Pan American League of Associations for Rheumatology Recommendations for the Treatment of Psoriatic Arthritis.

OBJECTIVE: Psoriatic arthritis (PsA) is chronic disease that compromises multiple domains and might be associated with progressive joint damage, increased mortality, functional limitation, and considerably impaired quality of life. Our objective was to generate evidence-based recommendations on the management of PsA in Pan American League of Associations for Rheumatology (PANLAR) countries. METHODS: We used the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE)-ADOLOPMENT approach to adapt the 2019 recommendations of the European Alliance of Associations for Rheumatology. A working group consisting of rheumatologists from various countries in Latin America identified relevant topics for the treatment of PsA in the region. The methodology team updated the evidence and synthesized the information used to generate the final recommendations. These were then discussed and defined by a panel of 31 rheumatologists from 15 countries. RESULTS: Theses guidelines report 15 recommendations addressing therapeutic targets, use of antiinflammatory agents and corticosteroids, treatment with disease-modifying antirheumatic drugs (conventional synthetic, biologic, and targeted synthetic), therapeutic failure, optimization of biologic therapy, nonpharmacological interventions, assessment tools, and follow-up of patients with PsA. CONCLUSION: Here we present a set of recommendations to guide decision making in the treatment of PsA in Latin America, based on the best evidence available, considering resources, medical expertise, and the patient's values and preferences. The successful implementation of these recommendations should be based on clinical practice conditions, healthcare settings in each country, and a tailored evaluation of patients.

Pan American League of Associations for Rheumatology recommendations for the management of axial spondyloarthritis.

Axial spondyloarthritis (axSpA) comprises a spectrum of chronic inflammatory manifestations affecting the axial skeleton and represents a challenge for diagnosis and treatment. Our objective was to generate a set of evidence-based recommendations for the management of axSpA for physicians, health professionals, rheumatologists and policy decision makers in Pan American League of Associations for Rheumatology (PANLAR) countries. Grading of Recommendations, Assessment, Development and Evaluation-ADOLOPMENT methodology was used to adapt existing recommendations after performing an independent systematic search and synthesis of the literature to update the evidence. A working group consisting of rheumatologists, epidemiologists and patient representatives from countries within the Americas prioritized 13 topics relevant to the context of these countries for the management of axSpA. This Evidence-Based Guideline article reports 13 recommendations addressing therapeutic targets, the use of NSAIDs and glucocorticoids, treatment with DMARDs (including conventional synthetic, biologic and targeted synthetic DMARDs), therapeutic failure, optimization of the use of biologic DMARDs, the use of drugs for extra-musculoskeletal manifestations of axSpA, non-pharmacological interventions and the follow-up of patients with axSpA.

2021 clinical practice guideline for the early detection, diagnosis, treatment, and monitoring of patients with axial spondyloarthritis. Colombian Association of Rheumatology / Guía de práctica clínica 2021 para la detección temprana, el diagnóstico, el tratamiento y el seguimiento de los pacientes con espondiloartritis axial. Asociación Colombiana de Reumatología

Abstract Introduction: Axial spondyloarthritis is a rheumatic condition affecting young patients with social and occupational consequences. Diagnosis delay is associated with functional impairment and impact on quality of life, requiring a multidisciplinary approach. Objective: To develop a set of recommendations based on the best available evidence for the early detection, diagnosis, treatment, and monitoring of adult patients with axial spondy-loarthritis. Methods: A working group was established, questions were developed, outcomes were graded, and a systematic search for evidence was conducted. A multidisciplinary panel of members was established (including patient representatives), minimizing bias in relation to conflicts of interest. The GRADE approach "Grading of Recommendations Assessment, Development and Evaluation" was used to assess the quality of the evidence as well as the direction and strength of recommendations. In total, 11 recommendations on diagnosis (n=2), pharmacological treatment (n=6), non-pharmacological treatment (n=2) and monitoring (n=1) are presented. Results: Sacroiliac joint radiography as the first diagnostic method, and the use of disease activity scales for patient monitoring (ASDAS or BASDAI), are recommended. Nonsteroidal anti-inflammatory drugs are the first treatment option; in case of intolerance or residual pain, acetaminophen or opioids are recommended. In patients with axial involvement, it is recommended not to use conventional disease-modifying antirheumatic drugs or systemic or local glucocorticoids. In patients with failure to non-steroidal anti-inflammatory drugs, anti-TNF or anti-IL17A are recommended. In those patients presenting with anti-TNF failure, starting an anti-IL17A is recommended. Exercise, physical and occupational therapy are recommended as part of treatment. It is recommended not to use unconventional therapies as the only treatment option. Conclusions: This set of recommendations provides an updated guideline for the diagnosis, treatment, and monitoring of patients with axial spondyloarthritis.

