Effectiveness and safety of tocilizumab in monotherapy in biologic-naïve and non-naïve patients with rheumatoid arthritis in a real-world setting.

OBJECTIVE: To evaluate the effectiveness and safety of tocilizumab (TCZ) monotherapy in biologic-naïve patients with rheumatoid arthritis (RA) versus patients with previous biologic exposure in a real-world setting. MATERIALS AND METHODS: Non-controlled clinical-trial, 32-week prospective multicenter study including RA patients with moderate-severe disease activity starting TCZ in monotherapy who had a prior inadequate response or were intolerant to methotrexate (MTX). Effectiveness according to EULAR response evaluated at 24-week and safety at 32-weekwere assessed. RESULTS: Of the 93 were enrolled of whom 84 (90%) were eligible for the effectiveness analysis. Biologic-naïve patients (n=46, 54.8%) were younger (51.5 versus 57.9) with shorter disease duration (6.4 versus 13.3) but presented similar comorbidities in comparison with non-naïve patients. DAS28 remission was achieved in a higher percentage in the group of patients with prior biological treatment. 89 adverse events (AE) were recorded in 50 patients, most of them non-serious AE (non-SAE) (86.3%). CONCLUSIONS: In a real world setting, TCZ exhibit similar effectiveness and safety in monotherapy in patients with RA regardless previous exposure to other biologic therapies. This study provides additional and valuable real-world findings on the use of TCZ in patients with RA.

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.

Recomendaciones para el uso del metotrexato en artritis reumatoide: incremento y reducción de dosis y vías de administración / Recommendations for the use of methotrexate in rheumatoid arthritis: up and down scaling of the dose and administration routes

Objetivos. Describir la estrategia terapéutica óptima de uso de metotrexato en AR sobre dosis inicial, vía de administración, incremento y disminución de dosis, seguimiento del paciente y uso de ácido fólico/folínico. Material y método. Once expertos plantearon los interrogantes clínicos a resolver. Se realizó una búsqueda bibliográfica sistemática. Los contenidos fueron seleccionados en una sesión de trabajo y el nivel de acuerdo se estableció posteriormente en una ronda de consenso vía correo. Resultados. La dosis de inicio de metotrexato no debe ser < 10 mg/semana, preferentemente por vía oral, considerando la vía parenteral como alternativa según el cumplimento, ineficacia o efectos secundarios gastrointestinales, polimedicación, obesidad (si requiere dosis > 20 mg/semana), preferencias del paciente, enfermedad muy activa o para evitar errores de medicación. Se cambiará a la vía parenteral cuando haya ineficacia, toxicidad gastrointestinal, incumplimiento o por coste-efectividad antes de pasar a fármacos más caros; y a la inversa, según preferencias del paciente, intolerancia a inyectables, reducción de dosis < 7,5 mg/semana, ineficacia, bajo cumplimiento o efectos adversos gastrointestinales. Se realizará escalada rápida de dosis si la respuesta es inadecuada hasta los 15-20 o, incluso, 25 mg/semana en unas 8 semanas, con incrementos de 2,5-5 mg. La reducción se realizará según la dosis a la que estuviera el paciente, con disminuciones de 2,5-5 mg cada 3-6 meses. El seguimiento del paciente deberá realizarse cada 1-1,5 meses hasta la estabilidad y luego cada 1-3 meses. Conclusiones. Este documento pretende resolver algunos interrogantes clínicos habituales y facilitar la toma de decisiones en la AR tratada con metotrexato (AU)

