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

Documento de posicionamiento de la Sociedad Española de Reumatología sobre fármacos biosimilares / Position paper from the Spanish Society of Rheumatology on biosimilar drugs

Un biosimilar (BS) es un fármaco biológico que contiene una versión de la sustancia activa de un producto biológico original ya autorizado. Los BS se comercializan al terminar el periodo de patente del fármaco original y tras demostrar que las diferencias con respecto al medicamento innovador no tienen ningún efecto relevante sobre su seguridad y su eficacia clínica. La Sociedad Española de Reumatología, en consonancia con la Agencia Europea del Medicamento, considera que por su naturaleza y complejidad de producción no se puede equiparar un BS a un genérico. La Sociedad Española de Reumatología manifiesta un compromiso inequívoco con la sostenibilidad del sistema sanitario y apoya medidas que, sin reducir la calidad asistencial, estén encaminadas a asegurar su continuidad. Por esto considera que, probablemente, la llegada de los BS mejorará el acceso de los pacientes con enfermedades reumáticas a los fármacos biológicos. Este artículo revisa la normativa de la Agencia Europea del Medicamento, el marco legal español y las controversias sobre los BS, y presenta el posicionamiento de la Sociedad Española de Reumatología sobre estos fármacos (AU)

A biosimilar (BS) is a biological drug that contains a version of the active substance of an already authorized original biological product. The BSs are marketed after patent period of the original drug has ended and once it has been demonstrated that the differences regarding the innovative medicine have no relevant effect on its safety or clinical efficacy. The Spanish Society of Rheumatology, in line with the European Medicines Agency, considers that because of its nature and complexity of production, a BS cannot be considered to be the same as a generic drug. The Spanish Society of Rheumatology expresses an unequivocal commitment to the sustainability of the health system in our country and our steadfast alignment with all measures designed to ensure continuity, without reducing the quality of care. Therefore, we believe that the advent of BSs will likely facilitate access of patients with rheumatic diseases to the biological drugs. This article reviews the European Medicines Agency requirements for authorization, the Spanish legal framework and controversies on BS and presents the position paper of the Spanish Society of Rheumatology on these drugs (AU)

El mito de la distinción entre criterios de clasificación y criterios diagnósticos / The myth of the distinction between classification and diagnostic criteria

No disponible

Position paper from the Spanish Society of Rheumatology on biosimilar drugs.

A biosimilar (BS) is a biological drug that contains a version of the active substance of an already authorized original biological product. The BSs are marketed after patent period of the original drug has ended and once it has been demonstrated that the differences regarding the innovative medicine have no relevant effect on its safety or clinical efficacy. The Spanish Society of Rheumatology, in line with the European Medicines Agency, considers that because of its nature and complexity of production, a BS cannot be considered to be the same as a generic drug. The Spanish Society of Rheumatology expresses an unequivocal commitment to the sustainability of the health system in our country and our steadfast alignment with all measures designed to ensure continuity, without reducing the quality of care. Therefore, we believe that the advent of BSs will likely facilitate access of patients with rheumatic diseases to the biological drugs. This article reviews the European Medicines Agency requirements for authorization, the Spanish legal framework and controversies on BS and presents the position paper of the Spanish Society of Rheumatology on these drugs.

Patterns of use and dosing of tocilizumab in the treatment of patients with rheumatoid arthritis in routine clinical practice: the ACT-LIFE study.

The aim of the study was to identify and describe the patterns of use of tocilizumab in clinical practice to ensure safety and optimal management of rheumatoid arthritis (RA). This is a 12-month prospective observational study in patients with moderate or severe RA of ≥6 months' duration who have started tocilizumab after failure of at least one previous disease-modifying antirheumatic drug (DMARD) including TNF inhibitors. For some analyses, patients were categorized by the use of tocilizumab as monotherapy or in combination, and by previous use of biological therapy. Overall, 379 were evaluable (84.4 % received tocilizumab after prior biologics and 78.4 % in combination with classic DMARDs). Tocilizumab was discontinued in 68/379 (17.9 %) patients after a median of 6.7 (3.7-10.4) months, mainly due to a lack of efficacy (24/379, 6.3 %) and adverse events (23/379, 6.1 %). Of 131 temporary interruptions of tocilizumab required in 101/379 (26.6 %) patients, 81/131 (61.8 %) were related to adverse events, and in 120/131 (91.6 %) cases, tocilizumab was reintroduced at 8 mg/kg. Thirty-six tocilizumab dose reductions occurred in 34/379 (9 %) patients due to abnormal laboratory values in 20/34 (55.6 %) cases. DAS28-ESR scores decreased from baseline (5.6 ± 1.0) to week 24 (3.0 ± 1.4) and week 52 (2.7 ± 1.3). DAS28 response differed between biologics-naive and biologics-experienced patients, both at weeks 24 and 52. In clinical practice, tocilizumab is effective in RA while retaining the expected safety and tolerability profile. Tocilizumab seems to be more effective for biologics-naive patients than for biologics-experienced patients, while it proves to be similarly effective when used in combination or monotherapy.