RESUMEN Introducción: La espondiloartritis axial es una enfermedad reumatológica que afecta a individuos jóvenes y tiene una gran repercusión sociolaboral. El retraso en el diagnóstico y el tratamiento se asocia con un mayor deterioro funcional y un impacto negativo en la calidad de vida, por lo que requiere un abordaje multidisciplinario. Objetivo: Desarrollar y formular un conjunto de recomendaciones específicas basadas en la mejor evidencia disponible para la detección temprana, el diagnóstico, el tratamiento y el seguimiento de los pacientes adultos con espondiloartritis axial. Métodos: Se configuró un grupo desarrollador, se formularon preguntas clínicas contestables, se graduaron los desenlaces y se realizó la búsqueda sistemática de la evidencia. El panel de la guía fue multidisciplinario (incluyendo representantes de los pacientes) y balanceado, minimizando el sesgo por conflictos de intereses. Se utilizó la aproximación Grading of Recommendations Assessment, Development and Evaluation (GRADE) para evaluar la calidad de la evidencia, al igual que la dirección y la fortaleza de las recomendaciones. Se presentan 11 recomendaciones relacionadas con diagnóstico (n = 2), tratamiento farmacológico (n = 6), tratamiento no farmacológico (n = 2) y seguimiento (n = 1). Resultados: Se recomienda la radiografía de articulaciones sacroilíacas como primer método diagnóstico, y el uso de escalas de actividad para el seguimiento de los pacientes (ASDAS o BASDAI). Los antiinflamatorios no esteroideos son la primera opción de tratamiento; en caso de intolerancia o dolor residual se recomienda acetaminofén u opioides. En pacientes con compromiso axial se recomienda abstenerse de utilizar medicamentos antirreumáticos modificadores de la enfermedad convencionales ni glucocorticoides sistémicos o locales. En pacientes con falla a los antiinflamatorios no esteroideos, se recomienda un anti-TNFα o un anti-IL17A. En pacientes con falla a anti-TNFα, se recomienda iniciar un anti-IL17A. El ejercicio y la terapia física y ocupacional se recomiendan como parte del tratamiento. Se recomienda no utilizar las terapias no convencionales como única opción de tratamiento. Conclusiones: Este conjunto de recomendaciones proporciona una guía actualizada sobre el diagnóstico y el tratamiento de la espondiloartritis axial.

Guía de práctica clínica 2021 para la detección temprana, el diagnóstico, el tratamiento y el seguimiento de los pacientes con espondiloartritis axial. Asociación Colombiana de Reumatología / 2021 clinical practice guideline for the early detection, diagnosis, treatment, and monitoring of patients with axial spondyloarthritis. Colombian Association of Rheumatology

Antecedentes: La espondiloartritis axial es una enfermedad reumatológica que afecta a individuos jóvenes y tiene una gran repercusión sociolaboral. El retraso en el diagnóstico y el tratamiento se asocia con un mayor deterioro funcional y un impacto negativo en la calidad de vida, por lo que requiere un abordaje multidisciplinario. Objetivo: Desarrollar y formular un conjunto de recomendaciones específicas basadas en la mejor evidencia disponible para la detección temprana, el diagnóstico, el tratamiento y el seguimiento de los pacientes adultos con espondiloartritis axial. Métodos: Se configuró un grupo desarrollador, se formularon preguntas clínicas contestables, se graduaron los desenlaces y se realizó la búsqueda sistemática de la evidencia. El panel de la guía fue multidisciplinario (incluyendo representantes de los pacientes) y balanceado, minimizando el sesgo por conflictos de intereses. Se utilizó la aproximación Grading of Recommendations Assessment, Development and Evaluation (GRADE) para evaluar la calidad de la evidencia, al igual que la dirección y la fortaleza de las recomendaciones. Se presentan 11 recomendaciones relacionadas con diagnóstico (n=2), tratamiento farmacológico (n=6), tratamiento no farmacológico (n=2) y seguimiento (n=1). Resultados: Se recomienda la radiografía de articulaciones sacroilíacas como primer método diagnóstico y el uso de escalas de actividad para el seguimiento de los pacientes (ASDAS o BASDAI). Los antiinflamatorios no esteroideos son la primera opción de tratamiento; en caso de intolerancia o dolor residual se recomienda acetaminofén u opioides. En pacientes con compromiso axial se recomienda abstenerse de utilizar medicamentos antirreumáticos modificadores de la enfermedad convencionales ni glucocorticoides sistémicos o locales. En pacientes con fallo a los antiinflamatorios no esteroideos, se recomienda un anti-TNF-α o un anti-IL-17A.(AU)

Background: Axial spondyloarthritis is a rheumatic condition affecting young patients with social and occupational consequences. Diagnosis delay is associated with functional impairment and impact on quality of life, requiring a multidisciplinary approach.ObjectiveTo develop a set of recommendations based on the best available evidence for the early detection, diagnosis, treatment, and monitoring of adult patients with axial spondyloarthritis. Methods: A working group was established, questions were developed, outcomes were graded, and a systematic search for evidence was conducted. A multidisciplinary panel of members was established (including patient representatives), minimizing bias in relation to conflicts of interest. The GRADE approach Grading of Recommendations Assessment, Development and Evaluation was used to assess the quality of the evidence as well as the direction and strength of recommendations. In total, 11 recommendations on diagnosis (n=2), pharmacological treatment (n=6), non-pharmacological treatment (n=2) and monitoring (n=1) are presented. Results: Sacroiliac joint radiography as the first diagnostic method, and the use of disease activity scales for patient monitoring (ASDAS or BASDAI), are recommended. Nonsteroidal anti-inflammatory drugs are the first treatment option; in case of intolerance or residual pain, acetaminophen or opioids are recommended. In patients with axial involvement, it is recommended not to use conventional disease-modifying antirheumatic drugs or systemic or local glucocorticoids. In patients with failure to non-steroidal anti-inflammatory drugs, anti-TNF or anti-IL17A is recommended. In those patients presenting with anti-TNF failure, starting an anti-IL17A is recommended. Exercise, physical and occupational therapy are recommended as part of treatment. It is recommended not to use unconventional therapies as the only treatment option.(AU)

2021 clinical practice guideline for the early detection, diagnosis, treatment, and monitoring of patients with axial spondyloarthritis. Colombian Association of Rheumatology.

