients with RA, PsA and AS starting treatment with biological agents between September 2009 and August 2010 and a follow-up longer than 3 years were included. Clinical-demographic characteristics, drugs, biological therapy survival, and reasons for discontinuation or switching were analyzed. RESULTS: Four hundred and sixty-three patients were included (183 RA, 119 PsA and 161 AS), with a mean follow-up of 3.8 years. At the end of follow-up, a high proportion continued with the first biological prescribed (41.0% of RA, 59.7% of PsA and 51.6% of AS), 31.1%, 47.9% and 42.9% of RA, PsA and AS patients requiring dosage adjustments, respectively. There was temporary discontinuation in 8.2%, 8.4% and 15.5% of patients, and a switch of biologic agent was required in 37.7%, 26.1% and 24.2%. Definitive discontinuation occurred in 13.1%, 5.9% and 8.7% of RA, PsA and AS patients, respectively. Mean time to discontinuation or switching was 30.1 months for RA and 35.7 months for PsA and AS. CONCLUSIONS: Our results suggest that, in practice, half of patients with RA and two thirds with PsA or AS maintained the first biological, but with frequent dose adjustments.

Registro Español de Artritis Psoriásica de Reciente Comienzo (estudio REAPSER). Objetivos y metodología / Spanish Registry of Recent-onset Psoriatic Arthritis (REAPSER study): aims and methodology

OBJETIVOS: Describir la metodología del Registro Español de Artritis Psoriásica de reciente comienzo de la Sociedad Española de Reumatología (REAPSER), así como sus fortalezas y limitaciones. El objetivo principal del proyecto es identificar factores pronósticos de la evolución clínica y radiográfica en una cohorte de pacientes que padecen artritis psoriásica (APs) diagnosticada con menos de 2 años de evolución. MATERIAL Y MÉTODO: Estudio observacional, prospectivo (2 años de seguimiento; periodicidad anual de las visitas), multicéntrico. La intención en la visita basal fue reflejar la situación del paciente antes de que la evolución de la enfermedad se viese modificada por los tratamientos pautados en los servicios de reumatología. Los pacientes fueron invitados a participar consecutivamente en una de sus visitas habituales al reumatólogo. El tamaño muestral finalmente alcanzado fue de 211 pacientes. Se recogen datos sociodemográficos; de situación laboral; historia familiar; antecedentes personales y comorbilidad; antropométricos; estilo de vida; uso de los servicios de salud; situación clínica al diagnóstico de APs; afectación articular y dolor espinal; dolor y valoración global de la enfermedad; entesitis, dactilitis y uveítis; afectación cutánea y ungueal; situación funcional y calidad de vida; evaluación radiográfica; determinaciones analíticas; tratamiento; brotes en esqueleto axial y periférico. CONCLUSIONES: El estudio REAPSER incluye una cohorte de pacientes con APs de inicio reciente reclutados antes de que la evolución de la enfermedad se viese modificada por la prescripción de FAME en los servicios de reumatología. Se espera que la información exhaustiva recogida en las visitas suponga una amplia fuente de datos para futuros análisis

AIMS: To describe the methodology of REAPSER (Spanish Registry of Recent-onset Psoriatic Arthritis), its strengths and limitations. The aim of this study is to identify prognostic factors for the clinical and radiographic course in a cohort of patients with psoriatic arthritis (PsA) diagnosed within 2 years of symptom evolution. METHODS: Multicenter, observational and prospective study (with 2-year follow-up including annual visits). Baseline visit intended to reflect patient situation before the disease course was modified by treatments prescribed in rheumatology departments. Patients were invited to participate consecutively in one of their routine visits to the rheumatologist. 211 patients were included. Following data were collected: sociodemographic variables; employment situation; family history; personal history and comorbidities; anthropometric data; lifestyle; use of healthcare services; clinical situation at the time of PsA diagnosis; joint involvement and spinal pain; pain and overall assessment; enthesitis, dactylitis and uveitis; skin and nail involvement; functional situation and quality of life; radiographic evaluation; analytical determinations; treatment; axial and peripheral flare-ups. CONCLUSIONS: The REAPSER study includes a cohort of patients with recent-onset PsA, before the disease course was modified by disease-modifying antirheumatic drugs prescribed in rheumatology departments. Exhaustive information collected in each visit is expected to be an important data source for future analysis

Spanish Registry of Recent-onset Psoriatic Arthritis (REAPSER study): Aims and methodology. / Registro Español de Artritis Psoriásica de Reciente Comienzo (estudio REAPSER). Objetivos y metodología.

