Patient preferences in chronic immune-mediated inflammatory diseases potentially treated with biological drugs: discrete choice analysis using real-world data analysis.

OBJECTIVES: Immune-mediated inflammatory diseases (IMIDs) represent a high burden due to their chronicity, high prevalence, and associated comorbidities. Chronic patients' preferences must be considered in IMIDs treatment and follow-up. The objective of this study was to further understand patient's preferences in private settings. METHODS: A literature review was performed to choose the most relevant criteria for patients. A D-efficient discrete choice experiment was designed to elicit preferences of adult patients with IMIDs and potential biological treatment prescription. Participants were collected from private practices (rheumatology, dermatology, and gastroenterology) from February to May 2022. Patients chose between option pairs, characterized by six health-care attributes, as well as monthly out-of-pocket drug price. Responses were analyzed through a conditional logit model. RESULTS: Eighty-seven patients answered the questionnaire. The most frequent pathologies were Rheumatoid Arthritis (31%) and Psoriatic Arthritis (26%). The most relevant criteria were choosing the preferred physician (OR 2.25 [SD0.26]); reducing time until visit with specialist (OR 1.79 [SD0.20]), access through primary care (OR 1.60 [SD0.08]), and an increase in monthly out-of-pocket price from 100€ to 300€ (OR 0.55 [SD0.06]) and to 600€ (OR 0.08 [SD0.02]). CONCLUSIONS: Chronic IMIDs patients showed a preference toward a faster, personalized service, even with a trade-off in terms of out-of-pocket price.

Initial Treatment with Biological Therapy in Rheumatoid Arthritis.

BACKGROUND: We aimed to analyse the effectiveness, efficiency, and safety of initial treatment with biological therapies in rheumatoid arthritis (RA). METHODS: Qualitative study. A group of RA experts was selected. A scoping review in Medline was conducted to analyse the evidence of initial RA treatment with biological therapies. Randomised clinical trials were selected. Two reviewers analysed the articles and compiled the data, whose quality was assessed using the Jadad scale. The experts discussed the review's findings and generated a series of general principles: Results: Seventeen studies were included. Most of the included patients were middle-aged women with early RA (1-7 months) and multiple poor prognostic factors. Initial treatment with TNF-alpha inhibitors combined with methotrexate (MTX) and an IL6R inhibitor (either in mono or combination therapy) is effective (activity, function, radiographic damage, quality of life), safe, and superior to MTX monotherapy in the short and medium term. In the long term, patients who received initial treatment with biologicals presented better results than those whose initial therapy was with MTX. CONCLUSIONS: Initial treatment of RA with biological therapies is effective, efficient, and safe in the short, medium, and long term, particularly for patients with poor prognostic factors.

Effectiveness and safety of tocilizumab in monotherapy in biologic-naïve and non-naïve patients with rheumatoid arthritis in a real-world setting / Eficacia y seguridad de tocilizumab en monoterapia en pacientes con artritis reumatoide naive y no naive a biológicos en un entorno del mundo real

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.(AU)

Objetivo: Evaluar la efectividad y seguridad de la monoterapia con tocilizumab (TCZ) en pacientes con artritis reumatoide (AR) sin tratamiento biológico en comparación con pacientes con exposición previa a biológico en un entorno real.Materiales y métodos: Ensayo clínico no controlado, estudio multicéntrico prospectivo de 32 semanas que incluyó pacientes con AR con actividad de la enfermedad moderada-grave que comenzaron con TCZ en monoterapia y que tuvieron una respuesta inadecuada previa o fueron intolerantes al metotrexato. La eficacia de acuerdo con la respuesta EULAR fue evaluada a las 24 semanas y la seguridad a las 32 semanas. Resultados: De los 93 pacientes seleccionados, 84 (90%) fueron elegibles para el análisis de efectividad. Los pacientes sin tratamiento biológico previo (n=46, 54,8%) eran más jóvenes (51,5 frente a 57,9 años), con una duración más corta de la enfermedad (6,4 frente a 13,3 años), pero presentaban comorbilidades similares en comparación con los pacientes con tratamiento previo. La remisión de DAS28 se logró en un mayor porcentaje en el grupo de pacientes con tratamiento biológico previo. Se registraron 89 eventos adversos en 50 pacientes, la mayoría de ellos no graves (86,3%). Conclusiones: En un entorno del mundo real, TCZ exhibe una eficacia y seguridad similares en monoterapia en pacientes con AR, independientemente de la exposición previa a otras terapias biológicas. Este estudio proporciona hallazgos adicionales y valiosos en el contexto del mundo real sobre el uso de TCZ en pacientes con AR.(UA)

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.

