ABSTRACT
INTRODUCTION: Inflammatory rheumatic diseases usually affect women of childbearing age treated with biologic drugs. However, there is a lack of literature on the efficacy and toxicity of biologic disease-modifying drugs during pregnancy. The aim of this study was to determine the presence of pregnant patients treated with bDMARDs in a real-world dataset and to examine the impact of pregnancy and lactation on the evolution of rheumatic disease in a registry of Spanish patients. METHOD: This was a multicentre prospective study with a real-world setting. Information was obtained from BIOBADASER registry. Patients included are women who got pregnant until November 2020 from 19 rheumatology units. We conducted proportions, means, and standard deviations (SD) to describe the study population and the use of treatments. T-test and Chi-square test were applied to assess differences between groups. RESULT: Ninety cases of pregnancy were registered (n=68 full-term pregnancies; n=22 spontaneous miscarriages). Most of the cases discontinued bDMARDs during pregnancy (78.9%) but 13 cases continued treatment during pregnancy, mainly using certolizumab pegol. These cases were obtaining better management of rheumatic disease, although the differences were not statistically significant [DAS28-CRP, 2.9 (SD: 1.6) vs. 2.0 (1.2), p=.255; DAS28-ESR, 2.2 (1.0) vs. 1.7 (.5), p=.266]. No serious adverse events were reported during pregnancy and lactation. CONCLUSION: Being pregnant is still an uncommon condition in patients with rheumatic diseases and using bDMARDs. Our results show that rheumatic disease tended to progress better during pregnancy in patients who continued to take bDMARDs.
Subject(s)
Biological Products , Rheumatic Diseases , Rheumatology , Pregnancy , Humans , Female , Male , Prospective Studies , Rheumatic Diseases/drug therapy , RegistriesABSTRACT
Introduction: Inflammatory rheumatic diseases usually affect women of childbearing age treated with biologic drugs. However, there is a lack of literature on the efficacy and toxicity of biologic disease-modifying drugs during pregnancy. The aim of this study was to determine the presence of pregnant patients treated with bDMARDs in a real-world dataset and to examine the impact of pregnancy and lactation on the evolution of rheumatic disease in a registry of Spanish patients.Method: This was a multicentre prospective study with a real-world setting. Information was obtained from BIOBADASER registry. Patients included are women who got pregnant until November 2020 from 19 rheumatology units. We conducted proportions, means, and standard deviations (SD) to describe the study population and the use of treatments. T-test and Chi-square test were applied to assess differences between groups.Result: Ninety cases of pregnancy were registered (n=68 full-term pregnancies; n=22 spontaneous miscarriages). Most of the cases discontinued bDMARDs during pregnancy (78.9%) but 13 cases continued treatment during pregnancy, mainly using certolizumab pegol. These cases were obtaining better management of rheumatic disease, although the differences were not statistically significant [DAS28-CRP, 2.9 (SD: 1.6) vs. 2.0 (1.2), p=.255; DAS28-ESR, 2.2 (1.0) vs. 1.7 (.5), p=.266]. No serious adverse events were reported during pregnancy and lactation.Conclusion: Being pregnant is still an uncommon condition in patients with rheumatic diseases and using bDMARDs. Our results show that rheumatic disease tended to progress better during pregnancy in patients who continued to take bDMARDs.(AU)
Introducción: Las enfermedades reumáticas inflamatorias afectan normalmente a mujeres en edad fértil tratadas con fármacos biológicos. Sin embargo, escasea la literatura sobre la eficacia y la toxicidad de los fármacos modificadores de la enfermedad (FAME) biológicos durante el embarazo. El objetivo de este estudio fue determinar la presencia de pacientes embarazadas tratadas con FAME biológicos en un conjunto de datos del mundo real y examinar el impacto del embarazo y la lactancia en la evolución de la enfermedad reumática en un registro de pacientes españoles.Método: Estudio prospectivo multicéntrico en un entorno del mundo real. La información se obtuvo del registro BIOBADASER. Los pacientes fueron mujeres embarazadas hasta el mes de noviembre del 2020, de 19 unidades de Rreumatología. Obtuvimos proporciones, medias y desviaciones estándar (DE) para describir la población de estudio y el uso de tratamientos. Se realizaron las pruebas t y χ2 para evaluar las diferencias entre grupos.Resultado:Se registraron 90 casos de embarazo (n=68 embarazos a término; n=22 abortos espontáneos). La mayoría de los casos suspendieron el tratamiento con FAME biológicos durante el embarazo (78,9%), pero 13 casos prosiguieron el tratamiento durante el embarazo, utilizando principalmente certolizumab pegol. Dichos casos obtuvieron un mejor manejo de la enfermedad reumática, aunque las diferencias no fueron estadísticamente significativas (DAS28-CRP, 2,9 [DE 1,6] vs. 2 [1,2], p=0,255; DAS28-ESR, 2,2 [1] vs. 1,7 [0,5], p=0,266). No se reportaron episodios adversos graves durante el embarazo y la lactancia.Conclusión: La situación de embarazo sigue siendo infrecuente en las pacientes con enfermedades reumáticas que utilizan FAME biológicos. Nuestros resultados reflejan que la enfermedad reumática tendió a progresar mejor durante el embarazo en las mujeres tratadas con FAME biológicos.(AU)