AIMS: To describe the methodology of REAPSER (Spanish Registry of Recent-onset Psoriatic Arthritis), its strengths and limitations. The aim of this study is to identify prognostic factors for the clinical and radiographic course in a cohort of patients with psoriatic arthritis (PsA) diagnosed within 2years of symptom evolution. METHODS: Multicenter, observational and prospective study (with 2-year follow-up including annual visits). Baseline visit intended to reflect patient situation before the disease course was modified by treatments prescribed in rheumatology departments. Patients were invited to participate consecutively in one of their routine visits to the rheumatologist. 211 patients were included. Following data were collected: sociodemographic variables; employment situation; family history; personal history and comorbidities; anthropometric data; lifestyle; use of healthcare services; clinical situation at the time of PsA diagnosis; joint involvement and spinal pain; pain and overall assessment; enthesitis, dactylitis and uveitis; skin and nail involvement; functional situation and quality of life; radiographic evaluation; analytical determinations; treatment; axial and peripheral flare-ups. CONCLUSIONS: The REAPSER study includes a cohort of patients with recent-onset PsA, before the disease course was modified by disease-modifying antirheumatic drugs prescribed in rheumatology departments. Exhaustive information collected in each visit is expected to be an important data source for future analysis.

Modelo de riesgo de mortalidad a 180 días en los pacientes ancianos ingresados en unidades de corta estancia: 6M UCE-SCORE / 180-day risk of mortality in older patients admitted to short-stay units: the 6-Month Short-Stay Unit (6M UCE) Score

Objetivos. Diseñar una escala de puntuación multidimensional con el fin de estratificar el riesgo de mortalidad a 180 días entre los ancianos ingresados en las unidades de corta estancia (UCE). Métodos. Estudio analítico observacional de cohortes prospectivo multicéntrico que seleccionó todos los pacientes >= 75 años ingresados en 5 UCE españolas del 1 de febrero al 30 de abril de 2014. Se recogieron variables demográficas, clínicas y de la valoración geriátrica. Se derivó un modelo de regresión logística multinivel para identificar los factores independientemente asociados con la mortalidad a 180 días y después se construyó una escala de puntuación. Resultados. Se incluyeron 593 pacientes (edad media 83,4 años, DE: 5,9; 359 mujeres, 60,7%), y 92 (15,5%) fallecieron a los 180 días. La escala de puntuación 6M UCE-SCORE incluyó la edad >= 85 años (1 punto), sexo varón (1 punto), presencia de pérdida de apetito o peso involuntaria en los últimos 3 meses (1 punto), síndrome confusional agudo (2 puntos), dependencia en las actividades básicas de la vida diaria al ingreso (2 puntos) y úlceras por presión (2 puntos). Se categorizó a los pacientes en bajo (0-2 puntos), intermedio (3-5 puntos) y alto (6-9 puntos) riesgo, con una mortalidad a 180 días de 5%, 18% y 54%, respectivamente. El ABC COR del modelo tras remuestreo fue de 0,72 (IC95%: 0,65-0,78). Conclusiones. La escala de puntuación 6M UCE-SCORE podría ser de utilidad a la hora de estratificar el riesgo a 6 meses entre los ancianos ingresados en las UCE con el fin de diseñar un plan individualizado de cuidados

Objectives. To develop a multidimensional score to assess risk of death for patients of advanced age 180 days after their admission to short-stay units (SSUs). Methods. Prospective, multicenter, observational and analytical study of a cohort of patients aged 75 years or older who were admitted to 5 Spanish SSUs between February 1 and April 30, 2014. We recorded demographic and clinical data as well as geriatric assessment scores. A multilevel logistic regression model was developed to identify independent factors associated with 180-day mortality. The model was used to construct a scale for scoring risk. Results. Data for 593 patients with a mean (SD) age of 83.4 (5.9) years entered the model; 359 (60.7%) were women. Ninety-two patients (15.5%) died within 180 days of SSU admission. Factors included in the final risk score were age over 85 years (1 point), male sex (1), loss of appetite or weight loss in the 3 months before admission (1), acute confusional state (2), functional dependence for basic activities of daily living at admission (2), and pressure ulcers (2). Low risk was indicated by a score of 0 to 2 points, intermediate risk by 3 to 5 points, and high risk by 6 to 9 points. Mortality rates at 180 days in these 3 risk groups were 5%, 18%, and 54%, respectively. The area under the receiver operating characteristic curve for the model after boots trapping was 0.72 (95% CI, 0.65-0.78). Conclusion. The SSU score could be useful for stratifying risk of death within 6 months of SSU admission of older patients, so that type of care can be tailored to risk

180-day risk of mortality in older patients admitted to short-stay units: the 6-Month Short-Stay Unit (6M UCE) Score. / Modelo de riesgo de mortalidad a 180 días en los pacientes ancianos ingresados en unidades de corta estancia: 6M UCE-SCORE.