Lupus eritematoso sistémico y púrpura trombótica trombocitopénica: un caso refractario sin actividad lúpica asociada / Systemic lupus erythematosus and thrombotic thrombocytopenia purpura: a refractory case without lupus activity

La asociación entre lupus eritematoso sistémico (LES) y púrpura trombótica trombocitopénica (PTT) es una situación descrita pero poco frecuente y suele ocurrir en casos con actividad lúpica y deterioro renal. Presentamos un caso de PTT con disminución de los niveles de ADAMST13 que ocurrió en una paciente afectada de LES pero sin actividad y sin afectación renal. Fue un caso que presentó dificultades diagnósticas iniciales y que, debido a su refractariedad, precisó recambios plasmáticos y tratamientos inmunosupresores, incluyendo rituximab (AU)

The association between systemic lupus erythematosus (SLE) and thrombotic thrombocytopenic purpura (TTP) has been infrequently reported. Usually, patients with TTP have more SLE activity and frequent renal involvement. Here we present a case of TTP associated to low-activity SLE. The absence of renal and major organ involvement increased the difficulty in making the initial diagnosis. ADAMTS13 activity in plasma in this patient was very low, as seen in other similar cases. The evolution of the patient was poor, needing plasma exchanges and immunosuppressive therapy, including the use of rituximab (AU)

Systemic lupus erythematosus and thrombotic thrombocytopenia purpura: a refractory case without lupus activity.

The association between systemic lupus erythematosus (SLE) and thrombotic thrombocytopenic purpura (TTP) has been infrequently reported. Usually, patients with TTP have more SLE activity and frequent renal involvement. Here we present a case of TTP associated to low-activity SLE. The absence of renal and major organ involvement increased the difficulty in making the initial diagnosis. ADAMTS13 activity in plasma in this patient was very low, as seen in other similar cases. The evolution of the patient was poor, needing plasma exchanges and immunosuppressive therapy, including the use of rituximab.

¿Es la puntuación DAS28 el método más adecuado para estimar la actividad de la artritis reumatoide? Consideraciones clinimétricas y escenarios de simulación / Is the DAS28 score the most adequate method to estimate activity in rheumatoid arthritis? Clinimetric considerations and simulations scenarios

Introducción: El índice DAS28 se ha consolidado como variable fundamental para valorar la actividad de la artritis reumatoide y es el principal parámetro utilizado para establecer decisiones terapéuticas en esta enfermedad, incluidos el inicio y el cambio de tratamientos biológicos. Objetivos: Estudiar las propiedades clinimétricas del DAS28, incluidos los efectos techo y suelo teóricos. Analizar el comportamiento de este índice compuesto al variar sus parámetros en una modelización teórica correspondiente a diversos escenarios hipotéticos de actividad clínica. Material y método: Estudio individualizado de las variables que componen el DAS28 a lo largo de su recorrido. Análisis de sensibilidad del comportamiento del DAS28 de cuatro variables en cuatro escenarios teóricos correspondientes a actividad baja (DAS28 = 2,43), media (DAS28 = 4,05), alta (DAS28 = 6,32) o muy alta (DAS28 = 8,40). Resultados: El recuento de articulaciones dolorosas y la velocidad de sedimentación globular (VSG) aportan, cada una de ellas, un 35-40% del valor del DAS28, en tanto que el recuento de articulaciones tumefactas y la valoración global del paciente aportan sólo un 15%, respectivamente. Dado que los recuentos de articulaciones dolorosas cuentan el doble que los de tumefactas, en los modelos de simulación con una articulación tumefacta son necesarias tan sólo 3 dolorosas para estar por encima del umbral de remisión (DAS28 > 2,6), mientras que con una dolorosa son necesarias 5 articulaciones tumefactas para estar encima de dicho umbral. Dado su carácter logarítmico en la fórmula DAS28, la contribución de VSG es mucho mayor en el rango más bajo de su recorrido, por lo que pequeñas variaciones de una VSG dentro del rango de normalidad influyen decisivamente en la puntuación final del DAS28. Conclusiones: El carácter asimétrico de los elementos incluidos en la compleja fórmula del DAS28 debe tenerse en cuenta al valorar sus cambios, especialmente en el rango inferior de puntuación, ya que pueden influir en la estimación de remisión y, por lo tanto, ser relevantes en la toma de decisiones terapéuticas (AU)