Utilidad de la consultoría reumaológica in situ: análisis de una experiencia prolongada en el tiempo / Usefulness of Rheumatology Consultancy in situ: Analysis of a Long-term Experience

Objetivo: Estudiar la utilidad a largo plazo de un reumatólogo consultor in situ (RCI) en un centro de salud (CS). Material y métodos: Estudio observacional retrospectivo sobre la cohorte completa de pacientes atendidos entre 2013 y 2019. Se analizaron lsa variables clínicas y de curso asistencial, intentando perfilar qué diagnósticos de los pacientes reumáticos tenían más probabilidades de continuar su atención en el CS con el médico de Atención Primaria (MAP). Resultados: Se atendieron 876 consultas; 205 de varones (23,4%) y 671 de mujeres (76,6%), con una edad media de 64,1 años (DE=16,6). La mayoría de las consultas (280; 33,2%) fueron diagnósticas. En 167 ocasiones (19,8%) se abordaron temas terapéuticos; en 47 (5,6%) se realizaron infiltraciones. La petición de pruebas no disponibles para el MAP se verificó en 154 situaciones (18,3%). El perfil de paciente con más opciones de continuar su seguimiento con el MAP en el CS es el que tenía artrosis (OR=0,13; IC 95%: 0,02-0,67), reumatismo de partes blandas (OR=0,06; IC 95%: 0,01-0,45) o hernia discal cervical (OR=0,13; IC 95%: 0,02-0,66). Los pacientes con menos probabilidades de seguimiento por MAP tras su paso por RCI son los que tenían artritis reumatoide (OR=0,03; IC 95%: 0,00-0,24), otras artropatías inflamatorias (OR=0,36; IC 95%: 0,16-0,80) o polimialgia reumática (OR=0,19; IC 95%: 0,06-0,64); también los que necesitan control de enfermo crónico (OR=0,16; IC 95%: 0,07-0,34). Conclusiones: El RCI facilita el seguimiento por el MAP de la artrosis, reumatismos de partes blandas y de la discopatía cervical, pues le permite disponer de determinadas pruebas complementarias para el diagnóstico.(AU)

Objective: To report the long-term experience of a rheumatologist consultant in situ (RCI) in a primary care centre (PCC). Material and methods: Observational retrospective study analysing the complete cohort of the patients seen by the RCI between 2013 and 2019. Rheumatology patients’ clinical characteristics and course of care were collected to estimate the diagnoses that were most likely to be monitored by a primary care physician (PCP). Results: A total of 876 consultations were attended; 205 were men (23.4%) and 671 women (76.6%). Most of the consultations (280, 33.2%) were diagnostic. On 167 occasions (19.8%) therapeutic issues were analysed; in 47 (5.6%) therapeutic infiltrations were performed. Chronic patient control was applied in 163 subjects (19.3%). A request for tests not available to the PCP was the reason for the consultation in 154 situations (18.3%). The profile most likely to continue being monitored in the PCC is the patient with osteoarthritis (OR=0.13, CI 95%: 0.02-0.67), soft tissue rheumatism (OR=0.006, 95%CI: 0.01-0.45) or cervical disc herniation (OR=0.13, 95%CI: 0.02-0.66). Less likely to be monitored by PCP after being seen by the RCI were subjects with rheumatoid arthritis (OR=0.03, 95%CI: 0.00-0.24), other inflammatory arthropathies (OR=0.36, 95%CI: 0.16-0.80) or with polymyalgia rheumatica (OR=0.19, 95%CI: 0.06-0.64), and those in need of chronic disease monitoring (OR=0.16, 95%CI: 0.07-0.34). Conclusions: The RCI makes it easier for the PCP to monitor patients with osteoarthritis, soft tissue rheumatism and cervical disc pathology.(AU)

Telerreumatología en tiempos de crisis durante la pandemia por COVID-19 / Tele-Rheumatology During the COVID-19 Pandemic

Introducción: Durante la pandemia por COVID-19 las necesidades de prevención de transmisión de la infección viral nos obligaron a potenciar las consultas virtuales. Objetivo: El objetivo de estudio es describir los resultados obtenidos con la anterior estrategia y definir el perfil de paciente más idóneo para aplicarla. Material y métodos: Durante el período comprendido entre el 16 de marzo y y el 10 de mayo del 2020 todas las consultas sucesivas de nuestro servicio fueron realizadas en formato de teleconsulta reumatológica (TCR). Se recogieron las características sociodemográficas, geofuncionales y clínicas de los pacientes; se evalúo mediante escala numérica verbal (0-10, donde 0 = muy insatisfecho hasta 10 = completamente satisfecho) el grado de satisfacción del paciente/médico con la TC. Resultados: La mayoría de los pacientes atendidos en las 469 TCR realizadas fueron mujeres, con una edad media de 60,83 años. Solo el 16% había realizado estudios universitarios. La distancia media recorrida para acudir a una consulta presencial era de 33km, con una inversión de tiempo total promedio de 2 h. La mayoría de los sujetos estaban diagnosticados de artrosis/reumatismos de partes blandas u osteoporosis; el 21% eran presentaban artritis reumatoide. La duración media de la TCR fue de 9,64 min. Encontramos una mayor satisfacción con la TCR por parte del paciente, cuando el nivel de estudios era más alto (OR = 4,33) y por parte del médico cuando el individuo manejaba mejor Internet (OR = 3,22). Conclusión: Es posible transferir actividad asistencial reumatológica hacia la TCR con un grado importante de satisfacción para el paciente y el médico.(AU)