BACKGROUND: Axial Spondyloarthritis is a rheumatic condition affecting young patients with social and occupational consequences. Diagnosis delay is associated with functional impairment and impact on quality of life, requiring a multidisciplinary approach. OBJECTIVE: To develop a set of recommendations based on the best available evidence for early detection, diagnosis, treatment and monitoring adult patients with axial spondyloarthritis. METHODS: A working group was established, questions were developed, outcomes were graded, and a systematic search for evidence was conducted. A multidisciplinary panel of members was established (including patient representatives), minimizing bias in relation to conflicts of interest. The GRADE approach "Grading of Recommendations Assessment, Development and Evaluation" was used to assess the quality of the evidence as well as the direction and strength of recommendations. In total, 11 recommendations with regard to diagnosis (n = 2), pharmacological treatment (n = 6), non-pharmacological treatment (n = 2) and monitoring (n = 1) are presented. RESULTS: Sacroiliac joint radiography as the first diagnostic method, and the use of disease activity scales for patient monitoring (ASDAS or BASDAI), are recommended. Nonsteroidal anti-inflammatory drugs are the first treatment option; in case of intolerance or residual pain, acetaminophen or opioids are recommended. In patients with axial involvement, it is recommended not to use conventional disease-modifying antirheumatic drugs or systemic or local glucocorticoids. In patients with failure to non-steroidal anti-inflammatory drugs, anti-TNF or anti-IL17A is recommended. In those patients presenting with anti-TNF failure, starting an anti-IL17A is recommended. Exercise, physical and occupational therapy are recommended as part of treatment. It is recommended not to use unconventional therapies as the only treatment option. CONCLUSIONS: This set of recommendations provides an updated guide on the diagnosis, treatment and monitoring of patients with axial spondyloarthritis.

2021 clinical practice guidelines for the diagnosis, treatment, and follow-up of patients with peripheral spondyloarthritis. Colombian Association of Rheumatology / Guía de práctica clínica 2021 para el diagnóstico, el tratamiento y el seguimiento de pacientes con espondiloartritis periférica. Asociación Colombiana de Reumatología

ABSTRACT Background: Peripheral spondylarthritis is a chronic Inflammatory disease whose clinical presentation is related to the presence of arthritis, enthesitis and/or dactylitis. This term is used interchangeably with some of its subtypes such as psoriatic arthritis, reactive arthritis, and undifferentiated spondyloarthritis. Objective: To develop and formulate a set of specific recommendations based on the best available evidence for the diagnosis, treatment, and monitoring of adult patients with peripheral spondyloarthritis. Methods: A working group was established, clinical questions were formulated, outcomes were graded, and a systematic search for evidence was conducted. The guideline panel was multidisciplinary (including patient representatives) and balanced. Following the for mal expert consensus method, the GRADE methodology "Grading of Recommendations Assessment, Development and Evaluation" was used to assess the quality of the evidence and generate the recommendations. The clinical practice guideline includes ten recommendations related to monitoring of disease activity (n = 1) and treatment (n = 9). Results: In patients with peripheral spondyloarthritis, the use of methotrexate or sulfasalazine as the first line of treatment is suggested, and local injections of glucocorticoids are conditionally recommended. In patients with failure to cDMARDs, an anti TNFα or an anti IL17A is recommended. In case of failure to bDMARDs, it is suggested to use another bDMARD or JAK inhibitor. In patients with peripheral spondylarthritis associated with inflammatory bowel disease, it is recommended to start treatment with cDMARDs; in the absence of response, the use of an anti TNFα over an anti-IL-17 or an anti-IL-12-23 is recom mended as a second line of treatment. In patients with psoriatic arthritis, the combined use of methotrexate with a bDMARD is conditionally recommended for optimization of dosing. To assess disease activity in Psoriatic Arthritis, the use of DAPSA or MDA is suggested for patient monitoring. Conclusions: This set of recommendations provides an updated guideline on the diagnosis and treatment of peripheral spondyloarthritis.

RESUMEN Antecedentes: La espondiloartritis periférica es una patología Inflamatoria crónica cuya presentación clínica está determinada por la presencia de artritis, entesitis y/o dactilitis. Este término se utiliza indistintamente con algunos de sus subtipos como artritis psoriásica, artritis reactiva y espondiloartritis indiferenciada. Objetivo: Desarrollar y formular un conjunto de recomendaciones específicas basadas en la mejor evidencia disponible para el diagnóstico, el tratamiento y el seguimiento de pacientes adultos con espondiloartritis periférica. Métodos: Se constituyó un grupo desarrollador, se formularon preguntas clínicas, se graduaron los desenlaces y se realizó la búsqueda sistemática de la evidencia. El panel de la guía fue multidisciplinario (incluyendo representantes de los pacientes) y balanceado. Siguiendo el método de consenso formal de expertos, se utilizó la metodología GRADE (Grading of Recommendations Assessment, Development and Evaluation) para para evaluar la calidad de la evidencia y generar las recomendaciones. La guía de práctica clínica incluye 10 recomendaciones: una sobre seguimiento de la actividad de la enfermedad y nueve sobre tratamiento. Resultados: En pacientes con espondiloartritis periférica se sugiere usar metotrexato o sulfasalazina como primera línea de tratamiento y se recomienda en forma condicional la inyección local de glucocorticoides. En los pacientes que fallan a cDMARDs, se recomienda iniciar un anti TNFα o un anti IL17A. Ante falla terapéutica a la primera línea con bDMARDs, se sugiere usar otro bDMARD o un inhibidor JAK. En pacientes con espondiloartritis periférica y enfermedad inflamatoria intestinal asociada, se recomienda iniciar tratamiento con cDMARDs; en ausencia de respuesta, se recomienda el uso de un anti TNFα sobre un anti IL-17 o un anti IL-12-23 como segunda línea de tratamiento. En pacientes con artritis psoriásica se recomienda, de forma condicional, el uso combinado de metotrexato con bDMARD para favorecer la optimización de la dosis de estos. Para evaluar la actividad de la enfermedad en artritis psoriásica, se sugiere el uso del DAPSA o MDA para el seguimiento de los pacientes. Conclusiones: Este conjunto de recomendaciones proporcionan una guía actualizada sobre el diagnóstico y el tratamiento de la espondiloartritis periférica.

