RESUMEN
BACKGROUND: Chronic Urticaria (CU) is a debilitating disease whose treatment is mainly symptomatic. UCREX study aimed to identify CU patients' profile, disease management and quality-of-life (QoL) in daily clinical practice in Spain. METHODS: Observational, 12-months prospective, multicenter study, included de novo or established CU patients attending to dermatology/allergy consultations in 39 Spanish hospitals. MAIN VARIABLES: Urticaria Activity Score (UAS), UAS over 7 days (UAS7). Secondary variables: CU-QoL Questionnaire (CU-Q2oL), EuroQol-5 dimensions (EQ-5D), Medical Outcomes Study Sleep (MOS-Sleep) scale, Hospital Anxiety and Depression Scale (HADS). RESULTS: 361 patients included. Of them, 176 (48.8%) considered for the main objective analysis. Mean age (SD) of 46.6 (14.2) years and 71.8% women. The year prior to inclusion, most patients (57.1%) were treated with non-sedating H1-antihistamines (NS-H1AH). At baseline, mean (SD) 3.6 (6.8) visits were registered to primary care. Mean (SD) UAS7 at baseline was 14.3 (11.0) and CU-Q2oL 24.1 (17.0) which tended to improve by 8.6 (9.7) and 13.9 (15.0), respectively, at 12-months. MOS-Sleep and EQ-5D remained steady during the study, except pain/discomfort and anxiety/depression which went from 58.7% and 49.6% to 29.6% and 26.9%, respectively. At baseline, HADS showed a mean (SD) anxiety of 8.7 (4.5) and depression 5.1 (4.4), decreasing to 7.0 (4.3) and 4.7 (4.3), respectively, at 12-months. CONCLUSIONS: Although most CU patients are treated with NS-H1AH, disease activity is still important, negatively affecting patients' QoL, work activity and healthcare resources use. An appropriate disease management could be the basis for symptoms control, QoL improvement and resources optimization.
RESUMEN
BACKGROUND: Chronic Urticaria (CU) is a debilitating disease whose treatment is mainly symptomatic. UCREX study aimed to identify CU patients' profile, disease management and quality-of-life (QoL) in daily clinical practice in Spain. METHODS: Observational, 12-months prospective, multicenter study, included de novo or established CU patients attending to dermatology/allergy consultations in 39 Spanish hospitals. MAIN VARIABLES: Urticaria Activity Score (UAS), UAS over 7 days (UAS7). Secondary variables: CU-QoL Questionnaire (CU-Q2oL), EuroQol-5 dimensions (EQ-5D), Medical Outcomes Study Sleep (MOS-Sleep) scale, Hospital Anxiety and Depression Scale (HADS). RESULTS: 361 patients included. Of them, 176 (48.8%) considered for the main objective analysis. Mean age (SD) of 46.6 (14.2) years and 71.8% women. The year prior to inclusion, most patients (57.1%) were treated with non-sedating H1-antihistamines (NS-H1AH). At baseline, mean (SD) 3.6 (6.8) visits were registered to primary care. Mean (SD) UAS7 at baseline was 14.3 (11.0) and CU-Q2oL 24.1 (17.0) which tended to improve by 8.6 (9.7) and 13.9 (15.0), respectively, at 12-months. MOS-Sleep and EQ-5D remained steady during the study, except pain/discomfort and anxiety/depression which went from 58.7% and 49.6% to 29.6% and 26.9%, respectively. At baseline, HADS showed a mean (SD) anxiety of 8.7 (4.5) and depression 5.1 (4.4), decreasing to 7.0 (4.3) and 4.7 (4.3), respectively, at 12-months. CONCLUSIONS: Although most CU patients are treated with NS-H1AH, disease activity is still important, negatively affecting patients' QoL, work activity and healthcare resources use. An appropriate disease management could be the basis for symptoms control, QoL improvement and resources optimization.