Introduction: The DAS28 score has now consolidated as a fundamental variable for the assessment of rheumatoid arthritis activity and is the main parameter used to establish therapeutic decisions in this disease, including the start and change of biologic therapies. Objectives: We have studied the clinimetric properties of DAS28, including ceiling and floor effects and its behavior in several clinical scenarios. Material and method: Individualized study of the variables included in the DAS28 formula along its possible range. Sensitivity analysis of the results of the DAS28 of 4 variables in four theoretical scenarios corresponding to low (DAS28=2.43), fair (DAS28=4.05), high (DAS28=6.32) or very high (DAS28=8.40) clinical activity. Results: Tender joint count (NAD) and erithrosedimentation rate (ESR) have a weight of 35- 40% each on the total DAS28 score, while swollen join count (SJC) and global health assessed by the patient (GH) only contribute with 15% each. As tender joints weights double than swollen joints, in the simulation models having one swollen joint needed just 3 tender joints to get the DAS28 above the non remission level (DAS28>2.6), while having one tender joint needed 5 swollen joints to be above remission. Given its logarithmic calculation in the DAS28 formula, ESR contribution is much higher in its lower range, and thus small variations of ESR in the normal range can influence decisively in the final DAS28 score. Conclusions: The asymmetric weight of each component in the complex DAS28 formula must be taken into account when interpreting changes in the DAS28 lower range as they influence the estimation of clinical remission and thus can be relevant when taking therapeutic decisions (AU)

[Is the DAS28 Score the Most Adequate Method to Estimate Activity in Rheumatoid Arthritis? Clinimetric Considerations and Simulations Scenarios]. / ¿Es la puntuación DAS28 el método más adecuado para estimar la actividad de la artritis reumatoide? Consideracionens clinimétricas y escenarios de simulación.

INTRODUCTION: The DAS28 score has now consolidated as a fundamental variable for the assessment of rheumatoid arthritis activity and is the main parameter used to establish therapeutic decisions in this disease, including the start and change of biologic therapies. OBJECTIVES: We have studied the clinimetric properties of DAS28, including ceiling and floor effects and its behavior in several clinical scenarios. MATERIAL AND METHOD: Individualized study of the variables included in the DAS28 formula along its possible range. Sensitivity analysis of the results of the DAS28 of 4 variables in four theoretical scenarios corresponding to low (DAS28=2.43), fair (DAS28=4.05), high (DAS28=6.32) or very high (DAS28=8.40) clinical activity. RESULTS: Tender joint count (NAD) and erithrosedimentation rate (ESR) have a weight of 35- 40% each on the total DAS28 score, while swollen join count (SJC) and global health assessed by the patient (GH) only contribute with 15% each. As tender joints weights double than swollen joints, in the simulation models having one swollen joint needed just 3 tender joints to get the DAS28 above the non remission level (DAS28>2.6), while having one tender joint needed 5 swollen joints to be above remission. Given its logarithmic calculation in the DAS28 formula, ESR contribution is much higher in its lower range, and thus small variations of ESR in the normal range can influence decisively in the final DAS28 score. CONCLUSIONS: The asymmetric weight of each component in the complex DAS28 formula must be taken into account when interpreting changes in the DAS28 lower range as they influence the estimation of clinical remission and thus can be relevant when taking therapeutic decisions.