Safety and effectiveness of bDMARDs during pregnancy in patients with rheumatic diseases: Real-world data from the BIOBADASER registry.

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.

Safety and effectiveness of bDMARDs during pregnancy in patients with rheumatic diseases: Real-world data from the BIOBADASER registry / Seguridad y efectividad de los FAME biológicos durante el embarazo en pacientes con enfermedades reumáticas: datos del mundo real procedentes del registro BIOBADASER

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)

Validez y utilidad de la ecografía en el síndrome del túnel carpiano / Validity and usefulness of echography in the carpal tunnel syndrome

Objetivo: Evaluar la validez y la utilidad de la ecografía en el síndrome del túnel carpiano (STC). Material y método: Estudio ecográfico ciego y prospectivo en 75 carpos de 42 pacientes consecutivos con sospecha de STC. Se utiliza la electromiografía (EMG) como prueba de referencia. Se miden distintos parámetros ecográficos y mediante curvas ROC se estiman las probabilidades tras la prueba para los diferentes cortes del área de sección transversal del mediano (AST). Se analiza la fiabilidad entre explorador y lector con tres exploradores diferentes y dos lectores. Finalmente se efectúa un estudio de costes y de satisfacción del paciente. Resultados: Las medias de los parámetros ecográficos son significativamente mayores en el grupo con STC. Hay una alta concordancia entre la ecografía y la conducción nerviosa. Un punto de corte del AST en 9,5 mm2 clasifica correctamente el 83% de los casos (sensibilidad del 88% y especificidad del 67%). Un punto de corte mayor de 14 mm2 o menor de 7 mm2 tiene una probabilidad tras la prueba para el STC del 100% de especificidad y sensibilidad respectivamente. Los coeficientes de correlación intraclase (ICC) entre observadores fueron 0,915-0,980, y entre lectores, 0,912-0,987. La ecografía puede resultar más económica y ahorrar en el estudio 3.217,59 euros (42,9 euros por muñeca sintomática). El malestar percibido por los pacientes fue significativamente menor: EVA, 6,3 con ecografía frente a 56 con el EMG (p < 0,0005). Conclusiones: La ecografía es fiable y válida para definir si hay o no STC. La ecografía como prueba de primera línea es coste-efectiva y más satisfactoria para los pacientes (AU)

Objective: To evaluate the accuracy and utility of ultrasonography for the diagnosis of carpal tunnel syndrome (CTS). Material and method: Prospective and blind study of 75 wrists in 42 consecutive patients with suspected CTS. Electrodiagnostic testing (EDT) was used as gold standard. We measure different ultrasonographic parameters and based on a fitted receiver operating characteristic curve, we estimated post-test probabilities for the proximal, middle and distal cross-sectional area of median nerve. We analyzed interobserver and interreader reliability by 3 different explorers and 2 different readers, cost and the patient discomfort. Results: Mean ultrasound measurements were significantly higher in the EDT positive group. There was a high concordance between sonography and nerve conduction. A cut-off of 9.5 mm2 resulted in the correct classification of 83% of cases (sensitivity 88% and specificity 67%). Conversely, a cut-off of >14 mm2 or <7 mm2 had excellent power to rule in CTS, with a post-test probability of 100% of specificity and sensitivity respectively. The interobserver acquisition ICC was 0.915-0.980, and the inter-reader ICC was 0.912-0.987. Ultrasound cost savings in this study were J3217.59 (J42.9 per symptomatic wrist) and the discomfort perceived by the patient was significantly lesser 6.3 vs 56 in EDT (P<.0005). Conclusions: Ultrasound median nerve crosssectional area is reliable and may be used to accurately rule in or rule out CTS. Sonography as a first-line test is cost-effective and is more satisfactory to the patients (AU)

[Validity and usefulness of echography in the carpal tunnel syndrome]. / Validez y utilidad de la ecografía en el síndrome del túnel carpiano.

OBJECTIVE: To evaluate the accuracy and utility of ultrasonography for the diagnosis of carpal tunnel syndrome (CTS). MATERIAL AND METHOD: Prospective and blind study of 75 wrists in 42 consecutive patients with suspected CTS. Electrodiagnostic testing (EDT) was used as gold standard. We measure different ultrasonographic parameters and based on a fitted receiver operating characteristic curve, we estimated post-test probabilities for the proximal, middle and distal cross-sectional area of median nerve. We analyzed interobserver and interreader reliability by 3 different explorers and 2 different readers, cost and the patient discomfort. RESULTS: Mean ultrasound measurements were significantly higher in the EDT positive group. There was a high concordance between sonography and nerve conduction. A cut-off of 9.5 mm(2) resulted in the correct classification of 83% of cases (sensitivity 88% and specificity 67%). Conversely, a cut-off of >14 mm(2) or <7 mm(2) had excellent power to rule in CTS, with a post-test probability of 100% of specificity and sensitivity respectively. The interobserver acquisition ICC was 0.915-0.980, and the inter-reader ICC was 0.912-0.987. Ultrasound cost savings in this study were €J3217.59 (€42.9 per symptomatic wrist) and the discomfort perceived by the patient was significantly lesser 6.3 vs 56 in EDT (P <.0005). CONCLUSIONS: Ultrasound median nerve crosssectional area is reliable and may be used to accurately rule in or rule out CTS. Sonography as a first-line test is cost-effective and is more satisfactory to the patients.