2021 clinical practice guidelines for the diagnosis, treatment, and follow-up of patients with peripheral spondyloarthritis. Colombian Association of Rheumatology.

BACKGROUND: Peripheral spondyloarthritis is a chronic inflammatory disease in which clinical presentation is related to the presence of arthritis, enthesitis and/or dactylitis. This term is used interchangeably with some of its subtypes such as psoriatic arthritis, reactive arthritis, and undifferentiated spondyloarthritis. OBJECTIVE: To develop and formulate a set of specific recommendations based on the best available evidence for the diagnosis, treatment and monitoring of adult patients with peripheral spondyloarthritis. METHODS: A working group was established, clinical questions were formulated, outcomes were graded, and a systematic search for evidence was conducted. The guideline panel was multidisciplinary (including patient representatives) and balanced. Following the formal expert consensus method, the GRADE methodology "Grading of Recommendations Assessment, Development and Evaluation" was used to assess the quality of the evidence and generate the recommendations. The Clinical Practice Guideline includes ten recommendations; related to monitoring of disease activity (n = 1) and treatment (n = 9). RESULTS: In patients with peripheral spondyloarthritis, the use of methotrexate or sulfasalazine as the first line of treatment is suggested, and local injections of glucocorticoids is recommended conditionally. In patients with failure to cDMARDs, an anti TNFα or an anti IL17A is recommended. In case of failure to bDMARDs, it is suggested to use another bDMARD or JAK inhibitor. In patients with peripheral spondyloarthritis associated to inflammatory bowel disease, it is recommended to start treatment with cDMARDs; in the absence of response, the use of an anti TNFα over an anti-IL-17 or an anti-IL-12-23 is recommended as a second line of treatment. In patients with psoriatic arthritis, the combined use of methotrexate with bDMARD is conditionally recommended for optimization of dosing. To assess disease activity in Psoriatic Arthritis, the use of DAPSA or MDA is suggested for patient monitoring. CONCLUSIONS: This set of recommendations provides an updated guide on the diagnosis and treatment of peripheral spondyloarthritis.

Guía de práctica clínica 2021 para el diagnóstico, el tratamiento y el seguimiento de pacientes con espondiloartritis periférica. Asociación Colombiana de Reumatología / 2021 Clinical Practice Guidelines for the Diagnosis, Treatment, and Follow-up of Patients with Peripheral Spondyloarthritis. Colombian Association of Rheumatology

Antecedentes: La espondiloartritis periférica es una patología inflamatoria crónica cuya presentación clínica está determinada por la presencia de artritis, entesitis y/o dactilitis. Este término se utiliza indistintamente con algunos de sus subtipos como artritis psoriásica, artritis reactiva y espondiloartritis indiferenciada. Objetivo: Desarrollar y formular un conjunto de recomendaciones específicas basadas en la mejor evidencia disponible para el diagnóstico, el tratamiento y el seguimiento de pacientes adultos con espondiloartritis periférica. Métodos: Se constituyó un grupo desarrollador, se formularon preguntas clínicas, se graduaron los desenlaces y se realizó la búsqueda sistemática de la evidencia. El panel de la guía fue multidisciplinario (incluyendo representantes de los pacientes) y balanceado. Siguiendo el método de consenso formal de expertos, se utilizó la metodología GRADE (Grading of Recommendations Assessment, Development and Evaluation) para para evaluar la calidad de la evidencia y generar las recomendaciones. La guía de práctica clínica incluye 10 recomendaciones: una sobre seguimiento de la actividad de la enfermedad y nueve sobre tratamiento. Resultados: En pacientes con espondiloartritis periférica se sugiere usar metotrexato o sulfasalazina como primera línea de tratamiento y se recomienda en forma condicional la inyección local de glucocorticoides. En los pacientes que fallan a cDMARDs, se recomienda iniciar un anti TNFα o un anti IL17A. Ante falla terapéutica a la primera línea con bDMARDs, se sugiere usar otro bDMARD o un inhibidor JAK. En pacientes con espondiloartritis periférica y enfermedad inflamatoria intestinal asociada, se recomienda iniciar tratamiento con cDMARDs; en ausencia de respuesta, se recomienda el uso de un anti TNFα sobre un anti IL-17 o un anti IL-12-23 como segunda línea de tratamiento.(AU)