Subject(s)
Humans , Female , Pregnancy , Rheumatic Diseases/complications , Pregnancy Complications , Certolizumab Pegol , Antirheumatic Agents/toxicity , Biological Products/toxicity , Rheumatology , Rheumatic Diseases/drug therapy , Prospective Studies , Lactation , Abortion , Antirheumatic Agents/therapeutic use , Biological Products/therapeutic useABSTRACT
This is the first report comparing EULAR and national treatment recommendations for PsA patients across Europe, and the first this decade to compare ASAS-EULAR and national treatment recommendations in axSpA patients. An electronic survey was completed from October 2021-April 2022 by rheumatologists in 15 European countries. One and four countries followed all EULAR and ASAS-EULAR recommendations, respectively. Five countries had no national treatment recommendations for PsA and/or axSpA, but followed other regulations. In several countries, national treatment recommendations predated the most recent EULAR/ASAS-EULAR recommendations. Entry criteria for starting biologic/targeted synthetic disease-modifying anti-rheumatic drugs varied considerably. In several countries, for PsA patients with significant skin involvement, interleukin-17 inhibitors were not given preference. The positioning of Janus Kinase inhibitors differed and Phosphodiesterase-4 inhibitors were not in use/reimbursed in most countries. This study may motivate European countries to update their national treatment recommendations, to align them better with the latest international recommendations.
ABSTRACT
Objetivo Valorar las diferencias de respuesta al tratamiento mediante DAS28 calculado mediante velocidad de sedimentación globular (VSG) y proteína C reactiva teniendo en cuenta el género del paciente y analizar el comportamiento individual de cada uno de sus componentes en una cohorte de pacientes de artritis precoz en el área 2 de la Comunidad de Madrid. Pacientes y métodos Se estudiaron un total de 134 pacientes (77,6% mujeres) que cumplían criterios del Colegio Americano de Reumatología para el diagnóstico de artritis reumatoide del registro de artritis precoz del Hospital de La Princesa. En dicho registro se realizaron 4 visitas protocolizadas en las que se recogen de forma sistemática los datos necesarios para calcular el DAS28 con VSG y proteína C reactiva, así como el tratamiento prescrito a los pacientes. Se analizaron las diferencias por género en la respuesta al tratamiento mediante ambos índices compuestos, así como de las variables que los componen y la valoración de la enfermedad por el médico. Resultados Las mujeres presentaron mayor actividad de la enfermedad y discapacidad al inicio del seguimiento. A pesar de que estas recibieron un tratamiento más intenso, su valor promedio de DAS28 no llegó a igualarse con el de los hombres a lo largo del seguimiento. Por el contrario, la valoración de la enfermedad por parte del paciente y del médico sí llegó a igualarse. Al analizar los componentes del DAS28 por separado, se observó que esta discordancia era debida principalmente a las variables VSG y recuento de articulaciones dolorosas. Conclusiones La VSG y el recuento de articulaciones dolorosas causan un sesgo en la evaluación de la actividad de la artritis reumatoide con el DAS28 que puede afectar a la evaluación de la respuesta al tratamiento (AU)
Objective To evaluate the differences between the responses to treatment using DAS28 based on erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) in male and female patients. We then analyzed the individual behaviour of each component in a cohort of early arthritis patients in zone 2 of Madrid. Patients and methods We studied a total of 134 patients (77.6% women) who met the American College of Rheumatology (ACR) criteria for the diagnosis of rheumatoid arthritis (RA) belonging to an early arthritis register of the Hospital de La Princesa. We performed 4 visits following a standardized protocol which included necessary variables to calculate the DAS28 with ESR and CRP as well as determining the treatment received by the patients. We analyzed the differences in responses to treatment in males and females using both indexes, as well as their component and the assessment of the disease by the physician. Results Women had higher disease activity and disability at baseline. Although they received more intensive treatment, their average value of DAS28 remained significantly higher compared to men during the follow-up. By contrast, the global disease assessment evaluated by the patient and by the physician remained similar in both gender. When we analyze the DAS28 components separately, it was observed that this discrepancy was due mainly to the tender joints count and the ESR. Conclusions Women with early RA have higher DAS28ESR scores as a result of higher tender joint counts and ESR. This may represent bias when assessing the response to treatment using the DAS28ESR (AU)