RESUMEN
Chronic spontaneous urticaria (CSU) is a heterogeneous condition that can severely impact quality of life. Consequently, rapid disease control is essential. First-line treatment of the symptoms of CSU is the licensed dose of second-generation H1 antihistamines. For second-line treatment, this dose may be increased by up to 4 times. In patients who fail to respond to higher doses of H1 antihistamines, omalizumab for up to 24 weeks is recommended to achieve disease control. After this 24-week period, the patient's response to omalizumab should be assessed in order to identify refractory patients. Optimal management of refractory patients has not been established. Therefore, the aim of the present consensus document, which was drafted by allergists and dermatologists with specific expertise in treating urticaria, was to define specific patient profiles based on differences in their response to omalizumab. We also developed a treatment algorithm based on the specific response profile. After a comprehensive literature review, a group meeting was held to discuss issues related to the therapeutic management of patients with CSU that had not been addressed in previous studies. The experts considered both the available evidence and their own clinical experience with omalizumab. We believe that implementation of the proposed algorithm will optimize management of CSU patients who are refractory to antihistamines, reduce disease-related costs, and improve quality of life.
Asunto(s)
Antialérgicos/uso terapéutico , Urticaria Crónica/tratamiento farmacológico , Omalizumab/uso terapéutico , Antialérgicos/administración & dosificación , Antialérgicos/efectos adversos , Urticaria Crónica/diagnóstico , Urticaria Crónica/etiología , Ensayos Clínicos como Asunto , Manejo de la Enfermedad , Humanos , Omalizumab/administración & dosificación , Omalizumab/efectos adversos , Calidad de Vida , Resultado del TratamientoRESUMEN
Background: Chronic Urticaria (CU) is a debilitating disease whose treatment is mainly symptomatic. UCREX study aimed to identify CU patients profile, disease management and quality-of-life (QoL) in daily clinical practice in Spain. Methods: Observational, 12-months prospective, multicenter study, included de novo or established CU patients attending to dermatology/allergy consultations in 39 Spanish hospitals. Main variables: Urticaria Activity Score (UAS), UAS over 7 days (UAS7). Secondary variables: CU-QoL Questionnaire (CU-Q2oL), EuroQol-5 dimensions (EQ-5D), Medical Outcomes Study Sleep (MOS-Sleep) scale, Hospital Anxiety and Depression Scale (HADS). Results: 361 patients included. Of them, 176 (48.8%) considered for the main objective analysis. Mean age (SD) of 46.6 (14.2) years and 71.8% women. The year prior to inclusion, most patients (57.1%) were treated with non-sedating H1-antihistamines (NS-H1AH). At baseline, mean (SD) 3.6 (6.8) visits were registered to primary care. Mean (SD) UAS7 at baseline was 14.3 (11.0) and CU-Q2oL 24.1 (17.0) which tended to improve by 8.6 (9.7) and 13.9 (15.0), respectively, at 12-months. MOS-Sleep and EQ-5D remained steady during the study, except pain/discomfort and anxiety/depression which went from 58.7% and 49.6% to 29.6% and 26.9%, respectively. At baseline, HADS showed a mean (SD) anxiety of 8.7 (4.5) and depression 5.1 (4.4), decreasing to 7.0 (4.3) and 4.7 (4.3), respectively, at 12-months. Conclusions: Although most CU patients are treated with NS-H1AH, disease activity is still important, negatively affecting patients QoL, work activity and healthcare resources use. An appropriate disease management could be the basis for symptoms control, QoL improvement and resources optimization
Antecedentes: La urticaria crónica (UC) es una enfermedad debilitante cuyo tratamiento es principalmente sintomático. El estudio UCREX tuvo como objetivo identificar el perfil de los pacientes con UC, el manejo de la enfermedad y la calidad de vida (CdV) en la práctica clínica diaria en España. Métodos: Estudio observacional, prospectivo, multicéntrico de 12 meses, que incluyó pacientes con UC de novo o establecida que acudieron a la consulta de dermatología/alergología de 39 hospitales españoles. Las variables principales fueron: el Urticaria Activity Score (UAS) y el UAS por siete días (UAS7). Las variables secundarias fueron: el cuestionario de CdV de urticaria