Introduction: During the COVID-19 pandemic strategies to prevent transmission of the viral infection obliged our hospital to promote virtual consultations. Objetive: The objective of this study is to describe the results obtained with the previous strategy of transferring activity to teleconsultation during the period of maximum impact of the pandemic. Material and methods: Between 16/03 and 10/05/2020 all successive consultations in our unit were performed in virtual rheumatology teleconference (RTC) format. The socio-demographic, geo-functional and clinical characteristics of all patients were collected; a numeric verbal scale (NVS) (where 0=very dissatisfied to 10=fully satisfied) was applied to assess the degree of satisfaction of the doctor/patient with the RTC. Results: 469 TC were included. Most patients seen by RTC were women, mean age: 60,83 years. Only 16% had university education. The mean distance travelled for face-to face consultation is 33 Km with a mean total time of 2hours. Most individuals were diagnosed with osteoarthritis/soft tissue rheumatic diseases and/or osteoporosis; 21% had rheumatoid arthritis. The mean length of the TC was 9.64minutes. We find more patient satisfaction with the TC when their level of education is higher (OR=4.12); doctor satisfaction was higher when the individual was better able to manage the Internet (OR=3.01). Conclusion: It is possible to transfer rheumatological care activity to TC with a considerable degree of satisfaction for both the patient and the doctor.(AU)

Experts document on methotrexate use in combined therapy with biological or targeted synthetic disease modifying drugs in patients with rheumatoid arthritis.

OBJECTIVE: We aimed to develop recommendations for the management of methotrexate (MTX) when considering the combination with biological (b) or targeted synthetic (ts) disease modifying drugs (DMARDs) in rheumatoid arthritis (RA). METHODS: Eleven experts on RA were selected. Two coordinators formulated 13 questions about the combination therapy of MTX with bDMARDs or tsDMARDs. A systematic review was conducted to answer the questions. Inclusion and exclusion criteria were established as well as the search strategies (Medline, Embase and the Cochrane Library were searched up to January 2019). Two reviewers selected the articles and collected data. Simultaneously, EULAR and ACR meeting abstracts were evaluated. Based on this evidence, the coordinators proposed preliminary recommendations that the experts discussed and voted in a nominal group meeting. The level of evidence and grade of recommendation was established using the Oxford Center for Evidence Based Medicine and the level of agreement with a Delphi. Agreement was established if at least 80% of the experts voted 'yes' (yes/no). RESULTS: The systematic review retrieved 513 citations of which 61 were finally included. A total of 10 recommendations were generated, voted and accepted. The level of agreement was very high in all of them and it was achieved in the first Delphi round. Final recommendations cover aspects such as the optimal MTX dosage, tapering strategy or patients' risk management. CONCLUSIONS: This document is intended to help clinicians solve usual clinical questions and facilitate decision making when treating RA patients with MTX in combination with bDMARDs or tsDMARDs.

Experts document on methotrexate use in combined therapy with biological or targeted synthetic disease modifying drugs in patients with rheumatoid arthritis / Documento de expertos sobre el uso de terapia combinada de metotrexato con terapias biológicas o terapias dirigidas a pacientes con artritis reumatoide

Objective: We aimed to develop recommendations for the management of methotrexate (MTX) when considering the combination with biological (b) or targeted synthetic (ts) disease modifying drugs (DMARDs) in rheumatoid arthritis (RA). Methods: Eleven experts on RA were selected. Two coordinators formulated 13 questions about the combination therapy of MTX with bDMARDs or tsDMARDs. A systematic review was conducted to answer the questions. Inclusion and exclusion criteria were established as well as the search strategies (Medline, Embase and the Cochrane Library were searched up to January 2019). Two reviewers selected the articles and collected data. Simultaneously, EULAR and ACR meeting abstracts were evaluated. Based on this evidence, the coordinators proposed preliminary recommendations that the experts discussed and voted in a nominal group meeting. The level of evidence and grade of recommendation was established using the Oxford Center for Evidence Based Medicine and the level of agreement with a Delphi. Agreement was established if at least 80% of the experts voted ‘yes’ (yes/no). Results: The systematic review retrieved 513 citations of which 61 were finally included. A total of 10 recommendations were generated, voted and accepted. The level of agreement was very high in all of them and it was achieved in the first Delphi round. Final recommendations cover aspects such as the optimal MTX dosage, tapering strategy or patients’ risk management. Conclusions: This document is intended to help clinicians solve usual clinical questions and facilitate decision making when treating RA patients with MTX in combination with bDMARDs or tsDMARDs.(AU)