Subject(s)
Humans , Male , Female , Cohort Studies , Arthritis, Rheumatoid/diagnosis , Arthritis, Rheumatoid/therapy , Gender and Health , C-Reactive Protein/analysis , Joints/pathologyABSTRACT
La radiografía convencional es una herramienta de gran importancia para evaluar a los pacientes con espondiloartropatías. No sólo es necesario valorar la eficacia de los distintos tratamientos, sino también reflejar la historia de la enfermedad, mantener un registro evolutivo del proceso de destrucción, evaluar la extensión de la afección y cuantificar el daño. Disponemos de tres métodos que han sido diseñados específicamente para valorar el daño estructural en la espondilitis anquilosante: el BASRI (Bath Ankylosing Spondylitis Radiology Index), el SASSS (Stoke Ankylosing Spondylitis Spine Score) y la modificación de éste. Este monográfico pretende realizar una descripción detallada de cada uno de estos métodos y exponer las ventajas e inconvenientes de utilizarlos (AU)
Conventional radiology is a very important tool used to evaluate patients with spondyloarthropathies. It is necessary not only to evaluate the efficacy of the different treatments but also to reflect the history of the disease, maintaining a registry of the progression of the destructive process, evaluating the affection and quantifying the damage. We have at our disposal three methods specifically designed for the evaluation of structural damage in SA: the BSARI (Bath Ankylosing Spondylitis Radiology Index), the SASSS (Stoke Ankylosing Spondylitis Spine Score) and a modification of the latter. This review intends to perform a detailed description of each one of these methods and expose the advantages and disadvantages of their use (AU)
Subject(s)
Humans , Spondylarthropathies , Spondylitis, Ankylosing , Radiography/methods , Sacroiliitis , SpondylarthritisABSTRACT
OBJECTIVE: To evaluate the differences between the responses to treatment using DAS28 based on erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) in male and female patients. We then analyzed the individual behaviour of each component in a cohort of early arthritis patients in zone 2 of Madrid. PATIENTS AND METHODS: We studied a total of 134 patients (77.6% women) who met the American College of Rheumatology (ACR) criteria for the diagnosis of rheumatoid arthritis (RA) belonging to an early arthritis register of the Hospital de La Princesa. We performed 4 visits following a standardized protocol which included necessary variables to calculate the DAS28 with ESR and CRP as well as determining the treatment received by the patients. We analyzed the differences in responses to treatment in males and females using both indexes, as well as their component and the assessment of the disease by the physician. RESULTS: Women had higher disease activity and disability at baseline. Although they received more intensive treatment, their average value of DAS28 remained significantly higher compared to men during the follow-up. By contrast, the global disease assessment evaluated by the patient and by the physician remained similar in both gender. When we analyze the DAS28 components separately, it was observed that this discrepancy was due mainly to the tender joints count and the ESR. CONCLUSIONS: Women with early RA have higher DAS28ESR scores as a result of higher tender joint counts and ESR. This may represent bias when assessing the response to treatment using the DAS28ESR.
ABSTRACT
Conventional radiology is a very important tool used to evaluate patients with spondyloarthropathies. It is necessary not only to evaluate the efficacy of the different treatments but also to reflect the history of the disease, maintaining a registry of the progression of the destructive process, evaluating the affection and quantifying the damage. We have at our disposal three methods specifically designed for the evaluation of structural damage in SA: the BSARI (Bath Ankylosing Spondylitis Radiology Index), the SASSS (Stoke Ankylosing Spondylitis Spine Score) and a modification of the latter. This review intends to perform a detailed description of each one of these methods and expose the advantages and disadvantages of their use.