Background: Peripheral spondyloarthritis is a chronic inflammatory disease whose clinical presentation is related to the presence of arthritis, enthesitis and/or dactylitis. This term is used interchangeably with some of its subtypes such as psoriatic arthritis, reactive arthritis, and undifferentiated spondyloarthritis. Objective: To develop and formulate a set of specific recommendations based on the best available evidence for the diagnosis, treatment, and monitoring of adult patients with peripheral spondyloarthritis. Methods: A working group was established, clinical questions were formulated, outcomes were graded, and a systematic search for evidence was conducted. The guideline panel was multidisciplinary (including patient representatives) and balanced. Following the formal expert consensus method, the GRADE methodology “Grading of Recommendations Assessment, Development and Evaluation” was used to assess the quality of the evidence and generate the recommendations. The clinical practice guideline includes ten recommendations related to monitoring of disease activity (n=1) and treatment (n=9). Results: In patients with peripheral spondyloarthritis, the use of methotrexate or sulfasalazine as the first line of treatment is suggested, and local injections of glucocorticoids are conditionally recommended. In patients with failure to cDMARDs, an anti TNFα or an anti IL17A is recommended. In case of failure to bDMARDs, it is suggested to use another bDMARD or JAK inhibitor. In patients with peripheral spondyloarthritis associated with inflammatory bowel disease, it is recommended to start treatment with cDMARDs; in the absence of response, the use of an anti TNFα over an anti-IL-17 or an anti-IL-12-23 is recommended as a second line of treatment. In patients with psoriatic arthritis, the combined use of methotrexate with a bDMARD is conditionally recommended for optimization of dosing.(AU)

Valores de referencia de la densidad mineral ósea por densitometría tipo DXA en una población adulta sana de Bogotá / Bone mineral density reference values by densitometry (DXA) in a healthy adult population of Bogota

RESUMEN Introducción: La actual definición de osteoporosis es basada en la absorciometría de energía dual de Rx (DXA, por sus siglas en inglés), lo cual representa la principal técnica para la cuantificación de la densidad mineral ósea (DMO) y la evaluación del riesgo de fractura. El objetivo de este estudio fue determinar la DMO en columna lumbar y cuello femoral de adultos sanos desde el punto de vista metabólico óseo en una población de Bogotá-Colombia. Métodos: Se realizó un estudio observacional, analítico, de corte transversal, basado en un cuestionario aplicado a la población de estudio. Las medidas densitométricas fueron realizadas con un equipo compacto de alto rendimiento de la General Electric, modelo iDXA, por el mismo tecnólogo en los sitios esqueléticos de interés, columna lumbar L1, L2, L3, L4 y L1-4 en proyección anteroposterior y en cuello femoral. El cálculo del tamaño de muestra se realizó teniendo en cuenta la estratificación por sexo y 2 grupos de edad: 20 a 29 años y 30 a 39 años. Se encuestó a 805 individuos y 432 se realizaron la densitometría ósea. Resultados: Los valores encontrados en columna lumbar para cada uno de los grupos de nuestra población, fueron: 1,150 g/cm2 (DE: 0,11), 1,180 g/cm2 (DE: 0,10), para mujeres y hombres de 20 a 29 años, y 1,169 g/cm2 (DE: 0,10), 1,209 g/cm2 (DE: 0,10) para mujeres y hombres de 30 a 39 años, respectivamente. A nivel del cuello femoral, 0,991 g/cm2 (DE: 0,10), 1,119 g/cm2 (DE: 0,13), para mujeres y hombres de 20 a 29 años, y 0,970 g/cm2 (DE: 0,11), 1,079 g/cm2 (DE: 0,13) para mujeres y hombres de 30 a 39 años, respectivamente. Conclusión: Este estudio pudo demostrar el comportamiento de la DMO en nuestra población, la cual es inferior a la detectada en otras latitudes y a las utilizadas como valores de referencia en nuestros equipos. Adicionalmente, se determinó el valor máximo de masa ósea en cada una de las regiones de interés para los rangos de edad de la población de nuestro estudio.

ABSTRACT Introduction: The current definition of osteoporosis is based on the dual energy X-ray absorptiometry (DXA), which represents the main technique for the quantification of bone mineral density (BMD) and the evaluation of fracture risk. The objective of this study was to determine the BMD in the lumbar spine and femoral neck of healthy adults from a bone metabolism point of view in a population of Bogotá-Colombia. Method: An observational, analytical, cross-sectional study was conducted based on a questionnaire completed by the study population. The densitometric measurements were carried out using a high-performance compact equipment of the General Electric, iDXA model, by the same technologist at the skeletal sites of interest, lumbar spine L1, L2, L3, L4 and L1-4 in anteroposterior projection, and in femoral neck. The sample size calculation was performed taking into account stratification by gender and 2 age groups: 20 to 29 years, and 30 to 39 years. A total of 805 individuals were surveyed, and 432 bone densitometries were performed. Results: The values found in the lumbar spine for each of the groups in our population were: 1.150 g/cm2 (SD: 0.11), 1.180 g/cm2 (SD: 0.10), for women and men aged 20 to 29 years, and 1.169 g/cm2 (SD: 0.10), 1.209 g/cm2 (SD: 0.10) for women and men aged 30 to 39, respectively. At the level of the femoral neck, 0.991 g/cm2 (SD: 0.10), 1.119 g/cm2 (SD: 0.13), for women and men aged 20 to 29 years, respectively, and 0.970 g/cm2 (SD: 0.11), 1.079 g/cm2 (SD: 0.13) for women and men aged 30 to 39, respectively. Conclusion: This study was able to demonstrate the behaviour of BMD in our population, which is lower than that detected in other latitudes and those used as reference values in our equipment. Additionally, the maximum bone mass value was determined in each of the locations of interest for the age ranges of the population in our study.