crónica (CU-Q2oL), el EuroQol-5 Dimensiones (EQ-5D), la escala Medical Outcomes Study Sleep (MOS-Sleep) y la escala hospitalaria de ansiedad y depresión (HADS). Resultados: Se incluyeron 361 pacientes, de los cuales 176 (48,8%) formaron parte del análisis del objetivo principal. La edad media (DE) fue de 46,6 (14,2) años y el 71,8% eran del sexo femenino. El año anterior al periodo de inclusión de los pacientes, la mayoría de ellos (57,1%) se habían tratado con antihistamínicos H1 no sedantes (AHNS-H1). En la basal, se registró una media (DE) de 3,6 (6,8) de visitas a atención primaria. La media (DE) del UAS7 en la basal fue de 14,3 (11,0) y del CU-Q2oL 24,1 (17,0), observándose una tendencia en la mejoría en 8,6 (9,7) y 13,9 (15,0), respectivamente, a los 12 meses. El MOS-Sleep y el EQ-5D se mantuvieron estables durante el estudio, excepto por el dolor/malestar y la ansiedad/depresión que pasaron de 58,7 y 49,6% a 29,6 y 26,9%, respectivamente. En situación basal, el HADS mostró una ansiedad media (DE) de 8,7 (4,5) y una depresión de 5,1 (4,4), disminuyendo respectivamente a 7,0 (4,3) y 4,7 (4,3) a los 12 meses. Conclusiones: Aunque la mayoría de los pacientes son tratados con AHNS-H1, la actividad de la enfermedad sigue siendo importante, afectando negativamente a su CdV (AU)
Asunto(s)
Humanos , Masculino , Femenino , Adulto , Persona de Mediana Edad , Pautas de la Práctica en Medicina , Urticaria/terapia , Calidad de Vida , Factores Socioeconómicos , Estudios Prospectivos , Enfermedad Crónica , EspañaRESUMEN
Antecedentes: La urticaria crónica (UC) es una enfermedad debilitante cuyo tratamiento es principalmente sintomático. El estudio UCREX tuvo como objetivo identificar el perfil de los pacientes con UC, el manejo de la enfermedad y la calidad de vida (CdV) en la práctica clínica diaria en España. Métodos: Estudio observacional, prospectivo, multicéntrico de 12 meses, que incluyó pacientes con UC de novo o establecida que acudieron a la consulta de dermatología/alergología de 39 hospitales españoles. Las variables principales fueron: el Urticaria Activity Score (UAS) y el UAS por siete días (UAS7). Las variables secundarias fueron: el cuestionario de CdV de urticaria crónica (CU-Q2oL), el EuroQol-5 Dimensiones (EQ-5D), la escala Medical Outcomes Study Sleep (MOS-Sleep) y la escala hospitalaria de ansiedad y depresión (HADS). Resultados: Se incluyeron 361 pacientes, de los cuales 176 (48,8%) formaron parte del análisis del objetivo principal. La edad media (DE) fue de 46,6 (14,2) años y el 71,8% eran del sexo femenino. El año anterior al periodo de inclusión de los pacientes, la mayoría de ellos (57,1%) se habían tratado con antihistamínicos H1 no sedantes (AHNS-H1). En la basal, se registró una media (DE) de 3,6 (6,8) de visitas a atención primaria. La media (DE) del UAS7 en la basal fue de 14,3 (11,0) y del CU-Q2oL 24,1 (17,0), observándose una tendencia en la mejoría en 8,6 (9,7) y 13,9 (15,0), respectivamente, a los 12 meses. El MOS-Sleep y el EQ-5D se mantuvieron estables durante el estudio, excepto por el dolor/malestar y la ansiedad/depresión que pasaron de 58,7 y 49,6% a 29,6 y 26,9%, respectivamente. En situación basal, el HADS mostró una ansiedad media (DE) de 8,7 (4,5) y una depresión de 5,1 (4,4), disminuyendo respectivamente a 7,0 (4,3) y 4,7 (4,3) a los 12 meses. Conclusiones: Aunque la mayoría de los pacientes son tratados con AHNS-H1 (AU)
Background: Chronic Urticaria (CU) is a debilitating disease whose treatment is mainly symptomatic. UCREX study aimed to identify CU patients profile, disease management and quality-of-life (QoL) in daily clinical practice in Spain. Methods: Observational, 12-months prospective, multicenter study, included de novo or established CU patients attending to dermatology/allergy consultations in 39 Spanish hospitals. Main variables: Urticaria Activity Score (UAS), UAS over 7 days (UAS7). Secondary variables: CU-QoL Questionnaire (CU-Q2oL), EuroQol-5 dimensions (EQ-5D), Medical Outcomes Study Sleep (MOS-Sleep) scale, Hospital Anxiety and Depression Scale (HADS). Results: 361 patients included. Of them, 176 (48.8%) considered for the main objective analysis. Mean age (SD) of 46.6 (14.2) years and 71.8% women. The year prior to inclusion, most patients (57.1%) were treated with non-sedating H1-antihistamines (NS-H1AH). At baseline, mean (SD) 3.6 (6.8) visits were registered to primary care. Mean (SD) UAS7 at baseline was 14.3 (11.0) and CU-Q2oL 24.1 (17.0) which tended to improve by 8.6 (9.7) and 13.9 (15.0), respectively, at 12-months. MOS-Sleep and EQ-5D remained steady during the study, except pain/discomfort and anxiety/depression which went from 58.7% and 49.6% to 29.6% and 26.9%, respectively. At baseline, HADS showed a mean (SD) anxiety of 8.7 (4.5) and depression 5.1 (4.4), decreasing to 7.0 (4.3) and 4.7 (4.3), respectively, at 12-months. Conclusions: Although most CU patients are treated with NS-H1AH, disease activity is still important, negatively affecting patients QoL, work activity and healthcare resources use. An appropriate disease management could be the basis for symptoms control, QoL improvement and resources optimization
Asunto(s)
Humanos , Masculino , Femenino , Adulto , Persona de Mediana Edad , Pautas de la Práctica en Medicina , Urticaria/terapia , Calidad de Vida , Factores Socioeconómicos , Estudios Prospectivos , Enfermedad Crónica , EspañaRESUMEN
Chronic spontaneous urticaria (CSU) is a heterogeneous condition that can severely impact quality of life. Consequently, rapid disease control is essential. First-line treatment of the symptoms of CSU is the licensed dose of second-generation H1 antihistamines. For second-line treatment, this dose may be increased by up to 4 times. In patients who fail to respond to higher doses of H1 antihistamines, omalizumab for up to 24 weeks is recommended to achieve disease control. After this 24-week period, the patient's response to omalizumab should be assessed in order to identify refractory patients. Optimal management of refractory patients has not been established. Therefore, the aim of the present consensus document, which was drafted by allergists and dermatologists with specific expertise in treating urticaria, was to define specific patient profiles based on differences in their response to omalizumab. We also developed a treatment algorithm based on the specific response profile. After a comprehensive literature review, a group meeting was held to discuss issues related to the therapeutic management of patients with CSU that had not been addressed in previous studies. The experts considered both the available evidence and their own clinical experience with omalizumab. We believe that implementation of the proposed algorithm will optimize management of CSU patients who are refractory to antihistamines, reduce disease-related costs, and improve quality of life
La urticaria crónica espontánea (UCE) es una afección heterogénea que puede afectar gravemente la calidad de vida, por lo que el control rápido de la enfermedad es esencial. El tratamiento sintomático de primera línea de CSU es la dosis autorizada de antihistamínicos H1 de segunda generación. Para el tratamiento de segunda línea, esta dosis se puede aumentar hasta cuatro veces. En pacientes que no responden a estas dosis más altas de antihistamínicos H1, se recomienda el tratamiento con omalizumab (hasta 24 semanas) para lograr el control de la enfermedad. Después de este período de 24 semanas, se debe definir el perfil de respuesta del paciente a omalizumab para identificar a los pacientes refractarios. El enfoque de manejo óptimo para pacientes refractarios no ha sido establecido. En este contexto, el objetivo del presente estudio de consenso de expertos que involucró a un grupo de especialistas (alergólogos y dermatólogos) con experiencia específica en el tratamiento de la urticaria fue definir perfiles de pacientes específicos en función de sus diferentes respuestas a omalizumab. Otro objetivo fue desarrollar un algoritmo de tratamiento basado en el perfil de respuesta específico. Primero, se realizó una revisión exhaustiva de la literatura. Luego, se llevó a cabo una reunión grupal para discutir todos los temas relacionados con el manejo terapéutico de estos pacientes que no se habían abordado en ningún estudio previo. En todos los casos, los expertos consideraron tanto la evidencia disponible como su propia experiencia clínica con omalizumab. Creemos que la implementación de este algoritmo propuesto ayudará a optimizar la gestión de los pacientes con CSU que son refractarios al tratamiento con antihistamínicos, reduciendo los costos relacionados con la enfermedad y mejorando la calidad de vida de los pacientes