Objetivo: Desarrollar recomendaciones sobre el uso de metotrexato (MTX) en combinación con medicamentos modificadores de la enfermedad (DMARD) biológicos (b) o sintéticos específicos (ts) en la artritis reumatoide (AR). Métodos: Se seleccionaron 11 expertos en AR. Dos coordinadores formularon 13 preguntas sobre la terapia combinada de MTX con bDMARD o tsDMARD. Se realizó una revisión sistemática para responder las preguntas. Se establecieron criterios de inclusión y exclusión, así como las estrategias de búsqueda (se realizaron búsquedas en Medline, Embase y la Biblioteca Cochrane hasta enero de 2019). Dos revisores seleccionaron los artículos y recopilaron datos. Simultáneamente, se evaluaron los resúmenes de las reuniones EULAR y ACR. Con base en esta evidencia, los coordinadores propusieron recomendaciones preliminares que los expertos discutieron y votaron en una reunión de grupo nominal. El nivel de evidencia y el grado de recomendación se establecieron utilizando el Centro de Oxford para Medicina Basada en Evidencia y el nivel de acuerdo con un Delphi. El acuerdo se estableció si al menos el 80% de los expertos votaron «sí» (sí/no). Resultados: La revisión sistemática recuperó 513 citas, de las cuales finalmente se incluyeron 61. Se generaron, votaron y aceptaron un total de 10 recomendaciones. El nivel de acuerdo fue muy alto en todas ellas y se logró en la primera ronda de Delphi. Las recomendaciones finales cubren aspectos como la dosis óptima de MTX, la estrategia de reducción o la gestión del riesgo de los pacientes. Conclusiones: Este documento está destinado a ayudar a los médicos a resolver preguntas clínicas habituales y facilitar la toma de decisiones al tratar a pacientes con AR con MTX, en combinación con bDMARD o tsDMARD.(AU)

Usefulness of rheumatology consultancy in situ: Analysis of a long-term experience.

OBJECTIVE: To report the long-term experience of a rheumatologist consultant "in situ" (RCI) in a primary care centre (PCC). MATERIAL AND METHODS: Observational retrospective study analysing the complete cohort of the patients seen by the RCI between 2013 and 2019. Rheumatology patients' clinical characteristics and course of care were collected to estimate the diagnoses that were most likely to be monitored by a primary care physician (PCP). RESULTS: A total of 876 consultations were attended; 205 were men (23.4%) and 671 women (76.6%).Most of the consultations (280, 33.2%) were diagnostic. On 167 occasions (19.8%) therapeutic issues were analysed; in 47 (5.6%) therapeutic infiltrations were performed. Chronic patient control was applied in 163 subjects (19.3%). A request for tests not available to the PCP was the reason for the consultation in 154 situations (18.3%). The profile most likely to continue being monitored in the PCC is the patient with osteoarthritis (OR = .13, CI 95%: .02-.67), soft tissue rheumatism (OR = .006, 95% CI: .01-.45) or cervical disc herniation (OR = .13, 95% CI: .02-.66). Less likely to be monitored by PCP after being seen by the RCI were subjects with rheumatoid arthritis (OR = .03, 95% CI: .00-.24), other inflammatory arthropathies (OR = .36, 95% CI: .16-.80) or with polymyalgia rheumatica (OR = .19, 95% CI: .06-.64 ), and those in need of chronic disease monitoring (OR = .16, 95% CI: .07-.34). CONCLUSIONS: The RCI makes it easier for the PCP to monitor patients with osteoarthritis, soft tissue rheumatism and cervical disc pathology.

Tele-Rheumatology during the COVID-19 pandemic.

INTRODUCTION: During the Covid-19 pandemic strategies to prevent transmission of the viral infection obliged our hospital to promote virtual consultations. OBJETIVE: The objective of this study is to describe the results obtained with the previous strategy of transferring activity to teleconsultation during the period of maximum impact of the pandemic. MATERIAL AND METHODS: Between 16/03 and 10/05/2020 all successive consultations in our unit were performed in virtual rheumatology teleconference (RTC) format. The socio-demographic, geo-functional and clinical characteristics of all patients were collected; a numeric verbal scale (NVS) (where 0 = very dissatisfied to 10 = fully satisfied) was applied to assess the degree of satisfaction of the doctor/patient with the RTC. RESULTS: 469 TC were included. Most patients seen by RTC were women, mean age: 60,83 years. Only 16% had university education. The mean distance travelled for face-to face consultation is 33 Km with a mean total time of 2 h. Most individuals were diagnosed with osteoarthritis/soft tissue rheumatic diseases and/or osteoporosis; 21% had rheumatoid arthritis. The mean length of the TC was 9.64 min. We find more patient satisfaction with the TC when their level of education is higher (OR = 4.12); doctor satisfaction was higher when the individual was better able to manage the Internet (OR = 3.01). CONCLUSION: It is possible to transfer rheumatological care activity to TC with a considerable degree of satisfaction for both the patient and the doctor.

Usefulness of Rheumatology Consultancy in situ: Analysis of a Long-term Experience. / Utilidad de la consultoría reumaológica in situ: análisis de una experiencia prolongada en el tiempo.