Recomendaciones sobre el manejo de pacientes adultos con enfermedades reumáticas en el contexto de la infección por SARS-CoV-2/COVID-19. Asociación Colombiana de Reumatología / Recommendations on the management of adult patients with rheumatic diseases in the context of SARS-CoV-2/COVID-19 infection. Colombian Association of Rheumatology

OBJETIVO: Generar las recomendaciones para la atención de pacientes con enfermedades reumáticas que reciben terapias inmunomoduladoras e inmunosupresoras (fármacos convencionales, biológicos y moléculas pequeñas) durante la pandemia por COVID-19. MATERIALES Y MÉTODOS: Las recomendaciones se realizaron utilizando el método Delphi como herramienta de acuerdo. Se conformó un panel de expertos con trayectoria académica y experiencia en investigación en reumatología. Se realizó la búsqueda de la literatura y se generó el cuestionario del ejercicio Delphi conformado por 42 preguntas. El grado de acuerdo se logró con el 80% de aprobación de los participantes. RESULTADOS: Se conformó un grupo de 11 reumatólogos de 7 ciudades del país. La tasa de respuesta fue del 100% para las 3 rondas de consulta. En la primera ronda se logró acuerdo en 35 preguntas, en la segunda ronda 37 y en la tercera ronda se logró el acuerdo de las 42 preguntas. CONCLUSIÓN: La recomendación para la mayoría de los tratamientos inmunomoduladores utilizados en reumatología es continuar con las terapias en pacientes que no tengan la infección y suspenderlas en aquellos con diagnóstico de SARS-CoV-2/COVID-19

OBJECTIVE: To produce recommendations for patients with rheumatological diseases receiving immunomodulatory and immunosuppressive therapies (conventional drugs, biologicals, and small molecules) during the COVID-19 pandemic. MATERIALS AND METHODS: The recommendations were determined using the Delphi method as an agreement tool. A panel of experts was formed, with academic backgrounds and research experience in rheumatology. A literature search was conducted and 42 questions were generated. The level of agreement was made with 80% of approval by the participants. RESULTS: A group of eleven rheumatologists from 7 cities in the country participated. The response rate was 100% for the three consultation rounds. In the first round, agreement was reached on 35 questions, on 37 in the second round, and on 42 questions in the third round. CONCLUSION: The recommendation for the majority of the pharmacological treatments used in rheumatology is to continue with immunomodulatory or immunosuppressive therapies in patients who do not have the infection, and to suspend it in patients with a diagnosis of SARS-CoV-2/COVID-19

Recomendaciones sobre el manejo de pacientes adultos con enfermedades reumáticas en el contexto de la infección por SARS-CoV-2/COVID-19. Asociación Colombiana de Reumatología / Recommendations on the management of adult patients with rheumatic diseases in the context of SARS-CoV-2/COVID-19 infection. Colombian Association of Rheumatology

RESUMEN Objetivo: Generar las recomendaciones para la atención de pacientes con enfermedades reumáticas que reciben terapias inmunomoduladoras e inmunosupresoras (fármacos convencionales, biológicos y moléculas pequeñas) durante la pandemia por COVID-19. Materiales y métodos: Las recomendaciones se realizaron utilizando el método Delphi como herramienta de acuerdo. Se conformó un panel de expertos con trayectoria académica y experiencia en investigación en reumatología. Se realizó la búsqueda de la literatura y se generó el cuestionario del ejercicio Delphi conformado por 42 preguntas. El grado de acuerdo se logró con el 80% de aprobación de los participantes. Resultados: Se conformó un grupo de 11 reumatólogos de 7 ciudades del país. La tasa de respuesta fue del 100% para las 3 rondas de consulta. En la primera ronda se logró acuerdo en 35 preguntas, en la segunda ronda 37 y en la tercera ronda se logró el acuerdo de las 42 preguntas. Conclusión: La recomendación para la mayoría de los tratamientos inmunomoduladores utilizados en reumatología es continuar con las terapias en pacientes que no tengan la infección y suspenderlas en aquellos con diagnóstico de SARS-CoV-2/COVID-19.

ABSTRACT Objective: To produce recommendations for patients with rheumatological diseases receiving immunomodulatory and immunosuppressive therapies (conventional drugs, biologicals, and small molecules) during the COVID-19 pandemic. Materials and methods: The recommendations were determined using the Delphi method as an agreement tool. A panel of experts was formed, with academic backgrounds and research experience in rheumatology. A literature search was conducted and 42 questions were generated. The level of agreement was made with 80% of approval by the participants. Results: A group of eleven rheumatologists from 7 cities in the country participated. The response rate was 100% for the three consultation rounds. In the first round, agreement was reached on 35 questions, on 37 in the second round, and on 42 questions in the third round. Conclusion: The recommendation for the majority of the pharmacological treatments used in rheumatology is to continue with immunomodulatory or immunosuppressive therapies in patients who do not have the infection, and to suspend it in patients with a diagnosis of SARS-CoV-2/COVID-19.

Recommendations on the management of adult patients with rheumatic diseases in the context of SARS-CoV-2/COVID-19 infection. Colombian Association of Rheumatology. / Recomendaciones sobre el manejo de pacientes adultos con enfermedades reumáticas en el contexto de la infección por SARS-CoV-2/COVID-19. Asociación Colombiana de Reumatología.