OBJECTIVES: To develop a multidimensional score to assess risk of death for patients of advanced age 180 days after their admission to short-stay units (SSUs). MATERIAL AND METHODS: Prospective, multicenter, observational and analytical study of a cohort of patients aged 75 years or older who were admitted to 5 Spanish SSUs between February 1 and April 30, 2014. We recorded demographic and clinical data as well as geriatric assessment scores. A multilevel logistic regression model was developed to identify independent factors associated with 180-day mortality. The model was used to construct a scale for scoring risk. RESULTS: Data for 593 patients with a mean (SD) age of 83.4 (5.9) years entered the model; 359 (60.7%) were women. Ninety-two patients (15.5%) died within 180 days of SSU admission. Factors included in the final risk score were age over 85 years (1 point), male sex (1), loss of appetite or weight loss in the 3 months before admission (1), acute confusional state (2), functional dependence for basic activities of daily living at admission (2), and pressure ulcers (2). Low risk was indicated by a score of 0 to 2 points, intermediate risk by 3 to 5 points, and high risk by 6 to 9 points. Mortality rates at 180 days in these 3 risk groups were 5%, 18%, and 54%, respectively. The area under the receiver operating characteristic curve for the model after boots trapping was 0.72 (95% CI, 0.65-0.78). CONCLUSION: The SSU score could be useful for stratifying risk of death within 6 months of SSU admission of older patients, so that type of care can be tailored to risk.

OBJETIVO: Diseñar una escala de puntuación multidimensional con el fin de estratificar el riesgo de mortalidad a 180 días entre los ancianos ingresados en las unidades de corta estancia (UCE). METODO: Estudio analítico observacional de cohortes prospectivo multicéntrico que seleccionó todos los pacientes 75 años ingresados en 5 UCE españolas del 1 de febrero al 30 de abril de 2014. Se recogieron variables demográficas, clínicas y de la valoración geriátrica. Se derivó un modelo de regresión logística multinivel para identificar los factores independientemente asociados con la mortalidad a 180 días y después se construyó una escala de puntuación. RESULTADOS: Se incluyeron 593 pacientes (edad media 83,4 años, DE: 5,9; 359 mujeres, 60,7%), y 92 (15,5%) fallecieron a los 180 días. La escala de puntuación 6M UCE-SCORE incluyó la edad 85 años (1 punto), sexo varón (1 punto), presencia de pérdida de apetito o peso involuntaria en los últimos 3 meses (1 punto), síndrome confusional agudo (2 puntos), dependencia en las actividades básicas de la vida diaria al ingreso (2 puntos) y úlceras por presión (2 puntos). Se categorizó a los pacientes en bajo (0-2 puntos), intermedio (3-5 puntos) y alto (6-9 puntos) riesgo, con una mortalidad a 180 días de 5%, 18% y 54%, respectivamente. El ABC COR del modelo tras remuestreo fue de 0,72 (IC95%: 0,65-0,78). CONCLUSIONES: La escala de puntuación 6M UCE-SCORE podría ser de utilidad a la hora de estratificar el riesgo a 6 meses entre los ancianos ingresados en las UCE con el fin de diseñar un plan individualizado de cuidados.

Eficacia y seguridad de golimumab añadido a fármacos antirreumáticos modificadores de la enfermedad en artritis reumatoide. Resultados del estudio GO-MORE en España / Efficacy and safety of golimumab as add-on therapy to disease-modifying antirheumatic drugs in rheumatoid arthritis: Results of the GO-MORE study in Spain