OBJECTIVE: To report the long-term experience of a rheumatologist consultant in situ (RCI) in a primary care centre (PCC). MATERIAL AND METHODS: Observational retrospective study analysing the complete cohort of the patients seen by the RCI between 2013 and 2019. Rheumatology patients' clinical characteristics and course of care were collected to estimate the diagnoses that were most likely to be monitored by a primary care physician (PCP). RESULTS: A total of 876 consultations were attended; 205 were men (23.4%) and 671 women (76.6%). Most of the consultations (280, 33.2%) were diagnostic. On 167 occasions (19.8%) therapeutic issues were analysed; in 47 (5.6%) therapeutic infiltrations were performed. Chronic patient control was applied in 163 subjects (19.3%). A request for tests not available to the PCP was the reason for the consultation in 154 situations (18.3%). The profile most likely to continue being monitored in the PCC is the patient with osteoarthritis (OR=0.13, CI 95%: 0.02-0.67), soft tissue rheumatism (OR=0.006, 95%CI: 0.01-0.45) or cervical disc herniation (OR=0.13, 95%CI: 0.02-0.66). Less likely to be monitored by PCP after being seen by the RCI were subjects with rheumatoid arthritis (OR=0.03, 95%CI: 0.00-0.24), other inflammatory arthropathies (OR=0.36, 95%CI: 0.16-0.80) or with polymyalgia rheumatica (OR=0.19, 95%CI: 0.06-0.64), and those in need of chronic disease monitoring (OR=0.16, 95%CI: 0.07-0.34). CONCLUSIONS: The RCI makes it easier for the PCP to monitor patients with osteoarthritis, soft tissue rheumatism and cervical disc pathology.

Potential Benefits of the Self-Administration of Subcutaneous Methotrexate with Autoinjector Devices for Patients: A Review.

The role of patient adherence in improving the efficacy of any treatment is widely accepted, as well as its impact in optimizing the use of healthcare resources and associated costs. Adherence is particularly affected in chronic conditions, such as rheumatoid arthritis (RA), requiring long-term therapies and a commitment of the patient to manage his/her disease. Methotrexate (MTX) is one of the mainstays of treatment for several immune-mediated inflammatory joint and skin diseases, especially RA. The use of parenteral MTX, particularly when administered as a subcutaneous (SC) injection, has recently raised a great interest to overcome the limitations of oral MTX. For addressing this issue, new optimized self-injection systems have been developed to improve the ease of use of SC MTX. Increasing evidence shows how patients tend to opt for autoinjectors over prefilled syringes or conventional syringes in terms of easiness of use, preference and satisfaction, regardless of whether the treatment is a biologic or MTX. Additionally, positive views and beliefs of patients about treatment may contribute to increasing expectations of effectiveness and treatment adherence. Similarly, the implementation of prefilled pens in clinical practice might be a way to facilitate and simplify the self-injection of SC MTX delivery, optimizing adherence and treatment outcomes as a consequence. This article aimed to review the available literature data on the use of MTX autoinjectors and their impact on treatment adherence and patients' perceptions.

Cardiovascular mortality and cardiovascular event rates in patients with inflammatory rheumatic diseases in the CARdiovascular in rheuMAtology (CARMA) prospective study-results at 5 years of follow-up.

OBJECTIVES: To determine cardiovascular (CV) mortality and incidence of the first CV event (CVE) in patients with chronic inflammatory rheumatic diseases (CIRD) after 5 years of follow-up. METHODS: This is an analysis of the CARdiovascular in rheMAatology (CARMA) study after 5 years of follow-up. It includes patients with RA (n = 775), AS (n = 738) and PsA (n = 721), and individuals without CIRD (n = 677) attending outpatient rheumatology clinics from 67 public hospitals in Spain. Descriptive analyses were performed for the CV mortality at 5 years. The Systematic COronary Risk Evaluation (SCORE) function at 5 years was calculated to determine the expected risk of CV mortality. Poisson models were used to estimate the incidence rates of the first CVE. Hazard ratios of the risk factors involved in the development of the first CVE were evaluated using the Weibull proportional hazard model. RESULTS: Overall, 2382 subjects completed the follow-up visit at 5 years. Fifteen patients died due to CVE. CV deaths observed in the CIRD cohort were lower than that predicted by SCORE risk charts. The highest incidence rate of CVE [7.39 cases per 1000 person-years (95% CI 4.63, 11.18)] was found in PsA patients. However, after adjusting for age, sex and CV risk factors, AS was the inflammatory disease more commonly associated with CVE at 5 years [hazard ratio 4.60 (P =0.02)], compared with those without CIRD. CONCLUSIONS: Cardiovascular mortality in patients with CIRD at 5 years of follow-up is lower than estimated. Patients with AS have a higher risk of developing a first CVE after 5 years of follow-up.

Tele-Rheumatology During the COVID-19 Pandemic. / Telerreumatología en tiempos de crisis durante la pandemia por COVID-19.

INTRODUCTION: During the COVID-19 pandemic strategies to prevent transmission of the viral infection obliged our hospital to promote virtual consultations. OBJETIVE: The objective of this study is to describe the results obtained with the previous strategy of transferring activity to teleconsultation during the period of maximum impact of the pandemic. MATERIAL AND METHODS: Between 16/03 and 10/05/2020 all successive consultations in our unit were performed in virtual rheumatology teleconference (RTC) format. The socio-demographic, geo-functional and clinical characteristics of all patients were collected; a numeric verbal scale (NVS) (where 0=very dissatisfied to 10=fully satisfied) was applied to assess the degree of satisfaction of the doctor/patient with the RTC. RESULTS: 469 TC were included. Most patients seen by RTC were women, mean age: 60,83 years. Only 16% had university education. The mean distance travelled for face-to face consultation is 33 Km with a mean total time of 2hours. Most individuals were diagnosed with osteoarthritis/soft tissue rheumatic diseases and/or osteoporosis; 21% had rheumatoid arthritis. The mean length of the TC was 9.64minutes. We find more patient satisfaction with the TC when their level of education is higher (OR=4.12); doctor satisfaction was higher when the individual was better able to manage the Internet (OR=3.01). CONCLUSION: It is possible to transfer rheumatological care activity to TC with a considerable degree of satisfaction for both the patient and the doctor.