Objectives, To describe the optimal therapeutic strategy for use of methotrexate in RA patients over the initial dose, route of administration, dose increase and decrease, patient monitoring, and use of folic/folinic acid. Materials and methods. Eleven clinical experts proposed some questions to be solved. A systematic literature search was conducted. The contents were selected in a work session and subsequently validated via email to establish the level of agreement. Results. The initial dose of methotrexate should not be <10 mg/week, preferably orally, but the parenteral route is considered as an alternative due to compliance, non-effectiveness of treatment or gastrointestinal side effects, polypharmacy, obesity (if required doses are >20 mg/week), patient preference, very active disease or to avoid administration errors. Changing to a parenteral administration is proposed when the oral route is not effective enough, gastrointestinal toxicity appears, there is non-compliance or due to cost-effectiveness reasons before using more expensive drugs. On the contrary, due to patient preferences, intolerance to injections, dose reduction <7.5 mg/week, non-effectiveness of the route, poor compliance or gastrointestinal side effects. There should be a rapid dose escalation if inadequate responses occur up to 15–20 or even 25 mg/week in about 8 weeks, with increments of 2.5–5 mg. The reduction will be carried out according to the dose the patient had, with decreases of 2.5–5 mg every 3–6 months. Patient monitoring should be performed every 1–1.5 months until stability is reached and then for every 1–3 months. Conclusions. This document pretends to solve some common clinical questions and facilitate decision-making in RA patients treated with methotrexate (AU)

Recommendations for the use of methotrexate in rheumatoid arthritis: up and down scaling of the dose and administration routes.

OBJECTIVES: To describe the optimal therapeutic strategy for use of methotrexate in RA patients over the initial dose, route of administration, dose increase and decrease, patient monitoring, and use of folic/folinic acid. MATERIAL AND METHOD: Eleven clinical experts proposed some questions to be solved. A systematic literature search was conducted. The contents were selected in a work session and subsequently validated via email to establish the level of agreement. RESULTS: The initial dose of methotrexate should not be <10mg/week, preferably orally, but considering the parenteral route as an alternative due to compliance, non effectiveness of treatment or gastrointestinal side effects, polypharmacy, obesity (if required doses are >20mg/week), patient preference, very active disease or to avoid administration errors. Changing to a parenteral administration is proposed when the oral route is not effective enough, gastrointestinal toxicity appears, there is non-compliance or due to cost-effectiveness reasons before using more expensive drugs. On the contrary, due to patient preferences, intolerance to injections, dose reduction <7.5mg/week, non effectiveness of the route, poor compliance or gastrointestinal side effects. There should be a rapid dose escalation if inadequate responses occurr up to 15-20 or even 25mg/week in about 8 weeks, with increments of 2.5-5mg. The reduction will be carried out according to the dose the patient had, with decreases of 2.5-5mg every 3-6 months. Patient monitoring should be performed every 1-1.5 months until stability and then every 1-3 months. CONCLUSIONS: This document pretends to solve some common clinical questions and facilitate decision-making in RA patients treated with methotrexate.

Artritis reactiva por Chlamydia pneumoniae / Reactive arthritis by Chlamydia pneumoniae

Las artritis reactivas son episodios inflamatorios articulares que aparecen tras un proceso infeccioso, habitualmente intestinal o genital, no pudiéndose cultivar el germen del material obtenido en la articulación inflamada. La artritis reactiva tras infección de vías aéreas es infrecuente; en este sentido son pocos los casos descritos tras infección por Chlamydia pneumoniae. Se describen 3 pacientes que presentaron artritis, dos de ellos con infección de vías respiratorias altas previa al inicio de la artritis, sin evidencia de infección por los gérmenes habitualmente responsables de artritis reactiva ni de infección viral, con cultivos de líquido sinovial negativos y con seroconversión de los anticuerpos específicos para Chlamydia pneumoniae. Tras recibir tratamiento con tetraciclinas, el cuadro se resolvió completamente en los 3 pacientes. Existen muy pocos casos en la bibliografía científica que asocien Chlamydia pneumoniae como causa de artritis reactiva. Su similitud clínica con la fiebre reumática obliga a pensar en este germen como agente causal de toda artritis precedida por un cuadro de vías respiratorias y a iniciar un tratamiento antibiótico adecuado para evitar cronicidad y/o recidivas. (AU)