OBJECTIVE: To produce recommendations for patients with rheumatological diseases receiving immunomodulatory and immunosuppressive therapies (conventional drugs, biologicals, and small molecules) during the COVID-19 pandemic. MATERIALS AND METHODS: The recommendations were determined using the Delphi method as an agreement tool. A panel of experts was formed, with academic backgrounds and research experience in rheumatology. A literature search was conducted and 42 questions were generated. The level of agreement was made with 80% of approval by the participants. RESULTS: A group of eleven rheumatologists from 7 cities in the country participated. The response rate was 100% for the three consultation rounds. In the first round, agreement was reached on 35 questions, on 37 in the second round, and on 42 questions in the third round. CONCLUSION: The recommendation for the majority of the pharmacological treatments used in rheumatology is to continue with immunomodulatory or immunosuppressive therapies in patients who do not have the infection, and to suspend it in patients with a diagnosis of SARS-CoV-2/COVID-19.

Colombian Association of Rheumatology. Consensus on recommendations to decrease and discontinue biological therapy in patients with rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis / Asociación Colombiana de Reumatología. Consenso sobre recomendaciones para disminución y descontinuación de la terapia biológica en pacientes con artritis reumatoide, espondilitis anquilosante y artritis psoriásica

A B S T R A C T Objective: The objective of this study was to establish recommendations for the reduction and discontinuation of biological disease-modifying antirheumatic drugs, with the aim of becoming a guide document for health professionals involved in the management of patients with rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis. Materials and methods: The recommendations were established through consensus by a panel of experts in rheumatology, and based on the analysis of available scientific evidence obtained from systematic reviews and the clinical experience of the panellists. Results: A total of 33 rheumatoid arthritis related studies were included, with 6 psoriatic arthritis related, and 9 ankylosing Spondylitis related. The recommendations for the reduction of biological therapies were made by establishing a plan to determine when and how to reduce the biological disease-modifying antirheumatic drugs in patients with these 3 diseases, and in some cases lead to the discontinuation of these treatments. Conclusion: The recommendations established in this document will serve as a guide to improve the efficiency of biological therapy in these diseases, reduce the variability in clinical practice, and establish an adequate risk/benefit ratio.

RESUMEN Objetivo: El objetivo de este estudio fue establecer recomendaciones para la disminución y descontinuación de la terapia biológica con el fin de que se convierta en un documento guía para los profesionales de la salud involucrados en el manejo de pacientes con artritis reumatoide, espondilitis anquilosante y artritis psoriásica. Materiales y métodos: Las recomendaciones fueron establecidas mediante consenso desarrollado a través de un panel de expertos en reumatología, basado en el análisis de la evidencia científica disponible obtenida de revisiones sistemáticas y sobre la experiencia clínica de los panelistas. Resultados: Se incluyeron 33 estudios relacionados con artritis reumatoide, 6 de artritis psoriásica y 9 de espondilitis anquilosante. Las recomendaciones para la disminución de las terapias biológicas se realizaron estableciendo un plan para determinar cuándo y cómo reducir los fármacos biológicos modificadores de enfermedades reumáticas en pacientes con estas 3 enfermedades y en algunos casos conducir a la descontinuación de estos tratamientos. Conclusión: Las recomendaciones establecidas en este documento servirán de guía para mejorar la eficiencia de la terapia biológica en estas enfermedades, reducir la variabilidad en la práctica clínica y establecer de manera adecuada una relación riesgo/beneficio.

Biosimilars: An Approach to some Current Worldwide Regulation Frameworks.

Developing new biologics has led to regulations and norms aimed at guaranteeing their safety, quality and effectiveness, in terms of marketing, prescription, use, interchangeability and switching. Biologics are of great importance in treating patients suffering from rheumatic, autoimmune, inflammatory and neoplastic diseases. The expiry/lapse of reference biologics or originators' patents has meant that developing biosimilars involves accompanying legal requirements for their approval in countries worldwide. This paper has thus approached the situation of biosimilar regulation worldwide, the pertinent technical concepts and regulatory differences in some countries of interest.

Label-Free Quantification of Anti-TNF-α in Patients Treated with Adalimumab Using an Optical Biosensor.

This study describes the development of an immunosensory label-free quantification methodology based on surface plasmon resonance (SPR) and its applicability in measuring/evaluating therapeutic drug monitoring (TDM) of anti-TNF-α monoclonal antibody (adalimumab) in rheumatoid arthritis (RA) patients. The experimental parameters evaluated in this study were immobilising ligands by pre-concentration assays, sensor surface regeneration, ascertaining the method's sensitivity and correlating the results from quantifying plasma samples by ELISA immunoassay. The results showed that TNF-α quantification values (in RU) were significantly different when comparing patients (~50-250 RU) to controls (~10-20 RU). Likewise, there was 0.97 correlation for patients and 0.91 for healthy volunteers using SPR and ELISA comparison methodologies. SPR immunosensory detection provided a precise, sensitive strategy, along with real-time determination, for quantifying adalimumab, having great potential for clinical routine regarding TDM.

Risk factors associated with pulmonary arterial hypertension in Colombian patients with systemic sclerosis: review of the literature.