Experts document on methotrexate use in combined therapy with biological or targeted synthetic disease modifying drugs in patients with rheumatoid arthritis.

OBJECTIVE: We aimed to develop recommendations for the management of methotrexate (MTX) when considering the combination with biological (b) or targeted synthetic (ts) disease modifying drugs (DMARDs) in rheumatoid arthritis (RA). METHODS: Eleven experts on RA were selected. Two coordinators formulated 13 questions about the combination therapy of MTX with bDMARDs or tsDMARDs. A systematic review was conducted to answer the questions. Inclusion and exclusion criteria were established as well as the search strategies (Medline, Embase and the Cochrane Library were searched up to January 2019). Two reviewers selected the articles and collected data. Simultaneously, EULAR and ACR meeting abstracts were evaluated. Based on this evidence, the coordinators proposed preliminary recommendations that the experts discussed and voted in a nominal group meeting. The level of evidence and grade of recommendation was established using the Oxford Center for Evidence Based Medicine and the level of agreement with a Delphi. Agreement was established if at least 80% of the experts voted 'yes' (yes/no). RESULTS: The systematic review retrieved 513 citations of which 61 were finally included. A total of 10 recommendations were generated, voted and accepted. The level of agreement was very high in all of them and it was achieved in the first Delphi round. Final recommendations cover aspects such as the optimal MTX dosage, tapering strategy or patients' risk management. CONCLUSIONS: This document is intended to help clinicians solve usual clinical questions and facilitate decision making when treating RA patients with MTX in combination with bDMARDs or tsDMARDs.

Recomendaciones de experto sobre el bloqueo de la interleucina 6 en pacientes con artritis reumatoide / Expert recommendations on the interleukin 6 blockade in patients with rheumatoid arthritis

OBJETIVO: Generar recomendaciones sobre el bloqueo de la interleucina 6 (IL-6) en pacientes con artritis reumatoide (AR), basadas en la mejor evidencia y experiencia. MÉTODOS: Se seleccionó a 10 expertos reumatólogos en el manejo de los inhibidores de la IL-6. Los 2 coordinadores generaron 23 preguntas sobre el bloqueo de la IL-6 en la AR (perfiles de indicación, eficacia, seguridad, etc.) para ser contestadas mediante una revisión sistemática de la literatura. Con base en las preguntas se definieron los criterios de inclusión y exclusión, y las estrategias de búsqueda (para interrogar Medline, Embase y la Cochrane Library). Dos revisores seleccionaron los artículos resultantes de la búsqueda. Se generaron tablas de evidencia. Paralelamente, se evaluaron abstracts de congresos de EULAR y ACR. Con toda esta evidencia los coordinadores propusieron 8 recomendaciones preliminares que se evaluaron, discutieron y votaron en una reunión de grupo nominal con el resto de los expertos. Para cada recomendación se estableció el nivel de evidencia y grado de recomendación, y el grado de acuerdo mediante un Delphi. Se definió acuerdo si al menos el 80% de los participantes contestaban sí a la recomendación (sí o no). RESULTADOS: Las 8 recomendaciones preliminares se aceptaron tras el Delphi. Abarcan aspectos como su uso en monoterapia, en combinación, en pacientes refractarios o intolerantes, la evaluación de su respuesta, la optimización o la gestión del riesgo. CONCLUSIONES: Este documento pretende resolver algunos interrogantes clínicos habituales y facilitar la toma de decisiones con el bloqueo de la IL-6 en el manejo de la AR

OBJECTIVE: To draft recommendations on interleukin 6 (IL-6) blockade in rheumatoid arthritis (RA), based on best evidence and experience. METHODS: A group of 10 experts on IL-6 blockade in RA was selected. The 2 coordinators formulated 23 questions about IL-6 blockade (indications, efficacy, safety, etc.). A systematic review was conducted to answer the questions. Using this information, inclusion and exclusion criteria were established, as were the search strategies (Medline, EMBASE and the Cochrane Library were searched). Two different reviewers selected the articles. Evidence tables were created. At the same time, European League Against Rheumatism and American College of Rheumatology abstracts were evaluated. Based on this evidence, the coordinators proposed preliminary recommendations that the experts discussed and voted on in a nominal group meeting. The level of evidence and grade of recommendation were established using the Oxford Centre for Evidence Based Medicine and the level of agreement with the Delphi technique (2 rounds). Agreement was established if at least 80% of the experts voted yes (yes/no). RESULTS: The 8 preliminary recommendations were accepted after the Delphi process. They covered aspects such as the use of these therapies in monotherapy, in combination, in patients with refractory disease or intolerant patients, response evaluation, optimization and risk management. CONCLUSIONS: The manuscript aims to solve frequently asked questions and aid in decision making strategies when treating RA patients with IL-6 blockade

Expert Recommendations on the Interleukin 6 Blockade in Patients with Rheumatoid Arthritis. / Recomendaciones de experto sobre el bloqueo de la interleucina 6 en pacientes con artritis reumatoide.