Objetivos: Analizar la eficacia y la seguridad de golimumab en los 140 pacientes incluidos en España en la parte 1 del estudio GO-MORE, un estudio multinacional en artritis reumatoide (AR) activa a pesar del tratamiento con distintos fármacos antirreumáticos modificadores de la enfermedad (FAME). Pacientes y métodos: Los pacientes recibieron golimumab 50 mg subcutáneo una vez al mes durante 6 meses. El criterio de valoración principal fue el porcentaje con respuesta DAS28-VSG EULAR buena o moderada tras 6 meses de tratamiento. Resultados: Se incluyó a 140 pacientes. El 76,4% tenía enfermedad muy activa (DAS28-VSG > 5,1). El 76,4% estaba tomando metotrexato, el 40,0% otros FAME en monoterapia o combinación, y el 65,0% esteroides. Al mes 6, el 82,9% de los pacientes logró una respuesta EULAR buena o moderada, el 41,4% alcanzó baja actividad y el 30,7% remisión. El porcentaje de pacientes con respuesta al mes de la primera dosis administrada fue del 69,3%. La eficacia fue similar en pacientes tratados con metotrexato u otro FAME, distintas dosis de metotrexato, con/sin esteroides o que habían fallado a uno o más FAME. El golimumab fue bien tolerado y el perfil de seguridad fue coherente con estudios previos. Se comunicaron acontecimientos adversos graves en 11 pacientes (7,9%). Conclusión: La adición de golimumab 50 mg subcutáneo mensual a distintos FAME en pacientes con AR activa deparó una respuesta moderada o buena a los 6 meses en el 82,9%. La respuesta comenzó a observarse tempranamente, ya al inicio del mes 2, tras una única dosis de golimumab (AU)

Objectives: To assess the efficacy and safety of golimumab in the 140 patients included in Spain as the first part of the GO-MORE trial, a multinational study involving patients with active rheumatoid arthritis (RA) despite treatment with different disease-modifying antirheumatic drugs (DMARDs). Patients and methods: The patients received subcutaneous golimumab 50 mg once a month during 6 months. The primary endpoint was the percentage of individuals with a good or moderate EULAR DAS28- ESR response after 6 months of treatment. Results: A total of 140 patients were included. Of these, 76.4% had very active disease (DAS28-ESR > 5.1). 76.4% were taking methotrexate, 40.0% other DMARDs in monotherapy or combined, and 65.0% received corticosteroids. After 6 months, 82.9% of the patients showed a good or moderate EULAR response, 41.4% had low disease activity, and 30.7% were in remission. The percentage of responders one month after the first dose was 69.3%. The efficacy was similar in patients treated with methotrexate or other DMARDs, with different methotrexate doses, with or without corticosteroids, or in subjects who had failed one or more DMARDs. The response to golimumab was observed from the first dose. Golimumab was well tolerated and its safety profile was consistent with the findings of previous studies. Serious adverse events were reported in 11 patients (7.9%). Conclusion: The addition of subcutaneous golimumab 50 mg once a month to different DMARDs in patients with active RA yielded a moderate or good response after 6 months in 82.9% of the cases. The response was observed early, from the start of the second month, after a single dose of golimumab (AU)

Efficacy and safety of golimumab as add-on therapy to disease-modifying antirheumatic drugs in rheumatoid arthritis: results of the GO-MORE study in Spain.

OBJECTIVES: To assess the efficacy and safety of golimumab in the 140 patients included in Spain as the first part of the GO-MORE trial, a multinational study involving patients with active rheumatoid arthritis (RA) despite treatment with different disease-modifying antirheumatic drugs (DMARDs). PATIENTS AND METHODS: The patients received subcutaneous golimumab 50mg once a month during 6 months. The primary endpoint was the percentage of individuals with a good or moderate EULAR DAS28-ESR response after 6 months of treatment. RESULTS: A total of 140 patients were included. Of these, 76.4% had very active disease (DAS28-ESR>5.1). 76.4% were taking methotrexate, 40.0% other DMARDs in monotherapy or combined, and 65.0% received corticosteroids. After 6 months, 82.9% of the patients showed a good or moderate EULAR response, 41.4% had low disease activity, and 30.7% were in remission. The percentage of responders one month after the first dose was 69.3%. The efficacy was similar in patients treated with methotrexate or other DMARDs, with different methotrexate doses, with or without corticosteroids, or in subjects who had failed one or more DMARDs. The response to golimumab was observed from the first dose. Golimumab was well tolerated and its safety profile was consistent with the findings of previous studies. Serious adverse events were reported in 11 patients (7.9%). CONCLUSION: The addition of subcutaneous golimumab 50 mg once a month to different DMARDs in patients with active RA yielded a moderate or good response after 6 months in 82.9% of the cases. The response was observed early, from the start of the second month, after a single dose of golimumab.