OBJECTIVE: Considering the significant morbidity and mortality of pulmonary arterial hypertension (PAH) in patients with systemic sclerosis (SSc) and the lack of precise information on disease in Latin America, we investigated the clinical and laboratory characteristics associated with PAH in Colombian patients with SSc and review the literature. METHODS: This multicenter study included patients followed at 5 rheumatology units that were systematically assessed using a pretested questionnaire on clinical and immunological variables, focusing on PAH. Conditional logistic regression was employed to assess association between PAH and specific clinical characteristics. A systematic review of the literature was performed through electronic databases. RESULTS: Of a total of 349 patients with SSc, 61 (17%) met the criteria for PAH. Pulmonary fibrosis [adjusted odds ratio (AOR) 7.37, 95% CI 3.67-14.81, p < 0.0001], microstomia (AOR 3.3, 95% CI 1.70-6.28, p < 0.0001), gastroesophageal reflux (AOR 2.41, 95% CI 1.31-4.43, p = 0.005), dysphagia (AOR 2.7, 95% CI 1.49-4.77, p = 0.001), hyperpigmentation (AOR 2.15, 95% CI 1.11-4.16, p = 0.02), and hypopigmentation (AOR 2.4, 95% CI 1.26-4.64, p = 0.008) were the most prevalent clinical characteristics associated with PAH, while anemia (AOR 5.4, 95% CI 1.98-14.93, p = 0.001) was observed as the unique laboratory risk factor. Association between subtypes of SSc and PAH was not observed. Significant differences in both clinical and laboratory data were observed among different series. CONCLUSION: PAH may be a frequent complication of SSc in the Colombian population regardless of disease subtype. The identified clinical and laboratory risk factors might assist earlier diagnosis and guide decisions on therapeutic interventions on this critical complication of SSc. The reasons underlying the reported divergences among patients from different ethnicities are not fully understood, but it is most likely that both genetic and environmental factors are responsible for them.

Development and validation of a simple tape-based measurement tool for recording cervical rotation in patients with ankylosing spondylitis: comparison with a goniometer-based approach.

OBJECTIVE: To compare a tape-based tool for measuring cervical mobility in patients with ankylosing spondylitis (AS) with the widely practiced goniometer-based approach. METHODS: We developed a novel tape-based approach to measurement of lateral cervical rotation of the neck that is minimally affected by flexion/extension movements of the neck. This requires measurement of the difference between a mark at the suprasternal notch and the tragus of the ear. Rotation score is measured in centimeters and constitutes the difference in length between the 2 extremes of cervical rotation (http://www.arthritisdoctors.org/researcher.html). We assessed the tape-based and goniometer-based methods in a total of 263 patients from 3 countries, Canada (n = 205), Australia (n = 29), and Colombia (n = 29), that included patients from community and tertiary-based practice. Intra- and interobserver reliability was assessed in a subset of 44 patients by ANOVA and a 2-way mixed effects model. The Bath AS Disease Activity (BASDAI) and Function (BASFI) Indices, and the modified Stoke AS Spinal Score (mSASSS), were also recorded to assess construct validity by correlation coefficient and regression analysis. Responsiveness was assessed in a subset of 33 patients that were either randomized to anti-tumor necrosis factor-a therapy:placebo (n = 22) or received open label infliximab (n = 4) or pamidronate (n = 7) over a period of 24 weeks. RESULTS: Scores obtained with the tape-based method were normally distributed, while those obtained using the goniometer were skewed towards normal values. Reliability for the goniometer-based approach was excellent [intraclass correlation coefficient (ICC) > 0.90] and very good for the tape-based approach (ICC > 0.80). Significant correlations were noted between age, disease duration, function and structural damage scores, and scores obtained with both methods. Responsiveness was high using raw scores obtained with the goniometer (standardized response mean > 0.80) but was not evident when the grading scheme proposed for the Bath AS Metrology Index (BASMI) was employed. CONCLUSION: The tape-based approach we describe provides a simple, feasible, and reliable index of cervical rotation that is comparable to the information obtained from the use of a goniometer. If the goniometer-based approach is used, raw scores should be used in the calculation of responsiveness rather than the grading scheme suggested in the BASMI.

Development and validation of the Edmonton Ankylosing Spondylitis Metrology Index.

OBJECTIVE: Assessment of spinal and hip mobility has been recommended by the Assessments in Ankylosing Spondylitis (AS) Working Group for clinical trials and record keeping, although suggested measures primarily reflect structural damage. Our objective was to validate a simple, 4-item composite measure of spinal and hip mobility, the Edmonton AS Metrology Index (EDASMI). METHODS: We assessed the EDASMI and the Bath AS Metrology Index (BASMI) using a total of 263 patients from 3 countries: Canada (n = 205), Australia (n = 29), and Colombia (n = 29). Intra- and interobserver reliability were assessed in a subset of 44 patients. Construct validity with respect to disease activity (Bath AS Disease Activity Index [BASDAI]), function (Bath AS Functional Index [BASFI]), and structural damage (modified Stoke AS Spinal Score [mSASSS]) was analyzed using correlation and hierarchical regression. Responsiveness was assessed in a subset of 33 patients who received either anti-tumor necrosis factor alpha therapy (n = 26) or pamidronate (n = 7) over 24 weeks. RESULTS: In contrast to the EDASMI, BASMI scores covered a limited range, with 70% of patients demonstrating a score < or =3 (range 0-10) and 4 of 5 individual measures demonstrating substantial floor effects. Both measures were highly reliable (intraclass correlation coefficient >0.90) and demonstrated similar construct validity (EDASMI correlated with disease duration [0.52], BASDAI [0.24], BASFI [0.61], Bath Ankylosing Spondylitis Radiology Index [0.79], mSASSS [0.75]; P < 0.001 for all). The change in EDASMI score was significant after 24 weeks of therapy (standardized response mean 0.40; P = 0.03), but change in the BASMI was not significant. CONCLUSION: The EDASMI is a simple, rapid, and reliable tool for the assessment of spinal mobility in AS that is responsive to therapeutic intervention.