OBJECTIVE: To draft recommendations on interleukin 6 (IL-6) blockade in rheumatoid arthritis (RA), based on best evidence and experience. METHODS: A group of 10 experts on IL-6 blockade in RA was selected. The 2 coordinators formulated 23 questions about IL-6 blockade (indications, efficacy, safety, etc.). A systematic review was conducted to answer the questions. Using this information, inclusion and exclusion criteria were established, as were the search strategies (Medline, EMBASE and the Cochrane Library were searched). Two different reviewers selected the articles. Evidence tables were created. At the same time, European League Against Rheumatism and American College of Rheumatology abstracts were evaluated. Based on this evidence, the coordinators proposed preliminary recommendations that the experts discussed and voted on in a nominal group meeting. The level of evidence and grade of recommendation were established using the Oxford Centre for Evidence Based Medicine and the level of agreement with the Delphi technique (2 rounds). Agreement was established if at least 80% of the experts voted yes (yes/no). RESULTS: The 8 preliminary recommendations were accepted after the Delphi process. They covered aspects such as the use of these therapies in monotherapy, in combination, in patients with refractory disease or intolerant patients, response evaluation, optimization and risk management. CONCLUSIONS: The manuscript aims to solve frequently asked questions and aid in decision making strategies when treating RA patients with IL-6 blockade.

Telerreumatología en tiempos de crisis durante la pandemia por COVID-19 / Tele-rheumatology during the COVID-19 pandemic

INTRODUCCIÓN: Durante la pandemia por COVID-19 las necesidades de prevención de transmisión de la infección viral nos obligaron a potenciar las consultas virtuales. OBJETIVO: El objetivo de estudio es describir los resultados obtenidos con la anterior estrategia y definir el perfil de paciente más idóneo para aplicarla. MATERIAL Y MÉTODOS: Durante el período comprendido entre el 16 de marzo y y el 10 de mayo del 2020 todas las consultas sucesivas de nuestro servicio fueron realizadas en formato de teleconsulta reumatológica (TCR). Se recogieron las características sociodemográficas, geofuncionales y clínicas de los pacientes; se evalúo mediante escala numérica verbal (0-10, donde 0 = muy insatisfecho hasta 10 = completamente satisfecho) el grado de satisfacción del paciente/médico con la TC. RESULTADOS: La mayoría de los pacientes atendidos en las 469 TCR realizadas fueron mujeres, con una edad media de 60,83 años. Solo el 16% había realizado estudios universitarios. La distancia media recorrida para acudir a una consulta presencial era de 33km, con una inversión de tiempo total promedio de 2 h. La mayoría de los sujetos estaban diagnosticados de artrosis/reumatismos de partes blandas u osteoporosis; el 21% eran presentaban artritis reumatoide. La duración media de la TCR fue de 9,64 min. Encontramos una mayor satisfacción con la TCR por parte del paciente, cuando el nivel de estudios era más alto (OR = 4,33) y por parte del médico cuando el individuo manejaba mejor Internet (OR = 3,22). CONCLUSIÓN: Es posible transferir actividad asistencial reumatológica hacia la TCR con un grado importante de satisfacción para el paciente y el médico

INTRODUCTION: During the COVID-19 pandemic strategies to prevent transmission of the viral infection obliged our hospital to promote virtual consultations. OBJECTIVE: The objective of this study is to describe the results obtained with the previous strategy of transferring activity to teleconsultation during the period of maximum impact of the pandemic. MATERIAL AND METHODS: Between 16/03 and 10/05/2020 all successive consultations in our unit were performed in virtual rheumatology teleconference (RTC) format. The socio-demographic, geo-functional and clinical characteristics of all patients were collected; a numeric verbal scale (NVS) (where 0=very dissatisfied to 10=fully satisfied) was applied to assess the degree of satisfaction of the doctor/patient with the RTC. RESULTS: 469 TC were included. Most patients seen by RTC were women, mean age: 60,83 years. Only 16% had university education. The mean distance travelled for face-to face consultation is 33 Km with a mean total time of 2hours. Most individuals were diagnosed with osteoarthritis/soft tissue rheumatic diseases and/or osteoporosis; 21% had rheumatoid arthritis. The mean length of the TC was 9.64minutes. We find more patient satisfaction with the TC when their level of education is higher (OR=4.12); doctor satisfaction was higher when the individual was better able to manage the Internet (OR=3.01). CONCLUSION: It is possible to transfer rheumatological care activity to TC with a considerable degree of satisfaction for both the patient and the doctor

Metotrexato en pacientes con artritis reumatoide en España: subanálisis del proyecto AR Excellence / Methotrexate in patients with rheumatoid arthritis in Spain: subanalysis of the AR Excellence project

OBJETIVO: El proyecto AR Excellence evalúa la atención clínica a los pacientes con artritis reumatoide (AR) en España. El objetivo del presente estudio es analizar la utilización de metotrexato (MTX) en AR Excellence y compararla con las recomendaciones vigentes. PACIENTES Y MÉTODOS: Se revisó a pacientes con AR que habían iniciado tratamiento con MTX, recogiendo datos demográficos, dosificación, vías de administración, combinaciones con otros fármacos antirreumáticos modificadores de enfermedad (FAME), tiempo hasta combinación con otro FAME (convencional o biológico) y efectos adversos. RESULTADOS: Se incluyó a 625 pacientes con AR (edad media de 55,1 años; 70,6% mujeres), con una duración media de la AR de 21,3 meses. El 90% inició tratamiento con MTX. La dosis media de inicio fue de 11mg semanales; en el 58% de los casos se incrementó la dosis. El tiempo medio hasta alcanzar la dosis plena de MTX (20mg semanales) fue de 6,67 meses. El tiempo hasta la combinación de MTX con otro FAME sintético o biológico fue de 3 meses. El 67,4% de los pacientes recibieron el MTX por vía oral y el 18,6%, subcutáneo. En el 12% de los casos se cambió la vía de administración, transcurrida una media de tiempo de 6 meses. En 544 pacientes se asociaron suplementos de folato. El 17,3% de los sujetos presentaron acontecimientos adversos por MTX. CONCLUSIÓN: El MTX es el fármaco sobre el que pivota el tratamiento de la AR. El subanálisis del proyecto AR Excellence nos informa de que la escalada a sus dosis plenas no se realiza con la rapidez adecuada. La vía subcutánea se utiliza en pocos pacientes

OBJECTIVE: The AR Excellence project evaluates clinical monitoring in patients with rheumatoid arthritis (RA) in Spain. The aim of the study was to analyze the use of methotrexate (MTX) in the AR Excellence cohort and to compare it with current recommendations. PATIENTS AND METHODS: We collected data from RA patients who initiated treatment with MTX. They included demographics, dose and routes of administration, switching among them, highest dose in each route, combinations with other disease-modifying antirheumatic drugs (DMARDs), time to combination with another DMARD (either conventional or biological) and adverse events. RESULTS: Six hundred twenty-five patients with RA (mean age 55 years; 70.6% women) were included, with an average disease duration of 21 months. Ninety percent of the patients initiated treatment with MTX. Therapy was begun with a mean dose of 11mg per week; this initial dose was increased in 58% of the individuals. The average time to reach the full dose of MTX (20mg a week) was 6,67 months. Time to combination of MTX with another DMARD, either synthetic or biological, was 3 months. In all, 67.4% of the patients received oral MTX and the route was subcutaneous in 18.6%. In 12% of the cases, there was a change in the route of administration after a period of 6 months. In 544 patients, folate supplements were added to MTX; MTX-related adverse events were detected in 17.3% of the patients. CONCLUSION: MTX is currently the pivotal treatment in RA. The subanalysis of the AR Excellence project demonstrates that MTX escalation to its full doses is not done with adequate speed. The subcutaneous route is used in a small proportion of patients

Incidence of first cardiovascular event in Spanish patients with inflammatory rheumatic diseases: prospective data from the CARMA project.

OBJECTIVES: To determine the incidence and risk factors of first cardiovascular event (CVE) in patients with chronic inflammatory rheumatic diseases (CIRD). METHODS: Analysis of data after 2.5 years of follow-up from the prospective study CARMA project, that includes patients with CIRD [rheumatoid arthritis (RA), ankylosing spondylitis (AS), and psoriatic arthritis (PsA)] and matched individuals without CIRD from 67 hospitals in Spain. CVE cumulative incidence per 1000 patients was calculated after 2.5 years from the start of the project. Weibull proportional hazard model was used to calculate hazard ratio (HR) and 95% confidence interval (95% CI) of the risk factors. RESULTS: 2595 (89.1%) patients completed the 2.5 years of follow-up visit. Cumulative incidence of CVE in patients with CIRD was 15.30 cases per 1000 patients (95% CI: 12.93-17.67), being higher in the subgroup with AS; 22.03 (95% CI: 11.01-33.04). Patients with AS (HR: 4.11; 95% CI: 1.07-15.79), those with older age (HR: 1.09; 95% CI: 1.05-1.13), systolic hypertension (HR: 1.02; 95% CI: 1.00-1.04) and long duration of the disease (HR: 1.07; 95% CI: 1.03-1.12) were at higher risk of first CVE during the 2.5 years of follow-up. In contrast, female gender was a protective factor (HR: 0.43; 95% CI: 0.18-1.00). CONCLUSIONS: Among CIRD patients prospectively followed-up at rheumatology outpatient clinics, those with AS show higher risk of first CVE. Besides cardiovascular risk factors, such as hypertension, being a man and older as well as having a long disease duration increase the risk of CVE in patients with CIRD.